GENDERED INNOVATIONS 2: How Inclusive Analysis Contributes to Research and Innovation Policy Review i Gendered Innovations 2: How inclusive analysis contributes to research and innovation European Commission Directorate-General for Research and Innovation Directorate E — PEOPLE Unit E.5 — Democracy and European Values Contact Mina Stareva, Head of Sector E5.001 - Gender Anne Pepin, Unit E5.001 Email RTD-GENDERINRE5EARCH@ec.europa.eu M ina.Stareva@ec.europa.eu Anne.Pepin@ec.europa.eu RTD-PUBLICATION5@ec.europa.eu European Commission B-1049 Brussels Manuscript completed in July 2020. This document has been prepared for the European Commission however it reflects the views only of the authors, and the European Commission is not liable for any consequence stemming from the reuse of this publication. More information on the European Union is available on the internet (http://europa.eu) Print ISBN 978-92-76-16417-3 doi:10.2777/53572 KI-03-20-108-EN-C PDF ISBN 978-92-76-16416-6 doi:10.2777/316197 KI-03-20-108-EN-N Luxembourg: Publications Office of the European Union, 2020 © European Union, 2020 The reuse policy of European Commission documents is implemented based on Commission Decision 2011/833/EU of 12 December 2011 on the reuse of Commission documents (OJ L 330, 14.12.2011, p. 39). Except otherwise noted, the reuse of this document is authorised under a Creative Commons Attribution 4.0 International (CC-BY 4.0) licence (https://creativecommons.Org/licenses/by/4.0/). This means that reuse is allowed provided appropriate credit is given and any changes are indicated. For any use or reproduction of elements that are not owned by the European Union, permission may need to be sought directly from the respective rightholders. EUROPEAN COMMISSION Gendered Innovations 2: How Inclusive Analysis Contributes to Research and Innovation H2020 Expert Group to update and expand "Gendered Innovations/ Innovation through Gender" Chairperson: Londa Schiebinger Rapporteur: Ineke Klinge 2020 Directorate-General for Research and Innovation PEOPLE Directorate, Gender Sector 3 TABLE OF CONTENTS FOREWORD........................................................................................................5 Executive Summary.......................................................................................7 1. List of Case Studies.........................................................................................................10 2. Terms.......................................................................................................................................11 Sex....................................................................................................................11 Gender..............................................................................................................14 Intersectionality...........................................................................................17 3. List of methods..................................................................................................................18 4. Abstracts of the 15 case studies.............................................................................20 Health......................................................................................................................................20 Climate change, energy and agriculture..................................................................23 Urban planning, transport..............................................................................................26 Information and communication technology (artificial intelligence, machine learning, robotics)...........................................................................................29 Finance, taxation and economics................................................................................32 Ad hoc case study: Coronavirus...................................................................................34 5. Policy recommendations for Horizon Europe....................................................36 6. Members of the expert group....................................................................................52 ANNEXES.........................................................................................................55 Annex A - Fifteen full case studies...............................................................................56 Health......................................................................................................................................56 Climate change, energy and agriculture..................................................................82 Urban planning, transport...........................................................................................114 Information and communication technology (artificial intelligence, machine learning, robotics)........................................................................................136 Finance, taxation and economics.............................................................................157 Ad hoc case study: Coronavirus................................................................................170 Annex B - Detailed methods.........................................................................................179 General methods.............................................................................................................179 Analysing sex...........................................................................................................................179 Analysing gender...................................................................................................................181 Intersectional approaches................................................................................................184 Co-creation and participatory research....................................................................189 Asking about gender and sex in surveys.................................................................192 Field-specific methods..................................................................................................195 Health and biomedicine................................................................................................195 Analysing gender in health and biomedicine........................................................195 Analysing sex in tissues and cells................................................................................202 Analysing sex in lab animal research........................................................................206 Analysing sex in biomedicine.........................................................................................215 Information and communication technologies..................................................220 Analysing gender and intersectionality in machine learning........................220 Analysing gender and intersectionality in social robotics..............................224 Climate change.................................................................................................................228 Analysing sex in hermaphroditic species.................................................................228 Urban planning/transportation..................................................................................232 Gender impact assessment.............................................................................................232 Innovation...........................................................................................................................236 Norm-critical innovation....................................................................................................236 FOREWORD The COVID-19 outbreak in 2020 has caused a major disruption in our global system. In many ways, the pandemic and the political measures taken to contain the spread of the virus have revealed gender inequalities and the importance of investigating sex and gender differences. While worldwide statistics suggest similar infection rates for men and women, a significantly higher proportion of men than women succumb to the disease across groups of similar age, and an increasing body of research is putting forward biological differences between the sexes, in particular relating to immune responses. At the same time, women are more exposed to the virus due to their disproportionate representation among healthcare workers. They are also being more severely affected than men by the economic and social consequences of the pandemic, due to their overwhelming role as care and education providers within households and their larger proportion among non-salaried, self-employed, part-time and precarious employees. Furthermore, they have fallen victim to a surge in gender-based and domestic violence, observed across the EU and worldwide. This report includes a recent case study on the impact of sex and gender in the COVID-19 pandemic, detailing findings that can inform a post-pandemic recovery strategy that is truly inclusive and leaves no one behind. Taking into account the gender dimension - that is, ensuring that the biological characteristics as well as the social and cultural features, behaviours and needs of both women and men are taken into consideration - is vital for the societal relevance and quality of research and innovation (R & I). Integrating sex and gender-based analysis into R & I, and adopting an inclusive approach which also considers intersecting social categories such as ethnicity, age or disability, is a matter of producing excellent research to the benefit of all European citizens. This policy report provides methodological tools and concrete case studies to researchers and innovators, showcasing projects funded under Horizon 2020 and illustrating a successful gender integration into key R & I areas, including health, artificial intelligence and robotics, energy, transport, marine science and climate change, urban planning, agriculture, fair taxation and venture funding. The report also offers specific policy recommendations for effective implementation in Horizon Europe, highlighting the strategic objectives set out for the different Clusters, Missions and partnerships. As the EU Commissioner for Innovation, Research, Culture, Education and Youth, and holding gender equality matters very close to my heart, I am determined to step up our efforts to make sure that the integration of the gender dimension into R & I content is a cornerstone of Horizon Europe, and that it is fully acknowledged in the European Research Area (ERA). It is indeed crucial that EU Member States make sure that their national R & I programmes also take account of this dimension. In this way, together, we can take great strides towards a new, inclusive, and transformative ERA. This report proves that effective action can be taken and embedded in R & l-funding programmes. I highly commend it and wish for it to be widely used and disseminated. Mariya GABRIEL Commissioner for Innovation, Research, Culture, Education and Youth EXECUTIVE SUMMARY The European Commission has become a global leader in setting policy for the integration of the gender dimension into research, as well as the implementation of these policies. Under the Horizon 2020 framework programme, applicants were asked to integrate, where relevant, sex and gender analysis into research content. Call topics for which this integration was considered mandatory were gender-flagged for easy identification. Despite these efforts, there is still room for improvement, not only in Europe, but worldwide, as findings from the She Figures 2018 report show1. The interim evaluation of Horizon 2020 found that fewer funded research proposals than expected incorporated sex and gender analysis; it correlated this to the lack of knowledge about how to effectively consider a gender perspective and conduct gender and sex analysis, in addition to the 'absence of training on gender issues'2. To address this, the European Commission convened an expert group to support the integration of the gender dimension into EU research and innovation under the next framework programme, Horizon Europe. In 2011 the European Commission created the Gendered Innovations / Innovation through Gender Expert Group, which produced the report entitled Gendered Innovations: How gender analysis contributes to research, published by the Commission in 20133. This new expert group updated and expanded the work. Integrating sex and gender analysis into research and innovation (R & I) adds value to research and is therefore crucial to secure Europe's leadership in science and technology, and to support its inclusive growth. The strengthening of the integration of the gender dimension into R & I is one of the gender equality priorities set for Horizon Europe. The gender dimension cuts across all aspects of Horizon Europe and contributes to numerous steps in the R & I cycle, ranging from disclosing the sex of cells in experiments to considering the needs of women, men and gender-diverse individuals as end-users of technological innovations. 1 Directorate-General for Research and Innovation (2019), She Figures 2018, European Commission (https://ec.europa.eu/info/pubHcations/she-fiqures-2018_en). 2 Directorate-General for Research and Innovation (2017), Interim Evaluation: Gender equality as a crosscutting issue in Horizon 2020, European Commission (https://ec.europa.eu/research/swafs/ pdf/pub_qender_equalitv/interim_evaluation_qender_lonq_final.pdf), p. 26. 3 Directorate-General for Research and Innovation (2013), Gendered Innovations: How gender analysis contributes to research, European Commission (https://op.europa.eu/en/publication-detail/-/publication/dl5a85d6-cd2d-4fbc-b998-42e55a75a449/lanquaqe-en/format-PDF/ source-159651854). Integrating sex and/or gender analysis into research and innovation: ► adds value to research in terms of excellence, creativity and business opportunities; ► helps researchers and innovators question gender norms and stereotypes, and rethink standards and reference models; ► leads to an in-depth understanding of diverse gender needs, behaviours and attitudes; ► addresses the diverse needs of citizens of the European Union and thereby enhances the societal relevance of the knowledge, technologies and innovations produced; ► contributes to the production of goods and services better suited to new markets. This policy report presents the output of the work carried out by the Gendered Innovations 2 Expert Group. The case studies, terms, methods and policy recommendations presented here address the global challenges, targeted impacts and key R & I orientations of the six clusters of Horizon Europe's Pillar II, as well as mission areas and foreseen European partnerships. These materials also provide guidance for future Horizon Europe work programmes and, in so doing, seek to contribute to the achievement of the United Nations Sustainable Development Goals. Case studies presented here are interdisciplinary by nature and often fall under several Horizon Europe cluster areas, thus illustrating the broad applicability of sex and gender analysis. The 15 case studies provide concrete examples of how sex and/or gender analysis can lead to new insights, discovery and innovation - and, in a number of cases, how taking into account other social categories intersecting with sex and gender such as ethnicity or age can do so4 These case studies cover the health sciences, focusing on how sex and gender analysis contribute to prescription drug development, understanding and treating chronic pain, and improving systems biology. A new, state-of-the-art case study on analysing sex in marine science is presented, demonstrating how understanding sex-based responses to climate change allows better modelling of demographic change among marine organisms and downstream effects on humans. To support a green, sustainable Europe and planet, case studies have been developed in smart mobility and energy solutions, waste management, quality urban spaces and aquaculture. In information and communications technology, three case studies focus on facial recognition, extended virtual reality, and virtual assistants and chatbots. Several new methods are designed to help computer scientists, roboticists, and artificial intelligence researchers and innovators embed gender and intersectional analysis in their technical research. The report 4 For a background paper, see Tannenbaum, C, Ellis, R. P., Eyssel, R, Zou, J. and Schiebinger, L. (2019), 'Sex and gender analysis improves science and engineering', Nature, 575(7781), 137-146 (https://www.nature.com/articles/s41586-019-1657-6.pdf). 9 also addresses the areas of taxation and economics in case studies on gender-fair taxation and gender equality in venture funding. Finally, a cutting-edge case study on the impact of sex and gender in the coronavirus disease 2019 (COVID-19) pandemic is included. This case study highlights important findings of gender and sex differences in the effects of COVID-19 on men and women due to biological factors, as well as behavioural differences. Such sex- and gender-sensitive findings build an important foundation for the development of appropriate medical treatments as well as policies to combat the spreading of the virus and its adverse socioeconomic consequences. The expert group to update and expand Gendered Innovations / Innovations through Gender was led by: Professor Londa Schiebinger (chairperson) Stanford University, United States Professor (emerita) Ineke Klinge (rapporteur) Maastricht University, Netherlands The full membership of the group is presented in Chapter 6 of this report. 10 1. LIST OF CASE STUDIES Health ► Prescription drugs: analysing sex and gender ► Systems biology: collecting sex- and gender-specific data ► Chronic pain: analysing how sex and gender interact Climate change, energy and agriculture ► Marine science: analysing sex ► Smart energy solutions: analysing intersectionality ► Agriculture: embedding gender norms in innovation processes Urban planning, transport ► Smart mobility: co-creation and participatory research ► Waste management: co-creation and participatory design ► High-quality urban spaces: gender impact assessment Information and communication technology (artificial intelligence, machine learning, robotics) ► Extended virtual reality: analysing gender ► Facial recognition: analysing gender and intersectionality in machine learning ► Virtual assistants and chatbots: analysing gender and intersectionality in social robots Finance, taxation and economics ► Fair tax: gender equality and taxation in the European Union ► Venture funding: analysing gender Ad hoc case study: coronavirus ► The impact of sex and gender in the COVID-19 pandemic 11 2. TERMS >> SEX refers to biological characteristics 'Sex' refers to biology. In humans, 'sex' refers to the biological attributes that distinguish male, female and intersex. In non-human animals, 'sex' refers to biological attributes that distinguish male, female and hermaphrodite. In engineering and product design research, sex includes anatomical and physiological characteristics that may affect the design of products, systems and processes. Defining sex for biomedical research: humans and lab animals Sex relates to the biological attributes that distinguish male, female and intersex according to functions that derive from the chromosomal complement, reproductive organs, or specific hormones or environmental factors that affect the expression of phenotypic traits in sexually reproducing organisms. These attributes may or may not be aligned in any individual (Faus-to-Sterling, 2012; Ainsworth, 2015). Sex may be defined according to the following. 1. Genetic sex determination: chromosomal make-up, generally XX/ XY for most mammals. The presence of sex-determining genes means that every nucleated human cell has a sex. 2. Gametes: germ cells. In species that produce two morphologically distinct types of gametes, the egg-sperm distinction is the basis for distinguishing between females and males. 3. Morphology: physical traits that differentiate female and male phenotypes. a. Primary sex characteristics in humans and other mammals include the following. i. Internal reproductive organs and genitalia derive from bipotential organs (e.g. indifferent gonads that become ovaries or testes) and dual structures. Usually one structure is maintained and the other regressed. ii. External genitalia generally differentiate towards one of two basic forms: distal vagina, labia and clitoris in females, and scrotum and penis in males. Nevertheless, external genitalia may not reflect karyotypical or internal genital sex (Fausto-Sterling, 2000). b. Secondary sex characteristics in humans and many other animals are phenotypic traits strongly associated with females or males that become prominent at puberty under the influence of endogenous oestrogens in females and androgens in males. Examples of secondary sex characteristics in humans include shorter stature and wider pelvis, breast development, and more fat in the thighs and buttocks in females, and broader shoulders, greater muscle mass, more facial and other body hair, and male pattern baldness in males. These traits vary within each sex, and ranges overlap. For instance, many women are taller than many men and some women are stronger than many men. 12 Intersex conditions may be defined as variations or combinations of what are considered XY male-typical and XX female-typical chromosomal, gonadal and genital characteristics. In some cases, intersex individuals (ranging from 1:100 to 1:4 500 depending on the criteria used) have genitalia or other traits not easily categorised as male or female (Kessler, 1998; Karkazis, 2008; Arboleda et al, 2014; Jones, 2018). Defining sex for research in non-human animals Sex relates to biological attributes that distinguish male, female and hermaphrodite. Sex may be defined according to the following. 1. Genetic sex determination: chromosomal make-up (female/male), such as XX/XY (mammals), ZW/ZZ (birds and some insects) and XX/XO (insects). Regardless of karyotype, the presence of sex-determining genes means that every nucleated cell has a sex. 2. Non-genetic sex determination: common in many species (Gilbert, 2010). These are diverse and include the following. a. Social sex determination. For a number of fish, mollusc and other species, sex is determined through social interactions with other members of a population. In the slipper limpet Crepidulafornicata, all young individuals are male but some later change to female, depending on their position in a mound of snails. b. Environmental sex determination. In the echiuran worm Bonellia viridis, sex is determined by physical environment. Larvae that land on the ocean floor develop as females (-10 cm long), whereas larvae that are engulfed by a mature female through her proboscis develop as males (~2 mm long) and live symbiotically. In all crocodilians, most turtles and some other reptiles, sex determination is determined partially or entirely by temperature. In certain species, sex is genetically determined within a temperature range but environmentally determined outside that range. 3. Gametes: germ cells. In species that produce two morphologically distinct types of gametes, the egg-sperm distinction is the basis for distinguishing between females and males. In some species (called sequential hermaphrodites), the type of germ cell produced by an individual can change at different stages of life. Hermaphrodite describes an individual that is able to produce both male and female gametes during its lifetime. Hermaphroditism is very common in nature, occurring in approximately 30 % of animal species (excluding insects) and most plants (Jarne and Auld, 2006). Hermaphrodites are classified as either simultaneous (individuals functioning as both male and female at the same time) or sequential (individuals first functioning as one sex and then changing to the other at some point). The factors determining the timing, direction and frequency of sex change are diverse throughout nature, and dependent on the species and an individual's social-ecological context (Munday et al, 2006; see case study 'Marine science'). Defining sex for engineering and design In engineering and product design research, sex includes anatomical and physiological characteristics that may affect the design of products, systems and processes (see Schiebinger et al, 2011-2020). Many devices and machines have been designed to fit male bodies. For example, military and commercial cockpits were traditionally based on male anthropometry, which made it difficult or even dangerous for some women (or small men) to be pilots (Weber, 1997). Crash test dummies are also based on male bodies; while small dummies are now 13 used to represent women, they do not model bodily differences, such as neck strength (Linder and Svedberg, 2019). Office building thermostats, which are based on male metabolic rates, may set temperatures too low for many women (van Hoof, 2015). Workplace safety gear (e.g. police vests) often does not fit women or small men. It is also important to understand differences within groups of women, men and gender-diverse people. Many period-tracking apps fail users who have irregular cycles (Tiffany, 2018). Works cited Ainsworth, C. (2015), 'Sex redefined', Nature, 518(7539), 288-291. Arboleda, V. A., Sandberg, D. E. and Vilain, E. (2014), 'DSDs: genetics, underlying pathologies and psychosexual differentiation', Nature Reviews Endocrinology, 10, 603-615. Fausto-Sterling, A. (2000), Sexing the Body: Gender politics and the construction of sexuality, Basic Books, New York. Fausto-Sterling, A. (2012), Sex/Gender: Biology in a social world, Routledge, New York. Gilbert, S. (2010), Developmental Biology, 9th Edition, Sinauer Associates, Sunderland. Jarne, P. and Auld, J. R. (2006), 'Animals mix it up too: the distribution of self-fertilization among hermaphroditic animals', Evolution, 60,1816-1824. Jones, T. (2018), 'Intersex studies: a systematic review of international health literature', Sage Open, 8(2), 2158244017745577. Karkazis, K. (2008), Fixing Sex: Intersex, medical authority, and lived experience, Duke University Press, Durham, NC. Kessler, S. (1998), Lessons from the Intersexed, Rutgers University Press, New Brunswick, NJ. Linder, A. and Svedberg, W. (2019), 'Review of average sized male and female occupant models in European regulatory assessment tests and European laws: gaps and bridging suggestions', Accident Analysis & Prevention, 127,156-162. Munday, P. L, Buston, P. M. and Warner, R. R. (2006), 'Diversity and flexibility of sex-change strategies in animals', Trends in Ecology & Evolution, 21(2), 89-95. Schiebinger, L, Klinge, I., Sanchez de Madariaga, I., Paik, H. Y, Schraudner, M. and Stefanick, M. (eds.) (2011-2020), 'Design thinking', Gendered Innovations in Science, Health & Medicine, Engineering, and Environment (http://qenderindesiqn.com/). Tiffany, K. (2018), 'Period-tracking apps are not for women', Vox, 16 November. van Hoof, J. (2015), 'Female thermal demand', Nature Climate Change, 5,1029-1030. Weber, R. N. (1997), 'Manufacturing gender in commercial and military cockpit design', Science, Technology, & Human Values, 22(2), 235-253. Gender >> GENDER refers to sociocultural attitudes, behaviours and identities 'Gender' refers to sociocultural norms, identities and relations that (1) structure societies and organisations and (2) shape behaviours, products, technologies, environments, and knowledges (Schiebinger, 1999; Ridgeway and Correll, 2004). Gender attitudes and behaviours are complex and change in time and place. Importantly, gender is multidimensional (Hyde et al, 2018) and intersects with other social categories, such as sex, age, socioeconomic status, sexual orientation and ethnicity (see 'Intersec-tional approaches' in Annex B). Gender is distinct from sex (Fausto-Sterling, 2012). Three related dimensions of gender As social beings, humans function through [earned behaviours. How we speak, our mannerisms, the things we use and our behaviours all signal who we are and establish rules for interaction. Gender is one such set of organising principles that structure behaviours, attitudes, physical appearance and habits. 1. Gender norms are produced through social institutions (such as families, schools, workplaces, laboratories, universities or boardrooms), social interactions (such as between romantic partners, colleagues or family members) and wider cultural products (such as textbooks, literature, films and video games). • Gender norms refer to social and cultural attitudes and expectations about which behaviours, preferences, products, professions or knowledges are appropriate for women, men and gender-diverse individuals, and may Gender Identity Gender Relations >> Problems to avoid when analysing gender Problems can arise if researchers assume that: ► all women as a group, all men as a group and all gender-diverse people as a group (their attitudes, preferences, needs, behaviours and knowledge) are the same; ► women, men and gender-diverse people are completely different; ► observed differences between women and men are solely biological in origin; ► observed gender differences hold across cultures; ► life conditions and opportunities are similar for women, men, and gender-diverse people; ► birth sex can be used as a proxy for gender identity in surveys; ► certain questions are relevant to only one gender (e.g. survey questions about caregiving relate primarily to women or questions about the strain of physical work primarily to men). influence the development of science and technology. • Gender norms draw upon and reinforce gender stereotypes about women, men and gender-diverse individuals. • Gender norms may be reinforced by unequal distribution of resources and discrimination in the workplace, families and other institutions. • Gender norms are constantly in flux. They change by historical era, culture or location, such as the 1950s versus the 2020s, Korea versus Germany or urban versus rural areas. Gender also differs by specific social contexts, such as work versus home. 2. Gender identities relate to how individuals or groups perceive and present themselves in relation to gender norms. Gender identities may be context-specific and interact with other identities, such as ethnicity, class or cultural heritage (see 'Intersectional approaches' in Annex B). 3. Gender relations relate to how we interact with people and institutions in the world around us, based on our sex and our gender identity. Gender relations encompass how gender shapes social interactions in families, schools, workplaces and public settings, for instance the power relation between a man patient and woman physician. • Social divisions of labour are another important aspect of gender relations, whereby women and men are concentrated in different types of (paid or unpaid) activities. One consequence of such gender segregation is that particular occupations or disciplines become marked symbolically with the (presumed) gender category of the larger group: for example, nursing is seen as a female profession, engineering as male. • Women and men who work in highly segregated roles acquire different kinds of knowledge or expertise, which can sometimes be usefully accessed for gendered innovations (see 'Co-creation and participatory research' in Annex B; see also Schiebinger et al, 2011-2020a). • Gender relations can also become embodied in products or urban environments, such as transportation systems (see case study 'Smart mobility'). Sex and gender interact. The term gender' was introduced in the late 1960s to reject biological determinism that interprets behavioural differences as the outcomes of biological disposition. 'Gender' was used to distinguish the sociocultural factors that shape behaviours and attitudes from biological factors related to sex. Gendered behaviours and attitudes are learned; they are neither fixed nor universal. Nonetheless, gendered experiences can affect biology. Moreover, some individuals seek to change aspects of their bodies to align them better with their gender identities. Sex and gender are often useful analytical terms even if in reality sex and gender interact (see Schiebinger et al, 2011-2020b). Legal gender categories. Governments typically require citizens to categorise their gender identity on official documents such as birth certificates, driving licences and passports. Numerous countries recognise a third gender category. These include Argentina, Australia, Bangladesh, Canada, Colombia, Denmark, Germany, India, Malta, Nepal, New Zealand and Pakistan, among others. Works cited Aultman, B. (2014), 'Cisgender', TransgenderStudies Quarterly, 1 (1-2), 61-62. Fausto-Sterling, A. (2012), Sex/Gender: Biology in a social world, Routledge, New York. Hyde, J. 5, Bigler, R. 5, Joel, D, Tate, C. C. and van Anders, 5. M. (2018), 'The future of sex and gender in psychology: five challenges to the gender binary', American Psychologist, 74(2), 171-193. Marshall, Z., Welch, V., Minichiello, A., Swab, M., Brunger, F. and Kaposy, C. (2019), 'Documenting research with transgender, nonbinary, and other gender diverse (trans) individuals and communities: introducing the Global Trans Research Evidence Map', Transgender Health, 4(1), 68-80. Nielsen, M. W., Peragine, D., Neilands, T. B., Stefanick, M. L, loannidis, J. P. A, Pilote, L, Prochaska, J. J, Cullen, M. R, Einstein, G, Klinge, I, LeBlanc, H, Paik, H. Y, Risvedt, 5. and Schiebinger, L. (forthcoming), 'Gender-related variables for health research' (https://doi.org/10.1101/20 20.09.17.20196824). Cisgender and transgender. Transgender' is an umbrella term that describes a range of gender identities, including individuals whose gender identity differs from that typically associated with the sex they were assigned at birth (Marshall et al, 2019; Scandurra et al, 2019). This is in contrast to 'cisgender', which describes individuals whose self-identified gender matches their birth sex assignment (Aultman, 2014). Other individuals refuse the concept of gender as binary altogether and may self-identify as genderqueer, non-binary, gender-fluid or bigender (Hyde et al, 2018). Gender is multidimensional. Gender is often described as existing on a masculinity-femininity spectrum, but such categories can reinforce stereotypes about women and men, and ignore individuals who fall outside traditional gender binaries (Nielsen et al, forthcoming). Gender is multidimensional: any given individual may experience configurations of gender norms, traits and relations that cannot be subsumed under the simple categories 'feminine' and 'masculine'. Ridgeway, C. L. and Correll, S. J. (2004), 'Unpacking the gender system: a theoretical perspective on gender beliefs and social relations', Gender & Society, 18, 510-5. Scandurra, C, Mezza, E, Maldonato, N. M., Bottone, M., Bochicchio, V, Valerio, P. and Vitelli, R. (2019), 'Health of non-binary and genderqueer people: a systematic review', Frontiers in Psychology, 10 (10.5589/fpsyq.2019.01455). Schiebinger, L. (1999), Has Feminism Changed Science?, Harvard University Press, Cambridge, MA. Schiebinger, L, Klinge, I., Sanchez de Madariaga, I., Paik, H. Y, Schraudner, M. and Stefanick, M. (eds.) (2011-2020a), 'Water infrastructure', Gendered Innovations in Science, Health & Medicine, Engineering, and Environment (http://qenderedinnovations.stanford.edu/case-studies/ water.html). Schiebinger, L, Klinge, I., Sanchez de Madariaga, I., Paik, H. Y, Schraudner, M. and Stefanick, M. (eds.) (2011-2020b), 'Analysing how sex and gender interact', Gendered Innovations in Science, Health & Medicine, Engineering, and Environment (http:// qenderedinnovations.stanford.edu/methods/how.html). Intersectionality 'Intersectionality' describes overlapping or intersecting categories such as gender, sex, ethnicity, age, socioeconomic status, sexual orientation and geographical location that combine to inform individuals' identities and experiences. Researchers and engineers should not consider gender in isolation; gender identities, norms and relations both shape and are shaped by other social attributes (Buolamwini and Gebru, 2018). In 1989, the legal scholar Kimberle Crenshaw coined the term 'intersectionality' to describe how multiple forms of discrimination, power and privilege intersect in Black women's lives, in ways that are erased when sexism and racism are treated separately (Crenshaw, 1989). Since then, the term has been expanded to describe intersecting forms of oppression and inequality emerging from structural advantages and disadvantages that shape a person's or a group's experience and social opportunities (Hankivsky 2014; Collins and Bilge, 2016; McKinzie and Richards, 2019; Rice et al, 2019). Works cited Buolamwini, J. and Gebru, T. (2018), 'Gender shades: intersectional accuracy disparities in commercial gender classification', Proceedings of Machine Learning Research, 81, 77-91. Collins, P. H. and Bilge, 5. (2016), Intersectionality, John Wiley & Sons. Crenshaw, K. (1989), 'Demarginalizing the intersection of race and sex: a Black feminist critique of antidiscrimination doctrine, feminist theory and antiracist politics, University of Chicago Legal Forum, 1,139-167. Hankivsky, 0. (2014), Intersectionality 101, Institute for Intersectionality Research & Policy, Simon Fraser University, Vancouver, British Colunbia. McKinzie, A. and Richards, P. (2019), 'An argument for context-driven intersectionality', Sociology Compass, 13, el2671. Rice, C, Harrison, E. and Friedman, M. (2019), 'Doing justice to intersectionality in research', Cultural Studies <-> Critical Methodologies, 19,409-420. 18 3. LIST OF METHODS Sex and gender can influence ail stages of research and innovation, from strategic considerations for establishing priorities and building theory to more routine tasks of formulating questions, designing methods and interpreting data Many pitfalls can be avoided - and new ideas or opportunities identified - by designing sex and gender analysis into research and innovation from the start. Sex and gender analyses work together with other methodologies in a field, and with inter-sectional approaches that take into account intersections with other social factors, such as ethnicity, gender identity and sexual orientation, in order to provide filters for bias and contribute to excellence in science and technology. As with any set of methods, new ones will be fashioned and others discarded as circumstances change. The value of their implementation depends on the creativity of the research and/or innovation team. There is no recipe that can simply be plugged into research or development processes. Researchers and innovators will want to consider all methods and think creatively about how these methods can enhance their research and innovations. The methods listed below have been developed by the Horizon 2020 (H2020) Expert Group to update and expand Gendered Innovations / Innovation through Gender (Gendered Innovations 2). These methods, described in Annex B, are applied in the case studies detailed in Annex A. Case study abstracts are presented in the next chapter. General methods ► Analysing sex ► Analysing gender ► Intersectional approaches ► Co-creation and participatory research ► Asking about gender and sex in surveys Field-specific methods ► Health and biomedicine • Analysing gender in health and biomedicine • Analysing sex in tissues and cells • Analysing sex in lab animal research • Analysing sex in biomedicine ► Information and communication technologies • Analysing gender and intersectionality in machine learning • Analysing gender and intersectionality in social robotics ► Climate change • Analysing sex in hermaphroditic species ► Urban planning/transportation • Gender impact assessment ► Innovation • Norm-critical innovation 19 In addition to these newly developed or updated methods, methods developed previously by the Gendered Innovations 1 Expert Group (Schiebinger et al, 2011-2020) include: rethinking research priorities and outcomes rethinking concepts and theories formulating research guestions analysing how sex and gender interact engineering innovation processes design thinking rethinking standards and reference models Works cited Schiebinger, L, Klinge, I., Sanchez de Madariaga, I., Paik, H. Y., Schraudner, M. and Stefanick, M. (eds.) (2011-2020), 'Methods of sex and gender analysis', Gendered Innovations in Science, Health & Medicine, Engineering, and Environment (http://qenderedinnovations.stanford.edu/methods-sex-and-qender-analvsis.html). rethinking language and visual representations. 4. ABSTRACTS OF THE 15 CASE STUDIES Health PRESCRIPTION DRUGS: ANALYSING SEX AND GENDER The challenge Historically, drug development has followed a 'one size fits all' model. Drug testing has been conducted predominantly on males, from preclinical research in rodents to clinical trials. As a result, women report more unwanted, and sometime deadly, side effects than men. # Method: analysing sex Females and males must be included in all drug trials - from early cell and animal testing to human clinical trials - and analysed separately. Age and genetic ancestry should also be considered, as these characteristics may affect drug efficacy, safety and toxicity. Pregnancy also requires attention, as pregnant women become ill and ill women become pregnant. Information about drug safety effects on the foetus is a priority. # Method: analysing gender Gender stereotypes can affect clinical care in several ways. First, gender and age bias can influence diagnostic questions. Physicians and researchers should pay attention to language and gender norms in diagnostic procedures. Second, gender relations between the healthcare provider and the patient can affect prescribing patterns and treatment outcomes. Age and race can also play a role. Gendered innovations 1. Including females and males in all stages of drug development will help us understand sex differences in efficacy toxicity and safety. This will allow the development of sex-specific dosing, when necessary, or treatments. 2. Disaggregating reporting of side effects by sex represents an essential step to increase our understanding of how medications work differently in women and men in real-world settings. 