Code of Ethics
Administrator(s) Project Administrator / Monika Sieberová
Approved by
Operational Director / Emilie Zichová 30.11.2011
Executive Director / Tomáš Hruda 30.11.2011
Coordination Board 14.12.2011
Applicable from 01/01/2012
Version 002/2012
Annexes
European Charter for Researchers and a Code of Conduct
for the Recruitment of Researchers 
Code of Ethics, version 002/2012
2 / 11
 
Content
1. INTRODUCTION ............................................................................................................................. 3
1.1 PURPOSE .................................................................................................................................. 3
2. PRINCIPLES ................................................................................................................................... 4
2.1 GENERAL ETHICAL PRINCIPLES ................................................................................................... 4
2.2 RESEARCH FREEDOM ................................................................................................................. 4
2.3 PROFESSIONAL RESPONSIBILITY ................................................................................................. 4
2.4 PRINCIPLES OF PUBLICATION ...................................................................................................... 5
2.5 TREATMENT OF CONFIDENTIAL DATA ........................................................................................... 5
2.6 INTELLECTUAL PROPERTY TREATMENT ........................................................................................ 6
2.7 FAIR, RESPECTFUL AND EFFICIENT USE OF THE PROJECT’S INFRASTRUCTURE................................ 6
2.8 CONDITIONS FOR RESEARCH ON PATIENTS AND ANIMALS.............................................................. 7
3. LIST OF ABBREVIATIONS............................................................................................................ 8
4. GLOSSARY..................................................................................................................................... 9
5. CHANGES FROM PREVIOUS VERSION.................................................................................... 10
6. ANNEXES ..................................................................................................................................... 11
Code of Ethics, version 002/2012
3 / 11
1. Introduction
CEITEC (Central European Institute of Technology) is a project focused on the establishment
of a European centre of excellence in the area of life sciences and advanced materials
and technologies.
Common Rules for Quality Management, Human Resources Management, Cooperation with the
Application Sphere, Code of Ethics and Common Publication Policy are an integral part of the
management and coordination of the centre in all CEITEC Organisational Units and the Central
Management Structure.
1.1 Purpose
The integrity of the whole project is maintained by common rules and policies. The Code of Ethics is
the key document covering ethical principles.
The purpose of this document is to establish a set of ethical principles and standards to guide
the CEITEC partners to achieve the goals and objectives of the project.
The CEITEC Code of Ethics (the “Code” hereinafter) is based on standard principles (best practises)
used by CEITEC’s Strategic Partners. It also fully recognizes The European Charter for Researchers1
and the Declaration of Helsinki2
. As stated in other CEITEC documents, certain standards are
emphasized. Specifically, they are:
 General ethical principles
 Research freedom
 Professional responsibility
 Principles of publication
 Treatment of personal data
 Intellectual property treatment
 Fair, respectful and efficient use of the project’s infrastructure
 Conditions for research on patients and animals
                                                            
1
The European Charter for Researchers is a set of general principles and requirements which specifies the roles,
responsibilities and entitlements of researchers as well as of employers and/or funders of researchers, released by European
Commission in 2005. Available at: <http://ec.europa.eu/eracareers/pdf/am509774CEE_EN_E4.pdf>.
2
World Medical Association: Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects.
Available at: < http://www.wma.net/en/30publications/10policies/b3/17c.pdf>.
Code of Ethics, version 002/2012
4 / 11
2. Principles
2.1 General ethical principles
No CEITEC employee should be discriminated against in any way on the basis of gender, age, ethnic,
national or social origin, religion or belief, sexual orientation, language, disability, political opinion,
social or economic condition.
All CEITEC employees should be familiar with the project’s strategic goals and they should be mindful
of CEITEC’s good reputation and name. They should also be familiar with national, European or
institutional legislative frameworks and adhere to them, specifically to The European Charter
for Researchers and Declaration of Helsinki (see Annex 2 and Annex 3).
Researchers should adhere to the recognized ethical principles and fundamental ethical principles
relevant to their discipline. In the case of specific project, researchers should also adhere
to the relevant ethical standards as documented in the various national, sectoral, and institutional
codes of ethics as well as to a multi-disciplinal code of ethics.
2.2 Research freedom
Researchers should focus their research on making advances for the good of mankind
and on expanding the frontiers of scientific knowledge, while enjoying the freedom of thought
and expression, and the freedom to identify methods by which problems are solved according
to recognized ethical principles and practices.3
2.3 Professional responsibility
Researchers do not duplicate research previously carried out elsewhere and should make every effort
to ensure that the research is relevant to society.
Researchers do not publish work redundantly or fragment their publications or results of research
without good reason, i.e. divide them unnecessarily into multiple publications for the purpose
of increasing the number of publications.
All internal and external cooperation should be properly contracted. The exploitation of centre’s
infrastructure (both tangible and intangible assets), IP or any other knowledge created
within or for the centre must always be fully used for the benefit of the centre.