3. Reporting sex differences on drug labels helps prescribers and patients administer the right drug in the right dose to the right person at the right time. 4. Promoting gender-transformative treatment approaches eliminates gender bias and stereotypes in diagnostic questions, allowing better detection of symptoms in women, men and gender-diverse people. 21 SYSTEMS BIOLOGY: COLLECTING SEX- AND GENDER-SPECIFIC DATA The challenge Sex and gender roles can affect the human metabolism. Consequently, prevention and treatment of many non-communicable diseases require a sex- and gender-related approach. Systems biology aims to predict individual disease risk and enable precision treatment by mathematically modelling metabolic processes. Such models are based largely on omics data (i.e. genomics, transcriptomics, proteomics, metabolomics). Sex bias in the collection of these datasets, however, leads to sex bias in the mathematical models and their predictions. # Method: collecting sex- and gender-specific data The amount, quality and precision of data have an essential influence on research output. The growing use of large datasets and their integration in fields such as precision medicine, pharmacotherapy and nutrition bring this aspect to the forefront. When collecting information about sex, clear decisions need to be made on how sex is operationalised (e.g. through genomic data alone or in combination with hormonal profiles and phenotypes). The same applies to the potential inclusion of gender in these analyses. Currently the only immediately available option is the collection of data about gender identity; however, as instruments become more refined, information on gender norms and behaviours could also be collected. The integration of this information could generate new personalised therapies or preventative offers. Gendered innovations 1. Collecting data on sexual dimorphism in gene expression improves biological modelling. Accurate biological modelling requires more studies of sexual dimorphism in human gene expression. Such studies should also take into account different ethnic, cultural and societal backgrounds, and different lifestyles. 2. Collecting sex and gender data fuels integrative omics. Integrative omics provides a basis for sex-specific precision applications in various fields such as medicine, pharmacotherapy and nutrition. Current datasets underrepresent females and underreport participants' gender identity. 3. Analysing sex improves understanding of the role of the microbiome in health and disease. Sex differences are found in the gut microbiome. Analysing these differences will enhance our understanding of how the microbiome influences the human metabolism and sharpen our efforts to improve human health. 4. Integrating sex difference improves systems biology models. Some researchers are retrofitting male models to account for sex differences. Researchers and funding agencies have a role to play in correcting sex bias in omics experiments. 22 CHRONIC PAIN: ANALYSING HOW SEX AND GENDER INTERACT The challenge Sex and gender affect ail parts of the pain pathway, from signalling through perception and expression to treatment. Recent studies have shown that women generally display a lower pain threshold for all types of pain: pressure, heat, cold, chemical or electrical stimulation and ischaemia. Some researchers attribute these differences solely to biological (sex) differences; others suggest that these observed differences are, at least in part, due to gender. The fact that women and men are raised to express pain differently may modify both their biological response to pain and their willingness to report it. A better understanding of biological (sex) and sociocultural (gender) mechanisms of pain, and how these interact with pain management regimes, may lead to better health outcomes for pain patients. # Method: analysing how sex and gender interact Biological mechanisms, such as sex hormones, influence the nervous and immune systems and thus the signalling, perception and expression of pain, and response to treatment of it. Gender roles and norms also influence pain. Gender norms, which vary between cultures, affect a patient's perceived sensitivity to pain. During childhood, boys may be taught to be tough and stoic, and girls to verbalise discomfort. Researchers have demonstrated that these gender norms can be changed and that this can affect perceived sensitivity to pain. Thus, observed biological differences (sexual dimorphism) might also be a consequence of gendered social and environmental influences. Gendered innovations 1. Studying the underlying biological mechanisms of pain in female-typical bodies and male-typical bodies. A better understanding of the influence of biological sex on the nervous and immune systems might help researchers design sex-specific pain treatments. 2. Studying how sex and gender interact, and how sex and sex interact. Men/ boys, women/girls and gender-diverse individuals are socialised to respond differently to pain and this might influence their sensitivity to pain. Researchers' sex might also influence a research subject's sex-related response to pain. 3. Understanding how gender affects the reporting and treatment of pain. Gender stereotypes can influence how pain is experienced, a patient's willingness to report pain and how healthcare professionals manage pain. Climate change, energy and agriculture Sex analysis is largely overlooked in marine science. A recent systematic review of ocean acidification literature, for example, revealed that only 3.7 % of recent studies tested for sex differences, and 85 % of studies failed to consider sex at all. Failing to account for such differences affects our ability to manage ecosystems effectively and set conservation priorities. MARINE SCIENCE: ANALYSING SEX The challenge # Method: rethinking concepts and theories The inclusion of sex in marine science requires challenging the widely held perception that sex plays no role in determining biological responses to environmental disturbances. We must also move beyond the assumption that sex is binary, fixed and genetically determined. Nature abounds with examples of sex along a continuum, labile sex and sex determined by an interacting suite of genetic, hormonal, physiological, social and/or environmental processes. In order to understand the importance of sex for basic biology, it is important to consider Gendered innovations 1. Understanding feminisation of marine organisms in a warming ocean is critical to elucidate the threat that climate change poses to animals whose sex is determined by temperature, such as marine turtles. Understanding such phenomena is vital to assess extinction risk under future climate change scenarios. 2. Understanding environmental sex determination beyond temperature is vital to population demography in a number of organisms of economic, the mechanisms, timings and direction of sex determination and differentiation, as well as differences in female, male and hermaphroditic responses to environmental perturbation. # Method: analysing sex Studies that disaggregate and analyse data by sex have highlighted the importance of considering female and male responses to climate change. In many marine organisms, sex cannot be easily seen. What is needed now is novel, non-invasive methods of sex analysis in non-model organisms, an effort that will be facilitated by the increasing affordability of omics approaches. ecological and experimental importance to humans under future climate change scenarios. 3. Effective population management using sex analysis will enable continued sustainable exploitation of natural resources. 4. Understanding the differential sensitivity of female and male marine organisms to climate change is critical to fully document the impact of environmental change on populations and ecosystems. 24 SMART ENERGY SOLUTIONS: ANALYSING INTERSECTIONALITY The challenge In the EU, buildings are responsible for approximately 40 % of energy consumption and 36 % of C02 emissions. They are therefore the single largest energy consumer in Europe. For climate change solutions, the world needs an effective energy transition. This energy transition depends, at least in part, on users' acceptance of new technologies and services, and on robust public engagement in conceptualising, planning and implementing low-carbon energy solutions. This case study analyses how to integrate gender and intersectional analysis into energy research and into the development, design and commercialisation of energy products and services in order to maximise the adoption of new energy efficiency tools and technologies. # Method: engineering innovation processes Energy efficiency tools and solutions need to attract everyone, both men and women, in order to support an effective energy transition. Although many energy-efficient technologies and products are available, they are often rejected by users in households, the public sector and industry because they do not meet the values, motivations and needs of different user groups, which are shaped and influenced by gender norms and different lifestyles. Redesigning the engineering process can lead to broader acceptance of energy efficiency tools and products. # Method: analysing intersectionality The energy debates often ignore the human factor. An intersectional approach is needed, one that recognises people's multiple, interdependent and overlapping axes of social identity, e.g. gender, socioeconomic status and age. A single factor, such as gender, both shapes and is shaped by other social attributes such as age, ethnicity and socioeconomic status. Together, these factors influence the life experiences of citizens engaging with the complex sociotechnical networks that constitute the energy system. Gendered innovations 1. Designing energy-efficient tools that integrate gender perspectives. Redesigning the engineering innovation process has led to new opportunities for environmental and economic solutions that can propel the energy transition by increasing users' adoption of novel technologies. 2. Driving the energy transition by taking an intersectional approach to gender, age and socioeconomic factors. Energy researchers, companies, policymakers and researchers need to better understand the role that gender and other social, economic and demographic factors play in energy policy. Gender analysis and intersectional analysis are required for effective and equitable energy technologies and policies. AGRICULTURE: EMBEDDING GENDER NORMS IN INNOVATION PROCESSES I 25 The challenge Agricultural innovations tend to affect women and men differently. Most innovations focus on resolving technical problems, such as raising yields, withstanding environmental stress and managing poor soil or seeds. Such innovations often fail to account for (1) how gender norms influence the implementation of technical solutions or (2) how the implementation of technical solutions will influence gender norms. Consequently, innovations may not reach women and may even amplify gender inequality. # Method: analysing gender Gender experts across the Consultative Group on International Agricultural Research (CGIAR) created Enabling gender equality in agricultural and environmental innovation (Gennovate), aimed at developing gender-transformative approaches that embed gender norms in innovation processes. These include: fostering critical examination of gender roles, norms and relations; recognising and strengthening positive norms that support equality; promoting the position of women, girls and marginalised groups; transforming underlying social structures, policies and widely held beliefs that perpetuate gender inequality. Gendered innovations 1. Gill nets in Bangladesh. Gender-related cultural and religious expectations prohibit women in rural Bangladesh from harvesting fish, even from their own ponds. Such tasks are seen as the responsibility of men. Women are also reluctant to enter ponds because they get their saris wet. To support gender equality and to ensure food security, WorldFish, a part of the CGIAR, introduced gill nets in the poorest parts of Bangladesh. The nets, which women can make themselves, are used to catch the nutrient-rich mola fish. Crucial to the success of this project were initiatives addressing gender consciousness to ensure that husbands, in-laws and neighbours supported the new role of women in cultivating fish and catching them with gill nets. 2. Embedding gender norms in innovation processes. CGIAR gender experts have proposed in-depth research methods to include gender norms in large-scale agricultural research and development (R & D) programmes. In a 4-year project (2014-2018) sponsored by the Bill and Melinda Gates Foundation, they collaborated in Gennovate to develop extensive methodologies, reports, articles, briefs and videos as resources for research teams, and to understand how gender norms and innovation processes in the management of agriculture and natural resources influence each other in diverse rural settings. 26 Urban planning, transport SMART MOBILITY: CO-CREATION AND PARTICIPATORY RESEARCH The challenge Mobility patterns tend to be gendered in terms of where, when and why people take trips from home. Transportation planning - for both modes and infrastructures - often does not take into account the diversity of needs and issues that affect transportation. For example, the need for safety can restrict mobility opportunities for specific groups. # Method: co-creation and participatory research National Household Travel Surveys form an important database for mobility analysis and transport planning. However, they underrate trips performed as part of caring work, i.e. doing errands to meet household needs or to accompany or care for others in the household. Surveys that include such aspects explicitly help to illuminate mobility needs. To go beyond observation and analysis of mobility evidence, participatory research and co-creation help planners integrate users' gender-specific needs into the process of new service and technology development from the outset. Gendered innovations 1. Understanding gender-specific needs for mobility services. An understanding of gender-specific needs throughout populations can add new perspectives to the collection of mobility data and can improve transportation for broader segments of the population. Attention should also be paid to other factors, such as age, abilities, ethnicity and socioeconomic status. 2. Creating new services and developing new technology design for mobility. Developing and applying gender-sensitive methodologies to assess gender-specific needs can improve mobility options for more passengers, and simultaneously promote environmentally friendly mobility behaviours. 27 WASTE MANAGEMENT: CO-CREATION AND PARTICIPATORY DESIGN The challenge The Fifth Assessment Report of the Intergovernmental Panel on Climate Change on urban and land use planning calls for adaptation and mitigation strategies to combat climate risk in cities. Innovative approaches to urban waste management will help reduce C02 emissions and increase the sustainability of cities and regions. This case study highlights Horizon 2020 research on mainstreaming gender analysis into urban strategies for waste prevention and management. # Method: co-creation and participatory design Participatory approaches are based on co-creation and co-design to investigate the needs of different user groups when designing new methods, tools and instruments from a gendered perspective. Both approaches are based on gendered participatory research using information and communication technology (ICT). Gendered innovations 1. Collecting data on gendered waste behaviours and intervening to change user behaviours. It is important to understand and minimise waste production in order to reduce greenhouse gas emissions. This will help cities and regions reach the EU's 2050 climate goals. 2. Using participatory gender mainstreaming to collect sex-disaggregated data on waste behaviours and to foster women's participation in waste management. Mainstreaming gender analysis into waste management innovates and transforms how we think about waste. 28 HIGH-QUALITY URBAN SPACES: GENDER IMPACT ASSESSMENT The challenge The quality of urban spaces in everyday life is important for many particularly children, caregivers and elderly people. These groups spend more time in public spaces than working-age women and men, and may face specific risks in public spaces. They are more likely to suffer life-limiting conditions when public spaces do not provide basic amenities supporting their daily needs or are not safe. Planning and designing public spaces that respond to the specific everyday needs of mothers of young children, children and the elderly is required to make cities work for all. This case study will look at innovations and methods used in various cities to improve the quality of urban spaces for working mothers, children and the elderly, in both suburban and dense urban environments, in the developed and the developing countries. # Method: gender impact assessments Gender impact assessments allow city planners to understand who benefits from urban design and who is left out. From the results, conclusions can be drawn about what could be relevant for broader applications. Gender impact assessments produce systematic evaluations for developing more general recommendations. Where relevant, these assessments should include intersectional variables, such as age, ethnicity, physical ability and geographical location. Gendered innovations 1. Building child-friendly and family-friendly streets and public spaces. Streets and urban public spaces are often designed and built giving priority to the needs of cars over the needs of people. High-quality streets and public spaces require careful attention to the daily needs of people, particularly of children, the elderly and their caregivers. 2. Building playgrounds for children of different ages and genders. Children of different ages and genders use spaces in different ways, which sometimes conflict with one another. Considering the specificities of age and gender will improve the quality of playgrounds for all children. Information and communication technology (artificial intelligence, machine learning, robotics) EXTENDED VIRTUAL REALITY: ANALYSING GENDER The challenge Research measuring progress in achieving gender equality concludes that innovative solutions are still required. Technologies such as extended virtual reality have been found to be useful for promoting gender equality by reducing bias and increasing empathy. # Method: analysing gender 'Extended virtual reality' refers to technologies such as virtual reality (VR), augmented reality (AR) and mixed reality (MR), which incorporate elements of the virtual world into our real world, thus enhancing the things we see, hear and feel. These technologies may prove fruitful in promoting gender equality; however, they also come with risks. Research shows that women, men and gender-diverse people may differ in how they experience virtual environments. These potential gender differences need to be taken into account in the development and testing of prototypes. Gendered innovations 1. Developing empathy through extended reality (XR). VR and AR may help us develop higher levels of empathy in specific contexts, which can, in turn, reduce implicit bias. 2. Promoting gender equality through VR. VR provides a technology for humans to create imaginary worlds - in this case, virtual worlds where gender equality exists - with the hope that these experiences will modify behaviours in the real world. 3. Improving healthcare with XR. XR technologies are increasingly used for diagnosing and managing patients. These technologies may improve women's health, for example by aiding early diagnosis of breast cancer or managing the symptoms of menopause. Studies have also shown that virtual reality is an effective tool to engage men in preventative healthcare; for example, men tend to seek screening for testicular disorders after being exposed to virtual reality interventions. FACIAL RECOGNITION: ANALYSING GENDER AND INTERSECTIONALITY IN MACHINE LEARNING I The challenge .. —■ ■—i i^k-^l * *—" Facial recognition systems (FRSs) can identify people in crowds, analyse emotion, and detect gender, age, race, sexual orientation, facial characteristics, etc. These systems are often employed in recruitment, authorising payments, security, surveillance or unlocking phones. Despite efforts by academic and industrial researchers to improve reliability and robustness, recent studies demonstrate that these systems can discriminate based on characteristics such as race and gender, and their intersections. In response, national governments, companies and academic researchers are debating the ethics and legality of facial recognition. One point is to enhance the accuracy and fairness of the technology itself; another is to evaluate its use and regulate deployment through carefully implemented policies. # Method: analysing gender and intersectionality in machine Learning Bias in machine learning (ML) is multifaceted and can result from data collection, or from data preparation and model selection. For example, a dataset populated with men and lighter-skinned individuals will misidentify darker-skinned females more often. This is an example of intersectional bias, in which different types of discrimination amplify negative effects on an individual or group. Gendered innovations 1. Understanding discrimination in facial recognition. Each step in an FR5 - from face detection to facial attribute classification, face verification and facial identification - should be checked for bias. To work, models must be trained on datasets that represent the target population. Models trained on mature adults, for example, will not perform well on young people. 2. Creating intersectional training datasets. To work properly in tasks such as validating the identity of people crossing international borders, training datasets may need to include intersectional characteristics, such as gender and race. The Gender Shades project, based at the Massachusetts Institute of Technology (MIT), developed and validated such a dataset for four categories: darker-skinned women, darker-skinned men, lighter-skinned women and lighter-skinned men. 3. Establishing parameters for a diverse set of faces. Wearing facial cosmetics can reduce the accuracy of facial recognition systems by 76 %. Transgender people, especially during transition, may be identified incorrectly. Publicly available face databases need to establish parameters to improve accuracy across diverse categories without endangering those communities. VIRTUAL ASSISTANTS AND CHATBOTS: ANALYSING GENDER AND INTERSECTIONALITY IN SOCIAL ROBOTS I 31 The challenge Chatbots and virtual assistants are often biased. Personal assistants, for example, are often feminised, reproducing harmful gender stereotypes about the role of women in society and the type of work women perform. The datasets and algorithms used in these artificial intelligences (Als) may also be biased, perpetuating existing discrimination and incorrectly interpreting the language of certain ethnic or socioeconomic groups. # Method: analysing gender and intersectionality in social robots When designing virtual assistants and chatbots, it is important to consider how they might perpetuate stereotypes and social inequalities. The designers of virtual assistants should be aware of how robots are gendered, e.g. by name or voice. Designers should adopt a participatory research approach to better understand how conversational Al agents can better fit a diverse group of users, based on intersecting traits such as gender, ethnicity, age and religion. Gendered innovations 1. Combating the harassment of conversational Al. Feminised chatbots are often harassed. Pushing back on harassment presents an opportunity for Al to help stop gender and sexual harassment. 2. De-biasing data and algorithms. Virtual assistants need to be trained on a wide variety of language so that they do not discriminate against gender- and ethnic-specific language variations or slang. 3. Gender-neutral conversation. To combat the harm caused by feminised virtual assistants, companies and researchers are developing gender-neutral voices and gender-neutral language that does not exclude women or gender-diverse people. Finance, taxation and economics FAIR TAX: GENDER EQUALITY AND TAXATION IN THE EUROPEAN UNION The challenge Tax laws can be structurally discriminatory because of socioeconomic inequalities, such as those that exist between men and women. A thorough understanding of gender aspects in tax policies, the implementation of legal and political requirements, and the realisation of gender equality requires many reforms and future research. # Method: analysing gender This case study is based on critical cross-disciplinary gender analyses. On the economy, it employs literature reviews, macroeconomic modelling, statistical comparisons and microsimulations. On the law, it employs doctrinal law studies, of both hard law (legal obligations that are binding and can be enforced before a court) and soft law (agreements, principles and declarations that are not legally binding). On tax policies, it employs soft law regulations and policies, combined with historical and comparative framework analyses. Gendered innovations 1. Understanding the impact income tax systems have on secondary earners. National tax systems of EU Member States have fuelled inactivity traps for secondary earners, hindering the equal participation of women in the labour market. To overcome this problem, the European Parliament has recommended that Member States phase in full individual taxation in their income tax systems, including the elimination of tax expenditures and benefits based on joint income. 2. Developing a new concept for fair and sustainable taxation that merges gender equality and tax policies. Gender-differentiated outcomes of tax policies result in the neglect of tax objectives, such as fairness linked to redistributive aspects of taxation. To alleviate this problem and reduce income inequalities, the European Parliament has called on Member States to retain progressive income tax systems and to pay attention to the role of taxes on corporations, wealth and capital. 33 VENTURE FUNDING: ANALYSING GENDER The challenge Entrepreneurship is one possible way to help women to empowerment and economic citizenship, and at the same time ensure necessary products and services for all, and thereby contribute to welfare development. However, women globally earn less than men, have fewer savings and own less property, i.e. women have less financial capital to put into venture creation to start their own businesses. In addition, the venture capital (VC) industry is highly gender-skewed. In the EU, firms with a woman chief executive officer (CEO) receive only 11 % of VC funding. In the United States, the percentage is even lower. Only 3 % of women-led firms receive VC funding, and that number has not changed over the last two decades. Further, statistics from the VC industry itself show that women hold few positions in the VC industry: 3 % of managing directors are women, 4 % of vice presidents are women and 2 % of investment managers are women. The relationship between the capital demand side (entrepreneurs) and the capital supply side (investors) should be a major concern for politicians and policymakers who want to understand - and change - how gender affects new venture funding, and thereby contribute to there being more women entrepreneurs. # Method: analysing gender Gendering the theory used to generate knowledge about the VC industry is one step towards overcoming the gender gap in venture funding. This creates awareness that knowledge production, i.e. research results, is often gendered. In this case we investigate how gender functions in signalling theory. Signalling theory is one example of theories used when learning more about venture funding. Gender cannot be treated as a separate variable; it must be understood as embedded in the relations in which entrepreneurs operate. Gendered innovations 1. Including gender analysis in theory on venture funding. Signalling theory that analyses the entrepreneur-investor relationship, for example, can consider how gender functions with respect to the signaller, the receiver, the signal and the feedback. 2. Identifying the impact of venture funding systems on women's entrepreneurship. Entrepreneurship and capital ownership are dominated by men, and women entrepreneurs must clearly communicate their legitimacy in order to overcome the inherent gender bias in the interpretation of signals. Ad hoc case study: Coronavirus THE IMPACT OF SEX AND GENDER IN THE COVID-19 PANDEMIC The challenge Although infectious diseases can affect everyone, sex and gender can have an impact on immune responses and the course of the disease in the human body. Biological impacts of the pandemic intersect with broader social and systemic challenges, such as limited healthcare and economic and logistical resources. Current worldwide statistics on COVID-19 show more men than women dying of acute infection, while women are projected to suffer more than men from the health, economic and social consequences of the pandemic in the long term. Innovative solutions beyond health, such as economic re-entry strategies, product development and Al solutions, also need to consider sex and gender. # Method: analysing sex All data related to COVID-19 morbidity and mortality should be disaggregated by sex. Females generally respond more intensely to contact with viruses, such as severe acute respiratory syndrome coronavirus 2 (5AR5-CoV2), both through natural infection and through vaccination. Potential impacts of these differences should be considered in diagnostics and therapeutics. Studies of COVID-19 need to integrate the sex variable, by using female and male cells and experimental animals in drug discovery and preclinical research, and women and men in clinical trials. All drug and vaccine trials should include sex-specific analyses, as females develop side effects more frequently than males. # Method: analysing gender Preventative measures should be designed in a gender-sensitive manner. Women reportedly comply more with hand hygiene. Gender affects the division of labour and care duties in families. Women are more often employed in professions with a high risk of infection, such as healthcare, and are more often responsible for the care of sick family members. The allocation of protective equipment, therapies and financial aid should be gender-equitable. Gender-sensitive design should be used when developing digital resources for preventative measures. 35 Gendered innovations 1. Studying sex differences in the immune response could help address the higher COVID-19 mortality in men than in women. 2. Focusing on dosing and sex-specific side effects of vaccines and therapeutics will be essential in the development of therapeutic responses against SARS-CoV2 infection and COVID-19. 3. Analysing gender-specific risk factors may help decrease mortality in women in the long term. In the EU, 76 % of healthcare workers are women. This has the potential to expose them significantly more to the virus; hence the need for fitted personal protective equipment. 4. Designing gender-sensitive prevention campaigns can increase compliance and reduce exposure. For effective public health campaigns, gender-specific preferences should be analysed and deployed in preventative measures, digital platforms, data collection wearables and Al prediction models. 5. Considering the gender-specific socioeconomic burden of public safety measures can mitigate their inequitable impact. Public health emergencies can lead to the disruption of gender roles. Women and gender-diverse individuals are at significantly more risk of experiencing economic insecurity, discrimination and gender-based violence. 36 5. POLICY RECOMMENDATIONS FOR HORIZON EUROPE 1. European Union policy context Integrating sex and/or gender analysis into the contents of R & I adds value to research in terms of excellence, creativity and business opportunities. Considering sex and/or gender analysis along with intersecting categories, such as ethnicity and socioeconomic status, also fosters innovation and enhances equality by ensuring that findings, products and programmes apply to all citizens and society as a whole. Policy is one driver of excellence in R & I. These policy recommendations aim to increase both the scientific quality and the societal relevance of R & I projects funded under Horizon Europe. These recommendations also support the political priorities set forth by the European Commission President, Ursula von der Ley-en, and strengthen the EU's response to global challenges, such as the achievement of the UN Sustainable Development Goals (SDGs), and pandemics, such as the COVID-19 outbreak. The European Commission is a global leader in policy for integrating the gender dimension into R & I content, which was set as a priority for Horizon 2020. The proportion of 'gender-flagged' topics - i.e. topics that explicitly require sex and/ or gender analysis in funded projects - has increased in every successive work programme, expanding from 16.1 % of topics in 2014-2015 to 36.4 % in the 2020 work programme5. Execution of this policy, however, has been lagging. The interim evaluation of gender as a cross-cutting issue revealed that fewer than expected research proposals funded under gender-flagged topics successfully incorporated sex and gender analysis. Evaluators traced this poor uptake to an 'absence of training on gender issues' (European Commission, 2017, p. 26). Based on the work of this expert group, these policy recommendations acknowledge and build on: ► the strengthened commitment to gender equality put forth in Horizon Europe and embedded in the orientation document developed for the first Horizon Europe strategic plan (European Commission, 2019a); ► the new gender equality strategy 2020-2025 (European Commission, 2020a) adopted by the European Commission on 5 March 2020, which proposes that Horizon Europe fund gender and intersectional research to help debunk gender stereotypes and foster equality in all domains. The following set of concrete recommendations have been elaborated by the H2020 Expert Group to update and expand Gendered Innovations / Innovation through Gender to foster the effective integration of the gender dimension into R & I content throughout the next framework programme. These recommendations assume an overall ambitious policy approach to foster and support gender equality in all aspects of R & I in the European Union. Such an approach addresses other gender equality objectives through general rules and targeted measures to ensure: ► increased participation of women in the programme, and gender balance in funded project teams; Provisional data for calls launched before July 2020 (including topics under the two special Coronavirus calls for expression of interest), to be updated with remaining call topics (e.g. European Green Deal). 37 ► gender balance in decision-making structures; ► the realisation of institutional change in R & I organisations through gender equality plans, which includes integrating the gender dimension into R & I and teaching content in higher education institutions, and entails providing comprehensive policy support to Member States, research-performing and research-funding organisations, businesses and innovation companies. These objectives should be embedded in Horizon Europe and also integrated into the framework of the future European Research Area (ERA) by mobilising Member States and Associated Countries to foster gender equality in R & I actions at the national level. 2. Work programmes Integrating the gender dimension into Horizon Europe work programmes as the norm In line with the proposal for a decision of the Council establishing the specific programme implementing Horizon Europe (Council of the European Union, 2019), integrating the gender dimension into R & I content should be considered as a matter of principle throughout the programme. ► We therefore recommend that all Horizon Europe topics, by default, require sex-and gender-based analysis, unless topic drafters clearly demonstrate that the gender dimension is not relevant to the proposed topic. ► This entails installing a 'negative' gender-flagging, by which only topics not requiring the gender dimension would be flagged, thus reversing the burden of proof. ► To execute this approach, topic descriptions should explicitly require proposals to include details about how sex and/or gender analysis will be integrated into the R & I content and specify how the work will contribute to achieving the topic's target outcomes. A topic's target outcomes should include combating and transforming gender norms and stereotypes, fostering broad social equalities and advancing SDG 5, gender equality. ► At the level of the call (which covers a set of topics, under a particular intervention area), the relevance of sex and/or gender analysis should be specified and related to the call's targeted impacts. Examples of gender-related targeted impacts, for each Horizon Europe Pillar II cluster and mission, are provided in Section 5.6 of this document and based on the case studies developed by this expert group. For bottom-up work programme parts, such as the European Research Council's calls and the Marie Sktodowska-Curie actions calls under Pillar I of Horizon Europe as well as European Innovation Council calls under Pillar III, the work programmes should explicitly encourage applicants to integrate the gender dimension into their proposals, wherever relevant. Dedicated call topics for advancing gender knowledge ► In addition to this gender mainstreaming approach throughout the programme, Horizon Europe should include call topics specifically dedicated to developing knowledge of gender equality issues. ► In an improvement on Horizon 2020, the Horizon Europe Specific Programme (Council of the European Union, 2019) and the Orientations towards the first strategic plan for Horizon Europe (European Commission, 2019a) now include, under Cluster 2, 'Culture, creativity and inclusive 38 society', of Pillar II, 'Global challenges and European industrial competitiveness', a broad line of activity supporting the development of cross-disciplinary gender research, i.e. advanced strategies and innovative methods for promoting gender equality in all social, economic and cultural domains. ► We welcome this important novelty and recommend among topics to be considered: • the development of gender knowledge related to all SDGs; • the development of intersectional knowledge, investigating in particular the multidimensional interactions between gender norms, gender relations, gender identity and sexual orientation (LGBTI+ issues5), ethnicity socioeconomic status, age, language, geographical location, religion, etc. ► Moreover, the Horizon Europe work programme part entitled 'Reforming and enhancing the European R & I system' of 'Widening participation and strengthening the European Research Area', which furthers the gender equality objectives that were addressed under the Science with and for Society work programme of Horizon 2020, should also be a vector for supporting the integration of the gender dimension into R & I content and higher education curricula at a structural level in R & I organisations. In particular, funding should be made available to support policy work with national research-funding organisations to foster policies and programmes aimed at ensuring that R & I integrates sex, gender and/or intersectional approaches. 3. Instructions for Horizon Europe applicants, evaluators and reviewers Practical guidance and briefing materials need to be developed to assist applicants, evaluators and reviewers to better understand the gender dimension. This includes inserting points relevant to integrating the gender dimension into R & I content into instructions to applicants, evaluators and reviewers, and updating those points. They should be tailored to different fields of R & I and, more specifically, to the different Pillar II clusters. Briefing materials The expert group recommends the development of: 1. Infosheets for applicants, evaluators, reviewers and topic drafters, drawn from the gendered innovations case studies, methods, terms and infographics concept developed by the expert group, to be included in all briefing and training materials. 2. Factsheets for the general public consisting of major R & I findings presented briefly and visually. Training The gender dimension in R & I content is a field of specialised expertise. Staff in the Directorate-General for Research and Innovation (DG R & I), applicants and evaluators need sophisticated understandings of how to integrate sex and gender analysis into R & I content. Training should be offered systematically throughout the Horizon Europe ecosystem. ► Tailored training on integrating sex, gender and intersectional analysis into R & I content should be developed for key players involved in developing and LGBTI+ stands for lesbian, gay, bisexual, transgender, intersex and other diverse sexual orientations and gender identities. 39 implementing Horizon Europe work programmes, including topic drafters/ scribes, programme officers and call coordinators, moderators and rapporteurs, proposal evaluators and project reviewers, mission board members and national contact points. ► The DG R & I should provide in-person or online training for Horizon Europe applicants, evaluators and reviewers. Researchers do not necessarily know what the 'gender dimension' means or how to integrate it into R & I using state-of-the-art methods (see Annex B of this document). We recommend that these courses be mandatory for all Horizon Europe proposal evaluators and available to applicants. ► In dialogue with relevant stakeholders (see Section 5 below), the DG R & I should promote and offer training for staff in European research-performing and research-funding organisations. Proposal templates Proposal templates are important, and here we offer specific guidelines. ► All Horizon Europe topics are considered by default to require sex- and gender-based analysis, unless a topic is negatively flagged. • This requirement should be clearly signalled to all applicants. - Under the 'excellence' criterion, details about how the gender dimension will be integrated must be provided in (1) the concept and (2) the methodology (see Annex B in this document). Those details should also appear in the summaries under general information. - Under the 'impact' criterion, proposals should address the sex- and gender-related targeted impacts as described in this document (Section 5.6). Regarding dissemination of project results, it should be clearly signalled to applicants that proposals that include sex and/or gender analysis are expected to report those findings in their peer-reviewed publications. ► For bottom-up work programmes (e.g. European Research Council, European Innovation Council and possibly calls relating to missions), applicants should be required to specify whether or not the gender dimension is relevant for their project. If so, applicants are to describe how sex and/or gender will be integrated into their project. If not, applicants are to briefly explain why sex and/or gender is not relevant to their proposed research. Proposal evaluation and project reviewing Under Horizon 2020, an evaluation of the proposed gender dimension is already part of all R & I actions and innovation actions under the 'excellence' criterion (concept and methodology), even for non-gender-flagged topics. For Horizon Europe, we make the following recommendations. ► The evaluation of the quality of proposed gender dimension should extend beyond the 'excellence' criterion to also include the 'impact' criterion (see above under 'Proposal templates'). ► An evaluation of the quality of the proposed gender dimension should be integrated into the current scoring system of 0-5, or receive a separate bonus point. Horizon Europe should develop criteria for scoring. For example, does the proposal have well-designed strategies 40 for data collection? Will data be properly disaggregated and analysed by sex and/or gender? Are sex, gender and/or intersectional factors carefully integrated into the research plan and properly analysed? Are there plans to report these results in peer-reviewed publications? For what to consider in these criteria, see Annex B in this document. ► Reviewers carrying out mid-term and final evaluations of funded projects should determine if the plans to include sex and/ or gender analysis have been effectively implemented. ► Gender experts in fields relevant to specific calls/topics should be included in evaluation panels, when possible. Gender experts should be invited by the European Commission to register in its database of experts annually. This database can be used by Commission staff to appoint evaluation panels. To facilitate this work, and for training purposes, the Commission might develop new Al tools to establish an interactive platform linked to the database to find gender expertise in different fields. Dissemination and communication ► All materials developed by the Gendered Innovations Expert Group, such as briefing materials, infosheets, factsheets and evaluation criteria, as well as full case studies, methodologies and terms should be made available online to applicants, evaluators and reviewers, as well as to the wider public, including through: • the online manual for Horizon Europe, accessible through the new European Commission Funding & Tenders Portal (replacing the Horizon 2020 Participant Portal); • a section of the European Commission's Europa website dedicated to gender equality in R & I. ► A communication strategy has been developed by the expert group. This includes social media actions through European Commission-related Twitter accounts, the use of the infosheets and factsheets, and concepts for infographics and for a video. This strategy also illustrates how these policy recommendations for Horizon Europe support the implementation of the new European Commission gender equality strategy 2020-2025, e.g. the EU-wide communication campaign combating gender stereotypes, which will be launched by the European Commission to 'tackle all spheres of life with an intersectional approach and a focus on youth engagement, in collaboration with the Member States' (European Commission, 2020). 4. Monitoring and evaluation of Horizon Europe's policy on the gender dimension ► Project reporting templates should reflect the proposal submission templates by requiring reporting on integrating the gender dimension into the project's R & I content. ► Horizon Europe programme monitoring should include relevant indicators measuring the impact of the gender dimension in R & I content to demonstrate a return on R & l-funding investment. • We recommend in particular the following regarding scientific impact. - Number and proportion of proposals for which sex and/or gender analysis receives the highest number of evaluation points, i.e. that are high-quality proposals. Many proposals will merely mention 41 sex and/or gender; these proposals will not result in scientific, social or economic impact and will not provide a return on investment. It is important to evaluate how many proposals employ sex and/or gender analysis by state-of-the-art methods. - Number and proportion of topics that are negatively gender flagged in each work programme. - Number and proportion of project-related peer-reviewed publications that include a gender dimension, as assessed from the list of output publications published on the European Commission Cordis website. This monitoring, which requires text mining for certain keywords, could be carried out in conjunction with the production of the She Figures publication (European Commission, 2019b), which includes an indicator on, and methodology for collecting, the number of publications integrating a gender dimension in their contents. Regarding societal impact, we recommend: - number and proportion of innovations, market opportunities, programmes or policies resulting from integrating sex and/or gender analysis into R & I; - number and proportion of innovations that can be classified as gender-sensitive. Regarding economic impact, we recommend: - number and proportion of R & I projects that support gender-inclusive economic transformations; these programmes should also address intersections between gender and other social categories, such as abilities, LGBTI+ and ethnicity. Horizon Europe interim and final evaluations should specifically assess progress made on gender as a cross-cutting priority in Horizon Europe. Data from Horizon Europe monitoring processes and progress reports on integration of the gender dimension should be available: • on the European Commission's Horizon Dashboard (accessible through the Funding & Tenders Portal (https://ec.europa.eu/info/fundinq-tenders/opportunities/portal/screen/ opportunities/horizon-dashboard)). • in She Figures, which includes an indicator on, and methodology for collecting, the number of peer-reviewed publications integrating a gender dimension in their contents. 5. Organisational framework for integrating the gender dimension into Horizon Europe research and innovation contents Effective integration of the gender dimension into R & I content in Horizon Europe requires enabling organisational structures within the European Commission and cooperation at the ERA level. This should include: ► a core structure within the DG R & I that coordinates the effective implementation of these policy recommendations into Horizon Europe, involving the DG R & I's Gender Sector and representatives from throughout the DG as well as from other 42 DGs and agencies concerned with Horizon Europe, where relevant; ► a body in the future ERA advisory structure that follows up on the current European Research Area and Innovation Committee Standing Working Group on Gender in Research & Innovation, consisting of delegates from Member States and Associated Countries to help implement the EU's policy on sex and/or gender analysis in research content; ► national contact points with gender expertise that can provide guidance, practical information and assistance on Horizon Europe's policies on integrating the gender dimension into R & I content, and can provide training at national level to research-funding organisations' policymakers, applicants, evaluators and staff; ► formal European cooperation building on the successful collaboration established between national research-funding organisations in several H2020-funded projects, and capitalising on the good practices developed by, for example, the Irish Research Council, the Research Council of Norway and the German Research Foundation. 6. Cluster- and mission-specific recommendations: targeted impacts Each case study developed by the current expert group includes targeted impact-oriented recommendations for future R & I actions. Here is a guide for each Horizon Europe Pillar II cluster and mission. Cluster-specific recommendations Cluster 1: Health These targeted impacts are drawn from the Gendered Innovations 2 Expert Group case studies 'Prescription drugs', 'Chronic pain', 'Systems biology', Agriculture', 'Extended virtual reality' and 'Facial recognition systems'. Staying healthy in a rapidly changing society Health and disease are strongly sex and gender related. Personalised and tailored solutions and advice can be achieved only when sex and gender are analysed in research aiming for personalised advice to promote health and prevent disease in individuals or for stratified solutions tailored to specific groups (see case study 'Systems biology'). Take account of the different health needs of women and men farmers and farm workers (some of whom may be foreign or seasonal). Analyse gender as it intersects with age, religion, race, ethnicity, socioeconomic status, geographical location, etc. (see case study Agriculture'). Tackling diseases and reducing disease burden Sex-disaggregated data are essential for better surveillance, prevention, timely detection, treatment and crisis management of infectious disease threats, for example COVID-19 (see case studies 'Prescription drugs', 'Systems biology' and 'The impact of sex and gender in the COVID-19 pandemic'). Ensuring access to innovative, sustainable and high-quality healthcare Gender aspects need to be considered when developing digital tools for medication regimens (e.g. apps to monitor diabetes therapy) that are managed by patients (see 'Co-creation 43 and participatory research' in Annex B). Special attention to the needs of rural populations is also required. The use of FRSs in healthcare to identify and monitor patients is increasing. Take into consideration how these apps deal with gender, race/ ethnicity, age and sexual orientation. Consider also that sex reassignment therapy may result in facial changes that may affect FRSs (see case study 'Facial recognition'). Unlocking the full potential of new tools, technologies and digital solutions for a healthy society Novel tools and technologies for biomedical research, prevention, diagnosis and therapy will probably be driven by data and ICT. It is crucial that these source data be precisely annotated for sex and gender (see 'Analysing gender and intersectionality in machine learning'). Extended VR is increasingly used in healthcare to diagnose and manage patients with pain, disability, obesity, neurological dysfunction, anxiety and depression. Potential sex and gender differences need to be taken into account in the development and testing of prototypes. Computer models and simulations aiming to understand health Improving personalised medicine again requires that sex and gender data be collected and precisely annotated (see case study 'Systems biology'). Maintaining an innovative, sustainable and globally competitive health industry Gender affects access to care globally, and incorporating this aspect may represent a unique selling proposition for companies. Decreased time to market must not mean reducing the variables tested, such as sex. Withdrawing a product from the market owing to lack of appropriate testing can damage companies (especially small and medium-sized enterprises, SMEs) permanently (see case study 'Prescription drugs'). Living and working in a health-promoting environment Analyse occupational health risks in all genders. For farm workers, this includes attention to risky equipment and chemicals. Cluster 2: Culture, creativity and inclusive society These targeted impacts are drawn from the Gendered Innovations 2 Expert Group case studies 'Fair tax', 'Venture funding', 'Agriculture' and 'Extended virtual reality'. Help reverse social, spatial, economic, cultural and political inequalities and their causes, and promote gender equality. ► Analyse how agricultural and rural transitions contribute to the social inclusion of marginalised groups by supporting their integration into researching, planning, implementing and monitoring. Include and address gender as it interacts with, for example, age, religion, race, ethnicity, socioeconomic status and geographical location. ► VR has been used in heritage sites such as museums, monuments and historical buildings. Without gender analysis, however, there is a risk that opportunities to foreground women's cultural heritage will be missed. VR provides an excellent opportunity to fill this gap (see case study 'Extended virtual reality'). ► Promote and conduct research on fair taxation and ensure the availability of appropriate gender-disaggregated data. Further research is needed on the gender-differentiated distributional effects of net wealth, property taxes, inheritance taxes, value added taxes, excise taxes, corporate taxes, tax expenditures and gender-differentiated allocative effects of corrective taxes. Research should also address the compliance of tax measures 44 with legal gender equality obligations (see case study 'Fair tax'). • Ensure political commitment at the EU level7 and define targets and indicators to achieve substantive gender equality with regard to taxation. • Integrate a gender equality perspective into taxing for the future, combining social changes with an economy that works for people and a European Green Deal. ► Address gender bias in venture funding, business ownership and wages (this could also be supported under Pillar III, 'Innovative Europe', through the European Innovation Council). • A first step is to analyse entrepreneurship for gender disparities in the venture funding sector and to ensure that stakeholders highlight and report on these disparities. • A next step is to include women entrepreneurs in target groups in both the private and public sectors. • A further step is to include gender equality demands in ownership and workforce in the public procurement of services and products (see case study 'Venture funding'). Cluster 3: Civil security for society These targeted impacts are drawn from the Gendered Innovations 2 Expert Group case studies 'Facial recognition', 'Virtual assistants and chatbots', 'Quality urban spaces' and 'Agriculture'. Disaster-resilient societies Farmers can help prevent natural disasters; it is important to include gender differences in farmers' perspectives on risk management, prevention and actions (see case study 'Agriculture'). Protection of public space, security and resilience of infrastructure and vital societal functions, and fighting crime and terrorism ► Digital safety and security are important in terms of how digital assistants and chatbots handle data in relation to current laws (e.g. the General Data Protection Regulation8). Data that virtual assistants may have recorded in the home in times of crisis (e.g. domestic violence) may prove useful for law enforcement and provide vulnerable people with added security; however, take care to consider major ethical issues with extracting such data (see case study 'Virtual assistants and chatbots'). Al may be recruited to better protect citizens from violent attacks in public spaces. FRSs are a new way of identifying criminals and terrorists. However, take care to implement proper design and ethical considerations so that facial recognition technology does not exacerbate existing gender and social inequalities (see case study 'Facial recognition'). ► Public urban space and transportation, digital worlds and cyberspaces, and disaster and risk management should ensure the safety of women, men and gender-diverse individuals, of various ages and ethnicities. VR 'walkthroughs' in settings such as cities, parks and railway In line with the Resolution on gender equality and taxation policies in the EU, European Parliament (2018/2095(INI)). Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). 45 stations have been used to understand users' experiences in terms of how they decode the environment when considering personal safety (see case study 'High-quality urban spaces'). Since women, men and gender-diverse people tend to experience threats to personal safety differently, it is important to apply a user-driven approach that includes diverse groups of people. Moreover, homes as well as public spaces should be understood in terms of security and safety. Smart homes, for example, have been shown to pose certain threats to women. In rural areas, safety can be an issue because there is less formal policing. Violence constitutes a particular risk for rural women and gender-diverse individuals, as remote housing prevents effective formal or social control, and specialised social services are absent. Investigate and include these specific risks as well as prevention and resilience options. Cluster 4: Digital, industry and space These targeted impacts are drawn from the Gendered Innovations 2 Expert Group case studies on ICT 'Extended virtual reality', 'Facial recognition' and 'Virtual assistants and chatbots'. Key digital technologies Digital assistants and chatbots have an important role to play in being inclusive and representative. Developers should take care not to reinforce gender stereotypes, e.g. by feminising chatbots. Artificial intelligence and robotics ► Ensure that Al technologies and their benefits are accessible to all citizens and address a diversity of needs and preferences. For example, women are more than twice as likely as men to feel unwell from using VR, with symptoms such as pallor, sweating and general discomfort (see case study 'Extended virtual reality'). ► In agriculture, digitalisation is becoming more important. Beyond automatisation through computers in warehouses, stables and milking parlours, the sector uses chips in animals, drones and self-driving tractors that are all connected to sensors, data processors and warning systems. Apply gender impact assessment to make sure gender-specific needs are taken into account (see 'Gender impact assessment' in Annex B). Advanced computing and big data ► Ensure that Al and big data are free of gender bias. For example, wearing makeup can reduce the accuracy of facial recognition methods by 76 %; automatic gender recognition may not recognise transgender people, especially during transition periods; and FRSs perform better on men's than women's faces overall, and better on lighter than darker skin overall (see case study 'Facial recognition'). Carefully construct datasets to overcome these issues (see Analysing gender and intersectionality in machine learning' in Annex B). Data containing human information should include metadata summarising statistics on factors such as participant gender, sex, ethnicity, age and geographical location. Data labelling using crowdsourcing, such as MS Turk, should include information about crowd participants, along with the instructions given for labelling (see 'Analysing gender and intersectionality in machine learning' and Analysing gender and intersectionality in social robots' in Annex B). ► Employ Al and big data, where appropriate, to better understand gender-specific needs when designing products and services. 46 Cluster 5: Climate, energy and mobility These targeted impacts are drawn from the Gendered Innovations 2 Expert Group case studies 'Smart energy solutions', 'Smart mobility', 'High-quality urban spaces' and 'Waste management'. Advancing climate science and solutions for a climate-neutral and resilient society R & I should consider: gender issues in access to energy including energy poverty, analysed by age; ► the gender dimensions in transportation services and infrastructure, and women's, men's and gender-diverse individuals' needs in transportation (see case study 'Smart mobility'); ► the gender dimensions in urban planning, including access to housing, employment and urban facilities, and ensuring the quality of public spaces (see case study 'High-quality urban spaces'); ► creating digital solutions that are free of gender bias and omissions (see case studies on ICT, and 'Analysing gender and intersectionality in machine learning' in Annex B); ► gender and diversity aspects when identifying causes of and solutions for climate change, ensuring that analysis factors in behavioural and structural determinants so that solutions will be adopted by a majority of European people and economies; ► disaggregating all data by sex and/or gender; ► analysing gender and diversity when developing climate services and decision-support tools and methodologies; ► disaggregating data by sex and/or gender when assessing impacts; ► employing gender impact assessments in agriculture and natural resource management sectors in order to avoid exacerbating inequalities when decarbonising the EU's economy and developing a fully circular economy. Developing sustainable infrastructure, services and systems for smart and sustainable communities and cities Consider the following suggestions. ► Employ co-creation and participatory research that include end-users when developing improved technologies, services and business models. Analysis should include attention to gender, age and socioeconomic status so that solutions appeal to users in their individual contexts (see case study 'Smart energy solutions', and 'Co-creation and participatory research' in Annex B). ► Employ co-creation and participatory research when developing methods of citizen engagement in energy and transport investment and transition policies. This research must understand what motivates citizens to participate or invest time and/or money in this work. ► Encourage citizen science or user-led innovation to engage in gender-sensitive and intersectional data collection, development and testing procedures to ensure greater acceptance of these solutions. 47 Empowering citizens to engage in the transformation to a decarbonised society ► Prioritise changing minds and behaviours to mitigate climate challenges. VR has proven successful in enhancing empathy and moving people to action. For example, studies have shown that VR exposure to climate issues, such as the negative effect of C02 emissions, has influenced travel-related decisions. Such programmes require intersectional analysis (e.g. analysing how gender intersects with economic status and geographical location) (for similar uses of VR, see case study 'Extended virtual reality'). ► Equip chatbots and digital assistants with excellent information about climate and energy issues. Digital assistants can be used, for example, to provide sustainable transport options (see case study 'Virtual assistants and chatbots'). ► Consider gendered issues in waste management. Gendered knowledge can contribute to better solutions for city/ district management of waste systems and contribute to meeting EU-wide low-carbon goals (see case study 'Waste management'). Employing co-creation and co-design can empower all citizens to engage in these transformation processes (see 'Co-creation and participatory research' in Annex B). Developing low-carbon and competitive transport solutions in all modes ► Consider the gender dimensions in mobility needs and behaviour when designing mobility services and infrastructure. ► Develop gender-sensitive digital solutions that enhance access for all. ► Make gender analysis central to the systemic transformation of transport and mobility (see case study 'Smart mobility'). Cluster 6: Food, bioeconomy, natural resources, agriculture and environment These targeted impacts are drawn from the Gendered Innovations 2 Expert Group case studies 'Agriculture' and 'Marine science'. Environmental observation Sex as a biological variable must be incorporated as a key component of environmental models that seek to determine species' sensitivity to climate change and species interactions. Only such models can be used for evidence-based policy (see case study 'Marine science'). Biodiversity and natural capital ► Research drivers of biodiversity loss. Analyse sex as a factor determining species' sensitivity to stressors (see 'Analysing sex' and 'Analysing sex in hermaphroditic species' in Annex B). ► Effective communication and dissemination activities are critical to raising societal awareness. Sex analysis in the context of climate change provides an intriguing and novel key message highlighting the differential sensitivity of female and male marine species to climate change, the impact of climate change on sex determination and differentiation, and the role sex plays in population sensitivity. Examples that resonate with the public can inspire action. Seas, oceans and inland waters ► Understanding, forecasting and monitoring changes within seas, oceans and inland waters will require analysing biological sex in marine organisms as a factor determining sensitivity. This includes disaggregating all results by sex (see case study 'Marine science', and 'Analysing sex in hermaphroditic species' in Annex B). 48 ► Sex analysis in marine organisms should become an integral component of robust world-class climate change science and must be incorporated into research, education, and environmental management and policy. Food systems ► The success of the European Green Deal in the agricultural and food sector depends on the contribution of all rural residents - across all genders, ages, nationalities, cultures, etc. The active engagement of all citizens is needed to address the influence of gender norms in these sectors (see case study 'Agriculture'). ► Analyse gendered approaches to waste management to support the food system by lowering food waste and decreasing the burden of food packaging. Mission-specific recommendations Sex and/or gender analysis in R & I content is almost completely absent from the five interim mission reports/outlines released on 25 June 2020, which were developed by the Horizon Europe mission boards, save for two mentions of sex/gender as determinants, in the cancer mission outline, and a reference to training and up-skilling a new gender-balanced blue workforce, in the outline of the mission on healthy oceans, seas, coastal and inland waters. Such omissions can lead to failed science. Integrating sex and/ or gender analysis along with intersecting categories, such as ethnicity and socioeconomic status, adds value to R & I in terms of excellence and creativity. Incorporating the gender dimension also enhances equality by ensuring that findings and innovations apply to all citizens and society as a whole. Mission area: cancer - 'Conquering cancer: mission possible' On the Mission Board, include representatives from groups with sex and gender-specific knowledge, such as the Gender in Oncology task force of the European Society for Medical Oncology (ESMO). To ensure equal access and benefits to all European patients and citizens, sex and gender must be considered in cancer studies, cancer data analysis and modelling of treatments. Data ► Sex is an important biological variable. All data collection and reporting must be sex-disaggregated to facilitate future metaanalyses. ► Gender is an important cultural variable. All data collection and reporting must be gender-disaggregated to facilitate future meta-analyses. ► If big data and machine learning techniques will be employed for low-cost population risk prediction, sex/gender bias in the source data needs to be investigated and corrected for. ► Polygenic risk score development needs to be based on sex-disaggregated data and possibly lead towards gender-sensitive risk counselling. Prevention ► Cancer prevention strategies should be gender-sensitive. This applies to the screening location (e.g. workplace versus primary care physician), delivery of information and facilitation of healthy lifestyle choices. Diagnosis ► Gender-specific barriers to access to early diagnostic and minimally invasive treatment technologies need to be removed in all EU Member States. 49 ► XR technologies are increasingly used for diagnosing and managing patients. These technologies may improve women's health, for example by aiding early diagnosis of breast cancer or managing the symptoms of menopause. Treatment ► The proposed European Cancer Patient Digital Centre needs to be equally accessible to all citizens, transcending possible inequalities in digital literacy. Sex-and gender-specific risk factors should be recorded. ► The future network of comprehensive cancer infrastructures needs to include expertise on sex/gender in oncology. ► Innovation and implementation of new technology in the field of cancer need to be gender-sensitive to guarantee equal access and benefit for all. Quality of life ► Quality-of-life (QoL) measurements of patients, survivors, family members and carers need to be gender-sensitive. Cancer may affect the QoL of women, men and other genders differently, which needs to be considered for optimal support. Pain ► The prevention of chronic pain related to cancer should integrate sex analysis into treatments and develop gender-sensitive approaches to pain management. ► Pharmacological pain management needs to be gender-sensitive and sex-specific to improve patients' outcomes and QoL. Personalised treatment ► Personalised medicine approaches for cancer need to be sex-specific and gender-sensitive to ensure equal access and benefits for all patients. Mission area: adaptation to climate change, including societal transformation - 'Accelerating the transition to a climate-prepared and resilient Europe' ► To enhance efficiency in the energy sector, integrate gender-sensitive and intersectional approaches into all aspects of research, including: • the behaviours and expectations of users with respect to energy use and energy technologies; • the impact of energy-related technologies, products, services and policies; diverse user groups can have diverse needs that must be taken into account in order to provide products, services and solutions that are adapted to those needs, and to provide products, services and solutions that will be widely accepted and implemented; • targets and action plans. ► Consumers should be actively involved in the R&D, design and testing. Mission area: healthy oceans, seas, coastal and inland waters - 'Regenerating our ocean and waters by 2030' ► Key factors determining species extinction in the face of climate change are population stability, sex ratios and the sensitivity of males and females. Incorporating sex analysis is therefore vital to accurately understand the threat of climate change (and other environmental stressors such as pollution) on marine organisms, and thus to effectively establish robust mitigation strategies. ► Sex must be analysed in the context of biodiversity loss and safeguarding life on Earth. ► Understanding, forecasting and monitoring changes within seas, oceans and inland waters requires the inclusion of sex as 50 a factor determining sensitivity at ail levels of experimentation, modelling and mitigation. ► Conservation of marine stocks could increase the annual profits of the seafood industry by EUR 49 billion. Sex analysis is shown to be a key factor for ensuring effective population management of marine organisms. Mission area: climate-neutral and smart cities - '100 climate neutral cities by 2030 - by and for the citizens' The June 2020 interim report on this mission (European Commission, 2020b) emphasises that cities can achieve climate neutrality only if citizens become agents of change through bottom-up initiatives and innovation and through new forms of governance. It declares that holistic and transformative missions aiming to create climate-neutral cities, based on citizens' participation and social inclusiveness, can help the EU progress towards achieving multiple SDGs, including equality. The Climate City Contract (CCC) will need to ensure that gender issues are an explicit part of designing and implementing these transformation processes. This includes: ► considering the specific needs of women, men, girls, boys and gender-diverse individuals across age groups, socioeconomic classes and abilities; ► ensuring that small towns are included -in this context, it is important to analyse gender differences in access, resources, affordability and connectedness; ► a gendered approach to better understand citizen behaviours, attitudes and potential engagement in minimising resource inputs, waste and carbon emissions in a circular economy; ► analysing how women, men, girls, boys, and gender-diverse people use cities differently; quality streets and public spaces must respond to the different daily needs of people, and particularly of children, the elderly and their caregivers. Mission area: soil health and food -'Caring for soil is caring for life' Humans ► Consider a gender-sensitive approach to new programmes to overcome bias and allow representation of specific interests, experiences and knowledges. Rural and gender impact assessments of programmes can identify potential exclusion patterns and ways to redress them upfront. ► Protect tangible and intangible agricultural cultural heritage produced by women, men, and gender-diverse individuals, and ensure its transfer. Examples include traditions and rituals, handicrafts, music and dances, food cultivation, wild food gathering, herbal medicines, storage and preservation techniques, and meal preparation. Connect heritage practices, where appropriate, to rural and agricultural transition challenges, health support systems, economic growth and mobility (entrepreneurship in tourism, rural business), and civil security in rural areas. Biodiversity ► Research drivers of biodiversity loss: analyse sex as a factor determining species sensitivity to stressors. Animals ► Bring sustainable and innovative solutions to tackle infectious animal diseases. Sex is a key factor determining the susceptibility of animals to disease-causing agents. Incorporating sex analysis is thus an important consideration for a partnership on animal health and infectious disease. 51 Works cited Council of the European Union (2019), Proposal for a decision of the Council establishing the specific programme implementing Horizon Europe - the Framework Programme for Research and Innovation -Partial General Approach (https://data.consilium.europa. eu/doc/document/5T-8550-2019-INIT/en/pdf). European Commission (2017), Interim Evaluation: Gender equality as a crosscutting issue in Horizon 2020. doi:10.2777/054612. European Commission (2019a), Orientations towards the first strategic plan for Horizon Europe (https://ec.europa.eu/ info/sites/info/files/research and innovation/strategy on research and innovation/documents/ec rtd orientations- European Commission (2019a), She Figures 2018 (https:// ec.europa.eu/info/publications/she-figures-2018 en). European Commission (2020a), Commission communication - A union of eguality: gender equality strategy 2020-2025 (https://ec.europa.eu/info/policies/ justice-and-fundamental-rights/gender-equality/gender-equality-strateqy en). European Commission (2020b), 100 climate-neutral cities by 2030 - by and for the citizens: Interim report of the mission board for climate-neutral and smart cities (https://op.europa.eu/en/web/eu-law-and-publications/ publication-detail/-/publication/82fldf57-b68b-llea-bb7a-01aa75ed71al). he-strateqic-plan 122019.pdf). 52 6. MEMBERS OF THE EXPERT GROUP The H2020 Expert Group to update and expand Gendered Innovations / Innovation through Gender (E03601) (European Commission, n.d.) (Gendered Innovations 2 Expert Group) was created in December 2018. It kicked off its activities in a first workshop organised on European Commission premises in Brussels by the DG R & I's Gender Sector, on 18-19 March 2019. Two more expert group workshops took place in Brussels, on 1-2 July 2019 and 25-26 November 2019. List of contracted experts Role in expert group Name and affiliation Country Chairperson Londa Schiebinger Professor of History of Science, Stanford University US Rapporteur Ineke Klinge Professor of Gender Medicine; President, Dutch Society for Gender and Health NL Subgroup 1: Methodology and conceptualisation Mathias Wullum Nielsen (Lead) Associate Professor, Department of Sociology, University of Copenhagen DK Anke Lipinsky Senior researcher, Centre of Excellence Women and Science (CEWS), GESIS - Leibniz Institute for the Social Sciences DE Petr Pavlik Professor, Department of Gender Studies, Faculty of Humanities, Charles University, Prague CZ Sabine Oertelt-Prigione Strategic Chair of Gender in Primary and Transmural Care, Radboud University, Nijmegen (also Lead of subgroup 2) NL Subgroup 2: Health, neuroscience, food Sabine Oertelt-Prigione (Lead) Strategic Chair of Gender in Primary and Transmural Care, Radboud University, Nijmegen (also in subgroup 1) NL Carole Clair Associate Professor, Gender and Medicine Unit Centre for Primary Care and Public Health, Lausanne University CH Edwin Mariman Professor of Functional Genetics, School of Nutrition and Translational Research in Metabolism, Department of Human Biology, Maastricht University NL Cara Tannenbaum Scientific Director, Institute of Gender and Health, Canadian Institutes of Health Research (also in subgroup 7) CA 53 Subgroup 3: Climate change, energy, environment, agriculture Meike Spitzner (Lead) Senior Expert at Wuppertal Institute for Climate, Environment, Energy, GmbH DE Robert P. Ellis NERC Industrial Innovation Fellow and Lecturer in Ecophysiology and Sustainable Aquaculture, University of Exeter UK Petra Piichner Commissioner for Europe at the Government of Baden-Württemberg; Head of Steinbeis-Europa-Zentrum DE Subgroup 4: Urban planning, geography, transport Ines Sanchez de Madariaga (Lead) Professor of Urban Planning and Director of UNESCO Chair on Gender Equality Policies in Science, Technology and Innovation, Universidad Politecnica de Madrid ES Barbara Lenz Director of the Institute of Transport Research, German Aerospace Centre; Professor for Transport Geography, Humboldt University Berlin DE Doris Damyanovic Associate Professor, Institute of Landscape Planning, Department of Landscape, Spatial and Infrastructure Sciences, University of Natural Resources and Life Sciences, Vienna (BOKU) AT Subgroup 5: ICT (Al, machine learning, Anat Katz-Arotchas (Lead) CEO, Standpoint - Product and Gender Consulting IL robotics), engineering and design Lorena Fernandez Alvarez Director of Digital Communication (Public Affairs), University of Deusto ES Sophia Ivarsson Program Director for Gender and Diversity for Innovation, Swedish Innovation Agency (Vinnova) SE Roger Andre Soraa Researcher at the Centre for Technology and Society, Norwegian University of Science and Technology (NTNU) NO Reuben Binns Associate Professor of Human Centred Computing, Department of Computer Science, University of Oxford UK Subgroup 6: Finance, taxation, Äsa Gunnarsson (Lead) Professor of Tax Law, Umeä University SE economics Subgroup 7: Communication Linda Marie Rustad (Lead) Director of Kilden Information Centre for Gender Perspectives and Gender Balance in Research NO Cara Tannenbaum Scientific Director Institute of Gender and Health, Canadian Institutes of Health Research (also in subgroup 2) CA Thomas Wachtel Director of Perlocutio UK 54 Assistant to Chairperson and Rapporteur Hannah Leblanc Mellon Postdoctoral Fellow in the Society for the Humanities and the Department of Science & Technology Studies, Cornell University US Coordinator of Communication and Dissemination Rosemary Rogers Programme manager and web expert, Stanford University, for the Gendered Innovations website US In addition to these 25 experts, four invited independent experts participated and contributed to this expert group: ► Nathalie da Silva, project manager, Energy Technology & Innovation, Steinbeis-Europa-Zentrum, Steinbeis 2i GmbH, Germany; ► Elisabet Ljunggren, professor at the Faculty of Social Sciences, Nord University, Norway; ► Margreet van der Burg, senior university lecturer/researcher in Gender Studies in Food, Agricultural and Rural Research and Development, Wageningen University, Netherlands; ► Bettina Bock, professor of Inclusive Rural Development, Wageningen University, Netherlands. Work cited European Commission (n.d), Register of Commission Expert Groups (https://ec.europa.eu/transparencv/reqexpert/index. cfm?do=qroupDetail.qroupDetail&qrouplD=5601& NewSearch=l&NewSearch=l). 