All professional assessments, evaluations, opinions and decisions must be conducted independently
and based purely on scientific principles and free of personal interests.
                                                            
3
The European Charter for Researchers, released by European Commission in 2005. Available at:
<http://ec.europa.eu/eracareers/pdf/am509774CEE_EN_E4.pdf>.
Code of Ethics, version 002/2012
5 / 11
All CEITEC employees should exert their best effort to avoid any conflict of interest. Should a conflict
of interest arise, it is to be reported by the employee to his/her direct superior, who is responsible for
taking appropriate measures.
Researchers at all career stages and other CEITEC employees should continually develop themselves
by regularly updating and expanding their skills and competencies. They can achieve this in different
ways, e.g. by attending seminars and courses, in formal training activities, through participation
in workshops, by attending conferences, etc.
2.4 Principles of publication
All CEITEC researchers should be familiar with the Common Publication Policy of the CEITEC project.
Scientific publication is governed by certain ethical principles that should be followed by authors,
editors, manuscript reviewers, and publishers.
Researchers must avoid any kind of plagiarism and adhere to the principles of intellectual property.
All sources must be properly quoted and listed in a bibliography. Researchers also quote the relevant
works that are not in accordance with their assumptions and interpretations of results.
Unless the data have been updated and the conclusions modified, the same manuscript should not be
published in more than one publication (e.g. a paper published in the proceedings of a workshop
should not be published as such in a journal, but it may be offered to a journal if its content has
substantially changed since it appeared in the workshop proceedings).
The editors and reviewers of CEITEC partners must treat manuscripts as confidential communications
and not divulge their contents without the consent of the author(s). Reviewers are responsible not only
for unbiased, objective critical analysis of manuscripts but also for completing their duties within the
time allotted.
The publisher (an Organisational Unit of the CEITEC project or other) must clear the manuscripts
with author(s) to ensure that changes in meaning have not occurred during copy editing.
Specific conditions are described in detail in the Publication Policy of the CEITEC project. 
2.5 Treatment of confidential data
For the purposes of this policy, the term, ‘confidential data’, refers to private project / centre
information or other private organizational and personal information not intended to be disclosed
outside the context of the organization responsible for that information.
Specific conditions are described in detail in the Common Rules for Quality Management
of the CEITEC project.
Code of Ethics, version 002/2012
6 / 11
2.6 Intellectual property treatment
The property rights to the IP generated by CEITEC employees are derived from the labour relation of
researchers and other employees generating the results concerned.
All IP must be treated in accordance with ethical principles and the use of such IP must take into
account the potential contribution to society. Protection of IP (e.g. patenting, licensing) is carried out
only if the scientist is convinced of its quality and benefits for society.
Specific conditions are described in detail in the Common Rules for Cooperation with the Application
Sphere.
2.7 Fair, respectful and efficient use of the project’s
infrastructure
Common rules and obligations of all users will lead to an open and transparent system of
infrastructure use that acknowledges the scientific quality and impact or contribution of individual
projects. All users of the infrastructure have the same right while using the infrastructure, however, the
price of infrastructure use or services provided may vary. The system of pricing and using the
infrastructure is defined in the Common Rules for Cooperation with the Application Sphere. All
partners use the infrastructure for the same price.
All users of the project’s infrastructure should follow instructions for the use of equipment or access to
the laboratory as stated by its owner and these general principles:
 Ensure that the research infrastructure is used with respect to the principles of fairness,
effectiveness and only for the specified purposes
 Define clear and realistic objectives and deliverables for the project using the research
infrastructure and communicate them as defined in the Common Rules for Cooperation with
the Application Sphere
 Ensure that the human, material and financial resources entrusted to them are used optimally
for the benefit of CEITEC
 Invest in CEITEC’s future by taking long-term effectiveness into account when managing short
and medium-term activities
 Share with other CEITEC employees any information that could benefit them in their work,
also provide advice and guidance to colleagues where appropriate and exercise adequate
supervision and control over tasks that are delegated
 Refrain from interfering with the settings of the research infrastructure equipment or the
equipment itself, unless previously discussed with the provider
 Maintain a professional environment characterized by good working relations and an
atmosphere of tolerance and mutual respect
 The equipment shall be treated with respect and users should take steps to avoid damage
through negligence or misuse, excessive use or break downs
Code of Ethics, version 002/2012
7 / 11
2.8 Conditions for research on patients and animals
In clinical research involving human subjects or animals, the well-being of the individual research
subject must take precedence over all other interests. Clinical research involving human subjects
or animals must conform to generally accepted scientific principles. Violation of protocols governing
research on human subjects is strictly forbidden. Using animals and human patients as research
subjects should be allowed only after alternative approaches have proved to be inadequate.
Researchers, as well as editors and publishers, all have ethical obligations with regard to the
publication of research results. Researchers are obliged to make the results of their research on
human subjects publicly available and they are also responsible for the correctness and completeness
of their reports on the results. The positive, negative and inconclusive results of clinical research
should be published or otherwise made publicly available. These principles are specified in the
Declaration of Helsinki (Annex 3).