55 ANNEXES ANNEX A - FIFTEEN FULL CASE STUDIES Health PRESCRIPTION DRUGS: ANALYSING SEX AND GENDER The challenge Historically, drug development has followed a 'one size fits all' model. Drug testing has been conducted predominantly on males, from preclinical research in rodents to clinical trials that include few women (Mazure and Jones, 2015). As a result, women report more unwanted, and sometimes deadly, side effects than men. In the late 1990s, 10 drugs were withdrawn from US markets. Of these, eight showed greater health risks for women (US General Accounting Office, 2001). Gendered innovation 1: Including females and males in all stages of drug development Female and male bodies metabolise drugs differently. For example, female bodies tend to take longer to digest food and to expel waste through their kidneys. Female and male livers process proteins and other molecules at different speeds (Franconi and Campesi, 2014). Because female-typical and male-typical bodies process drugs at different speeds, people with female-typical bodies may be at higher risk of side effects and overdose than people with male-typical bodies (Freire et al, 2011). In a recently published study, researchers reported that 76 out of the 86 drugs investigated displayed higher concentrations in female-typical bodies (Zucker and Prendergast, 2020). This was not explained by differences in body size, but seems to relate to complex physiological differences. The two main types of medications are small molecules (that bind to receptors in the body) and biologies (proteins, antibodies and other substances already found in humans). Small molecules may have sex-specific pharmacokinetics (how the body metabolised the drug) and pharmacodynamics (how the drug affects the body; see Figure 1). Female-typical bodies and male-typical bodies may also respond differently to biologies, since the production and function of immune cells and antibodies can be affected by an individual's sex chromosomes and levels of oestrogens and androgens. Women tend to have smaller body size and more fat tissue than men, which affects drug distribution, and smaller kidneys, which leads to slower drug elimination. Liver enzymes may behave differently because of oral contraception and some hormone therapy. Women's heart rhythms are different from men's (longer QT interval), which makes women more susceptible to fatal heart disturbances, called arrhythmias. © Sabine Oertelt-Prigione If female cells and animals are not included in the early phases of drug development, sex-specific differences in efficacy and toxicity will not be detected. And, if women are not included in clinical trials, the real-world effects of a medicine will not be detected before it is released to the market. Recognising these problems, the United States created the Food and Drug Administration Office of Women's Health (FDA-OWH) in 1994 57 SEX DIFFERENCES IN DRUG PROCESSING PHYSIOLOGICAL DIFFERENCES Body Composition SLOWER PROCESSING OF MOST DRUGS MORE ACCUMULATION OF LIPOPHILIC DRUGS DIFFERENT CONCENTRATIONS OF HYDROPHILIC DRUGS (ALSO THROUGHOUT THE MENSTRUAL CYCLE) ♦ Fat Mass * ♦ Lean Mass ♦ ♦ Free Water * FASTER PROCESSING OF MOST DRUGS LESS ACCUMULATION OF LIPOPHYLIC DRUGS DIFFERENT CONCENTRATIONS OF HYDROPHILIC DRUGS HIGHER RESTING HEART RATE LONGER QT INTERVALS HIGHER RISK OF ARRHYTHMIAS ♦ Heart Rate Variation * LOWER RESTING HEART RATE SHORTER QT INTERVALS LOWER RISK OF ARRHYTHMIAS SLOWER ABSORPTION OF DRUGS * Gastric Motility ♦ ♦ Stomach Acidity ♦ Liver Enzymes FASTER ABSORPTION OF DRUGS DIFFERENT EXPRESSION OF CYTOCHROME P450 (E.G. CYP3A4 MORE IN WOMEN) ESTROGENS AND PROGESTERONE COMPETE WITH DRUGS FOR DEGRADATION BY CYP450 DIFFERENT EXPRESSION OF CYTOCHROMES p450 (CYP; E.G. CYP2D6 AND CYP2E1 MORE IN MEN) SLOWER EXCRETION OF DRUGS * Kidney Excretion MEN Include 50% women Include adults over 75 Collect hormone status data Use sex-specific thresholds for biomarkers Investigate pharmacogenomic mechanisms Stratify sampres by age & sex Disaggregate & report results by age & sex 1. Promote data sharing Calculate sample size to detect age 2. Disaggregate results by sex or sex differences 3. Stratify by age \ 2 Recruit and retain women & older adults 4. Analyse sex and age interactions \ 3- Include pregnant women & adults with dementia 5. Consider dose adjustment \ 4- Collect hormone status data 6. Reverse translate observations into \ 5- Consider adaptive clinical trial designs basic science mechanisms to determine age- & sex-based dosing \ 6- Disaggregate and report raw data by age and sex Sex and age considerations in drug development and testing. Source: Tannenbaum et aL (2017), With permission. 60 Once gender bias is recognised, solutions should be implemented to narrow gaps in adverse outcomes (Tannenbaum et al, 2016). In the case of heart disease, it is well known that women experience symptoms of heart attack differently from men, leading to underdiagnoses in women (see case study 'Heart disease in diverse populations'). To redress this inequity, emergency physicians developed a four-step gendered protocol to bypass many of the gender biases in symptoms, testing, diagnosis and access to treatment (Huded et al, 2018). The study found that this protocol, coupled with improved access to treatment, cut mortality rates for women in half. # Method: analysing gender in biomedicine and health Gender stereotypes can affect clinical care in several ways. First, gender and age bias can affect the diagnostic questions asked to detect health conditions (Sheehan and Tucker-Drob, 2017; Verdam et al, 2017). Physicians and researchers should pay attention to language and gender norms in diagnostic procedures. Second, gender relations between the healthcare provider and the patient can affect prescribing patterns and treatment outcomes (Greenwood et al, 2018; Rochon et al, 2018). Age and race can also play a role. Gendered innovation 4: Promoting gender-transformative treatment approaches Gender-transformative approaches address the causes of gender-based inequities and seek to transform harmful gender norms, roles and relations (WHO, 2011). Consider that antianxiety and antidepressant drugs are prescribed more frequently to women, even though men are more likely to commit suicide. Is it because women behave differently, seeking healthcare services more often? Or do gender norms dictate how women and men are socialised to express feelings and emotions? Do the screening tools prescribers use to detect symptoms exhibit gender bias, preferentially asking about crying and helplessness? The result is a prescription regime that differs not only by sex but as a result of gender norms, behaviours and relations (Rochon et al, 2018). Raising awareness about gender bias in the expression of symptoms, screening questions and patterns of prescribing will help prevent harm. Gender bias in prescribing can affect men and women. Older women are more likely to receive inappropriate prescriptions both because of age and sex differences in pharmacokinetics and because of gendered patterns in prescribing (Tannenbaum et al, 2009; Morgan et al, 2016; Sramek et al, 2016). This is especially true among women diagnosed with dementia (Moga et al, 2017). Sometimes, however, the situation is reversed: when taking antipsychotic medication for the first time, subsequent hospitalisation and death rates among men with dementia exceed those in women. The use of antipsychotic and other medications can rapidly lead to the prescription of a second medication to treat the side effects of the first drug: a prescribing cascade. To help prevent prescribing cascades, sex and gender differences need to be understood. This is the aim of the project Identifying key prescribing cascades in the elderly (iKascade), funded by GENDER-NET Plus (n.d.), which is evaluating how men and women may react to an adverse event differently and to what extent they fall victim to prescribing cascades. Conclusions Addressing sex and gender in drug prescribing can start with relatively simple yet powerful steps, from including female and male cells, tissues and organisms throughout the testing process to reporting all data disaggregated by sex. These approaches will provide the knowledge needed to develop sex-specific dose adaptations of existing drugs, such as desmopressin or Zolpidem, and may lead to sex-specific treatments in the future. Physicians, pharma- 61 cists and patients should consider gender differences in how symptoms are experienced and expressed. What is reported and how it is reported affect which diagnostic steps occur and which medications are prescribed. Targeted impact-oriented recommendations for future research and innovation actions funded under Horizon Europe Cluster 1: Health Staying healthy in a rapidly changing society ► Medicines need to be more extensively tested in pregnant women (with safety as the first goal). ► Citizens need to be able to trust that the medicines they are taking are safe for everyone, that citizens are protected from inappropriate medicines, and that therapies are sufficiently tested in women, men and gender-diverse individuals, taking into account other intersecting factors, such as age and ethnicity, where relevant. ► Health literacy needs to be promoted in all patients to increase informed health decision-making. Tackling diseases and reducing disease burden ► Effective, cost-efficient and affordable treatment needs to be made available to all patients: women, men and other genders (taking into account other intersecting factors, such as age and ethnicity, where relevant). ► Strengthen expertise in sex-sensitive and gender-sensitive R & I in order to guarantee the excellence, inclusion and reach of the products developed. ► Diagnostics need to be tested for sex and gender sensitivity and specificity. ► Sex-disaggregated data are essential for the better surveillance, prevention, detection, treatment and crisis management of infectious disease threats. » Next Steps Accelerating these developments needs the following steps.: 1. Regulatory agencies should require (not simply recommend) sex-disaggregated reporting of all drug trial results by the pharmaceutical industry. Regulatory agencies should also ensure that sex-specific information is available to prescribers and patients on websites and drug labels. 2. Post-marketing surveillance studies should aim to detect sex-specific side effects and differences in response. Many pharmaceuticals currently on the market were tested and approved in years when women were excluded from clinical trials. Post-marketing surveillance is the only way to obtain data on sex differences in efficacy and toxicity in these drugs. 3. Researchers and physicians should further investigate gendered norms, identity and relations in medical communication and prescription outcomes. 62 Ensuring access to innovative, sustainable and high-quality healthcare ► A shift from hospital-based to community-based care needs to take gender dynamics into account. ► Healthcare leadership needs to be representative of social diversity. This will improve the ability to understand healthcare problems, find targeted and patient-centred solutions, and foster patient empowerment. ► The gender-related digital divide among healthcare professionals, e.g. in the nursing profession, needs to be addressed to guarantee quality and to ensure job retention. ► Gender aspects need to be considered in the development of digital tools to accompany medication regimens that are managed by patients (e.g. apps to monitor diabetes therapy). ► A holistic approach to health policy and systems requires a gender-sensitive intersectional approach. Unlocking the full potential of new tools, technologies and digital solutions for a healthy society ► To be innovative and world-class, healthcare must be sex-sensitive and gender-sensitive. ► Bias in Al solutions due to the sex bias in datasets (former and newly acquired) is a priority that needs to be addressed. Gender impact assessments of new Al solutions for drug targeting (and many other functions) should be mandated. ► Legal, regulatory and ethical frameworks need to consider gender inequalities in access and therapy, as well as sex and gender bias in the knowledge base used to develop innovative solutions. ► Co-creative approaches to health solution design need to include diverse patient and user groups. Maintaining an innovative, sustainable and globally competitive health industry ► For the EU health industry to be competitive internationally, solutions need to be diversified to reflect an international market. Gender affects access to care in parts of the world beyond the EU, and incorporating this aspect may represent a unique selling proposition for companies. ► Decreased time to market must not mean reducing the variables tested. Sex differences affect product efficacy in potentially 50 % of the population; withdrawing a product from the market owing to lack of appropriate testing can damage companies (especially SMEs) permanently. Mission area: cancer Since pharmacotherapy is a cornerstone of cancer therapy, all the considerations noted above for drug development apply to this mission. Furthermore, Al technologies are increasingly being used to diagnose cancer and identify viable therapeutic options. For these fields the considerations formulated for Al are highly significant. ► The proposed European initiative to understand cancer (UNCAN.eu) should ensure that all data collected will be sex-disaggregated and all results reported in a sex-disaggregated manner to facilitate future meta-analyses. ► Polygenic risk score development needs to be based on sex-disaggregated data and possibly lead to gender-sensitive risk counselling. ► Cancer prevention strategies should be gender-sensitive. This applies to the screening location (e.g. workplace versus primary care physician), delivery of information and facilitation of healthy lifestyle choices. 63 ► If big data and machine learning techniques will be employed for low-cost population risk prediction, inherent sex/ gender bias in the source data needs to be investigated and corrected for. ► Personalised medicine approaches for cancer need to be sex-specific and gender-sensitive to ensure equal access and benefits for all patients. ► Gender-specific barriers to access to early diagnostic and minimally invasive treatment technologies need to be removed in all EU Member States. ► QoL measurements of patients, survivors, family members and carers need to be gender-sensitive, calibrated according to differences in the general population and differentiated according to the dimensions of QoL. The impact of cancer on QoL might affect different domains in women, men and other genders. This needs to be considered for optimal support. ► The proposed European Cancer Patient Digital Centre needs to be equally accessible to all citizens, transcending possible inequalities in digital literacy. Sex-and gender-specific risk factors should be recorded. ► The future network of comprehensive cancer infrastructures needs to include expertise on sex/gender in oncology. ► Innovation and implementation of new technology in the field of cancer needs to be gender-sensitive to guarantee equal access and benefit for all. ► Person-centred care has to be gender-sensitive, patient participation should be equitable and include intersectional groups of women, men and other genders living with cancer. ► Sex- and gender-specific knowledge should be aggregated through expert committees for the mission board, such as ESMO's Gender in Oncology task force. Partnerships on health EU-Africa partnership on health security to tackle infectious diseases ► Focus on the sex- and gender-specific impacts of zoonoses and emerging and existing infectious diseases. Socioeconomic and logistic factors need to be considered alongside biological mechanisms of infection. ► Ensure gender-balanced representation of researchers in each country involved, and diversity of thematic approaches and methodologies. Innovative health initiative ► Ensure equal representation of interests and priorities among diverse stakeholder networks. ► Innovation should include a social, economic and cultural dimension in addition to its technical goals. European partnership for chemicals risk assessment ► Sex-specific aspects of exposure and metabolisation of chemicals should be addressed. ► The impact of gender on exposure, detection and protection should be considered. Large-scale innovation and transformation of health systems in digital and ageing society ► Include a focus on sex and gender in the innovation process. Dissect the needs of ageing women, men and individuals of other genders to ensure needs-driven innovation options. ► Investigate intrinsic biases in current health systems against women, other genders, ethnic minorities and socially disadvantaged individuals. Apply the results to develop socially impactful solutions. 64 Personalised medicine ► Avoid limiting the focus on solely biological and omics data when proposing preventative, diagnostic and therapeutic solutions. Social factors, e.g. gender, socioeconomic status and discrimination, can modify epigenetic and metabolic markers. These variables also affect access to personalised medicine and should be accounted for. Rare diseases ► Gendered aspects in the networks of care of people living with rare diseases should be analysed. ► Although complex statistics are limited by sample size, descriptive statistics should always report sex-specific data. Authors Professor Cam Tannenbaum, Scientific Director, Institute of Gender and Health Canadian Institutes of Health Research Professor, Medicine and Pharmacy Universite de Montreal Canada Professor Sabine Oertelt-Prigione Strategic Chair of Gender in Primary and Transmural Care Radboud University, Nijmegen Netherlands Works cited Bachelet, D., Hassler, 5., Mbogning, C, Link, J., Ryner, M., Ramanujam, R., Auer, M., Jensen, P. E. H., Koch-Henriksen, N., Warnke, C, Ingenhoven, K., Buck, D., Grummel, V., Lawton, A., Donnellan, N., Hincelin-Mery, A., Sikkema, D., Pallardy, M., Kieseier, B., Hemmer, B., Hartung, H. P., Sorensen, P. 5., Deisenhammer, R, Donnes, P, Davidson, J, Fogdell-Hahn, A, Broet, P. and ABIRISK Consortium (2016), 'Occurrence of anti-drug antibodies against interferon-beta and natalizumab in multiple sclerosis: a collaborative cohort analysis', PLoS ONE, 11, e0162752. doi:10.1371/journal.pone.0162752. Conforti, F, Pala, L, Bagnardi, V, De Pas, T, Martinetti, M, Viale, G, Gelber, R. D. and Goldhirsch, A. (2018), 'Cancer immunotherapy efficacy and patients' sex: a systematic review and meta-analysis', Lancet Oncology, 19(6), 737-746 (https://doi.orq/10.1016/51470-2045(18)30261-4). Dandara, C, Swart, M., Mpeta, B., Wonkam, A. and Masimirembwa, C. (2014), 'Cytochrome P450 pharmacogenetics in African populations: implications for public health', Expert Opinion on Drug Metabolism & Toxicology, 10(6), 769-785 (https://doi.org/10.1517/1742 5255.2014.894020). Docherty, J. R, Stanford, S. C, Panattieri, R. A, Alexander, S. P., Cirino, G, George, C. H, Hoyer, D, Izzo, A. A, Ji, Y, Lilley, E., Sobey, C. G., Stanley, P., Stefanska, B., Stephens, G., Teixeira, M. and Ahluwalia, A. (2019), 'Sex: a change in our guidelines to authors to ensure that this is no longer an ignored experimental variable', British Journal of Pharmacology, 176,4081-4086. doi:10.1111/bph.l4761. Franconi, F. and Campesi, I. (2014), 'Sex and gender influences on pharmacological response: an overview', Expert Review of Clinical Pharmacology, 7(4), 469-485. doi:10.1586/17512433.2014.922866. Freire, A. C, Basit, A. W, Choudhary, R, Piong, C. W. and Merchant, H. A. (2011), 'Does sex matter? The influence of gender on gastrointestinal physiology and drug delivery', International Journal of Pharmaceutics, 415(1-2), 15-28 (https://doi.orq/10.1016/i.iipharm.2011.04.069). G-Definer (2020), 'Gender difference in side effects of immunotherapy: a possible clue to optimize cancer treatment' (https://qdefiner.net/). GENDER-NET Plus (n.d.), 'Identifying key prescribing cascades in the elderly: a transnational initiative on drug safety' (http://qender-net-plus.eu/ioint-call/funded-projects/ikascade/). 65 Giefing-Kroll, C, Berger, P., Lepperdinger, G. and Grubeck-Loebenstein, B. (2015), 'How sex and age affect immune responses, susceptibility to infections, and response to vaccination', Aging Cell, 14(3), 309-321. doi:10.1111/ acel.12326. Greenwood, B. N., Carnahan, 5. and Huang, L. (2018), 'Patient-physician gender concordance and increased mortality among female heart attack patients', Proceedings of the National Academy of Sciences, 115(14), 8569-8574. Huded, C. P, Johnson, M, Kravitz, K, Menon, V, Abdallah, M., Gullett, T. C, Hantz, 5., Ellis, 5. G., Podolsky, 5. R., Meldon, 5. W, Kralovic, D. M, Brosovich, D, Smith, E, Kapadia, S. R. and Khot, U. N. (2018), 'Four-step protocol for disparities in STEMI care and outcomes in women', Journal of the American College of Cardiology, 71(19), 2122-2132. doi:10.1016/j.jacc.2018.02.039. Juul, K. V., Klein, B. M., Sandstrom, R., Erichsen, L. and Norgaard, J. P. (2011), 'Gender difference in antidiuretic response to desmopressin', American Journal of Physiology-Renal Physiology, 300(5), F1116-1122. doi:10.1152/ajprenal.00741.2010. Mastroianni, A. C, Faden, R. and Federman, D. (eds.) (1994), Women and Health Research: Ethical and legal issues of including women in clinical studies, Vol. I, National Academies Press, Washington, DC. Mazure, C. M. and Jones, D. P. (2015), 'Twenty years and still counting: including women as participants and studying sex and gender in biomedical research', BMC Women's Health, 15(1), 94. doi:10.1186/sl2905-015-0251-9. Moga, D. C, Taipale, H., Tolppanen, A. M., Tanskanen, A., Tiihonen, J., Hartikainen, S., Wu, Q., Jicha, G. A. and Gnjidic, D. (2017), 'A comparison of sex differences in psychotropic medication use in older people with Alzheimer's disease in the US and Finland', Drugs & Aging, 34(1), 55-65. doi:10.1007/s40266-016-0419-5. Morgan, S. G., Weymann, D., Pratt, B., Smolina, K., Gladstone, E. J., Raymond, C. and Mintzes, B. (2016), 'Sex differences in the risk of receiving potentially inappropriate prescriptions among older adults', Age and Ageing, 45(4), 535-42. doi:10.1093/ageing/afw074. Obias-Manno, D., Scott, P. E., Kaczmarczyk, J., Miller, M., Pinnow, E., Lee-Bishop, L, Jones-London, M., Chapman, K., Kallgren, D. and Uhl, K. (2007), 'The Food and Drug Administration Office of Women's Health: impact of science on regulatory policy', Journal of Women's Health, 16(6), 807-817 (https://doi.org/10.1089/iwh.2006.0135). Rochon, P. A, Gruneir, A, Bell, C. M, Savage, R, Gill, S. S, Wu, W, Giannakeas, V, Stall, N. M, Seitz, D. P, Normand, S.-L, Zhu, L, Herrmann, N., McCarthy, L, Faulkner, C, Gurwitz, J. H, Austin, P. C. and Bronskill, S. E. (2018), 'Comparison of prescribing practices for older adults treated by female versus male physicians: a retrospective cohort study', PLoS ONE, 13(10), e0205524 (https://doi. orq/10.1371/iournal.pone.0205524). Schiebinger, L, Klinge, I., Sanchez de Madariaga, I., Paik, H. Y., Schraudner, M. and Stefanick, M. (eds.) (2011-2020), 'Policy recommendations', Gendered Innovations in Science, Health & Medicine, Engineering, and environment (http://qenderedinnovations.stanford. edu/policy landinq.html). Sheehan, C. M. and Tucker-Drob, E. M. (2017), 'Gendered expectations distort male-female differences in instrumental activities of daily living in later adulthood', Journals of Gerontology: Series B, 74(4), 715-723. Spoletini, I., Vitale, C, Malorni, W. and Rosano, G. M. C. (2012), 'Sex differences in drug effects: interaction with sex hormones in adult life', in: Regitz-Zagrosek, V. (ed.), Sex and Gender Differences in Pharmacology: Handbook of experimental pharmacology, Vol. 14, Springer, Berlin and Heidelberg, pp. 91-105 (https://doi.org/10.1007/978-3-642-30726-3 5). Sramek, J. J, Murphy, M. F. and Cutler, N. R. (2016), 'Sex differences in the psychopharmacological treatment of depression', Dialogues in Clinical Neuroscience, 18(4), 447-457. Tannenbaum C, Day D. and Matera Alliance (2017), 'Age and sex in drug development and testing for adults', Pharmacological Research, 121,83-93 (https://doi. orq/10.1016/i.phrs.2017.04.027). Tannenbaum, C, Lexchin, J., Tamblyn, R. and Romans, S. (2009), 'Indicators for measuring mental health: towards better surveillance', Healthcare Policy = Politiques de sante, 5(2), el77-el86. Tannenbaum, C, Greaves, L. and Graham, I. D. (2016), 'Why sex and gender matter in implementation research', BMC Medical Research Methodology, 16(1), 145. US General Accounting Office (2001), Drug Safety: Most drugs withdrawn in recent years had greater health risks for women, Government Publishing Office, Washington, DC. Verdam, M. G, Oort, F. J. and Sprangers, M. A. (2017), 'Item bias detection in the Hospital Anxiety and Depression Scale using structural equation modeling: comparison with other item bias detection methods', Quality of Life Research, 26(6), 1439-1450. 66 Welch, V, Petticrew, M, Petkovic, J, Moher, D, Waters, E, White, H, Tugwell, P., Atun, R, Awasthi, 5, Barbour, V. and Bhutta, Z. A. and PRISMA-Equity Bellagio group (2012), 'PRISMA-Equity 2012 extension: reporting guidelines for systematic reviews with a focus on health equity', PLOS Medicine, 9(10), el001333 (https://doi.org/10.1371/ iournal.pmed.1001333). Welch, V. A, Norheim, 0. F, Jull, J, Cookson, R, Sommerfelt, H, Tugwell, P. and CONSORT-Equity and Boston Equity Symposium (2017), 'CONSORT-Equity 2017 extension and elaboration for better reporting of health equity in randomised trials', BMJ, 359, J5085. WHO (2011). 'WHO Gender Responsive Assessment Scale: criteria for assessing programmes and policies', in: WHO Gender Mainstreaming Manual for Health Managers: A practical approach (https://www. who.int/qender/mainstreaminq/GMH Participant GenderAssessmentScale.pdf). Zucker, I. and Prendergast, B. (2020), 'Sex differences in pharmacokinetics predict adverse drug reactions in women', Biology Sex Differences, 11(1), 1-14 (https://doi. orq/10.1186/sl3293-020-00308-5). 67 SYSTEMS BIOLOGY: COLLECTING SEX- AND GENDER-SPECIFIC DATA The challenge Systems biology is the computational and mathematical modelling of complex biological systems. It is an interdisciplinary field of study that focuses on complex interactions within biological systems (Tavasso-[y et al, 2018). Systems biology lets us understand how interactions among multiple components form functional networks at the organism level. For example, Tareen et al. (2019) used systems biology to identify a molecular switch that tissues use to rely either on glucose or on fatty acids as fuel. Systems biology also develops computational predictive models of disease that will transform disease taxonomies from phenotypical to molecular and will enable personalised/precision therapeutics (Bielekova et al, 2014). Systems biologists often use omics data (genomics, transcriptomics, proteomics, metabolomics) to provide broad insight into the molecular dynamics that accompany genetic, cultural, ethnic and societal influences on a living organism. For example, a high daily intake of fat (related to cultural and societal factors) has a negative influence on the metabolic performance of tissues in the body and increases the risk of type II diabetes. Systems biologists use omics data to understand a tissue's metabolic status over time. Since there is sex and gender bias in omics data, current biological models mainly apply to cisgender men, whereas models of other bodies and genders are underrepresented. Gendered innovation 1: Collecting data on sexual dimorphism in gene expression improves biological modelling Omics studies of animal organs and body fluids have demonstrated sex differences in biochemistry and the regulation of gene activities. In the liver, for example, over 1000 genes are expressed differently in females and males. Sex differences in metabolic and gene regulatory pathways have also been demonstrated in humans. For example, metabolomic analysis of serum from participants in the German Kooperative Gesundheitsforschung in der Region Augsburg (Cooperative health research in the Augsburg region, KORA) cohort9 showed significant sex differences in concentration for 102 of 131 examined metabolites (Mit-telstrass et al, 2011). Sex-specific genome-wide association studies showed that some of these sex differences resulted from genetic differences. Despite these suggestive results, most systems biology studies have not considered sex. Data on human sexual dimorphism are limited. Because biopsy material cannot be taken from many of the organs of living individuals, new strategies need to be designed to intensify studies on sexual dimorphism in genome expression such as the use of induced pluripotent stem cells or organoids. Ideally, such studies would take into account differences in lifestyle, ethnicity, and cultural and social background in an attempt to incorporate intersectional factors into the datasets. KORA studies are conducted at regular intervals in order to assess the health status of the population in Augsburg and the surrounding area (https://www.helmholtz-muenchen.de/en/kora/). 68 Female vs Male tissue samples Ethnicity Culture Social environment Genetic variation Epigenetic influences Omics-analysis Sexual dimorphism Female vs male Ä omics data Transcriptomics Wgii Proteomics Metabolomics Multi-omics Sex-specific precision applications Next generation sequencing GI2 Metagenomics Sex-specific microbiome GI3 Fluxomics Computational modeling Female/male metabolic models GI4 Schematic overview of the gendered innovations in relation to genetics and genomics approaches underlying systems biology. © Edwin Mariman Gendered innovation 2: Collecting sex and gender data fuels integrative omics Integrative omics serves as a foundation for precision medicine, pharmacotherapy and nutrition (Karczewski & Snyder, 2018). Meta-analysis of omics data is a way to find novel diagnostic biomarkers, drug targets or nutritional pathways to prevent the onset of disease. Integrating sex and gender identity into the source data for integrative omics will be an essential first step towards more personalised medicine. Current datasets underrepresent females and lack information about participants' gender identity. Concerning information on the influence of gender identity, in 2018 the gender dysphoria treatment in Sweden (GETS) study was announced to investigate if and how cross-sex hormone treatment to align gender identity with physical appearance leads to metabolic and functional changes including at the genomic and epigenomic levels (Wiik et al, 2018). Big data that include social and cultural information can open the way to sex- and gender-specific precision medicine. 69 # Method: collecting sex- and gender-specific data The amount, quality and precision of data have an essential influence on research output The growing use of large datasets and their integration into fields such as precision medicine, pharmacotherapy and nutrition bring this aspect to the forefront When collecting information about sex, clear decisions need to be made on how sex is operationalised (e.g. through genomics data alone or in combination with hormonal profiles and phenotype). The same applies to the potential inclusion of gender in these analyses. Currently, the only immediately available option is the collection of data about gender identity; however, as instruments become more refined, information on gender norms and behaviours could also be collected. The integration of this information could generate new personalised therapies or preventative offers. Microbial Status Development and dynamic changes of the gut microbiome over the course of human life. Perturbing factors help to shape the microbiome during early life but also influence its composition and diversity during adulthood. Some factors may eventually lead to dysbiosis and reduced diversity leading to increased risk of certain diseases. Source: Chen et al. (2018), with permission Gendered innovation 3: Analysing sex improves understanding of the role of the microbiome in health and disease Awareness of the gut microbiome's role in health and disease is growing. Using gene sequencing to construct a metagenome, researchers can now analyse the composition of the microbiome and quantify different types of microorganisms present in our gut. The mi- crobiome is influenced by the genetic make-up of the host as well as by cultural and societal circumstances. Such sequencing has found differences in women's and men's microbiomes. Sex differences in the microbiome may not only contribute to sex differences of gut-related diseases, but could also underlie sex differences in neurological and neurodegenerative disorders (Thion et al, 2018) (see the Horizon 2020 project A systems medicine approach to chronic 70 inflammatory diseases (Syscid; Syscid, 2020)). Research has shown that women tend to have microbiomes with significantly higher microbial diversity than men (Chen et aL, 2018). The make-up of the microbiome is likely influenced by contraceptives with oestrogen, which modify the growth conditions in the gut. Women's microbiomes display higher resistance to various classes of antibiotics, which seem to follow differences in antibiotics use (Sinha et aL, 2019) (see the Horizon 2020 project The role of the virome in shaping the gut ecosystem during the first year of life (BabyVir; BabyVir, 2017)). These novel observations warrant more profound investigation and may result in sex-specific analysis of health and disease. Gendered innovation 4: Integrating sex difference into systems biology models Because biomedical experiments more often use male animals and humans, more data about males than females are available to systems biology researchers. Consequently, mathematical models in biology are almost exclusively based on male data. In order to close this sex gap, journals and granting agencies should promote data collection on females, which is a prerequisite for the generation of female-based models in parallel to the existing male-based models. In the meantime, systems biologists should label the sex of the data on which their models are built. Naik et al. (2014) constructed the in silico model SteatoNet using liver metabolic data, to help research better understand liver disease aetiology, but this model is valid for males only (Naik et al, 2014). Cvitanovic Tomas et al. (2018) have adapted SteatoNet to include sex differences by using data on oestrogen and androgen receptor responses and consequent differences in growth hormone release. They call their computational model LiverSex and hope it will provide insight into sex-dependent liver pathologies. It has been validated for mice, but not yet for humans. Liver glucose-l-phosphate Phospho- ^ glucomutase 200.18 glucose-6- f phosphate/\ e.g., Glucose-B-phosphate isomerase 473.91 pyruvate L-alanine transaminase 117.29 T Blood glycogen r, ># TGlycogen i Phosphorylase 57.844' • Muscle Glucose exchange 976.02 D-glucose Glucose exchange 10.00 D-glucose D-glucose Hexokinase 24.73 L-lactate dehydrogenase 906.34 Lactate exchange .1268.04 Lactate exchange 644.38 L-lactate dehydrogenase 520.08 L-lactate L-lactate L-lactate L-alanine L-alanine exchange 144.23 L-alanine L-alanine exchange 144.23 phosphate e.g., Pyruvate kinase 28.04 V ♦pyruvate ■alanine transaminase •130.33 ■•py tre 4"13 e L-alanine Single reaction ■ ^ Pathway, only one reaction shown Systems biologic analysis of the metabolic Cori and Cahill cycle fluxes in Harvetta. Source: Thiele et al, 2018, with permission 71 In the context of physiology and metabolism, researchers at the universities of Luxembourg and Leiden recently presented two validated, sex-specific, whole-body metabolic reconstructions, named Harvey and Harvetta (Thiele et al, 2018). The models represent the metabolism of 20 organs, 6 sex organs, 6 types of blood cells, the systemic blood circulation, the blood-brain barrier and the gastrointestinal lumen with microbiome. Eventually, such models can be used to determine treatment methods in situations in which experimental testing is impossible, such as for pregnant women. Conclusion The human metabolism is influenced by sex and gender where genetic backgrounds interact with environmental factors that include lifestyle, ethnicity, culture and social norms. Systems biology is a relatively new discipline with a growing impact on medical science. In the near future, it will enable the construction of mathematical models that can predict individual risk for common non-communicable diseases and guide best practices for prevention or therapy. Modelling is largely based on omics data, which at present lack information regarding sex and gender. This should be addressed in the following ways: ► Studies on sexual dimorphism need to be performed in humans in different living conditions. ► Integrative omics will enable more individualised approaches to disease prevention and therapy. Source data need to include information on sex and gender (including cis- and non-binary genders). ► The gut microbiome plays a role in health and risk of disease. Since the microbiome differs by sex, analysis of the microbiome should include sex as a robust variable. ► Although a few examples of male and female models of the human metabolism have been developed, the majority of published models have been generated using male data. In such cases, the limitations of the model should be addressed. In some instances, the model can be retrofitted to include sex. » Next Steps In systems biology the influence of sex and gender has received only limited attention. However, systems biology is still a young field. It is now the time to incorporate sex and gender as significant parameters in the design of omics experiments and mathematical modelling. Researchers, journals and funding agencies can raise awareness of the limits of single-sex datasets and make sex and gender analysis the norm in genomics, genetics and systems biology research. Targeted impact-oriented recommendations for future research and innovation actions funded under Horizon Europe In the context of omics applications and systems biology, it is necessary to integrate sex and/or gender analysis in the following. Cluster 1: Health Staying healthy in a rapidly changing society Research needs to better understand human health during all stages of life, delineating the factors affecting health and defining resilience to disease. Sex and gender are such factors and must be integrated into research design. Research aims to personalise advice regarding health promotion and disease prevention for individuals, or to tailor stratified solutions for 72 specific groups. Health and disease are strongly sex and gender related. Personalised and tailored solutions and advice can only be achieved when sex and gender are analysed in the research. Tackling diseases and reducing disease burden Research seeks to improve methodologies and diagnostics that allow timely and accurate diagnosis, identification of personalised treatment options and assessment of health outcomes. Methodologies and diagnostics often still exclude sex and gender; incorporating sex and gender analysis (along with other intersecting health factors) in novel research will lead to significant improvement. Unlocking the full potential of new tools, technologies and digital solutions for a healthy society Researchers are developing novel tools and technologies for biomedical research, prevention, diagnosis and therapy of diseases, and tools for monitoring treatment progression. Novel tools and technologies will probably be data driven. It is crucial that these source data be clearly and precisely annotated for sex and gender. Research aims to develop computer models and simulations for understanding health, and improving healthcare and person-centred care. Computer models and simulations must rigorously incorporate sex and gender. Again, this requires that sex and gender be integrated into the production process starting from precisely annotated sex- and gender-specified source data. Mission area: cancer Top experts propose that, by 2030, more than 3 million more lives can be saved, with people living longer and better. We can achieve a thorough understanding of cancer, improve prevention, improve diagnosis and treatment, support the quality of life of all people exposed to cancer and ensure equitable access to the above across Europe. Sex and gender are inherent to cancer risk, cancer development and precision treatment. To ensure equitable access for all Europeans, sex and gender must be considered in cancer studies, cancer data analysis and modelling of treatments. Partnerships on health: personalised medicine Personalised medicine is a medical model using the characterisation of individuals' phenotypes and genotypes (e.g. molecular profiling, medical imaging, lifestyle data) to tailor the right therapeutic strategy for the right person at the right time, and/or to determine predisposition to disease and/or to deliver timely and targeted prevention. Because sex and gender are elements of each individual's genotype and phenotype, it is strongly recommended that sex and gender be integrated into all research aimed at implementing and improving personalised medicine. The partnership on personalised medicine will be composed of European and international stakeholders such as health and research/ innovation ministries, regional authorities, research-funding agencies and healthcare institutions. Partners are strongly encouraged to incorporate sex and gender expertise into proposals for collaborative and coordinative activities regarding personalised medicine. Author Professor Edwin Mariman NUTRIM School of Nutrition and Translational Research in Metabolism Department of Human Biology Maastricht University Netherlands 73 Works cited BabyVir (2017), 'The role of the virome in shaping the gut ecosystem during the first year of life', CORDIS, 22 February (https://cordis.europa.eu/project/id/715772). Bielekova, B., Vodovotz, Y., An, G. and Hallenbeck, J. (2014), 'How implementation of systems biology into clinical trials accelerates understanding of diseases', Frontiers in Neurology, 5,102. Chen, L, Garmaeva, 5., Zhernakova, A., Fu, J. and Wijmenga, C. (2018), 'A system biology perspective on environment-host-microbe interactions', Human Molecular Genetics, 27(R2), R187-R194. Cvitanovic Tomas, I, Urlep, Z., Moskon, M., Mraz, M. and Rozman, D. (2018), 'LiverSex computational model: sexual aspects in hepatic metabolism and abnormalities', Frontiers in Physiology, 9, 360. Karczewski, K. J. and Snyder, M. P. (2018), 'Integrative omics for health and disease', Nature Reviews Genetics, 19(5), 299-310. Mittelstrass, K., Ried, J. 5., Yu, Z., Krumsiek, J., Gieger, C, Prehn, C, Roemisch-Margl, W., Polonikov, A., Peters, A., Theis, F. J., Meitinger, I, Kronenberg, F, Weidinger, 5., Wichmann, H. E, Suhre, K, Wang-Sattler, R, Adamski, J. and lllig, T. (2011), 'Discovery of sexual dimorphisms in metabolic and genetic biomarkers', PLoS Genetics, 7(8), el002215. Naik, A, Rozman, D. and Belie, A. (2014), 'SteatoNet: the first integrated human metabolic model with multi-layered regulation to investigate liver-associated pathologies', PLoS Computational Biology, 10(12), el003993. Sinha, I, Vich Vila, A., Garmaeva, 5., Jankipersadsing, 5. A., Imhann, F, Collij, V., Bonder, M. J., Jiang, X., Gurry, T, Aim, E. J, D'Amato, M, Weersma, R. K, Scherjon, S.,Wijmenga, C, Fu, J., Kurilshikov, A. and Zhernakova, A. (2019), 'Analysis of 1135 gut metagenomes identifies sex-specific resistome profiles', Gut Microbes, 10(3), 358-366. Syscid (2020), 'A systems medicine approach to chronic inflammatory disease', CORDIS, 13 September (https:// cordis.europa.eu/project/id/733100). Tareen, S. H., Kutmon, M., Arts, I. C, de Kok, T. M., Evelo, C. T. and Adriaens, M. E. (2019), logical modelling reveals the PDC-PDK interaction as the regulatory switch driving metabolic flexibility at the cellular level', Genes & Nutrition, 14, 27. Tavassoly, I., Goldfarb, J. and Iyengar, R. (2018), 'Systems biology primer: the basic methods and approaches', Essays Biochemistry, 62(4), 487-500. Thiele, I., Sahoo, S., Heinken, A., Heirendt, L, Aurich, M. K., Noronha, A. and Fleming, R. M. T. (2018), 'When metabolism meets physiology: Harvey and Harvetta', bioRxiv (https://doi.org/10.1101/255885). Thion, M. S., Low, D., Silvin, A., Chen, J., Grisel, P., Schulte-Schrepping, J., Blecher, R., Ulas, T., Squarzoni, P., Hoeffel, G., Coulpier, F, Siopi, E., David, F. S., Scholz, C, Shihui, F, Lum, J., Amoyo, A. A., Larbi, A., Poidinger, M., Buttgereit A., Lledo, P.-M, Greter, M, Kok Yen Chan, J, Amit, I, Beyer, M., Schultze, J. L, Schlitzer, A., Pettersson, S., Ginhoux, F. and Garel, S. (2018), 'Microbiome influences prenatal and adult microglia in a sex-specific manner', Cell, 172(3), 500-516. Wiik, A., Andersson, D. P., Brismar, T. B., Chanpen, S., Dhejne, C, Ekstrom, T. J., Flanagan, J.N., Holmberg, M., Kere, J, Lilja, M., Lindholm, M. E., Lundberg, T. R., Maret, E, Melin, M, Olsson, S. M, Rullman, E, Wahlen, K., Arver, S. and Gustafsson, T. (2018), 'Metabolic and functional changes in transgender individuals following cross-sex hormone treatment: design and methods of the GEnder Dysphoria Treatment in Sweden (GETS) study', Contemporary Clinical Trials Communications, 10, 148-153. 74 CHRONIC PAIN: ANALYSING HOW SEX AND GENDER INTERACT The challenge Sex and gender affect ail parts of the pain pathway, from signalling, through perception, to expression and treatment Recent studies have shown that women generally display a lower pain threshold for all types of pain: pressure, heat, cold, chemical or electrical stimulation, and ischaemia (Bartley & Fillingim, 2013; Mogil, 2012; Mogil, 2020). Some researchers attribute these differences solely to biological (sex) differences; others suggest that these observed differences are, at least in part, diminished or amplified by gender (Boerner et al, 2018). The fact that women and men are raised to express pain differently may modify both their biological response to pain and their willingness to report it (Samulowitz et al, 2018). This case study focuses on how sex and gender interact in pain. Chronic pain affects 20 % of the adult population. 'Chronic pain' means pain that persists past normal healing time and is commonly defined as pain that lasts more than 3 months (Merskey & Bogduk, 1994). Women, men and gender-diverse people all experience chronic pain. A higher prevalence of chronic pain has been reported in women than in men (Greenspan et al, 2007; Mogil, 2012); see figure below. Differences in the sources of pain also vary: migraine, rheumatoid arthritis and fibromyalgia are more prevalent in women, while cluster headaches are more prevalent in men (Sorge & Totsch, 2017). Musculoskeletal 60---^ b. Widespread 60--^^-;-.-;................ ■ Male 50-B Female ........... £ 40............................ oj ! 20..........J.............. * lo-j-tH...........i 111111 c rö oj +d <£ c NU > ä * 1 I f c. Migraine 60—— -.............................. ■ Male 50- ■ Female .........................■ £ 40........................................... cu u JmJjJJJJj ^ 3 c >- "C ■—i I"-- ir, rC -9_aj£,ca!oo£E 3 3 CL CL I- d. Neuropathic 60 —■■■■ ■ ■ Male 50-HI Female £ 40 cu u 1 ™ °- 10............. 0- g a s 1/1 rd rö t e. Back 60- 50-^40. £ 30- 20-10- I Male I Female 1.11 1 o £ rö (u E 3 o 'ŠT t= OJ í= Z> E o g. Oral ■ Male 50......Female £ 40 u o c (u rö Tg S 3 B <3 I Difference in prevalence of several common chronic pain conditions in females and males. Data from Mogil (2012); chart created by Jeff Mogil, used with permission 75 The differences between female-typical bodies and male-typical bodies have been studied the most. Evidence is only beginning to emerge for other genders. Recent reports indicate that transgender people are more likely to suffer from chronic pain than cisgender people (Dragon et aL, 2017), but comprehensive statistics in this field are still missing. Gendered innovation 1: Studying the underlying biological mechanisms of pain in female-typical bodies and male-typical bodies may promote sex-specific treatment The nervous system and the immune system are both involved in the development, maintenance and control of chronic pain. In experiments with male and female mice, injuries to peripheral nerves caused increased sensitivity to pain. In females, T-lymphocytes (white blood cells) mediated the response. In males, the response depended on central nervous system cells called microglia (which act as immune cells) instead. The researchers found that testosterone activates microglia and suppresses T-cells, whereas oestrogens activate T-cells. Although in both cases the result is increased sensitivity to pain, the pathways are different. In the future this could possibly lead to the development of female- and male-specific painkillers (Sorge and Totsch, 2017). The researchers were also able to show that changing hormonal profiles throughout the lifespan influenced the pain pathway. Pregnant female mice, for example, switched to the male-typical pathway, while male mice that lacked testosterone switched to the female-typical pathway. If the results can be confirmed in humans, this could have an impact on humans throughout their lifetimes, and affect treatment choices in patients undergoing hormone therapy. Additional mechanisms might influence pain perception in females and males. Animal studies have shown that the number of certain pain receptors is higher in female brains (Sorge & Totsch, 2017), while the descending pain control pathways - where the brain inhibits pain perception despite injury - activate more strongly in males (Sorge & Totsch, 2017). Similar sex differences may influence human pain. In the EU-funded Horizon 2020 project Modelling neuron-glia networks into a drug discovery platform for pain efficacious treatments (NGN-PET; NGN-PET, 2019), researchers are modelling neuron-glia networks in an effort to discover new pain treatments. The role of both neurons and glial cells in chronic pain is well documented but has not been exploited to develop novel specific painkillers that target neuronal-glial interactions. One objective of this project is to understand the specific mechanisms involved in common neuropathic diseases and if these explain the higher susceptibility of women to neuropathic pain. This approach might lead to a better understanding of sex-specific pain mechanisms, help identify new targets for pain treatments and improve pain treatments in a sex-specific manner. Gendered innovation 2: Studying how sex and gender interact, and how sex and sex interact Sex and gender interact Pain perception and expression are influenced by many factors, for example social support, previous experience of pain, ethnicity and the concomitant presence of other diseases such as depression. Gender stereotypes can also modulate pain perception. In a study of 120 men in Germany, two groups of men were enrolled and given opposite preliminary information. One group was told that men were less sensitive to pain than women because of their evolutionary role as hunters, while the other group was told that women are less sensitive to pain because of the painful process of childbirth. The men in the first group reported less sensitivity to pain in the subsequent experiments. The associated functional magnetic resonance imaging study suggests that this gender priming changed pain perception, and not just the willingness to report pain (Schwarz et aL, 2019). More research in this area, including with gender-diverse people, is needed. 76 Sex and sex interact Researchers' sex can also influence response to pain. In animal studies, mice and rats exposed to painful stimuli displayed less discomfort when the experimenter was male than when it was a female (Sorge et al, 2014). The phenomenon appears to be mediated by olfactory stimuli, i.e. the animals smell the pheromones of the experimenter. Male rodents experienced physiological stress when smelling other males (in this case humans), which dampened the intensity of the perceived pain. This phenomenon, which the authors label the 'male observer effect', seemed to be present in both male and female rodents, although it was more pronounced in female rodents. The role of olfactory substances in the modulation of pain has also been reported in humans (Villemure & Bushnell, 2007). In one study, olfactory exposure to androstadienone (a male sexual steroid) improved mood in women but not in men. When women were exposed to a pain stimulus, androstadienone increased pain intensity among women which might be explained by a heightened attentional state produced by the exposure to steroid hormones. Unfortunately, the researchers did not report the gender identity or sexual orientation of the participants, which might affect the female and male reactions to androstadienone. # Method: analysing how sex and gender interact How the Interaction of Sex and Gender Influences Pain Signaling Perception Emotion Expression Motor Verbal Physiologic Treatment 4 Delay in treatment Choice of treatment Treatment dosage Treatment effect SEX & GENDER Hormones Immune cells Genetic predisposition Gender role expectations Gender priming Gender relations (patients & providers) Systems biologic analysis of the metabolic Cori and Cahill cycle fluxes in Harvetta. Source: Thiele et al., 2018, with permission Several biological mechanisms influence the signalling, perception, expression and treatment of pain in female-typical and male-typical bodies (Bartley & Fillingim, 2013; Fillingim et al, 2009). Gender roles and stereotypes can also influence pain signalling and perception, although more work is needed to understand these mechanisms. Gender also affects the expression and treatment of pain. 77 The EU-funded Horizon 2020 project Understanding risk factors and determinants for neuropathic pain (DOLORisk; DOLORisk, 2020) is exploring factors and determinants for neuropathic pain: pain caused by damage to the nervous system. The researchers consider genetic, environmental/societal and clinical risk factors for neuropathic pain. By including gender and sex dimensions in both the genetic and environmental aspects of pain, the authors are increasing the chances of identifying vulnerable patients. Gendered innovation 3: How gender affects the reporting and treatment of pain Gender roles and identity influence how pain is experienced, patients' readiness to report pain and pain management by healthcare professionals. Patient gender Men may be less willing to report pain than women because dominant masculine gender roles associate male identity with toughness and stoicism (Robinson et al, 2001; Myers et al, 2003). Similarly, women are expected to report pain more readily. From childhood, girls and boys are frequently socialised to respond differently to pain, and these attributes can vary between cultures and countries (Samulowitz et al, 2018). Researchers have demonstrated that these gender norms can be changed and that this can affect perceived sensitivity to pain (Robinson et al, 2003). Gender assumptions in healthcare providers Healthcare providers, who themselves embody gender identity, roles and relations, may treat their patients differently depending on their beliefs and subconscious assumptions. For example, some reports have shown that healthcare providers are more likely to classify pain as of psychological rather than physical origin in women than in men (Hoffmann & Tarzian, 2001). Men who suffer from chronic pain might find their masculinity questioned (Bernardes & Lima, 2010). Pain might also be managed differently in women and men. Gender stereotypes may influence the treatments that physicians prescribe for women versus men reporting pain, and the choice of therapy in acute versus chronic settings. For example, in emergency medicine and prehospital settings, women with acute pain have been reported to obtain fewer painkillers, especially opioids (Lord et al, 2009), and wait longer than men for treatment (Chen et al, 2008). In these acute settings, women appear to receive more non-specific diagnoses, be treated less aggressively and be prescribed more antidepressants than painkillers compared with men (Hamberg et al, 2002; Hirsh et al, 2013; Hirsh et al, 2014). Conversely, women with chronic pain are more likely to be prescribed opioids than men (Serdarevic et al, 2017; Simoni-Wastila, 2000). This places women at higher risk of developing dependency and overdosing on prescribed opioids than men (Green et al, 2009; Unick et al, 2013). Nevertheless, deadly overdoses are higher in men than in women (Calcaterra et al, 2013). This is in line with the fact that although women attempt suicide more than men, men more often die given their weapons of choice. Women's higher risk of opioid dependency may be due to differences in metabolism (sex) but also to experiences of trauma or distress (gender), which are more prevalent in women. Some women - including women who have experienced violence, Aboriginal and Indigenous women (in Canada), non-cisgender women and trans women - have been found to be at higher risk of opioid dependency (Hemsing et al, 2016). The gender relations between provider and patient are complex. Researchers have found that women physicians were more likely to prescribe analgesics (painkillers) to patients in general and opioids to women patients, whereas men physicians were more likely to prescribe opioids to men patients (Safdar et al, 2009). In contrast, in an experimental study (as opposed to an observational one), Hirsh and colleagues found that women providers prescribed more antidepressants and offered more mental health referrals to women patients than to men (Hirsh et al, 2014). Women providers might » Next Steps ► Preclinical and clinical studies must integrate new findings on sex differences in pain pathways to develop new treatments tailored to patient sex. ► More research on the interaction between gender and the biology of pain is needed. These studies should include women, men, and gender-diverse and transgender people. ► Understanding how gender roles and behaviours affect pain management needs to be taught to future healthcare providers. All healthcare professionals have a role to play in changing gender roles and behaviours, beginning in early childhood, by raising awareness in parents, families and educators. 78 be more inclined to consider psychosocial factors with women patients, which is in line with previous reports of the increased tendency of women physicians to discuss emotions and explore psychosocial factors (Roter et al, 2002). However, although emotional and psychological factors can contribute to chronic pain, women, men and gender-diverse patients alike should have equal access to both medication and mental health treatment. Other sociocultural factors, including age, ethnicity and sexual orientation, can also influence pain treatments. In US emergency rooms, for example, white people are 25 % more likely to receive medication for acute pain than Hispanic people and 40 % more likely than African American people (Hoffman et al, 2016). Failing to consider how sex interacts with gender in pain may result in poor patient management and lead to chronic pain and patient decline. Gender-sensitive and possibly sex-specific pharmacological pain management is needed to improve patients' outcomes and quality of life. Conclusions Both biological and sociocultural differences between women, men and gender-diverse people influence chronic pain at all stages from signalling to treatment. A better understanding of sex-specific neuronal and immune mechanisms in chronic pain might help researchers develop novel and more effective sex-specific treatments. Gender roles and behaviours influence pain expression by patients and treatment by healthcare providers. A better understanding of the influence of sex and gender on pain may improve the quality of care provided to patients, the control of their pain and their overall quality of life. Targeted impact-oriented recommendations for future research and innovation actions funded under Horizon Europe Cluster 1: Health Staying healthy in a rapidly changing society Health policies and actions for health promotion and disease prevention should be knowledge based, targeted to citizens' needs and designed to reduce health inequalities. The prevention of chronic pain should integrate sex and gender into treatments and propose gender-sensitive approaches to pain management. 79 Living and working in a health-promoting environment Policymakers and regulators should be aware of and better informed about environmental, socioeconomic and occupational risk factors as well as health-promoting factors, including the combination of factors, for health and well-being throughout society Accordingly, knowledge-based policies at EU and global levels should better protect and promote citizens' health and well-being, and reduce health inequalities. Integrating social determinants of health, such as gender and ethnicity, into health-promoting policies can help decrease disparities caused by socioeconomic and occupational risk factors. Tackling diseases and reducing disease burden The health burden of diseases in the EU and worldwide should be reduced through effective disease management, including through the development and integration of innovative diagnostic and therapeutic approaches, personalised medicine approaches, and digital and other people-centred solutions for health and care. In particular, patients should be diagnosed early and accurately and receive effective, cost-efficient and affordable treatment, including patients with a rare disease, thanks to the effective translation of research results into new diagnostic tools and therapies. Personalised medicine must include gender-sensitive and sex-sensitive approaches. Gender-sensitive and sex-specific pharmacological pain management is needed to improve patients' outcomes and quality of life. Ensuring access to innovative, sustainable and high-quality healthcare Citizens should play a key role in managing their own health and care, informal carers (i.e. unpaid carers) should be fully supported (e.g. by preventing overburdening and economic stress) and specific needs of more vulnerable groups should be recognised and addressed. They will benefit from improved access to healthcare services, including financial risk protection and time- ly access to high-quality essential healthcare services, including safe, effective and affordable essential medicines and vaccines. Access to healthcare (pain management) for men, women and gender-diverse people means avoiding discrimination and stereotypes (e.g. undertreat-ment of pain in certain population groups). Mission area: cancer Beating cancer means not only saving lives, but also extending life expectancy while maintaining a good quality of life for cancer patients and survivors. Pain is a symptom that may accompany cancers or may be a side effect of certain treatments. A better understanding of the impact of cancers and their treatments in men, women and gender-diverse people, could help improve quality of life, whether from a curative or a palliative perspective. In addition, inequities exist in access to treatment, quality of care and support to cancer patients. These inequities may be gender related and addressing them may improve not only patients' prognosis but also their quality of life. Partnerships on health By taking gender-sensitive approaches, partnerships on health can better contribute to finding innovative solutions for societal and health challenges, including in the field of pain. For example, the Innovative Health Initiative, which brings together the pharmaceutical, diagnostic, medical devices, imaging and digital sectors, can prioritise people-centred and gender-sensitive healthcare innovations. Personalised medicine partnerships should account for both biological and sociocultural differences between men, women and gender-diverse people in order to develop truly personalised approaches. This will contribute, for example, to developing more targeted and effective pain treatments. Author Associate Professor Carole Clair Gender and Medicine Unit Center for Primary Care and Public Health Lausanne University Switzerland 80 Works cited Bartley, E. J. and Fillingim, R. B. (2013), 'Sex differences in pain: a brief review of clinical and experimental findings', British Journal of Anaesthesia, 111(1), 52-58. doi:10.1093/bja/aetl27. Bernardes, 5. F. and Lima, M. L. (2010), 'Being less of a man or less of a woman: perceptions of chronic pain patients' gender identities', European Journal of Pain, 14(2), 194-199. doi:10.1016/j.ejpain.2009.04.009. Boerner, K. E., Chambers, C. I, Gahagan, J., Keogh, E, Fillingim, R. B. and Mogil, J. 5. (2018), 'Conceptual complexity of gender and its relevance to pain', Pain, 159(11), 2137-2141. Calcaterra, 5., Glanz, J. and Binswangen I. A. (2013), 'National trends in pharmaceutical opioid related overdose deaths compared to other substance related overdose deaths: 1999-2009', Drug and Alcohol Dependence, 131(3), 263-270. doi:10.1016/j. drugalcdep.2012.11.018. Chen, E. H., Shofer, F. 5., Dean, A. J., Hollander, J. E., Baxt, W. G., Robey, J. L, Sease, K. L. and Mills, A. M. (2008), 'Gender disparity in analgesic treatment of emergency department patients with acute abdominal pain', Academic Emergency Medicine, 15(5), 414-418. doi:10.1111/j.l553-2712.2008.00100.x. Dance, A. (2019), The pain gap', Nature, 567,448-450. DOLORisk (2020), 'DOLORisk: Understanding risk factors and determinants for neuropathic pain', CORDIS, 3 July (https://cordis.europa.eu/proiect/id/633491). Dragon, C. N., Guerino, P., Ewald, E. and Laffan, A. M. (2017), Transgender medicare beneficiaries and chronic conditions: exploring fee-for-service claims data', LGBT Health, 4(6), 404-411. doi:10.1089/lgbt.2016.0208. Fillingim, R. B., King, C. D., Ribeiro-Dasilva, M. C, Rahim-Williams, B. and Riley, J. L, 3rd (2009), 'Sex, gender, and pain: a review of recent clinical and experimental findings', Journal of Pain, 10(5), 447-485. doi:10.1016/j. jpain.2008.12.001. Green, T. C, Grimes Serrano, J. M., Licari, A., Budman, S. H. and Butler, S. F. (2009), 'Women who abuse prescription opioids: findings from the Addiction Severity Index-Multimedia Version Connect prescription opioid database', Drug and Alcohol Dependence, 103(1-2), 65-73. doi:10.1016/j.drugalcdep.2009.03.014. Greenspan, J. D., Craft, R. M., LeResche, L, Arendt-Nielsen, L, Berkley, K. J, Fillingim, R. B, Gold, M. S, Holdcroft, A., Lautenbacher, S., Mayer, E. A. and Mogil, J. S. (2007), 'Studying sex and gender differences in pain and analgesia: a consensus report', Pain, 132(Suppl. 1), S26-45. doi:10.1016/j.pain.2007.10.014. Hamberg, K., Risberg, G., Johansson, E. E. and Westman, G. (2002), 'Gender bias in physicians' management of neck pain: a study of the answers in a Swedish national examination', Journal of Women's Health & Gender-Based Medicine, 11(7), 653-666. doi:10.1089/152460902760360595. Hemsing, N., Greaves, L, Poole, N. and Schmidt, R. (2016)., 'Misuse of prescription opioid medication among women: a scoping review', Pain Research and Management, 2016,1754195. doi:10.1155/2016/1754195. Hirsh, A. T, Hollingshead, N. A, Bair, M. J, Matthias, M. S, Wu, J. and Kroenke, K. (2013), 'The influence of patient's sex, race and depression on clinician pain treatment decisions', European Journal of Pain, 17(10), 1569-1579. doi:10.1002/j.l532-2149.2013.00355.x. Hirsh, A. T, Hollingshead, N. A, Matthias, M. S, Bair, M. J. and Kroenke, K. (2014), 'The influence of patient sex, provider sex, and sexist attitudes on pain treatment decisions', Journal of Pain, 15(5), 551-559. doi:10.1016/j. jpain.2014.02.003. Hoffmann, D.E. and Tarzian, A J. (2001), 'The girl who cried pain: a bias against women in the treatment of pain', Journal of Law, Medicine & Ethics, 29(1), 13-27. Hoffman, K. M, Trawalter, S, Axt, J. R. and Oliver, M. N. (2016), 'Racial bias in pain assessment and treatment recommendations, and false beliefs about biological differences between blacks and whites', Proceedings of the National Academy of Sciences, 113(16), 4296-4301. Lord, B, Cui, J. and Kelly, A. M. (2009), The impact of patient sex on paramedic pain management in the prehospital setting', American Journal of Emergency Medicine, 27(5), 525-529. doi:10.1016/j. ajem.2008.04.003. Merskey, H. and Bogduk, N. (1994), Classification of Chronic Pain, 2nd edition, IASP Press, Seattle, Washington. Mogil, J. S. (2012), 'Sex differences in pain and pain inhibition: multiple explanations of a controversial phenomenon', Nature Reviews Neuroscience, 13(12), 859-866. doi:10.1038/nrn3360. 81 Mogil, J. 5. (2020), 'Qualitative sex differences in pain processing: emerging evidence of a biased literature', Nature Reviews Neuroscience, 21, 353-365. Myers, C. D, Riley, J. L, 3rd and Robinson, M. E. (2003), 'Psychosocial contributions to sex-correlated differences in pain', GinicalJournal of Pain, 19(4), 225-232. NGN-PET (2019), 'Modelling neuron-glia networks into a drug discovery platform for pain efficacious treatments', CORDIS, 26 September (https://cordis.europa. eu/project/rcn/210123/factsheet/en). Robinson, M. E., Gagnon, C. M., Riley, J. L, 3rd and Price, D. D. (2003), 'Altering gender role expectations: effects on pain tolerance, pain threshold, and pain ratings', Journal of Pain, 4(5), 284-288. Robinson, M. E, Riley, J. L, 3rd, Myers, C. D, Papas, R. K, Wise, E. A, Waxenberg, L. B. and Fillingim, R. B. (2001), 'Gender role expectations of pain: relationship to sex differences in pain', Journal of Pain, 2(5), 251-257. doi:10.1054/jpai.2001.24551. Roter, D. L, Hall, J. A. and Aoki, Y. (2002), 'Physician gender effects in medical communication: a meta-analytic review', JAMA, 288(6), 756-764. doi:10.1001/ jama.288.6.756. Safdar, B., Heins, A., Homel, P., Miner, J., Neighbor, M, DeSandre, P. and Todd, K. H. (2009), 'Impact of physician and patient gender on pain management in the emergency department - a multicenter study', Pain Medicine, 10(2), 364-372. doi:10.1111/j.l526-4637.2008.00524.x. Samulowitz, A., Gremyr, I., Eriksson, E. and Hensing, G. (2018), '"Brave men" and "emotional women": a theory-guided literature review on gender bias in healthcare and gendered norms towards patients with chronic pain', Pain Research and Management, 2018, 6358624. doi:10.1155/2018/6358624. Schwarz, K. A., Sprenger, C, Hidalgo, P., Pfister, R., Diekhof, E. K. and Büchel, C. (2019), 'How stereotypes affect pain', Scientific Reports, 9(1), 8626. doi:10.1038/s41598-019-45044-y. Serdarevic, M, Striley, C. W. and Cottier, L. B. (2017), 'Sex differences in prescription opioid use', Current Opinion in Psychiatry, 30(4), 238-246. doi:10.1097/ YCO.0000000000000337. Simoni-Wastila, L. (2000), 'The use of abusable prescription drugs: the role of gender', Journal of Women's Health & Gender-Based Medicine, 9(3), 289-297. doi:10.1089/152460900318470. Sorge, R. E. and Totsch, S. K. (2017), 'Sex differences in pain', Journal of Neuroscience Research, 95(6), 1271-1281. doi:10.1002/jnr.23841. Sorge, R. E, Martin, L. J, Isbester, K. A, Sotocinal, S. G, Rosen, S, Turtle, A. H, Wieskopf, J. S, Acland, E. L, Dokova, A., Kadoura, B., Leger, P., Mapplebeck, J. C. S., McPhail, M, Delaney, A, Wigerblad, G, Schumann, A. P., Quinn, T., Frasnelli, J., Svensson, C. I., Sternberg, W. F. and Mogil, J. S. (2014), 'Olfactory exposure to males, including men, causes stress and related analgesia in rodents', Nature Methods, 11(6), 629-632. doi:10.1038/ nmeth.2935. Unick, G. J., Rosenblum, D., Mars, S. and Ciccarone, D. (2013), 'Intertwined epidemics: national demographic trends in hospitalizations for heroin- and opioid-related overdoses, 1993-2009', PLoS One, 8(2), e54496. doi:10.1371/journal.pone.0054496. Villemure, C. and Bushnell, M. C. (2007), 'The effects of the steroid androstadienone and pleasant odorants on the mood and pain perception of men and women', European Journal of Pain, 11(2), 181-191. doi:10.1016/j. ejpain.2006.02.005. Climate change, energy and agriculture MARINE SCIENCE: ANALYSING SEX The challenge Anthropogenically induced climate change is one of the most serious and pervasive global challenges (Hoegh-Guldberg and Bruno, 2010; Diffenbaugh and Field, 2013). To minimise adverse outcomes, it is critical to establish and enforce effective ecosystem management (Hoegh-Guldberg and Bruno, 2010), which in turn depends on a robust understanding of organism and ecosystem resilience to environmental change (O'Leary et al, 2017; Patricio et al, 2019). We do not yet sufficiently understand the extent to which such resilience varies with sex. The sex ratio of a population is a major determinant of its resilience to environmental disturbance (Ospina-Alvarez and Piferrer, 2008). Sex ratios are driven in part by differential sensitivity of females, males and hermaphrodites to climate change stressors. Nonetheless, sex is rarely analysed as an experimental variable (Tannenbaum et al, 2019). A recent systematic review of ocean acidification literature, for example, revealed that only 3.77 % of recent studies tested for sex-based differences (see figure below), while 85 % of studies failed to consider sex at all (Ellis et al, 2017). This results in a lack of experimental evidence on which to assess sex-specific impacts of ocean acidification, limiting our ability to accurately appraise the resilience of marine populations to reduced seawater pH. Where tested, clear sex-based differences to elevated partial pressure of carbon dioxide (pC02) have been documented (Ellis et al, 2017). Failing to account for such differences affects our ability to effectively manage ecosystems and to determine conservation priorities. Proportion of Ocean Acidification Studies that Analyse sex From studies on key taxonomic groups (Echinodermata, Crustacea, Mollusca & Fish) published between 2008 and 2016 Fish Mollusca Crustacea Echinodermata Average Sex not mentioned Sex measured or accounted for, but not tested statistically Sex differences tested statistically Data Ellis et al., 2017. With permission Proportion of ocean acidification studies that analyse sex. Source: Ellis et al. (2017), used with permission 83 # Method: rethinking concepts and theories A major barrier to the inclusion of sex as an experimental variable is the widely held perception that sex is unimportant for interpreting species' responses to changing environmental conditions. In many instances, such perceptions stem from the lack of documented sex differences in organisms beyond traditional model organisms, such as Caenorhabditis elegans. Challenging such perceptions requires an integrated approach across all three pillars of academic research: policy, publication and education (Tannenbaum et al, 2019). Funding agency policies can drive increased sex-based research in non-model organisms. This increase in research and subsequent peer-reviewed literature will provide the next generation of experimentalists with key examples of how to successfully implement robust methods of sex and gender analysis in relevant areas of research. A further widely held assumption across both science and society is that sex is binary, genetically determined and fixed at fertilisation. Exceptions to this rule are often considered # Method: analysing sex Disaggregating experimental results by sex reveals biologically significant differences that would otherwise be masked if data were pooled (see figure below). To do this, however, requires accu-rate techniques for ascertaining an organism's sex (and where possible these techniques should be noninvasive). The recent development of novel methods for sexing individuals in non-model ma-rine organisms, which anomalous (Bachtrog et al, 2014). Throughout nature, however, diverse sexual forms and mechanisms of sex determination challenge these norms and support instead an understanding of a sex continuum (Ainsworth, 2015). Hermaphroditism (the presence of male and female gametes in the same individual), for example, occurs in 94 % of flowering plants (Renner & Ricklefs, 1995) and in one in three species of non-insect animals (Jarne and Auld, 2006). When hermaphroditism is sequential (an individual changes from one distinct sex to another during its lifetime - in some species on more than one occasion), sex is shown to be a labile trait (Munday et al, 2006). Even if distinct female and male sexual forms become clear, unambiguous and fixed, sex determination often depends on an interacting suite of genetic, hormonal, physiological, social and/or environmental processes. In order to understand the importance of sex for basic biology, it is important to consider the mechanisms, timings and direction of sex determination and differentiation, as well as differences in female, male and hermaphroditic responses to environmental perturbation (Ellis et al, 2017; Tannenbaum et al, 2019). include genetic (Benestan et al, 2017; Hines et al, 2007), metabolomic (Ellis et al, 2014; Hines et al, 2007) and endocrine techniques (Jensen et al, 2018), has signifi-cantly enhanced our ability to accurately project climate change impacts in certain groups. But concerted efforts to expand these approaches to wider groups of marine organisms are vital. These efforts will be advanced through the continued innovation and increased affordability of omics approaches. 84 Impact of Pooling Data for Experimental Interpretation Data from Cripps et al, 2016 showing impact of elevated pCo2 on copepod respiration 15 15 2 1.0 f -> 2 io ; ^ Biologically important | "-^>r- differences between 2 .......^^r.^T........ males and females §" 0.5 ........?....................- \ are masked bv Doolina data by pooling data 0 - 0 - AB AB (Control C02) (High C02) (Control C02) (High C02) Adapted from Tannenbaum et al, 2019 Pooled experimental data () can mask key biological responses, in this instance the difference in respiration rate of female () and male () copepods under control and high C02 conditions. Source: adapted from Tannenbaum et al. (2019); data from Cripps et al. (2016) Gendered innovation 1: Understanding feminisation of marine organisms in a warming ocean Temperature-dependent sex determination (T5D) in marine turtles is perhaps the most widely studied and well-known mechanism of environmental sex determination in nature. However, species that exhibit T5D are also widely considered among the most vulnerable to climate change given the possibility that increasing temperatures favour the production of one sex over the other, destabilising population sex ratios (Mitchell & Janzen, 2010). In marine turtles, sex is determined by temperature during egg incubation, with higher temperatures resulting in a greater proportion of females (Hawkes et al, 2007, 2009; Patricio et al, 2019). Studies have projected highly female-skewed population sex ratios in marine turtles based on future climate warming, using temperature recordings during incubation as a proxy for population demography (e.g. Hawkes et al, 2007; Fuentes et al, 2011; Laloe et al, 2014). Such sex ratio estimates, however, depend on the proxy used in sex determination, and may differ substantially when different proxies are used (Fuentes et al, 2011). Recent advances in the sexing of marine turtles, which combine laparoscopic and endocrinological techniques, have, for the first time, provided empirical evidence for the impact of recent warming on contemporary marine turtle populations. Robust sex analysis enabled the researchers to link male and female green sea turtles to their natal beaches, leading to the discovery that northern (warmer) Great Barrier Reef (GBR) populations have become highly female biased. Over 99 % of juveniles and sub-adults originating from northern sites are female (compared with 67 % female at southern sites) (Jensen et al, 2018). Despite the ability of marine turtles to maintain population viability even at highly female-biased sex ratios, a subadult female bias of 99.8 % in northern green sea turtle populations indicates that the complete feminisation, and thus local extinction, of northern GBR populations is possible in the near future (Jensen et al, 2018). 85 Green sea turtle hatchling. Image credit: 'Green-Turtle_Projeto_Tamar_l' by Oregon State University is licensed under CC BY-SA 2.0 (https://creativecommons.Org/licenses/by-sa/2.0/) Gendered innovation 2: Understanding environmental sex determination beyond temperature Sex determination mechanisms fail on a continuum from environmental to genetic. Primary sex differentiation has been shown to respond to a diverse range of environmental factors in a growing number of species. Hypoxia, for example, results in a higher ratio of males in zebra fish (Shang et al, 2006). Ocean acidification, in contrast, results in 16 % more female oysters over a single generational cycle (Parker et al, 2018). Similarly, increased aquatic pH results in more female cichlids (Oldfield, 2005). What is increasingly apparent is that alterations in sex ratio, in either direction, will result in populations less resilient to further disturbance and potentially lead to demographic collapse. A mechanistic understanding of sex-change processes and other ecologically significant sex-based responses is thus vital to accurately model impacts of anthropogenic disturbance (e.g. overfishing or climate change) at a population level. Gendered innovation 3: Sex analysis enhances effective population management An accurate understanding of population structures enhances effective ecosystem management. Recent advances in next-generation sequencing technology has facilitated research focused on the causes and consequences of changes in population structure in a wide range of non-model species (Narum et al, 2013). However, only 9.6 % of studies on marine and diadromous (tolerant of both seawater and freshwater) species have reported sex information (Benestan et al, 2017). Benestan and colleagues (2017) demonstrate the importance of understanding sex ratios when employing sequencing to interpret population structure. In the American lobster, for example, these authors demonstrate how two subpopulations (inshore and offshore) can be misunderstood as two distinct populations if the sex ratio of samples is unintentionally biased. Studies that sample correctly, i.e. take care to collect equal numbers of males and fe- 86 males, show that in reality inshore and offshore American lobsters are a connected population that is mixed genetically Omitting sex information in this instance leads to the incorrect classification of two distinct populations, which in turn may result in ineffective management recommendations. The American lobster is the most valuable catch in North America. Effective population management has been demonstrated to successfully maximise its sustainable exploitation. Proactive harvester-driven conservation of commercial stocks in the Gulf of Maine, for example, has resulted in record hauls, despite warming (Le Bris et al, 2018). Conversely in the absence of such management, warming has led to the collapse of the fishery in southern New England (Le Bris et al, 2018). Accurate population demographic data are especially important when conservation efforts are sex biased. Lobster conservation efforts have protected large berried females (females carrying fertilised eggs on the underside of the abdomen), but not large males. This female-biased protection leads to selective harvesting of large males, which subsequently restricts mate choice and limits sperm, resulting in reduced reproductive success (Tang et al, 2019). In the face of climate change, effective management of this natural resource will become increasingly critical to preserve the reproductive potential of lobster stocks. Robust sex analysis will ensure population structure is understood, and therefore managed and protected accurately. Gendered innovation 4: Understanding the differential sensitivity of female and male marine organisms to climate change Anthropogenically induced climate change results in rising seawater temperatures, ocean acidification, hypoxic zones and storm events. Where tested, sex analysis has emerged as a key parameter for determining species responses to these environmental challenges. Elevated seawater pC02 (dissolved carbon di- oxide), for example, results in differential mortality between the sexes in Crustacea. Both female shrimp (Kurihara et al, 2008) and female copepods (Cripps et al, 2014) show greater sensitivity to climate change than their male counterparts. This pattern, however, does not always hold, and analyses must be done carefully. In the copepod Arcatia tonsa, females show greater tolerance of elevated temperatures (Sasaki et al, 2019). Failing to account for sex differences in response to elevated temperatures risks underestimating population-level impacts by overlooking population decline caused by sperm limitation from greater male sensitivity to temperature. Sex differences in response to climate change can be complex. A recent study of copepod response to elevated pC02 by Cripps and colleagues (2016) demonstrated this complexity. Under normal conditions, males have a higher baseline metabolic rate than females. In response to elevated pC02 however, females increase and males decrease their metabolic rate (Cripps et al, 2016). Omitting sex analysis in this case masks sex-specific responses in physiological performance that are fundamental for determining population responses. The differential sensitivity of female and male organisms to changing environmental conditions can also have a large, indirect and often unexpected impact on experimental outcomes. In marine copepods, for example, environmental conditions influence where individuals aggregate in the water column. Studies have shown that differential energy and reproductive requirements lead females to aggregate primarily in oxygenated surface layers of the water; males cluster in deeper water, where oxygen concentrations are lower, as their location is primarily driven by temperature (Pierson et al, 2017). If this behaviour is overlooked, researchers collecting specimens from a single depth would inadvertently introduce a sex ratio bias that would yield incorrect experimental conclusions. 87 Conclusions Incorporating sex analysis throughout marine and environmental science innovation will facilitate discovery research efficiency reproducibility and robustness. Recent advances in sexing technologies will enable wider inclusion of sex analysis throughout these disciplines and facilitate better modelling of demographic change among marine organisms. This, in turn, will enhance our ability to effectively manage ecosystems and set conservation priorities. » Next Steps To advance sex analysis in marine science and enhance its incorporation throughout the discipline, we recommend the following. ► Policy developments in funding agencies and peer-reviewed journals that require sex analysis in marine science, and more broadly throughout the life sciences. ► Development of novel sexing techniques for an increasingly wide array of non-model marine organisms, especially for species in which morphological sexual dimorphism is not conspicuous. ► Development of sexing techniques to improve accessibility, reliability, cost and ease. The increasing affordability of omics approaches and advances in computing power will enable this. ► Development of research that considers the role of hermaphroditism in sex-disaggregated reporting of results (see 'Analysing sex in hermaphroditic species' in Annex B). This will enable better modelling of the timing, direction and duration of sex change, as well as sex determination mechanisms. This research should also consider individual responses to environmental stress where cells/ behaviours/physiologies of different sexes coexist simultaneously. ► Modelling of ecosystem functioning and responses to climate change that incorporates sex analysis, where sex-disaggregated data of sufficient quality are available. Such an endeavour will improve conservation efforts and designation/management of marine protected areas, as well as enable better management of fisheries. 88 Targeted impact-oriented recommendations for future research and innovation actions funded under Horizon Europe Cluster 5: Climate, energy and mobility Advance climate science and solutions for a climate-neutral and resilient society ► Produce state-of-the-art science on climate change impacts. Disaggregate results by sex to account for and quantify its role in determining organism response to climate change. ► Further study the interactions between climate change and biodiversity. When investigating the impacts of climate change, factors such as sex ratio, sex determination and sex differentiation are key population parameters that determine sensitivity to stress and require further investigation. ► Advance climate science and create a knowledge base to inform societal and social transition and to guide the development of policy measures. Sex analysis is an integral component of robust world-class climate change science that must be incorporated into research, education, and environmental management and policy. Cluster 6: Food, bioeconomy, natural resources, agriculture and environment Environmental observation ► Innovate models and data assimilation to support indicators, scenarios, service capacity and innovation for biodiversity, species and ecosystem health, food security and food safety, marine conservation and natural resource management. Sex as a biological variable must be incorporated as a key component of environmental models that seek to determine species sensitivity to climate change and species interactions. Only such models can be used for evidence-based policy. Biodiversity and natural capital ► Understand and address the drivers of biodiversity loss and their interactions better. Research assessing drivers of biodiversity loss, namely species' sensitivity to stressors and their interaction, needs to assess sex as a factor determining sensitivity. ► Effective communication and dissemination activities are critical to raise societal awareness. Sex analysis in the context of climate change provides an intriguing and novel key message highlighting the differential sensitivity of females and males to climate change, the impact of environmental change on sex determination and differentiation, and the role sex plays in population sensitivity. Examples that resonate with the public can inspire action. Seas, oceans and inland waters ► Better understand, forecast and monitor the ocean and its changes, the climate-ocean interface and the impact of stressors and global changes on ecosystems and maritime sectors. Understanding, forecasting and monitoring changes within seas, oceans and inland waters will require the inclusion of sex as a factor determining sensitivity at all levels of experimentation, modelling and mitigation. 89 Mission area: healthy oceans, seas, coastal and inland waters ► Adapt to and mitigate pollution and climate change in the ocean. Sex differences in response to climate change are complex. Incorporating sex analysis is therefore vital to accurately understand the threat of climate change (and other environmental stressors such as pollution) on marine organisms, and thus establish effective and robust mitigation strategies. ► Sustainably use and manage ocean resources. Conservation of marine stocks could increase the annual profits of the seafood industry by EUR 49 billion globally (Barbier et al, 2018). Sex analysis is shown to be a key factor for ensuring the effective population management of marine organisms. Mission area: adaptation to climate change including societal transformation ► Inducing adaptation to climate change through societal transformation requires strong, clear and compelling case studies to highlight the challenges facing natural ecosystems, as well as champions to induce change in public perception. Sex analysis in marine organisms provides a key example that can capture the imagination of the general public and inspire public action for change. Partnerships: food, bioeconomy, natural resources, agriculture and environment Animal health: fighting infectious diseases ► Bring sustainable and innovative solutions to tackle infectious animal diseases. Sex is a key factor determining the susceptibility of animals to disease-causing agents. Incorporating sex analysis is therefore an important consideration for a partnership on animal health and infectious disease. Rescuing biodiversity to safeguard life on Earth ► Deploy solutions to stop the ongoing mass extinction of species caused by human activity. Key factors determining species extinction in the face of climate change are population stability, sex ratios and the sensitivity of males and females. Sex must therefore be considered in the context of biodiversity loss and safeguarding life on Earth. A climate-neutral, sustainable and productive blue economy ► Sustainably unlock, demonstrate and harvest the full potential of Europe's oceans and seas. Effective population management of marine stocks could result in a EUR 49 billion increase in the annual profits of the seafood industry globally (Barbier et al, 2018). In highlighting the role of sex analysis in effective population management of marine species, consideration of sex is an important consideration for a sustainable and productive blue economy. Commission priority: the European Green Deal The European Green Deal outlines key actions to 'boost the efficient use of resources by moving to a clean, circular economy' and 'restore biodiversity and cut pollution', enabling a transition to being the first carbon-neutral continent by 2050 (European Commission, 2019). ► Climate ambition • New EU strategy on adaptation to climate change. As a key determinant of organism sensitivity to climate change, sex is a critical factor that 90 must be considered when establishing climate thresholds and strategies for adaptation to climate change. ► Preserving and protecting biodiversity • EU biodiversity strategy for 2030. The differential sensitivity of males and females to environmental stress, as well as the impact of the environment on sex determination and sex ratio, is a key driver of species extinction in the face of climate change. Any biodiversity strategy must therefore take into consideration the role of sex in determining biodiversity loss or preservation. • Measures to address the main drivers of biodiversity loss. Sex is a significant factor affecting population-level responses to environmental stress, so sex analysis is a critical component of understanding, and subsequently addressing, the main drivers of biodiversity loss. ► The EU as a global leader • EU to continue to lead the international climate and biodiversity negotiations, further strengthening the international policy framework. Incorporating sex analysis within international climate and biodiversity negotiations, as well as subsequent policy, will ensure that the EU remains a global leader in this area. Author Dr Robert P. Ellis NERC Industrial Innovation Fellow, College of Life and Environmental Science University of Exeter United Kingdom Works cited Ainsworth, C. (2015), 'Sex redefined', Nature News, 518(7539), 288-291. Bachtrog, D, Mank, J. E, Peichel, C. L, Kirkpatrick, M, Otto, S. P, Ashman, T. L, Hahn, M. W, Kitano, J, Mayrose, I., Ming, R., Perrin, N., Ross, L, Valenzuela, N, Vamosi, J. C. and Tree of Sex Consortium (2014), 'Sex determination: why so many ways of doing it?', PLoS Biology, 12(7) (https://doi.org/10.1371/iournal.pbio.1001899). Barbier, E. B, Burgess, J. C. and Dean, T. J. (2018), 'How to pay for saving biodiversity', Science, 360(6388), 486-488. Benestan, L, Moore, J. S., Sutherland, B. J., Le Luyer, J., Maaroufi, H., Rougeux, C, Normandeau, E., Rycroft, N., Atema, J., Harris, L. N., Tallman, R. R, Greenwood, S. J., Clark, F. K. and Bernatchez, L. (2017), 'Sex matters in massive parallel seguencing: evidence for biases in genetic parameter estimation and investigation of sex determination systems', Molecular Ecology, 26(24), 6767-6783. Cripps, G., Lindegue, P. and Flynn, K. J. (2014), 'Have we been underestimating the effects of ocean acidification in zooplankton?', Global Change Biology, 20, 3377-3385. Cripps, G., Flynn, K. J. and Lindegue, P. K. (2016), 'Ocean acidification affects the phyto-zoo plankton trophic transfer efficiency', PLoS ONE, 11 (https://doi.org/10.1371/ iournal.pone.0151739). Diffenbaugh, N. S. and Field, C. B. (2013), 'Changes in ecologically critical terrestrial climate conditions', Science, 341(6145), 486-492. Ellis, R. P., Spicer, J. I., Byrne, J. J., Sommer, U., Viant, M. R, White, D. A. and Widdicombe, S. (2014), '1H NMR metabolomics reveals contrasting response by male and female mussels exposed to reduced seawater pH, increased temperature, and a pathogen', Environmental Science & Technology, 48(12), 7044-7052. Ellis, R. P., Davison, W, Queirös, A. M, Kroeker, K. J, Calosi, P., Dupont, S, Spicer, J. I, Wilson, R. W, Widdicombe, S. and Urbina, M. A. (2017), 'Does sex really matter? Explaining intraspecies variation in ocean acidification responses', Biology Letters, 13(2) (https://doi.org/10.1098/ rsbl.2016.0761). European Commission, Communcation on the European Green Deal (19 December 2019) (https://ec.europa.eu/info/ strategv/priorities-2019-2024/european-green-deal en). 91 Fuentes, M. M. P. B, Limpus, C. J. and Hamann, M. (2011), 'Vulnerability of sea turtle nesting grounds to climate change', Global Change Biology, 17(1), 140-153. Hawkes, L. A., Broderick, A. C, Godfrey, M. H. and Godley, B. J. (2007), 'Investigating the potential impacts of climate change on a marine turtle population', Global Change Biology, 13(5), 923-932. Hawkes, L. A., Broderick, A. C, Godfrey, M. H. and Godley, B. J. (2009), 'Climate change and marine turtles', Endangered Species Research, 7(2), 137-154. Hines, A., Yeung, W. H., Craft, J., Brown, M., Kennedy, J, Bignell, J, Stentiford, G. and Viant, M. R. (2007), 'Comparison of histological, genetic, metabolomics, and lipid-based methods for sex determination in marine mussels', Analytical Biochemistry, 369(2), 175-186. Hoegh-Guldberg, O. and Bruno, J. F. (2010), 'The impact of climate change on the world's marine ecosystems', Science, 328(5985), 1523-1528. Jarne, P. and Auld, J. R. (2006), 'Animals mix it up too: the distribution of self-fertilization among hermaphroditic animals', Evolution, 60(9), 1816-1824. Jensen, M. P., Allen, C. D, Eguchi, T, Bell, I. P., LaCasella, E. L, Hilton, W. A., Hof, C. A. M. and Dutton, P. H. (2018), 'Environmental warming and feminization of one of the largest sea turtle populations in the world', Current Biology, 28(1), 154-159. Kurihara, H., Matsui, M., Furukawa, H., Hayashi, M. and Ishimatsu, A. (2008), long-term effects of predicted future seawater C02 conditions on the survival and growth of the marine shrimp Palaemon pacificus', Journal of Experimental Marine Biology and Ecology 367,41-46. Laloe, J. O., Cozens, J., Renom, B., Taxonera, A. & Hays, G. C. (2014), 'Effects of rising temperature on the viability of an important sea turtle rookery', Nature Climate Change, 4(6), 513-518. Le Bris, A., Mills, K. E., Wahle, R. A., Chen, Y., Alexander, M. A, Allyn, A. J, Shuetz, J. G, Scott, J. D. and Pershing, A. J. (2018), 'Climate vulnerability and resilience in the most valuable North American fishery', Proceedings of the National Academy of Sciences, 115(8), 1831-1836. Mitchell, N. J. and Janzen, F. J. (2010), 'Temperature-dependent sex determination and contemporary climate change', Sexual Development, 4(1-2), 129-140. Munday, P. L, Buston, P. M. and Warner, R. R. (2006), 'Diversity and flexibility of sex-change strategies in animals', Trends in Ecology & Evolution, 21(2), 89-95. Narum, S. R, Buerkle, C. A, Davey, J. W, Miller, M. R. and Hohenlohe, P. A. (2013), 'Genotyping-by-sequencing in ecological and conservation genomics', Molecular Ecology, 22(11), 2841-2847. Oldfield, R. G. (2005), 'Genetic, abiotic and social influences on sex differentiation and the evolution of sequential hermaphroditism', Fish and Fisheries, 6,93-110. O'Leary, J. K, Micheli, F, Airoldi, L, Boch, C, De Leo, G, Elahi, R, Ferretti, F, Graham, N. A. J, Litvin, S. Y, Low, N. H., Lummis, S., Nickols, K. J. and Wong, J. (2017), 'The resilience of marine ecosystems to climatic disturbances', Bioscience, 67(3), 208-220. Ospina-Alvarez, N. and Piferrer, F. (2008), Temperature-dependent sex determination in fish revisited: prevalence, a single sex ratio response pattern, and possible effects of climate change', PloS ONE, 3(7) (https://doi.org/10.1371/ ioumal.pone.0002837). M, O'Connor, W. A, Byrne, M, Dove, M, Coleman, R. A, Portner, H. 0, Scanes, E, Virtue, P, Gibbs, M. and Ross, P. M. (2018), 'Ocean acidification but not warming alters sex determination in the Sydney rock oyster, Saccostrea glomerata', Proceedings of the Royal Society B: Biological Sciences, 285(1872), 20172869. Patricio, A. R, Varela, M. R, Barbosa, C, Broderick, A. C, Catry, P., Hawkes, L. A, Regalia, A. and Godley, B. J. (2019), 'Climate change resilience of a globally important sea turtle nesting population', Global Change Biology, 25(2), 522-535. Pierson, J. J, Slater, W. C. L, Elliott, D. and Roman, M. R. (2017), 'Synergistic effects of seasonal deoxygenation and temperature truncate copepod vertical migration and distribution', Marine Ecology Progress Series, 575, 57-68. Renner, S. S. and Ricklefs, R. E. (1995), 'Dioecy and its correlates in the flowering plants', American Journal of Botany, 82(5), 596-606. Sasaki, M., Hedberg, S., Richardson, K. and Dam, H. G. (2019), 'Complex interactions between local adaptation, phenotypic plasticity and sex affect vulnerability to warming in a widespread marine copepod', Royal Society Open Science, 6(3) (https://doi.org/10.1098/rsos.182115). Shang, E. H., Yu, R. M. and Wu, R. S. (2006), 'Hypoxia affects sex differentiation and development, leading to a male-dominated population in zebrafish', Environmental Science & Technology, 40(9), 3118-3122. Tang, F, Sainte-Marie, B., Gaudette, J. and Rochette, R. (2019), 'Role of gamete limitation in the occurrence of "abnormal early clutches" on female American lobster, Homarus americanus, in eastern Canada', Marine Biology, 166(11). Tannenbaum, C, Ellis, R. P., Eyssel, F, Zou, J. and Schiebinger, L. (2019), 'Sex and gender analysis improves science and engineering', Nature, 575(7781), 137-146. 92 SMART ENERGY SOLUTIONS: ANALYSING INTERSECTIONALITY The challenge Over the past few decades, governments and intergovernmental agencies have set ambitious energy efficiency and reduction targets. For example, the EU's Directive on Energy Efficiency sets a target of 32.5 % increase in energy efficiency by 2030 (Directive 2012/27/EU, amended by Directive (EU) 2018/2002; European Parliament and Council of the European Union, 2012, 2018). These targets are part of the United Nations' global effort to ensure access to affordable, reliable and sustainable energy for all. The UN aims to substantially increase the share of renewable energy in the global energy mix by 2030, which will require expanding infrastructure and upgrading technology (UN, 2015). Despite energy-efficient construction and smart home installations, energy targets for the EU building sector have not been met. Consumers are often blamed for not using the technologies correctly. At the same time, smart technologies are often complex and frustrating to users. To overcome these problems, engineers and design experts need to integrate user perspectives in the design of technologies for homes and public buildings. This case study analyses how energy-efficiency projects can integrate gender perspectives, along with sensitivity to age, socioeconomic and other social factors, into design. Getting it right for a broad user base will help realise the potential of smart technologies that support EU and global energy targets. Gendered innovation 1: Designing energy-efficient tools that integrate gender perspectives Over the past few decades, product developers have integrated user-centric perspectives to better meet user needs and expectations. The field of energy efficiency, however, has lagged behind. Danfoss, an international manufacturer and service provider for energy-efficient smart heating solutions, experienced low sales figures for one of its new products. When looking at its customer base, the company realised that women should constitute 50 % of their users, but they were, in fact, significantly underrepresented. To address the problem, Danfoss teamed up with design-people, a Danish design agency, to investigate the values, motivations and needs of women in relation to technology. The agency used surveys to cluster users into five segments, characterised by different attitudes to technology. The largest segment was characterised as pragmatic tech users (37 %, finely balanced with 53 % women and 47 % men). Danfoss chose this group as the target for the company's new entry-level smart thermostat. The company created a persona, named Johanna, to represent this group. A careful focus on Johanna's preferences along the entire customer journey allowed the design and engineering team to create an award-winning user experience for the new Danfoss ECO thermostat (https://www. desiqn-people.com/portfolio/danfoss-eco/). Two years after introduction, the sales figures of the new thermostat - a good proxy for user adoption - exceeded Danfoss's expectations. This approach can be made more inclusive by including other social identities in the survey. The H2020-funded project Energy system transition through stakeholder activation, education and skills development (Entrust; Entrust, 2017) (Dunphy et al, 2017,b) has broadened the design approach to include users of different ages and socioeconomic backgrounds (see below). Other relevant variables may include educational level, race/ethnicity, sexual orientation and non-binary gender identity. Tech-users Navigator European Smart Home user profiles (2015) Unsettled Urban Tech lover Brand oriented Aesthetic aware C? 9 62% 38% the SOCIAL JUNKIE r Community Sharing Digital life Mobile first c? 9 55% 45% Single (parent) Routine driven No nonsense Tech comes 2nd Home maker Low tech-confidence Traditional Advice seeker C? 9 47% 53% 44% 56% Living alone Traditional Digital novice Help seeker c? 9 36% 64% Five customer segments. Source: design-people (2015), with permission Danfoss Eco App Thermostat Sales Curve. Source: Danfoss, with permission # Method: engineering innovation processes 1. Evaluating past innovation practices By analysing the traditional engineering innovation process of Danfoss smart home appliances, the engineering team identified a lack of diversity in user perspectives as a problem. Without a clear focus on target personas, engineers and designers may subconsciously use themselves as a benchmark for the user experience. 2. Building diverse development and design teams The Danfoss case clearly demonstrates the advantages of including women and men with diverse attitudes to technology in the design process. Integrating a wide range of new and diverse perspectives will lead to further innovation. New research priorities and research questions can lead to new findings and innovative ideas (see Schiebinger et al, 2011-2020a,b). 3. Analysing users and markets User needs and behaviours can be identified through surveys, interviews, focus groups and direct observation. Engineers and designers can analyse gender by collecting quantitative survey data, as in the Danfoss example, or by observing user practices and learned behaviours. The best user research will include an intersectional approach to gender, ethnicity, age, socioeconomic status, etc. 4. Obtaining user input In the Danfoss project, participatory research allowed designers to tap into users' tacit knowledge (see 'Co-creation and participatory research' in Annex B). User research revealed that women valued easy temperature control, air quality control and thermostat design. The engineers had not considered air quality or the aesthetics of thermostat design in the product development, and they had not been confronted with different experiences of the ease of use of their product. 5. Evaluation and planning To improve the engineering innovation process, companies should assess the benefits and problems of current products and services in view of the users' expectations and abilities, including all gender types. They should then transfer the lessons learned to other areas of the organisation. Guidelines for the evaluation and planning of the engineering innovation process can be based on design-people (2015) and Schiebinger et al. (2011-2020a). 95 Discreet Indoor Climate Sensor. Based on a 'female interaction concept', Dan-foss and design-people translated their research findings and principles into a more user-responsive indoor climate solution, i.e. including not only temperature but also air quality controls. They replaced the wall-mounted control panels with more discreet sensors controlled from tablets and smartphones. This allowed users to balance climate comfort and energy saving by controlling their heating systems remotely. In addition, Danfoss paid attention to air quality. The surface of the new thermostat and sensors ruptured into crystal patterns when air quality deteriorated, indicating that users should refresh the air. Gendered innovation 2: Driving the energy transition by integrating an intersectional approach to gender, age and socioeconomic factors To tackle the energy transition, the EU-funded Horizon 2020 research project Entrust focused on the social dimensions of the energy system. This project introduced an intersectional approach to understand how gender, age and socioeconomic status affect the transition to a low-carbon energy system. Entrust focused on attitudes to different energy technologies, including energy sources: fossil fuels, renewa- bles and nuclear energy. Other projects might use different social analytics, such as sexuality, gender-diverse individuals, religion, etc. Each project must hypothesise the social factors most relevant to its goals. Entrust analysed the daily domestic routines of users from six European communities that differed socially, economically and geographically. The intersectionality approach analysed gender, socioeconomic status and age as these relate to energy practices. The results showed that culture, age or poverty may have more impact on energy use than gender; see also case study 'Climate change'. Laundry, for example, is a gendered issue. Men often leave laundry to women or to a laundry service, and therefore do not mention it when describing their daily routines (Dunphy et al, 2018a, p. 77). Income also affects laundry practices. One low-income participant (male), conscious of the high cost of electricity, paid extra to buy an ecological washing machine. Two other low-income participants (female) did laundry at off-peak times when electricity rates were lower or simply did less washing to reduce costs. It is important to consider both gender and socioeconomic status as intersecting factors in order to forge solutions that cater for all social groups (Dunphy et al, 20118a, pp. 56-57). Another example is cooking, which neither women nor men typically mention as energy intensive. In lower-income households, however, both women and, especially, men have developed specific practices to reduce costs when preparing hot meals (Dunphy et al, 20118a, pp. 62-63). Furthermore, analyses show that older generations consider today's availability of electricity and energy a privilege, not a given. Lifestyle changes that could reduce energy consumption are less appealing to this group (over 65). For different cohorts, different short-term and long-term perceptions of change will affect their choice of energy source and service, as shown below, and intersect with other sociode-mographic factors such as gender or socioeconomic status. 96 General attitude Key ideas Cohort I Reluctance to change Finding it hard to transition, not wanting to give 65+ up comforts, shorter term perspective is due to perceptions of shorter life expectancy, energy transition difficult to prioritise in old age. Energy today is often wasted and overused. Long-term perception of change. II A problem for the next This is a task for the coming generations. Younger generation generations are more aware, more educated and have a better upbringing. Younger generations have more years of life to see these changes through. Current quality of life standards are valued high. Long-term perception of change. Key priority is to achieve sustainability. Ensure 45-64; wellbeing for future generations. Narratives associated 25-44 with concerns for young families and welfare of children. Short - and long-term perception of change. IV See change now Critical view of slow pace of change, wanting to see 18-24; greater efforts toward transition, socio-political factors 25-44 are a barrier toward change. Greater emphasis on citizenship and reclaiming control over energy issues. Short-term perception of change. 45-64; 65+ III Caring for future generations Based on this research, Entrust developed new approaches to public policy, business innovation and community engagement. Twelve business models emerged for energy production and supply, urban environments and shared mobility, with a particular focus on public-private partnerships and community-based approaches. Other approaches included public-private modularised building, community-based energy service companies, peer-to-peer community energy trading, and free-floating car sharing with an operational area (Dunphy et al, 2018c). # Method: intersectional analysis of the energy sector The Entrust project applies the concept of intersectionality to highlight how various sociodemographic factors interact. The project seeks to understand how energy attitudes and behaviour are shaped by social attributes, such as gender, age and socioeconomic status. The researchers were particularly interested in understanding the life experiences of citizens engaging with the complex sociotechnical networks that constitute the energy system. This intersectional approach allows a more differentiated analysis of energy-related attitudes and behaviours. The following table demonstrates the benefits of an intersectional analysis in comparison with other, more restricted, approaches (Hancock, 2013). 97 Unitary Approach Multiple Approach Intersectional Approach Number of Relevant Categories/Processes One More than one More than one Posited Relationship Between Categories/Processes None Predetermined and conceptually distinguishable relationships Relationships are open empirical questions to be determined Conceptualization of Each Category Static at individual or institutional level Static at individual or institutional level Diverse; members often differ in politically significant ways Case Makeup of Category/ Class Uniform Uniform Diverse; members often differ in politically significant ways Approach to Intersectionality Lip service or dismissal Intersectionality as testable explanation Intersectionality as paradigm/research design Conclusions The case study provides clear examples of how to improve R & I processes relevant to energy efficiency measures. It also shows how to improve new and existing technologies and enhance their market acceptance by integrating gender and diversity perspectives into development, design and testing. Targeted impact-oriented recommendations for future research and innovation actions funded under Horizon Europe Cluster 5: Climate, energy and mobility The long-term targeted impact of this cluster covers climate action as well as energy and transport. This case study is focused on the intersectionality of citizens' gender, age and socioeconomic status, and the impact of these factors on energy demand, use and supply; consequently, our recommendations focus on future R & I actions related to energy, with recommendations for the climate and mobility topics at the end. Cross-sectoral solutions for decarbonisation Targeted impact: Increased energy and resource efficiency through attractiveness to citizens and reduced energy consumption, and facilitation of the transformation by engaging » Next Steps ► To reach the United Nations SDGs for energy infrastructure and technology, it will be important to implement gender and intersectional analyses as a cross-cutting issue. This will enhance the acceptance and usability of energy products and services, and stimulate the market uptake of energy solutions. ► We recommend regular and systematic audits to evaluate energy systems and solutions from a gender perspective and an intersectional perspective. 98 and empowering citizens (European Commission, 2019, pp. 90-91). ► Related R & I projects must show an understanding of how to use an intersectional approach to identify different use cases for energy demand and use as well as understanding the variety of expectations involved. Misunderstanding expectations may lead to frustration with R & I actions, and new services, tools and methods, whereas the right analysis and focus on those citizens who are highly motivated may lead to rapid change. ► This means that proposed research, innovation and development activities need to consider the impacts on various social groups in order to not leave anyone out. This goes beyond considering gender alone. It requires understanding the effects of energy solutions on all users and citizens. As a result, the new technologies and solutions will become inclusive by default. Energy systems centred on renewables Targeted impact: New approaches to enable more interaction and optimisation between producers, consumers, and ensuring cost effective and affordable supply of energy to households and advancing decentralised energy storage for domestic applications (European Commission, 2019, p. 93). ► When designing participatory models to engage citizens, research must include methods to understand what motivates citizens to participate or invest time and/ or money in the proposed measure. This requires extensive socioeconomic analyses of citizens' underlying attitudes and practices that can then guide investment and policy levers and frameworks. Participatory methodologies also include active citizen involvement in R & D, design and testing processes. This means that researchers or engineers in these disciplines cannot simply think of and decide what would be best for the citizens (or best for the research); they need to show an awareness that 'the citizen' does not exist but there are a variety of personas (embodying differences related to gender, age, socioeconomic status, ethnicity, etc.) that have to be seen in their specific contexts and have to be involved in feedback and pilot phases. Develop demand-side solutions to decarbonise the energy system Targeted impact: 'Delivering the technology and socio-economic breakthroughs ... bearing in mind user needs' (European Commission, 2019, pp. 96). ► R & I related to the EU building stock must take into account that any renovation work success must go hand in hand with the users/citizens. Cultural backgrounds and types of users (families or singles, high or low income, etc.) need to be considered because they influence user acceptance of the new facilities. Thus, a clear action plan and involvement of relevant users' experience and backgrounds in the project are mandatory. Mission areas: Adaptation to climate change: accelerating the transition to a climate-prepared and resilient Europe The mission is built on the active inclusion of citizens, principles of solidarity and intergen-erational justice, and a system approach. The mission can only reach its goals if new norms, practices and habits are built, to achieve a systemic change of the socioecological system. ► Motivations for change differ strongly among people, depending on their socioeconomic status and way of life as well as their gender, age, and educational and cultural background. The case study on energy provides valuable insights for considering these factors. 99 ► The EU Entrust project demonstrates how an intersectional approach reveals motivations for and habits of energy consumptions, e.g. based on the age group of citizens; it also demonstrates that social issues such as income have a significant impact on energy consumption behaviour. ► Integrating a gender perspective into innovation engineering processes when designing energy-efficient tools is another example of innovation. It reveals how tools, and especially the design and functionality of tools (e.g. for heating or air conditioning), can be adapted to better fit citizens' expectations and motivations, whether they are at home or at work. Clean air, for example, is very important for parents and for those caring for elderly people. Tools that are easy to understand and operate and also linked to digital monitors of related energy consumption or energy savings can motivate behavioural changes. Climate-neutral and smart cities, by and for the citizens Climate city contracts, which also embrace neighbourhoods and their citizens, are a key issue in this mission. ► The EU Entrust project shows that human behaviour is not easily changed, and that different citizen groups have different motivations as well as understandings of what makes a valued and safe lifestyle. The intersectional approach is here an equivalent method to take gender into consideration as well as age, education and culture. ► To achieve the necessary systemic transition of society, the mission has to identify the group(s) of people whose motivation and lifestyle match the global sustainability goals most closely. Those groups can implement new habits faster, because their motivation is already strong. This means that the intersectional approach helps to create a faster and thus bigger impact. ► On the other hand, all other societal gender and intersectional groups have to be helped to understand the personal transition they need to enable the lifestyle they want. The case study gives the relevant example for the energy sector, which is a key issue for climate-neutral and smart cities. Partnerships Built environment and construction The vision of the partnerships is high-quality low-carbon, energy- and resource-efficient built environments that drive the transition towards sustainability, including scientific (holistic innovation), economic (sustainable operation) and societal (behavioural change) objectives, and reached through a user-centric approach. ► To create a people-centric, sustainable built environment, partnerships need to be strengthened along the value chain all the way to the user/citizen (e.g. by implementing co-development and co-creation activities with the building industry and residents) and across sectors (e.g. construction and transport). Since the impacts of clean energy solutions can differ widely between socioeconomic groups, intersectional factors as well as behavioural and structural determinants of the varying user groups must be taken into consideration here as well as when crafting new solutions. Strategic partnerships between players along the value chain can create solutions that are more widely accepted and have a greater impact. 100 Clean energy transition ► Partnerships are needed between publicly funded research and innovation programmes, industry, public organisations and especially citizens' organisations to create inclusive solutions. Partnerships must also be at eye level to ensure that all voices and ideas are heard, to take well-informed decisions about which solutions to pursue. Equal access for market players, consumers and local energy communities to solutions needs to be a determining factor to ensure the uptake and acceptance of those solutions. Successful methods for citizen engagement and participation need to be considered when shaping energy and transport investment and transition policies. Both researchers and policymakers must understand what motivates citizens to participate or invest time and/or money in these solutions. Based on the extensive socioeconomic analyses of user and citizen attitudes and practices, such drivers can be identified and used as levers and frameworks for investments and policies. Authors Dr Petra Püchner Commissioner for Europe of the Minister of Economic Affairs, Labour and Housing, Baden-Württemberg Head, Steinbeis-Europa-Zentrum Germany Nathalie da Silva Junior Expert on Gendered Innovation Project Manager for Innovation and Energy Steinbeis-Europa-Zentrum Germany 101 Works cited design-people (2015), Tech-user Navigator' (https://www. desiqn-people.com/wp-content/uploads/2017/09/Tech-user Navigator Light 9-17b.pdf). Dunphy, N., Revez, A., Gaffney, C, Lennon, B., Aguilo, A. R., Morrissey, J. and Axon, 5. (2018a), Intersectional Analysis of Energy Practices: Deliverable 3.2 of the ENTRUST H2020 project, Cork (https://ec.europa.eu/research/participants/documents/ downloadPublic?documentlds=080166e5b4f6dc79& appld=PPGM5). Dunphy, N., Revez, A., Gaffney, C, & Lennon, B. (2018b), Intersectional Analysis of Perceptions and Attitudes towards Energy Technologies: Deliverable 3.3 of the ENTRUST H2020 project, Cork (https:// ec.europa.eu/research/participants/documents/ downloadPublic?documentlds=080166e5b46a967c& appld=PPGM5). Dunphy, N., Lennon, B., Sanvicente, E., Tart, 5., Kielmanoicz, D. and Morrissey, J. (2018c), Innovative Business Models to Foster Transition: Deliverable 6.4 of the ENTRUST H2020 project, Cork (https:// ec.europa.eu/research/participants/documents/ downloadPublic?documentlds=080166e5ba68c72b& appld=PPGM5). Entrust (2017), 'Energy system transition through stakeholder activation, education and skills development', CORDIS, 12 July (https://cordis.europa.eu/proiect/ id/657998). European Commission (2019), Orientations towards the first strategic plan for Horizon Europe (https://ec.europa.eu/ info/sites/info/files/research and innovation/strategy on research and innovation/documents/ec rtd orientations-he-strateqic-plan 122019.pdf). European Parliament and Council of the European Union (2012), Directive 2012/27/EU of the European Parliament and of the Council of 25 October 2012 on energy efficiency, amending Directives 2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC: Text with EEA relevance (https://eur-lex. europa.eu/eli/dir/2012/27/oi). European Parliament and Council of the European Union (2018), Directive (EU) 2018/2002 of the European Parliament and of the Council of 11 December 2018 amending Directive 2012/27/EU on energy efficiency (text with EEA relevance) (https://eur-lex.europa.eu/eli/ dir/2018/2002/oi). Hancock, A. M. (2013), 'Empirical intersectionality: a tale of two approaches', UC Irvine Law Review, 3,259-296 (https://www.law.uci.edu/lawreview/vol3/no2/hancock.pdf). Schiebinger, L, Klinge, I., Sanchez de Madariaga, I., Paik, H. Y., Schraudner, M. and Stefanick, M. (eds.) (2011-2020a), 'Rethinking research priorities and outcomes', Gendered Innovations in Science, Health & Medicine, Engineering, and Environment (http:// qenderedinnovations.stanford.edu/methods/priorities. html). Schiebinger, L, Klinge, I., Sanchez de Madariaga, I., Paik, H. Y., Schraudner, M. and Stefanick, M. (eds.) (2011-2020b), 'Formulating research questions', Gendered Innovations in Science, Health & Medicine, Engineering, and Environment (http://qenderedinnovations.stanford. edu/methods/questions.html). UN (2015), 'Goal 7: Ensure access to affordable, reliable, sustainable and modern energy', Sustainable Development Goals (https://www.un.orq/ sustainabledevelopment/enerqy/). 102 AGRICULTURE: EMBEDDING GENDER NORMS IN INNOVATION PROCESSES The challenge Agricultural innovations tend to affect women and men differently. Most innovations focus on resolving technical problems, such as raising yields, withstanding environmental stress and managing poor soil or seeds. Such innovations often fail to account for how gender norms influence the implementation of technical solutions or how the implementation of technical solutions will influence gender norms. Consequently, innovations may not reach women and may even amplify gender inequality (Quisumbing et al, 2014; Bock and van der Burg, 2017; Lawless et al, 2017; Rola-Rubzen et al, 2020; Sachs et al, forthcoming). Agricultural science covers research on crops, livestock, fishing, forestry, horticulture, trees, soil, natural resources, food, biofuels and related production processes, as well as their management, such as natural resource management covering water, post-harvest processing, supply and added value chains, markets and consumption (Meinzen-Dick et al, 2010). Research shows that gender and other normative social structures often lead to unequal benefits from innovation opportunities. Restrictive gender norms are deeply engrained in institutions such as the family, education and banking. These constrain the agency of women, their access to resources and services, mobility, representation and decision-making capacity, especially for less privileged groups (Cole et al, 2015; Badstue et al, 2018). This is the case worldwide (Bock and Shortall, 2017), but solutions need to be context specific. Gender-transformative approaches have been developed to address these issues by: ► fostering the critical examination of gender roles, norms and relations; ► recognising and strengthening positive norms that support equality; ► promoting the position of women, girls and marginalised groups; ► transforming underlying social structures, policies and broadly held beliefs that perpetuate gender inequality (Petesch et al, 2017, 2018a-c; Badstue et al. 2018; Danielsen et al, 2019; see also Hillenbrand et al, 2015; Aregu et al, 2019; van der Burg, 2019; Fischer et al, 2019). Gendered innovation l.-Gill nets in Bangladesh To overcome food poverty, WorldFish led the United States Agency for International Development (USAID)-funded project Aquaculture for income and nutrition, with local partners in Bangladesh (Keus et al, 2017). WorldFish is one of the institutes of the worldwide CGIAR. The project combined the introduction of new technology with a gender-transformative approach (Kruijssen et al, 2016; see also WorldFish, 2016a,b) Fish is the most important animal-source food in Bangladesh. Approximately 60 % of the population eats fish at least every other day, with daily per capita consumption at 44 grams for the poorest households. In 2012, around 4.27 million households (20 % of rural households) had a fish pond (Belton and Azad, 2012). # Method: co-creation and participatory research Project researchers compared five nets with different mesh sizes to identify which nets performed best for catching small fish and which nets best met women's needs and preferences. They found that gill nets with 1.7-cm mesh were women's top choice. Gender-related cultural and religious expectations prohibit women from harvesting fish even from their own ponds. Such tasks are seen as the responsibility of men. Women are also reluctant to enter ponds because they get their sarees wet, which then need to be laundered. As a consequence, women mostly feed the fish and help clean the ponds, while men harvest and market the fish, and make financial decisions for the household. To support gender equality and to ensure food security, WorldFish started to introduce mola gill nets in the poorest parts of Bangladesh. Gill nets are fishing nets that are lightweight enough for women to cast from the bank of the pond, without getting into the water. Gill nets come in meshes of different sizes. Mesh size determines the type of fish caught. A fish swims into the net but passes only partway through the mesh. When it struggles to free itself, the netting slips behind the gill cover to trap the fish. Since the nets are used to catch only nutrient-rich mola fish (Amblypharyn-godon mola), men did not feel threatened, as there was little danger of netting the larger fish, which men catch and regard as theirs. Women attended an 8-day training course on how to make and use a gill net. The nets were 7.5 metres wide by 1.8 metres high. Women were taught to make their own nets by buying low-cost mesh and rope from the market and using empty bottles (for floats) and rocks or broken bricks (as sinkers). Harvesting fish with these nets takes around 30 minutes from setting the net to pulling in the catch. Women were also taught to manage mola fish farming and were provided with nutrition education on mola. Mola is a small fish rich in vitamin A, iron and zinc. When eaten whole, including the head, organs and bones, mola is rich in micronutrients, which are important for good health and child development. The mola gill net allows frequent harvesting and consumption of mola. Just 17 mg of mola can provide the recommended vitamin A intake for a child under the age of 5 (Kataki, 2002). 104 # Method: analysing gender Crucial to the success of this project was recognising and transforming gender norms. Because fishing has traditionally been men's work, workshops addressed gender consciousness to ensure that husbands, in-laws and neighbours supported the new role of women in cultivating and catching fish with gill nets. These workshops addressed gender dynamics ranging from intra-household power hierarchies to food distribution. They also addressed gender norms that limited individual and family well-being and enhanced ways to collaboratively shift gender relations. These workshops are outlined in the manual Promoting Gender-Transformative Change with Men and Boys (Promundo-US and the CGIAR Research Program on Aquatic Agricultural Systems, 2016), discussed under 'Gendered innovation 2' below. Women were also coached in self-confidence, negotiating skills and assertiveness. Results showed changed attitudes among men and women, enhanced collaboration between family members and greater acceptance of technology uptake by women (Kruijssen et al, 2016; IFPRI Gender Breakfast with CARE and WorldFish, 2017; personal information from A. Choudhury, WorldFish, 23 June 2017). WorldFish also monitored changes in production, attitudes and practices (both technical and social) through surveys and interviews with women, their partners and other household members (Kruijssen et al, 2016). Gendered innovation 2: Embedding gender norms in innovation processes -M. GENNOVATE Through Gennovate (n.d.), gender experts from CGIAR institutes, including WorldFish, collaborated to integrate social processes and especially gender norms into large-scale agricultural R&D programmes. They developed extensive methodologies, reports, articles, briefs and videos for research teams in this 4-year research project (2014-2018), sponsored by the Bill and Melinda Gates Foundation. Gennovate advanced in-depth research methods to understand how gender norms and innovation processes in agriculture and natural resource management influence each other, in diverse rural settings. Its core research addressed the following questions (Petesch et al, 2017). 1. How do gender norms advance or impede the adoption of innovative technologies in agriculture and natural resource management across different contexts and social structures? 2. How and where do new agricultural technologies or practices advance or weaken women's agency and change gender norms to the benefit or harm of women? 3. When and under which circumstances do changes in gender norms and women's and men's agency catalyse innovation and promote inclusive outcomes? What contextual factors influence this relationship? Gennovate exemplifies standardised methodologies and tools for research that include gender norms. Its conclusions are based on the participation of over 7 000 men and women from 137 rural communities in 26 countries in dis- 105 cussion groups and interviews (split by sex, age and socioeconomic status; see Badstue et al, 2018; Petesch et al, 2018a). Gennovate's methodologies for examining gender norms can be applied in any gender-sensitive baseline study or preferably in an ex ante gender impact assessment (GIA) as part of a large-scale agricultural R&D programme. The manual Promoting Gender-Transformative Change with Men and Boys (Promundo-US and the CGIAR Research Program on Aquatic Agricultural Systems, 2016), developed by Promundo and CGIAR-WorldFish, contains 13 activity-based group sessions to engage men and boys in gender-transformative dialogue as developed for aquatic agricultural systems. The sessions focus on: ► understanding how power and gender inequality perpetuates poverty and harms well-being; ► taking action to create more inclusive environments for women in aquatic agricultural development; ► promoting shared financial and household decision-making; ► increasing negotiation and communication skills; ► promoting men's involvement in care work; and ► understanding how to stop cycles of violence. Conclusion Early evidence suggests that gender equality is enhanced when the introduction of a technological innovation is accompanied by a gender-transformative approach. Kruijssen et al. (2016) state that projects are able to trigger transformation in norms when focusing on the root causes of inequality, such as traditional attitudes and behaviour, internal functioning and outreach routines in institutions and gender-specific norms, that limit women's participation. PROMOTING GENDER-TRANSFORMATIVE CHANGE WITH MEN AND BOYS A Manual to Spark Critical Reflection on Harmful Gender Norms with Men and Boys in Aquatic Agricultural Systems An integrated systems approach that starts from the interaction of technological and social dimensions may produce favourable outcomes, as demonstrated in the example of gill net fishing in Bangladesh. It demonstrates how an agri-food or farm systems approach that integrates different participants and activities (diverse crop, livestock and natural resource management) is best equipped to include the gender dimension (Fisher et al, 2019; van der Burg, 2019; Feldstein, 2000). Gennovate provides the research evidence and methodological tools to address the ways in which gender norms influence and are influenced by innovations in agricultural and resource management. This gender-transformative approach gives new entry points to advance transformative change worldwide - including in European agricultural contexts - that goes beyond women's representation and includes addressing the root causes of existing inequalities. The methodologies developed for in-depth gender analysis and ex ante GIA combined with co-creation and participatory research are relevant to EU-funded projects, such as Farming tools for external nutrient inputs and water management (Fatima, http://fatima-h2020.eu; Fatima, 2017) (e.g. Osann, 2018), Social innovation in 106 marginalised rural areas (SIMRA, http://www. simra-h2020.eu; SIMRA, 2020) (Ravazzoli et al, 2019) , Small farms, small food businesses and sustainable food and nutrition security (SALSA, http://www.salsauevora.pt/about-salsa/; SALSA, 2020) (Sutherland et al, 2019), New entrant network: business models for innovation, en-trepreneurship and resilience in European agriculture (Newbie, http://www.newbie-academv. eu; Newbie, 2020) and more in the future. The EU project Gender in science management of agriculture and life sciences, including research and teaching (Gender-SMART, https://www.qen-dersmarteu; Gender-SMART, 2020) is further elaborating how to include gender analysis and address gender and other social norms in agricultural R&D. Gender-SMART is part of the science with and for society programme and funded by Horizon 2020 grant No 824546. » Next Steps The good practices presented in this case study can be broadly applied in agricultural R&D. They can be further supported and expanded in the following ways. ► New designs of agricultural R&D projects should include gender and other social norms, especially in baseline studies or ex ante GIAs. Gennovate researchers have already provided examples (e.g. Farnworth et al, 2017, 2018a,b; Kawarazuka et al, 2018; Rietveld and Farnworth 2018a,b; Bergman Lodin et al, 2019; Lawless et al, 2019). ► European research on agricultural innovation will benefit from addressing the influence of gender and other social norms on access to and benefits from resources such as land ownership, training, credit, mobility, decision-making power, and support from family and community members (EIGE, 2016; Bock and Shortall, 2017). ► Research in this area calls for an intersectional perspective to address heterogeneity in women and men related to other social dimensions or identities, such as socioeconomic status, geographical location, family structures, religion, ethnicity, age and physical ability (see for example Elias et al, 2018; Rietveld et al, 2020; van der Burg, forthcoming). Policy ► Commission comparative research into the design and implementation of innovations that contribute to social and gender equality in agriculture, forestry, fisheries and nature management in various rural settings in Europe and around the world. ► Support coordinated awareness-raising about the influence of gender and other social norms in (inter)national agriculture- related organisations and platforms such as European innovation partnerships, and provide them with instruction manuals on how to sustainably reduce inequality and achieve higher equality through innovations. ► Request context-specific ex ante GIA research as part of research and policymaking. 107 Targeted impact-oriented recommendations for future research and innovation actions funded under Horizon Europe Since transition is key to the strategic plans for Horizon Europe, an urgent challenge is to achieve transformative change sustainably Research can significantly sustain the far-reaching transformation in the agricultural and food sector that the European Green Deal demands, especially under the Farm2Fork strategy (European Commission, 2020). Success will depend on the contribution of all rural residents, whether in farming or not, whether permanent or temporary, of all genders, ages, nationalities, cultures, etc. and across all European regions. To secure the active engagement of all and to ensure that transitions will benefit all, gender disparities, and gender and other social norms, should be analysed and addressed from the outset in order to better advance equality and equal benefits in social outcomes and impacts. To implement transformations that will promote gender and social equality (SDGs 5 and 10), R & I needs to consider the influence of gender and social norms in relation to other SDGs, such as reducing poverty, including rural poverty (SDG 1), eliminating hunger (SDG 2), responsible consumption and production (SDG 12), climate action (SDG 13) and life below water and on land (SDGs 14 and 15). It is important to include gender norms in baseline studies, to include ex ante GIA in research design and to include gender analysis of specific contexts in order to understand the needs and perspectives of all gender-diverse individuals in all agriculture-related domains and rural settings, whether these individuals are directly or indirectly participating or affected. Cluster 6: Food, bioeconomy, natural resources, agriculture and environment Circular economy, the bioeconomy, the blue economy, agroecology and the food system in Cluster 6 are all presented as providing opportunities to balance environmental, social and economic goals, and set human activities on a path to sustainability. It is acknowledged that the challenges and impacts in this cluster are highly interconnected, and systems-based approaches will be encouraged. Multi-actor involvement, as well as interdisciplinary or even transdisciplinary approaches in the R & I orientations, is encouraged. Carefully investigate all social aspects and, in particular, integrate in-depth social and gender analysis and apply ex ante GIA to determine who will benefit and who will not from the implementation of sustainability and economic growth. Currently, these key research areas do not analyse by gender and other social factors and do not evaluate gender and social impacts as part of these systems-based approaches. Consider how the quality of urban and rural lives can be improved while advancing equality, not only at the individual level but also structurally, within sectors, regions and vulnerable environments. Consider including the gender dimension as it intersects with other social dimensions in ecological, agricultural and food transitions, by op-erationalising, investigating and assessing gender and other inequalities with regard to: ► technologies, digitalisation, new business and governance models, and social and environmental innovation; ► growing efficient management and sustainable use of biological resources; ► socially disadvantaged regions; ► representation and voice in multi-stakeholder living labs; ► interactive and integrated approaches to fair and just pathways. Consider including specifically the rural context and rural inhabitants alongside the focus on the producers and consumers of the agricultural and food sector in general. 108 Synergies between Cluster 6 and other clusters Cluster 6 is linked to other clusters because agriculture and food relate to all aspects of society. This means that the gender analysis and gender-sensitive approaches developed in other clusters will benefit Cluster 6; and Cluster 6 can support other clusters by integrating agricultural and rural contexts into their thematic gender analyses. Clusters 1-5 include in-depth analysis of socioeconomic and cultural factors but require better integration of rural and agricultural contexts. All clusters should work together (and not in silos). Synergies with Cluster 1: Health Staying healthy in a rapidly changing society ► Consider the different ways in which societal changes affect female and male farmers and female and male (including foreign or refugee) seasonal farm workers. ► Analyse gender-specific health issues resulting from gender-specific responsibilities for family farms. ► Consider how family organisation and composition differ by gender and other social dimensions, such as generation, religion, race, ethnicity, class/wealth, geographical location, civic, marital status and health status. Living and working in a health-promoting environment ► Consider the occupational health risks to farmers and farm workers of all genders related to transition-related stress, high-risk equipment and chemicals. Ensuring access to innovative, sustainable and high-quality healthcare ► Consider rural areas when defining high-quality healthcare systems. Synergies with Cluster 2: Culture, creativity and inclusive society Help reverse social, spatial, economic, cultural and political inequalities and their causes, and promote gender equality Consider how agricultural and rural transitions contribute to the social inclusion of marginalised groups by integrating these groups into researching, planning, implementing, monitoring and evaluating rural and agricultural programmes: ► include and address the influence of gender and other social norms; ► consider how the effective participation of rural women - and farm women in professional organisations - at local and other levels of governance can be secured; ► protect the transfer of tangible and intangible rural and agricultural cultural heritage produced by women, men and gender-diverse individuals, for instance in traditions and rituals, traditional handicrafts, music and dances, but also in food cultivation, wild food gathering, herbal medicines, storage and preservation techniques, and meal preparation; ► connect heritage practices, where appropriate, to rural and agricultural transition challenges, health support systems, economic growth and mobility (entrepreneurship in tourism, rural business), and civil security (rural extremism). 109 Synergies with Cluster 3: Civil security for society Disaster-resilient societies ► Consider that farmers of diverse genders are key in preventing and fighting natural disasters; include gender differences and gender norms in farming people's perspectives on risk management, prevention and actions when researching and preparing new arrangements and measures. Include the intersections of gender with other social dimensions. Safety of public space, vital infrastructure and societal functions, and fighting crime and terrorism ► In rural areas, safety can be an issue, since there is less formal policing. Undermining forces do increasingly take control in rural areas, for instance by illegally producing and trading in drugs. Violence constitutes a particular risk to rural women and gender-diverse individuals, as remote housing prevents effective formal or social control, and specialised social services are absent. Investigate and include these specific risks as well as prevention and resilience options. ► Farmers can help prevent natural disasters; it is important to include gender differences in farmers' perspectives on risk management, prevention and actions. Synergies with Clusters 5 and 6: Climate, energy and mobility and Food, bioeconomy, natural resources, agriculture and environment Ensure that villages and small towns and their inhabitants are included in climate, energy and mobility missions. ► Include rural and gender impact assessments from the very beginning of the research process in order to identify potential patterns of exclusion and redress them up front. ► Include rural areas and their inhabitants in smart innovations to assure the maintenance of infrastructure and its viability. Be sure to assess gender needs, norms and conditions. ► In addition to individual users, consider how sectors, such as in agriculture and natural resource management, will be affected. These sectors can be included by adding sectoral gender analysis and impact assessments. ► Consider the specific circumstances and addres differences between women and men in access, resources, affordability and connectedness. ► Take into account how not only individual users but also sectors, such as agriculture and natural resource management, are affected and can be included by adding sectoral gender analysis and impact assessments to recognise direct and indirect effects on inequalities while decarbonising the EU's economy and working towards a full circular economy. Mission areas Accelerating the transition to a climate-prepared and resilient Europe ► As stated above, include rural and gender impact assessments from the very beginning of the research process in order to identify potential patterns of exclusion and redress them up front. ► Include rural areas and their inhabitants in smart innovations to assure the maintenance of infrastructure and its viability. Be sure to assess gender needs, norms and conditions. 110 ► In addition to individual users, consider how sectors, such as in agriculture and natural resource management, will be affected. These sectors can be included by adding sectoral gender analysis and impact assessments. ► Implement a just transition as mentioned in the Farm2Fork strategy (equity between regions, fair trade or affordable food) by investigating gender and other social dimensions in the content of the R & I. Literature to support this includes Bock and van der Burg (2017), Allwood (2017), Swim et al. (2018) and Alston (2014). Regenerating our ocean and waters by 2030 In addition to training and upskilling a new gender-balanced blue workforce, this mission uses the wording of 'citizens', 'communities' and 'governance' without operationalising how to address existing inequalities. Internationally, concerns have been expressed that environmental sustainability now overshadows concerns about social equity. It is important to understand that sustainability as fairness and environmental sustainability are two sides of the same coin. Inequality in national ocean economies should therefore be explicitly addressed (see Osterblom et al, 2020): ► include gender analysis and ex ante GIA to optimise equality in working and living pathways, livelihood, labour force, foodways, new technologies and education. Caring for soil is caring for life Gender is mentioned only once in this mission in regard to inclusive language. Sex and/or gender analysis must also be integrated into the R & I content: ► address gender and intersectional transformative approaches in this mission. Partnerships Partnership for Accelerating Farming Systems Transition: Agroecology Living Labs and Research Infrastructures European Partnership for Blue Oceans Partnership for Animal Health Partnership for Safe and Sustainable Food Systems for People, Planet and Climate Partnerships tend to emphasise ecological practices in relation to cost-effective solutions and often overlook the need to foster social equalities. For all partnerships: ► analyse gender and intersectional factors to ensure that environmentally friendly measures will support social equality including gender equality, and avoid social harms; ► consider gender-sensitive communication strategies and inclusive governance as these intersect with other social dimensions, such as ethnicity and socioeconomic status. Authors Dr Margreet van der Burg Senior University Lecturer/Researcher Gender in Food, Agricultural and Rural Research and Development Wageningen University Netherlands Professor Bettina Bock Inclusive Rural Development Wageningen University Netherlands With thanks to Afrina Choudhury, research fellow (senior gender specialist), CGIAR-WorldFish; and Dr Lone B. Badstue, research theme leader, Gender & Social Inclusion, CGIAR-lnternational Maize and Wheat Improvement Center (CIMMYT). Ill Works cited Allwood, G. (2017), 'Gender mainstreaming and EU climate change policy', in: MacRae, H. and Weiner, E. (eds.), Towards Gendering Institutionalism: Equality in Europe, Rowman & Littlefield, Louisville, CO, pp. 43-61. Alston, M. (2014), 'Gender mainstreaming and climate change', Women's Studies International Forum, 47, 287-294. Aregu, L, Choudhury, A., Rajaratnam, 5., van der Burg, M. and McDougall, C. (2019), 'Implications of agricultural innovation on gender norms: Gender approaches in aquatic agriculture in Bangladesh', in Sachs, C. (ed.), Gender, Agriculture and Agrarian Transformations: Changing relations in Africa, Latin America and Asia, Routledge, Abingdon, pp. 162-179. Badstue, L, Petesch, P., Feldman, S., Prain, G., Elias, M. and Kantor, P. (2018), 'Qualitative, comparative and collaborative research at large scale: an introduction to GENNOVATE', Journal of Gender, Agriculture and Food Security, 3(1), 1-27. Belton, B. and Azad, A. (2012), 'The characteristics and status of pond aquaculture in Bangladesh', Aquaculture, 358,196-204. Bergman Lodin, J., Tegbaru, A., Bullock, R., Degrande, A., Wopong Nkengla, L. and Ibrahim Gaya, H. (2019), 'Gendered mobilities and immobilities: women's and men's capacities for agricultural innovation in Kenya and Nigeria', Gender, Place & Culture, 26 (12), 1759-1783. Bock, B. and van der Burg, M. (2017), 'Gender and international development', in: Bock, B. and Shortall, 5. (eds.), Gender and Rural Globalization, CABI, Wallingford and Cambridge, MA, pp. 245-252. Bock, B. and Shortall, S. (eds.) (2017), Gender and Rural Globalization, CABI, Wallingford and Cambridge, MA. Cole, S. M, Puskur, R, Rajaratnam, S. and Zulu, F. (2015), 'Exploring the intricate relationship between poverty, gender inequality, and rural masculinity: a case study from an aquatic agricultural system in Zambia', Culture, Society and Masculinities, 7(2), 154-170. Danielsen, K., Wong, F. and Mukhopadhyay, M. (2019), Integrating "Gender" in Research for Development: How you interpret the term can shape project achievements, CIMMYT Gender Resources for Agricultural Research and Development Professionals, CIMMYT, Mexico City. Elias, M., Mudege, N., Lopez, D. E., Najjar, D., Kandiwa, V., Luis, J., Yila, J., Tegbaru, A., Ibrahim, G. and Bentaibi, A. (2018), 'Gendered aspirations and occupational trajectories among the rural youth: a cross-regional perspective', Journal of Gender, Agriculture and Food Security, 3(1), 82-107. EIGE (European Institute for Gender Equality) (2016), Gender in Agriculture and Rural Development, Publications Office of the European Union, Luxembourg. European Commission (2020), Commission communication - A farm to fork strategy: for a fair, healthy and environmentally-friendly food system (COM/2020/381 final). Farnworth, C. R., Jafry, T., Lama, K., Chatterjee, S. and Badstue, L. (2017), Challenging Gender Myths: Promoting inclusive wheat and maize research for development in Nepal, GENNOVATE Resources for Scientists and Research Teams, CIMMYT, Mexico City. Farnworth, C. R., Bharati, P., Jafry, T. and Badstue, L. (2018a), Strengthening Women in Wheat Farming in India: Old challenges, new realities, new opportunities, GENNOVATE Resources for Scientists and Research Teams, CIMMYT, Mexico City. Farnworth, C. R., Jafry, T., Rahman, S. and Badstue, L. (2018b), Leaving No One Behind: Supporting women, poor people, and indigenous people in wheat-maize innovations in Bangladesh, GENNOVATE Resources for Scientists and Research Teams, CIMMYT, Mexico City. Fatima (2017), 'Farming tools for external nutrient inputs and water management', CORDIS, 22 August (https:// cordis.europa.eu/proiect/id/633945). Feldstein, H. S. (2000), 'Gender analysis: making women visible and improving social analysis', in: Collinson, M. (ed.), A History of Farm Systems Research, CABI and FAO, Wallingford and Rome, pp. 67-76. Fischer, G, Wittich, S. and Frundt, S. (2019), Gender analysis informing systems and action research: A training manual, IITA, Ibadan. Gender-SMART (2020), 'Science management of agriculture and life sciences, including research and teaching', CORDIS, 3 March (https://cordis.europa.eu/ project/id/824546). Gennovate (n.d.), 'Towards gender equality in agriculture' (https://qennovate.org). Hillenbrand, E, Karim, N, Mohanraj, P. and Wu, D. (2015), Measuring Gender Transformative Change: A review of literature and promising practices, working paper, CARE USA. 112 IFPRI (International Food Policy Research Institute) Gender Breakfast, CARE and WorldFish (2017), 'Measuring gender-transformative change', paper presented at Agriculture: A review of the literature and promising practices, 16 February. Kataki, P. (2002), 'Food systems for improved human nutrition: linking agriculture, nutrition, and productivity', Journal of Crop Production, 6 (1/2), 7-29. Kawarazuka, N., Prain, G., Forsythe, L, Mayanja, 5., Mudege, N. N, Babini, C. and Polar, V. (2018), Gender in Agricultural Mechanization: Key guiding questions, CIP, Lima. Keus, E., Subasinghe, R., Aleem, N., Sarwer, R., Islam, M., Hossain, M., Masum, A., Rahman, M., Alan, M., Anisuzzaman, A., Bhuiyan, M., Rahman. M. and Bhuiya, M. (2017), Aquaculturefor Income and Nutrition: Final report, Programme report: 2017-30, WorldFish, Penang, Malaysia. Kruijssen, F., Audet-Belanger, G., Choudhury, A., Crissman, C, Dalsgaard, J. P. T., Dawson, C, Dickson, M., Genschick, 5, Islam, M. M, Kaminski, A, Keus, H. J, McDougall, C. Banda, L. E., Muyaule, C. and Rajaratnam, 5. (2016), Value Chain Transformation: Taking stock of WorldFish research on value chains and markets, working paper AAS-2016-03, CGIAR Research Program on Aquatic Agricultural Systems, Penang. Lawless, S., Doyle, K., Cohen, P., Eriksson, H., Schwarz, A. M., Teioli, H., Vavekaramui, A., Wickham, E., Masu, R., Panda, R. and McDougall, C. (2017), Considering Gender: Practical guidance for rural development initiatives in Solomon Islands, program brief, WorldFish, Penang. Lawless, S., Cohen, P., McDougall, C, Orirana, G., Siota, F. and Doyle, K. (2019), 'Gender norms and relations: implications for agency in coastal livelihoods', Maritime Studies, 18, 347-358. Meinzen-Dick, R., Quisumbing, A., Behrman, J., Biermayr-Jenzano, P., Wilde, V., Noordeloos, M., Ragasa, C. and Beintema, N. (2010), Engendering Agricultural Research, discussion paper 973, IFPRI. Newbie (2020), 'New entrant network: business models for innovation, entrepreneurship and resilience in European agriculture', CORDIS, 14 October (https://cordis. europa.eu/project/id/772835). Osterblom, H., Wabnitz, C. C. C. and Tladi, D. (2020), Towards Ocean Equity, World Resources Institute, Washington, DC. Osann, A. (2018), D6.6 Gender Action Report, European Commission (http://fatima-h2020.eu/wp-content/ uploads/2015/07/D-6_6.pdf). Petesch, P., Badstue, L, Prain, G., Elias, M. and Tegbaru, A. (2017), Entry points for enabling gender equality in agricultural and environmental innovation, GENNOVATE Resources for Scientists and Research Teams, CIMMYT, Mexico City. Petesch, P., Badstue, L. and Prain, G. (2018a), Gender norms, agency, and innovation in agriculture and natural resource management: The GENNOVATE methodology, CIMMYT, Mexico City. Petesch, P., Badstue, L. B., Camfield, L, Feldman, S., Prain, G. and Kantor, P. (2018b), 'Qualitative, comparative and collaborative research at large scale: the GENNOVATE field methodology', Journal of Gender, Agriculture and Food Security, 3(1), 28-53. Petesch, P., Bullock, R, Feldman, S, Badstue, L, Rietveld, A., Bauchspies, W., Kamanzi, A., Tegbaru, A. and Yila, J. (2018c), 'Normative dimensions of agency and agricultural decision-making in sub-Saharan Africa', Journal of Gender, Agriculture and Food Security, 3(1), 108-130. Promundo-US and the CGIAR Research Program on Aquatic Agricultural Systems (2016), Promoting Gender-Transformative Change with Men and Boys: A manual to spark critical reflection on harmful gender norms with men and boys in aquatic agricultural systems, Promundo-US and CGIAR, Washington, DC, and Penang. Quisumbing, A., Meinzen-Dick, R., Raney, T. L, Croppenstedt, A., Behrman, J. A. and Peterman, A. (eds.) (2014), Gender in Agriculture: Closing the knowledge gap, Springer, Dordrecht. Ravazzoli, E., Torre, C. D. and Streifeneder, T. (2019), 'Transforming the role of women farmers and of refugees: two Italian experiences of social innovation in mountain areas', Journal of Alpine Research I Revue de geographie alpine, 107-2 (https://doi.org/104000/rqa.6025). Rietveld, A. and Farnworth, C. R. (2018a), Towards gender-responsive banana research for development in the East-African Highlands, GENNOVATE Resources for Scientists and Research Teams, CIMMYT, Mexico City. Rietveld, A. and Farnworth, C. R. (2018b), Continuity and Change: Negotiating gender norms in agricultural research for development in Rwanda, GENNOVATE Resources for Scientists and Research Teams, CIMMYT, Mexico City. 113 Rietveld, A. M, van der Burg, M. and Groot, J. C. (2020), 'Bridging youth and gender studies to analyse rural young women and men's livelihood pathways in Central Uganda', Journal of Rural Studies, 75,152-163. Rola-Rubzen, M. R, Paris, T., Hawkins, J. and Sapkota, B. (2020), 'Improving gender participation in agricultural technology adoption in Asia: from rhetoric to practical action', Applied Economic Perspectives and Policy, 42(1), 113-125. Sachs, C. E., Jensen, L, Castellanos, P. and Sexsmith, K. (eds.) (forthcoming), Routledge Handbook of Gender and Agriculture, Routledge, London. SALSA (2020), 'Small farms, small food businesses and sustainable food and nutrition security', CORDIS, 3 July (https://cordis.europa.eu/proiect/id/677363). SIMRA (2020), 'Social innovation in marginalised rural areas', CORDIS, 15 June (https://cordis.europa.eu/proiect/ id/677622). Sutherland, L-A, Zengeni, T, Adolph, B, Atela, J, Bj0rkhaug, H., Brunori, G., Burns, V., Cerrada-Serra, P., Ellis, R., Galli, R, Hopkins, J., KTlis, E., Noble, C, Ortiz-Miranda, D., Prosperi, P., Rocha, R., Sumane, S., Toma, I., Tonui, C. and Yeboa, R. (2019), Deliverable 5.2: Report on governance frameworks and gender, Work Package 5 Analysis of the Governance of Small Rarms and Rood Chains, SALSA project (https:// ec.europa.eu/research/participants/documents/ downloadPublic?documentlds=080166e5c6b0afa5& appld=PPGMS). Swim, J. K., Vescio, T. K., Dahl, J. L. and Zawadzki, S. J. (2018), Gendered discourse about climate change policies', Global Environmental Change, 48, 216-225. van der Burg, M. (2019),' "Change in the making": 1970s and 1980s building stones to gender integration in CGIAR agricultural research', in: Sachs, C. (ed.), Gender, Agriculture and Agrarian Transformations: Changing relations in Africa, Latin America and Asia, Routledge, London, pp. 35-57. van der Burg, M. (forthcoming), 'Gender integration in international agricultural research', in Jensen, L, Castellanos, P. and Sexsmith, K. (eds.), Routledge Handbook of Gender and Agriculture, London: Routledge, Chapter 5. WorldRish (2016a), 'Gill nets enable women to harvest nutritious fish in Bangladesh' (http://worldfishcenter.orq/ paqes/qill-net/). WorldRish (2016b), 'Gill nets boost women's involvement in aquaculture in Bangladesh' (https://youtu.be/ eoYCxLISteY). 114 Urban planning, transport SMART MOBILITY: CO-CREATION AND PARTICIPATORY RESEARCH The challenge Mobility patterns are gendered. Typically, one can observe, for instance, gender norms, gender-specific divisions of labour in households and 325 ^iT^lTri gender disparities in resources. Gendered household labour is particularly important on the demand side, since trips related to caring - running the household, errands or caring for others - are different from commuting to work in terms of distance and frequency. Another aspect to consider is safety, which is of particular importance to women, who tend to feel more at risk when using public transport than men. On the supply side, urban transportation is increasingly offering smart mobility options underpinned by ICT platforms designed to ease access to transportation services and to personalise modern transportation. These developments, however, have largely ignored gender (Nobis and Lenz, 2009, 2019; Lenz, 2020). To close the gap between gender-specific needs and new smart mobility services, we need to (1) understand gender-specific needs throughout populations by also taking into account other aspects, such as abilities, age, ethnicity and socioeconomic status, and (2) develop and apply gender-sensitive methodologies to assess those needs and to co-create services that enhance mobility options. Gendered innovation 1: Mobility of care Effective transportation systems rely on big data. Transportation planners collect data to understand how people use different modes of transport: cars, bikes, trains, underground railways and buses. The gendered innovation is to reconceptualise how data are collected and analysed. Researchers examining public transport often categorise trips by purpose, to better understand existing transportation patterns and to plan infrastructure changes. Traditional categories used in transportation surveys collect information about trips for employment, education, shopping, leisure and the like (see left-hand side of graph below). Categories used by European national household travel surveys, such as the ones in the Netherlands or Germany, for example, include trip to work, work-related trip, trip to kindergarten/school/university, shopping/ running errands, activities, picking someone up/ dropping someone off, leisure, accompanying an adult person, sports, meeting friends, home, other private activity. This includes the recommendations made by Eurostat (2018). The innovative concept 'mobility of care' reveals significant travel patterns otherwise concealed in data collection variables (Sanchez de Madariaga, 2009, 2013). The charts below represent public transport trips made in Madrid, Spain, in 2014. The left-hand side of the graph below displays transportation data as traditionally collected and reported. It privileges paid employment by presenting it as a single large category. Caring work (shown in red) is divided into numerous small categories and hidden under other headings, such as escorting, shopping and leisure. The right-hand side reconceptualises public transport trips by collecting care trips into one category. Visualising care trips in one dedicated category recognises the importance of caring work and allows transportation engineers to design systems that work well for broader segments of the population (Sanchez de Madariaga and and Zucchini, 2019). 115 # Method: reconceptualising data collection TRIPS BY PURPOSE, POPULATION 30-45 YEARS, MADRID 2014 Data as traditionally collected Data collected using the concept "mobility of care" Employment Personal Escorting Shopping Other 5% Leisure I [4% Errand ■ 3% Visiting 3% Health 3% Strolling 3% Social 33% 17% 16% I 11% 33% ■ 29% I 15% I 1% | Escorting 7% Shopping 5% lother 3% 2% 2% 1% 1% 0,6% I Employment Care-Related Work Personal I Leisure Errand Visiting Health Strolling Social Care-Related Trips Traditional data collection categories (left) and the new umbrella category mobility of care (right). Source: Sanchez de Madariaga and Zucchini (2019), with permission Reconceptualising data collection is important because women perform a relatively large proportion of accompanying trips. They make more short trips and more chained trips (several destinations visited along the same route) than men. Women also tend to prefer shorter distances between home and the workplace. These observations are true in particular of households with two or more adults between the ages of 30 and 50. These differences do not apply to younger or single-person households (Nobis and Lenz, 2005). Gendered innovation 2: Analysing gender to enhance fair mobility Beyond how data are collected and analysed, it is important to develop gender-sensitive methodologies to better address the needs of public transport users. To introduce dynamic ICT-based public transport services, a 'LivingLab' was set up in Schorndorf (Germany), to experiment with gender-sensitive methodologies (Center for Interdisciplinary Risk and Innovation Studies, 2018; Gebhardt et al, 2019). The objective was to make public transport more user-friendly and more efficient. To this end, conventional public transport was transformed into an on-demand bus service at times when demand tended to be low and variable, such as evenings and weekends. The service used a digital platform with access by a smartphone app, the internet or telephone. The LivingLab introduced smaller buses with flexible routes and a dense pattern of flexible stops that allowed people to get on or off the bus close to the start or end of their journey. Users did not have to walk to traditional designated bus stops. This gender-sensitive on-demand service addressed the specific needs of women and contributed to the comfort of all users in need of safe and efficient off-peak services. ► Users, especially young women and girls, found the on-demand bus provided a safe way home. Longer walks from the flexible 116 bus stop to home, sometimes leading through pedestrian underpasses, could be eliminated. At the same time, waiting times for the bus were considerably reduced. ► Smaller on-demand buses provided an improved feeling of safety for people travelling in the evening or at night, as all seats were close to the driver. (The need for the presence of a driver to ensure safety was a reason women argued against autonomous vehicles.) Providing mobility services that are perceived as safe enhances options for out-of-home activities, especially for elderly people, who often restrict those activities to daylight hours (Giesel and Rahn, 2015). The LivingLab included participatory research, in which users contributed to concepts and evaluated designs (see method below). Users emphasised a need for multifunctional spaces in the on-demand vehicle that could accommodate pushchairs, shopping trolleys or walking aids, required by elderly passengers in particular. A kerb-to-bus ramp allowed barrier-free access to the vehicle for passengers and their equipment. While designed with women in mind, this project has the potential to improve safety for all users: men, gender-diverse people and people from diverse socioeconomic and regional backgrounds. # Method: co-creation and participatory research The LivingLab used co-creation and co-design, also known as participatory research, to investigate different user groups and their needs when designing the new mobility services. These methods enable new services to be conceptualised from customer perspectives and include a gender-sensitive framework. This method added new insights into the relevant functionalities, i.e. what services are needed; the configuration of vehicles and infrastructures, i.e. vehicle features and routes; and relevant ICT access to the service. To apply this participatory research within the LivingLab, 'typical representatives' (similar to per-sonas) of the overall population were developed to stimulate discussion among those involved in the co-design workshops (Pruitt and Adlin, 2006; Baumann, 2010; Miaskiewicz and Kozar, 2011; Beyer and Muller, 2019). The goal was to understand the specific needs, contexts, and conditions of users throughout the broader population (not E Ingrid Henke, 73 Jahre, Rentnerin "Ich fahre nur mit dem Auto, wenn es sein muss Über Ingrid Ingrid i-st pensionierte Pflegerin und wohnt gemeinsam mit ihrem Mann seit über 30 Jahren in ihrem Haus. Routinen sirrl ihr wichtig, 2.B. fährt sie jeden Dienstag und Samstag mit dem Bus zum Markt. Mit tfrm Auto lahri Ingrid nur noch ungern, weil tAt-Pruti leine mil den AuflRn hat flri rrnfiffffrL E-HlkJfuTrii \f.1u\ Auifluflen mit 4t* f ftlirln H ob bi es/I nteresaen VtrkfhrimiUtl •Q (1 g Freut sich über: . ■ ruftgSrißpr/nnpn mil ^^^pfcj/^Broitc, übersichtlich Korwm unlkHtlam mi ieai Haltestellen 4 lange Fußwege_ Wünscht sieb: r Halte! =»—'■■ i «J unmir Währ Kflmfe_____Transpo. The persona profile of 'Ingrid Henke'. 117 just the participants themselves) and across gender groups in particular. These 'typical representatives' emerged from a survey of the population to be served. The people participating in the co-design workshops developed services (including vehicles) for these 'typical representatives'. For example, the senior citizen 'Ingrid Henke' represented elderly people who own a car but use it only if there is no alternative, and 'Hans Lehmann' represented disabled people who depend on barrier-free public transport to get to their workplace. One advantage of this co-design approach was the immediate integration into the research and development process of both a new mobility option and accessibility/access to the new option. Another advantage was that, from the outset, the engineers and designers understood the system as a whole from the perspective of how individuals use it in their everyday lives. Improving and enhancing options for public transport and supplementing services may also help reduce environmental harm in cities. The German Environmental Agency (UBA) has analysed greenhouse gas and air pollutant emissions per person-kilometre. The results indicate, for instance, that car users in Germany emit 0.004 g particulate matter per person-km (given the average occupancy of 1.5 persons per car) versus. 0.000 g for public transport users in cities (UBA, 2019). Enhancing the usability of public transport helps cities and regions meet their environmental goals. Mode Emission Car Aeroplane (inland) Railway (long Coach (long Railway (local Public bus Light rail and distance) distance) transport) metro Greenhouse gases 147 230 32 29 58 80 58 Carbon monoxide 1.00 0.48 0.02 0.02 0.04 0.06 0.04 Volatile 0.14 0.13 0.00 0.01 0.01 0.03 0.00 hydrocarbons Nitric oxide 0.43 1.01 0.04 0.06 0.20 0.32 0.05 Particulate matter 0.004 0.011 0.000 0.001 0.002 0.003 0.000 Average 1.5 71 % 56% 55 % 28% 19% 19% occupation rate persons per car Gendered innovation 3: Mobility for new urban lifestyles The share of heavy users of public transport is particularly large among the urban population. To serve existing customers and to attract new customers, public transport operators such as BVG in Berlin (Germany) are supplementing conventional mass transit with individual ride-hailing services. These services are designed to ease the last mile from the mass transit terminus to the final destination, or to allow door-to-door transport. These new services respond to customer comfort and safe- ty needs. For example, passengers need to get home safely at night even when their route requires travel through unsafe areas. The services started in 2019 on an experimental basis and will be scaled up to cover all of Berlin in 2020. Although not suited to rural areas or parts of the city far from the centre, these mobility services are an ideal way to connect city centres with suburbs and outer areas. Commercial providers such as Uber are also responding with new features to enhance user safety. Uber's 'follow my ride' feature allows friends and family to track a user's trip. 118 Gendered innovation 4: A toolbox for gender-sensitive decisionmaking Gender-sensitive research combines quantitative methods such as data mining and analytics with qualitative methods such as surveys, focus groups or individual in-depth interviews aimed at understanding user needs, preferences, barriers or objections. The use of quantitative and qualitative methods is featured in the H2020-funded project Revealing fair and actionable knowledge from data to support women's inclusion in transport systems (Diamond, 2018-2021; see Diamond 2020), which seeks to enhance fairness in transport. Fairness, here, is defined as a state in which people are treated similarly, unimpeded by prejudices or unnecessary distinctions or barriers, unless these are well understood and justified. Diamond is aimed specifically at supporting gender inclusion in current and future transport systems. Starting from specific use cases, such as vehicle sharing and automated vehicles, Diamond collects data that can be fed into a self-diagnostic tool (Decision Support System) that can be used by transportation system engineers to understand individual user characteristics such as gender, age, ethnicity, religion, family, disability and socioeconomic status. Designers can then develop fairness measures. For vehicle sharing, for example, knowing what percentage of shared vehicles are used by elderly women, young men, gender-diverse individuals or persons in need of physical assistance helps planners make gender-sensitive decisions about fleet distribution across geographical locations. gender action planning to smart mobility. Their goal is to develop recommendations that help address gender issues among diverse groups in a Europe-wide framework for smart mobility. Conclusion Numerous projects based in Europe are developing methods to integrate gender-sensitive and diversity-sensitive data into the design and development of smart mobility. These methods include co-creation and participatory research that gathers feedback from users early in the design process in order to understand the range of their needs. They also include quantitative and qualitative methods designed to promote fair, safe and efficient transportation. Gendered innovation 5: Observatory for gender-smart transport The H2020-funded Transport innovation gender observatory (TlnnGO) project (see TinnGO, 2020) is establishing a pan-European observatory to provide a nexus or clearing house for data collection and analysis supporting gender-sensitive and diversity-sensitive smart mobility. TlnnGO is applying tools such as GIA and » Next Steps ► Implement the emerging tools that incorporate gender-sensitive and diversity-sensitive approaches into all smart mobility projects. ► Provide guidelines for gender-sensitive and diversity-sensitive data collection, and the assessment of data collected on user attitudes and behaviours. ► Provide guidelines for gender-sensitive and diversity-sensitive collection and assessment of national travel survey data. ► Implement improved consideration of gender equity and diversity equity for smart mobility applications and their assessment in smart urban mobility plans. ► Investigate how experienced or feared bullying or violence affects the travel behaviour of women, the elderly, and transgender and gender non-conforming individuals (Lubitow et al, 2017), and develop countermeasures. 119 Recommendations for future basic research ► Include gender analysis as an integral part of socioeconomic and behavioural research for innovation in the field of mobility. ► Integrate gender analysis in research on mobility needs and travel patterns. Consider the mobility options and local environments - including infrastructures for daily household needs, childcare, education and employment - available to different groups, such as the elderly, women, men and gender non-conforming people. ► Design new services using participatory methods that integrate gender analysis. ► Research mobility-related infrastructures in built-up environments using gender analysis and participatory methods. ► Research mobility behaviour and mobility environments, including causal relationships between exposure to stressors and health impacts. ► Develop innovative large-scale experimental approaches that address the role of mobility in the context of social challenges. Research the integration of digital and physical aspects from a gender-sensitive perspective to develop new solutions. Policy recommendations ► Disseminate existing research and best practices. ► Create guidelines and manuals to improve gender-sensitive planning for new services and the adaptation of existing services. ► Promote the engagement of relevant stakeholders to support gender-sensitive mobility policies in the city and beyond. ► Support experimentation at local and regional levels. Targeted impact-oriented recommendations for future research and innovation actions funded under Horizon Europe Cluster 5: Climate, energy and mobility ► Analyse gender specific requirements for the improvement of quality of life through demand-based, zero carbon, accessible and safe mobility, and integrate these gender-specific factors into the development of vehicles, infrastructures and services. ► Develop technologies and services that empower women to enhance individual capabilities and satisfaction with decisionmaking for sustainable mobility choices. ► Develop and enhance methods of citizens' engagement in long-term energy planning, transport investment planning and transition policies. Ensure that these methods explicitly address gender issues. ► Consider gender dimensions when developing and defining new governance models for accessible, smart mobility services for all. ► Analyse and consider human factors through the lens of gender, including societal behaviours, new mobility patterns, perception of (ICT-based) information, situational awareness and interaction with automation. ► Make gender analysis central to the systemic transformation of transport and mobility. Mission areas The board of the EU Mission for climate-neutral and smart cities has declared 100 climate-neutral cities in Europe a target for 2030, and it 120 emphasises 'by citizens and for citizens' (European Commission, 2020). Within the framework of a CCC (between the city, the European Commission and the national level), strategies for achieving climate-neutral goals will be city-specific. The focus on the citizen requires planners to include all genders in a way that effectively connects each individual with their city. The June 2020 report on climate-neutral cities (European Commission, 2020) emphasises that cities can achieve climate-neutrality only if citizens become agents of change through bottom-up initiatives and innovation and through new forms of governance. It declares that holistic and transformative missions aiming to create climate-neutral cities, based on citizens' participation and social inclusiveness, can help the EU progress towards achieving multiple SDGs, including equality. The CCC will need to ensure that gender issues are an explicit part of designing and implementing these transformation processes. Partnerships Relevant candidates for European partnerships will relate to quality of life in terms of where and how people live, and also to technologies that aim to augment people's well-being. These recommendations are important for the following partnerships: ► Sustainable, Smart and Inclusive Cities and Communities ► Towards Zero-Emission Road Transport (2ZER0) ► Mobility and Safety for Automated Road Transport (MOSART) ► People-Centric Sustainable Built Environment. Author Professor Barbara Lenz Director of the Institute of Transport Research, German Aerospace Centre Professor for Transport Geography, Humboldt University Berlin Germany Works cited Baumann, K. (2010), 'Personas as a user-centered design method for mobility-related services', Information Design Journal, 18(2), 157-167. Beyer, 5. and Muller, A. (2019), 'Evaluation of persona-based user scenarios in vehicle development', in: Ahram, T., Karwowski, W. and Taiar, R. (eds.), Conference on Human Systems Engineering and Design: Advances in Intelligent Systems and Computing, Springer, Cham, pp. 750-756. Diamond (2020), 'Revealing fair and actionable knowledge from data to support women's inclusion in transport systems', CORDIS, 16 July (https://cordis.europa. eu/project/id/824526). European Commission (2020), 100 Climate-Neutral Cities by 2030 - By and for the Citizens (https://op.europa.eu/ en/web/eu-law-and-publications/publication-detail/-/ Publication/82fldf57-b68b-llea-bb7a-01aa75ed71al). Eurostat (2018), EU Transport Statistics: Eurostat guidelines on passenger mobility statistics, Eurostat Manuals and Guidelines (https://ec.europa.eu/eurostat/ news/themes-in-the-spotliqht/mobility-2018). Gebhardt, L, Brost, M. and König, A. (2019), 'An inter- and transdisciplinary approach to develop and test a new sustainable mobility system', Sustainability, 11(24), 7223. Giesel, F. and Rahn, C. (2015), 'Everyday life in the suburbs of Berlin: consequences for the social participation of aged men and women', Journal of Women & Aging, 27(4), 330-351. Lenz, B. (2020), 'Smart mobility - for all? Gender issues in the context of new mobility concepts', in: Uteng, T. P., Levin, L. and Romer Christensen, H. (eds.), Gendering Smart Mobilities, Taylor & Francis, Abingdon, pp. 8-27. 121 Center for Interdisciplinary Risk and Innovation Studies (2018), living lab Schorndorf: citizen-oriented optimisation of performance, efficiency and attractiveness of local transport' (https://www.zirius.uni-stuttqart.de/en/proiekte/reallabor-schorndorf/). Lubitow, A, Carathers, J, Kelly, M. and Abelson, M. (2017), 'Transmobilities: mobility, harassment, and violence experienced by transgender and gender nonconforming public transit riders in Portland, Oregon', Gender, Place & Culture, 24(10), 1398-1418. Miaskiewicz, T. and Kozar, K. A. (2011), 'Personas and user-centered design: how can personas benefit product design processes?', Design Studies, 32(5), 417-430. Nobis, C. and Lenz, B. (2009), 'Communication and mobility behaviour: a trend and panel analysis of the correlation between mobile phone use and mobility', Journal of Transport Geography, 17(2), 93-103. Nobis, C, & Lenz, B. (2005). Gender differences in travel patterns: role of employment status and household structure. Research on Women's Issues in Transportation, Report of a Conference, Volume 2: Technical Papers, Transportation Research Board Conference Proceedings, 35,114-123. Nobis, C. and Lenz, B. (2019), 'Gender differences in using digital mobility services and being mobile', paper presented at 6th International Conference on Women's Issues in Transportation, Irvine, California, 10-13 September. Pruitt, J. S. and Adlin, T. (eds.) (2006), The Persona Lifecycle: Keeping people in mind throughout product design, Elsevier, Amsterdam. Sanchez de Madariaga, I. (2009), 'Vivienda, movilidad, y urbanismo para la igualdad en la diversidad: ciudades, genero, y dependencia', Ciudad y Territorio Estudios Territoriales, 41(161-162), 581-598. Sanchez de Madariaga, I. (2013), 'The mobility of care: a new concept in urban transportation', in Sanchez de Madariaga, I. and Roberts, M. (eds.), Fair Share Cities: The impact of gender planning in Europe, Ashgate, London, pp. 33-48. Sanchez de Madariaga, I. and Zucchini, E. (2019), 'Measuring mobilities of care, a challenge for transport agendas', in Schölten, C. L. and Joelsson, T. (eds.), Integrating Gender into Transport Planning: From one to many tracks, Palgrave Macmillan, Cham, pp. 145-173. TlnnGO (2020), 'Transport Innovation Gender Observatory', CORDIS, 22 July (https://cordis.europa.eu/ project/id/824349). UBA (Umweltbundesamt) (2019), 'Handbuch für Emissionsfaktoren (HBEFA)' (https://www. umweltbundesamt.de/themen/verkehr-laerm/ emissionsdaten#handbuch-fur-emissionsfaktoren-hbefa). WASTE MANAGEMENT: CO-CREATION AND PARTICIPATORY DESIGN The challenge Sustainable waste management aims to minimise waste production and reduce greenhouse gas emissions. Currently, waste constitutes 3 % of the European Union's greenhouse gas emissions (European Commission, 2018) and 0.1 % of global emissions (Ritschie and Roser, 2019). These global data are probably inaccurate, since many countries are not able to calculate their waste emissions. Scholars point out that 'gender issues have been poorly understood and largely neglected in waste management and most other environmental and technical sectors' (Buckingham and Perello, 2019, p. 11). This case study will analyse EU Horizon 2020 research that has successfully addressed these issues and will highlight how sex and gender analysis can lead to innovation in this sector. Gendered innovation 1: Collecting data on gendered waste behaviours and intervening to change user behaviours Pioneering Horizon 2020 projects have tried to mainstream gender into all phases of waste management: design, structure, implementation and evaluation (UrBAN-WASTE, 2020; Eco-sistemi et al, 2019; Waste4Think, 2019). Data highlight gender inequities in the field of waste management. Most waste management employees are still men, for example (OECD, n.d.; Table 1 below). Women, by contrast, do somewhat more unpaid labour in household waste management. For example, 73 % of women versus 68 % of men seek to reduce waste and take time to separate waste (European Commission, 2014; Buckingham and Perello, 2019; Table 2 below). COUNTRY MALE(%) FEMALE (%) Denmark 96,000 (72.2%) 37,000 (27.8%) Greece 212,000 (77.4%) 62,000 (22,6%) Italy 2,015,000 (87.5%) 287,000 (12.5%) Portugal 286,000 (78.4%) 79,000 (21.6%) Spain 1,128,000 (84.2%) 244,000 (17.8%) Numbers and percentages of men and women employed in the water supply, sewerage, and waste management and remediation sectors in 2017 Source: Buckingham and Perello (2019; from OECD, 2017), with permission Gender % reduce % reduce Avoids Avoids over- Drinks tap Thinks reducing or separate consumption food packaged rather than waste is not waste waste goods bottled water important Female 73 59 85 65 70 12 Male 68 52 81 59 63 20 Gendered attitudes to and behaviours in avoiding waste in 2014, 2017 Source: Buckingham and Perello (2019; from European Commission, 2014), with permission # Method: participatory methods using the UrBAN-WASTE app preferNotToSay other I female Gendered use of the waste app. Source: Buckingham and Perello (2019), with permission UrBAN-WASTE is an interactive mobile application to promote more sustainable waste behaviours. The H2020-funded UrBAN-WASTE project (UrBAN-WASTE, 2020) focuses on reducing waste in 11 tourist destinations, such as Florence, Lisbon and Nice, but the approach is transferable to other cities. The app is based on a gamification model in which the user's good practices in recycling, avoiding food waste and refilling reusable water bottles (among others) are rewarded with points. Users are scored on the correct use of waste receptacles and on how much they promote the UrBAN-WASTE app on social media. Users with high scores receive gifts or services from cities or participating vendors, such as restaurants. Interactive maps show the location of waste resources (recycling bins, receptacles) and water fountains (to refill reusable water bottles). The app also includes tips for sustainable behaviours, useful links (waste collection times, general rules) and the option to report to the city any problems that users encounter. The prototype design included gender perspectives from gender experts, gender-sensitive co-design with the whole project team and gender as a category in the monitoring software. Evaluations confirmed that the app helped users improve their waste management behaviours and helped cities facilitate more responsible user behaviour. Despite the attention given to gender in the development of the UrBAN-WASTE app, data analysis showed that it attracted more male users, which is typical of games and electronics in general (Horelli and Wallin, 2013; EIGE, 2016). This project could have been improved if researchers had used participatory methods to better capture 124 user behaviours. It is possible that a completely redesigned user interface is needed to ensure parity in user uptake. It is also possible that engaging more men is a positive outcome, since women are already more motivated to reduce waste. For data collection, the UrBAN-WASTE app project included the non-binary gender category 'other'. For this project, the designers expected people who do not identify as a woman or a man to choose the 'other' category. It is possible that in the future better designations will be devised (see 'Asking about gender and sex in surveys' in Annex B). One additional possibility could be 'diverse', which is a third category used for the collection of socioeconomic statistical data, for example in Germany. Gendered innovation 2: Using participatory gender mainstreaming to collect sex-disaggregated data on waste behaviours and to foster women's participation in waste management To reduce waste and improve reuse and recycling rates, a number of municipalities have developed programmes that include: ► monitoring systems for dustbins/trash cans and lorries/trucks; ► decision-making information systems for short-term and long-term planning; ► economic instruments (project Pay as you throw, PAYT; PAYT, 2005); ► incentives (H2020-funded project Waste4Think; see Waste4Think, 2020). (December 201B) Hotcls& Restaurants Participative process • 2 meetings to explain the implementation of PAYT and decide the tax • 4G% of participation (66% women) • Satisfaction Level 3.6/5 (November 2019) Approval of new Regulation (May ZQ1S) Shops Participative process • The implementation of IWfl was explained and thetax was decided ♦ 22% of participation (75% women) * Satisfaction Level 4,5/S {January 20191 Industry Participative procesí • 2 meetings to explain the implementation ot PAYT and decide the tax ■ fj.3% of participation (3854 women) ■ Satisfaction Level 4.3/5 [January 2018) Citizens 3rd Participative process • The implementation of PAYT was explained and the tax was decided • Participation of 14families (50% women) ■ Satisfaction Level 4,4/5 (October 2017) Citizens 2nd Participative process • PAYT was expl a i ned a nd possi ble ca se s were d eua ted • Participation of 13 families. (46% women) • Satisfaction Level 4,1/5 (May 2017) Citizens 1st Participative process The challenges and objectives were presented and there was a debate on consumption, recycling and the environment Paiticipaliun of 12 families (42% women) Salisfaclion level 4rJ/5 Participatory process. Source: Waste4Think (2019), with permission 125 Take for example Zamudio (Basque Country, Spain), a community with around 3 200 residents. The PAYT project developed there included seven industrial areas and the largest science and technology park in the province. Industrial waste represented 68 % of the total waste generated in the municipality. During the 2-year project, the city organised work- # Method: information on waste generation patterns via citizen cards (Waste4Think) In the particular case of Zamudio, waste generation is monitored through the use of electronic locks on containers with chambers that restrict waste volume. Users are identified by their citizen cards: cards they use for other municipal services. PAYT is calculated for each household when the different containers are opened (e.g. residual, glass, plastic or organic waste). Each member of a household has their own citizen card so that use can be analysed by sex and age (Waste4Think, 2019). Example of information collected for Ways25ort game. Source: Waste4Think (2019), with permission shops with citizens and representatives from the service sector and industry to discuss the regulations and rates governing PAYT. The participants could also evaluate the quality of the workshops (satisfaction level 5, very good). One objective was to foster women's participation in these workshops to increase their representation in the field of waste management. Conclusions Mainstreaming gender analysis in waste management means considering gender at every stage of the process. Important steps to foster gender analysis include: ► raising gender awareness in this field of research and practice; ► gathering sex-disaggregated and gender-disaggregated data in the waste management sector; ► gathering data on gendered attitudes and behaviours with respect to waste; ► employing gender-sensitive participatory methods. # Method: behaviour analysis data from serious games and digital teaching units (Waste4Think) One of these projects is a smartphone game called Ways2Sort, which teaches users how to sort 200 waste items of different types, e.g. glass or biowaste. Preliminary data about sex and age, as well as information about habits and previous knowledge, were collected during citizen card logins. To foster citizen participation, tests were performed for particular target groups (schoolchildren, university students, professionals in the sector, etc.). » Next Steps The European Union and the Horizon 2020 project have shown that integrating gender into urban policies and planning processes for waste management will help reduce waste and encourage a circular economy. Targeted impact-oriented recommendations for future research and innovation actions funded under Horizon Europe Waste management addresses local and global challenges and the SDGs, especially 5DG 5 (gender equality), 5DG 11 (responsible consumption and production) and 5DG 13 (climate action). Sustainable waste management serves as a foundation for a circular economy and one of the main building blocks for the European Green Deal. Cluster 5: Climate, energy and mobility Advance climate science and solutions for a climate-neutral and resilient society Profound knowledge of gendered issues in waste management contributes to understanding gender in waste generation behaviours and how to intervene to change those behaviours. This knowledge contributes to decision-making tools at different governance levels (from local to global) and to effective waste treatment that serves as a pillar of gendered climate-neutral and smart cities. Empower citizens to engage in the transition to a decarbonised society Co-creation and co-design can empower all citizens to engage in the transition to climate-neutral cities (see 'Co-creation and participatory research' in Annex B). In particular, co-creation and co-design foster women's participation in waste management, which is currently dominated by men. Mission area: 100 climate-neutral cities by 2030 Research has identified the potential and added value of a gendered perspective for minimising resource inputs, waste and carbon emissions in a circular economy. Waste treatment is a key indicator for measuring and monitoring greenhouse gas emissions. In this case, a gendered approach leads to a better understanding of citizen engagement in waste management, which is necessary to achieve gender-inclusive climate-neutral cities. A gender-sensitive approach can foster the engagement of different (gender) groups of citizens and experts (see also 'Intersectional approaches' and 'Gender impact assessment' in Annex B). Author Associate Professor Doris Damyanovic Institute of Landscape PlanningDepartment of Landscape, Spatial and Infrastructure SciencesUniversity of Natural Resources and Life Sciences, Vienna (BOKU)Austria Develop sustainable infrastructure, services and systems for smart and sustainable communities and cities Sustainable waste management is a key factor for smart gendered thinking about sustainable communities and cities. Gendered knowledge can contribute to better solutions for city/district management for waste systems and assist the EU in achieving its low-carbon goals. 127 Works cited Buckingham, 5. and Perello, M. (2019), Urban Waste: Urban strategies for waste management in tourist cities, D3.6 - paper on gender mainstreaming in waste planning (http://www.urban-waste.eu/wp-content/uploads/2019/07/ D3.6-Gender-mainstreaminq-in-urban-planninq-case-on-waste-manaqementpdf). Ecosistemi, Ecoteca, CTM (Eurecat), IUAV, Linea Gestioni, I5TAT, Metropolitan City of Rome, Chamber of Commerce of Cremona, Municipality of Cremona (2019), UrbanWINS Toolkit: A guide on urban metabolism and participatory processes for more efficient urban waste policies (https://www.urbanwins.eu/wp-content/ uploads/2019/05/190527 UW Toolkit final version A4 v2 PRINT.pdf). EIGE (European Institute of Gender Equality) (2016), Gender and Digital Agenda, Publications Office of the European Union, Luxembourg. European Commission (2014), 'Flash Eurobarometer 388: attitudes of Europeans towards waste management and resource efficiency' (https://data.europa.eu/euodp/en/data/ dataset/51102 588). European Commission (2018), 'Greenhouse gas emission statistics - carbon footprints' (http://ec.europa.eu/ eurostat/statistics-explained/index.php/Carbon dioxide emissions from final use of products). Horelli, L. and Wallin, 5. (2019), 'Gender-sensitive e-planning for sustaining everyday life', in: Sanchez de Madariaga, I. and Roberts, M. (eds.), Fair Shared Cities: The impact of gender planning in Europe, Ashgate, New York, pp. 193-230. OECD (n.d.), 'Employment by activities and status (ALFS)' (https://stats.oecd.orq/viewhtml.aspx?datasetcode=ALF5 EMP&lanq=en#), accessed March 2020. OECD (2017), 'Employment by gender in water supply, sewerage, waste management & remediation activities' (https://stats.oecd.org/viewhtml.aspx?datasetcode=ALF5_ EMP&lang=en#) PAYT (2005), 'Variable rate pricing based on pay-as-you-throw as a tool of urban waste management', CORDIS, 28 July (https://cordis.europa.eu/project/id/EVK4-CT-2000-00021). Ritschie H. and Roser, M. (2019), 'CO2 and greenhouse gas emissions', Our World in Data (https://ourworldindata. orq/co2-and-other-qreenhouse-qas-emissions#per-capita-co2-emissions). UrBAN-WASTE (2019), 'Urban strategies for waste management in tourist cities' (http://www.urban-waste. ey/)- " UrBAN-WASTE (2020), 'Urban strategies for waste management in tourist cities', CORDIS, 16 July (https:// cordis.europa.eu/proiect/id/690452). Waste4Think (2019), 'Ecosolutions' (https://waste4think. eu). Waste4Think (2020), 'Moving towards life cycle thinking by integrating advanced waste management systems', CORDIS, 3 July (https://cordis.europa.eu/proiect/ id/688995). 128 QUALITY URBAN SPACES: GENDER IMPACT ASSESSMENT The challenge The physical features of urban space are key elements for supporting everyday life for all citizens independent of gender, age, socioeconomic status, race, physical ability, ethnicity or other personal circumstances. When urban spaces are unsafe or inadequate, everybody suffers. Issues include narrow, poorly maintained or non-existent pavements; scarce or remote healthcare, educational, cultural or sports facilities, shops and workplaces; and scarce or unsafe playgrounds and green areas. The lives of some people, including children, elderly people and caregivers, can become especially difficult and limited (Bernard Van Leer Foundation, 2018; Unicef, 2018). While men are increasingly taking up more caring responsibilities (O'Brien and Shemilt, 2003), women remain the main caregivers. In 10 EU countries, in households with parents living as a different-sex couple with small children, women perform an average of 2 hours and 21 minutes of childcare per day compared with men's 59 minutes (European Communities, 2004). This pattern holds in the United States as well. In 2018, the average US mother spent 1 hour and 49 minutes caring for and helping children in her household, more than twice the average US father's 52 minutes (United States Bureau of Labor Statistics, 2019). Single-parent households constitute a growing percentage of all households, and the parent is typically a woman. These households face additional difficulties in combining paid employment with caring duties and are among those in most need of support. Where urban design is inadequate, children will not have the chance to grow up safely while exploring new boundaries and gaining autonomy. Elderly people will not be able to lead an active autonomous life. Mothers and other caregivers will struggle to balance paid employment with their care responsibilities. Lower-income people, as well as racial and ethnic minorities, who are often concentrated in lower-income areas, will live in neighbourhoods with comparatively poor urban spaces because of patterns of spatial segregation in cities around the world. As a result, women, children and elderly people from these groups will endure comparatively greater life limitations because of poor-quality urban spaces. While transgender and gender-diverse individuals suffer bullying and violence in public spaces (Eisenberg et al, 2019), the extent to which this can be addressed through urban design is limited. Quality urban spaces designed to respond to the specific everyday life needs of women, children and elderly people are not, however, the norm. Suburban, single-family, low-density areas, typical of North American cities, lack sufficient density to ensure that facilities used on a daily basis, such as schools, doctors offices or sports fields, are within walking distance, which would allow young people to access them unaccompanied. In addition, often there are insufficient passers-by in these areas to provide the informal supervision that affords a sense of safety. At the same time, cities in which high-density development and residential neighbourhoods are the norm often lack open green areas and playgrounds that can be used safely by unaccompanied young people. In suburban areas, such outdoor spaces are on private property, as part of patios or gardens in residential developments. In high-density neighbourhoods, green space is often missing, and children lack opportunities for play and exercise. Both children and adults often lack opportunities for social interaction and a sense of community. In the developing world, all these problems coalesce and are often more severe, with a lack of walkable streets, public spaces, playgrounds, easily accessible facilities and amenities, and 129 basic urban infrastructure such as pavements or even lighting (NIUA, 2017). Improving the quality of urban spaces by looking at the specific needs of children, elderly people and caregivers will create better urban environments for everyone. Improving the quality of urban spaces in ways that provide better support for these groups is a challenge that will require design solutions and measures tailored to both low-density and high-density environments, taking into account the economic capacities and constraints of cities and countries. The main physical characteristics of streets and public spaces that support the daily lives of children and their families include (ODI, 2017; Gehl Institute, 2018; Krishnamurthy et al, 2018; NACTO, 2018; Sanchez de Madariaga and Neuman, 2020): ► walkable streets with reduced traffic that enable and encourage active independent mobility for young people, elderly people and everyone else, and reduce the adverse health effects of pollution (particularly severe for children, because they breathe at the height of exhaust pipes and their bodies are still maturing); ► formal and informal natural public spaces for outdoor play that encourage the physical, psychological, emotional and mental development of children and support their caregivers; ► formal and informal indoor and outdoor community spaces that create opportunities for social connectedness, promote a sense of ownership, and support the development of agency and the decision-making capabilities of young people; ► sufficiently dense and mixed-use spaces to facilitate undertaking daily activities within walking distance from home, including independent school attendance, shopping for groceries, seeing a doctor and sport. Gendered innovation 1: Building child-friendly and family-friendly streets and public spaces Numerous initiatives around the world have improved public spaces for children and their families. Japan provides a striking example of how cities can develop child-friendly routes to school. Unlike in most countries today, Japanese children are expected to go to school on their own from a very young age, either using public transport or on foot. Both schools and local governments work together to plan, design and build physical features of pavements and streets along children's school routes. Physical improvements can include one or several of the following (Kry-siak, 2019): relocating pedestrian crossings; longer green lights for pedestrians; temporary traffic closures near schools at peak times; signs to alert drivers that there are schoolchildren nearby; pictograms such as small feet painted at crossings to remind children to watch out for traffic. The Bernard van Leer Foundation, a Dutch organisation, works with cities around the world to improve urban space and streets for toddlers and children through its Urban95 programme (Bernard van Leer Foundation, 2018). In Lima, for instance, Urban95 has developed child-friendly routes to preschool, bringing together three local governments - the municipalities of Carabayllo, Comas and San Juan de Miraflores - with non-governmental organisations. The project, launched in 2018, addressed the travel needs of toddlers and parents living in the hilly neighbourhood of Alto Peru who chose to take long and expensive taxi trips because the shortest pedestrian route was dangerously steep, rubbish-ridden and uneven. The project involved cleaning up rubbish, building retaining walls, installing double handrails at adult and toddler heights, planting trees and vegetation, and adding seating and rest areas. In 2002 the city of Vienna developed a specific pilot project to improve public space in Maria-hilf (Irschik and Kail, 2013), a small and dense central district with narrow streets and some vertical inclines of up to 31 metres. Before the intervention, Mariahilf had about 50 public stairways and flights of steps, more than 30 of which were without ramps; about 25 % of all pavements were less than 2 metres wide, narrower than the minimum width needed for walking in pairs; and about 50 % of all intersections were difficult for pedestrians to cross. The project sought to reduce these architectural barriers and improve safety. This involved developing a checklist for street design to address both technical standards for pedestrian movement and social factors such as pedestrian routes to major destinations in the district. As a result, planners: widened more than 1 000 metres of pavement; improved more than 60 intersections that reduced pedestrian crossing times; implemented barrier-free design throughout the neighbourhood; installed numerous seating facilities; installed new lighting in 26 spots; and refurbished three public squares. In the United States, the non-profit organisation KaBOOM! works to support child development in low-income areas by creating opportunities for play in public space for children in collaboration with cities around the country. In collaboration with the William Penn Foundation of Philadelphia, KaBOOM! developed Play Everywhere Philly in 2018 (KaBOOM!, 2018). This is a city-wide competition awarding USD 1 million in grants for local groups working with professional designers to create interactive play installations. The interventions involve the creation of play-oriented learning features for children aged 0-8 on pavements and footpaths, at bus stops and outside business premises. These included objects, sculptures, drawings, plantings, signs, symbols, words, texts and games aimed at stimulating children's attention, involvement and imagination. Pioneering work on women's safety was developed and carried out by Montreal and Toronto in the 1990s (Michaud, 1997). Numerous cities around the world are now implementing the methodology developed in Canada. This methodology, called exploratory safety audits, includes walking with women to determine the following safety principles (UN Women, 2011). Principle 1: Know where you are and where you are going. Signposting. Principle 2: See and be seen. Visibility. Principle 3: Hear and be heard. The presence of people. Principle 4: Be able to escape and get help. Formal surveillance and access to help. Principle 5: Live in a clean and friendly environment. Spatial design and maintenance. Principle 6: Act together. Community participation. Morning women's safety audit at the Pradolongo Park, Usera District, Madrid, December 2016. Exploratory safety walks with women allow city planners to identify dangerous neighbourhoods or transportation segments (Sanchez de Madar-iaga, 2004). A study in the area surrounding the Pradolongo Park in the Usera district of Madrid applied this methodology through the following steps (Novella Abril, 2020): an initial workshop in which neighbourhood women worked with professional planners; the exploratory walk itself; the drafting of the report; a final workshop with the local women. The results were mapped, and specific recommendations were made to the city on where and how to improve urban design. 131 ■Mi WW WOMEN'S SAFETY AUDIT USERA DISTRICT, MADRID UK BAN ANALYSIS DIAGRAM I ZONE 1); ISQUIMA Of ANAIISIS URBANOIZONA I): _ _ Participant women's usual route arid access to the-Pradolongo Pa rfc H Pecorridos. r occeso al eafQue hatjituQles rfe tof par^Kinantei en e> taller