Code of Ethics, version 002/2012
8 / 11
3. List of Abbreviations
CEITEC Central European Institute of Technology
IP Intellectual Property
Code of Ethics, version 002/2012
9 / 11
4. Glossary
CEITEC employee
Employee of an Organisational Unit of a CEITEC partner or of the Central
Management Structure. There are two basic categories of CEITEC
employees: (1) research employees and (2) non-research employees.
confidential data
Private project / centre information or other private organisational
information not intended to be disclosed outside the context of the
organisation responsible for that information
Code of Ethics, version 002/2012
10 / 11
5. Changes from Previous
Version
Date Chapter Description
 
Code of Ethics, version 002/2012
11 / 11
6. Annexes
ANNEX 1 European Charter for Researchers and a Code of Conduct for the Recruitment of
Researchers
ANNEX 2 Declaration of Helsinki
EUR21620
HUMAN RESOURCES AND MOBILITY
www.europa.eu.int/eracareers/europeancharter
The European
Charter
for Researchers
The Code
of Conduct for
the Recruitment
of Researchers
Interested in European research?
RTD info is our quarterly magazine keeping you in touch with main developments
(results, programmes, events, etc). It is available in English, French and German.
A free sample copy or free subscription can be obtained from:
European Commission
Directorate-General for Research
Information and Communication Unit
B-1049 Brussels
Fax: (32-2) 29-58220
E-mail: research@cec.eu.int
Internet: http://europa.eu.int/comm/research/rtdinfo/index_en.html
EUROPEAN COMMISSION
Directorate-General for Research
Directorate The human factor, mobility and Marie Curie activities
Unit D1 – Sector Researchers’ careers
E-mail: sieglinde.gruber@cec.eu.int
Contact: Sieglinde Gruber
European Commission
Office SDME 03/51
B-1049 Brussels
Tel. (32-2) 29-84342
Fax (32-2) 29-99079
Directorate-General for Research
Human resources and mobility (Marie Curie Actions) EUR 216202005
EUROPEAN COMMISSION
The European Charter
for Researchers
The Code of Conduct
for the Recruitment
of Researchers
LEGAL NOTICE:
Neither the European Commission nor any person acting on behalf of the Commission is
responsible for the use which might be made of the following information.
A great deal of additional information on the European Union is available on the Internet.
It can be accessed through the Europa server (http://europa.eu.int).
Cataloguing data can be found at the end of this publication.
Luxembourg: Office for Official Publications of the European Communities, 2005
ISBN 92-894-9311-9
© European Communities, 2005
Reproduction is authorised provided the source is acknowledged.
Printed in Belgium
PRINTED ON WHITE CHLORINE-FREE PAPER
Europe Direct is a service to help you find answers
to your questions about the European Union
Freephone number:
00 800 6 7 8 9 10 11
3
The Commission of the European Communities
Having regard to the Treaty establishing the European Community, and in
particular Article 165 thereof
Whereas
(1) The Commission considered it necessary in January 2000 1
to establish
the European Research Area as the linchpin of the Community’s
future action in this field with a view to consolidating and giving structure
to a European research policy.
(2) The Lisbon European Council set the Community the objective of
becoming the most competitive and dynamic knowledge economy in
the world by 2010.
(3) The Council has addressed issues related to the profession and the
career of researchers within the European Research Area in its Resolution
of 10 November 2003 2
and welcomed in particular the Commission’s
intention to work towards the development of a European Researcher’s
Charter and a Code of Conduct for the Recruitment of Researchers.
Commission Recommendation
of 11 March 2005
on the European Charter for Researchers
and on a Code of Conduct for the Recruitment
of Researchers
1
COM(2000) 6 final of 18.1.2000.
2
JO C 282, p. 1-2, of 25.11.2003. Council Resolution of 10 November 2003 (2003/C 282/01 on
the profession and the career of researchers within the European Research Area).
4
(4) The identified potential shortage of researchers 3
, particularly in certain
key disciplines, will pose a serious threat to EU’s innovative
strength, knowledge capacity and productivity growth in the near
future and may hamper the attainment of the Lisbon and Barcelona
objectives. Consequently, Europe must dramatically improve its
attractiveness to researchers and strengthen the participation of
women researchers by helping to create the necessary conditions for
more sustainable and appealing careers for them in R&D 4
.
(5) Sufficient and well-developed human resources in R&D are the cornerstone
of advancement in scientific knowledge, technological
progress, enhancing the quality of life, ensuring the welfare of European
citizens and contributing to Europe’s competitiveness.
(6) New instruments for the career development of researchers should be
introduced and implemented, thus contributing to the improvement
of career prospects for researchers in Europe.
(7) Enhanced and more visible career prospects also contribute to the
building of a positive public attitude towards the researchers’ profession,
and thereby encourage more young people to embark on
careers in research.
(8) The ultimate political goal of this Recommendation is to contribute to
the development of an attractive, open and sustainable European
labour market for researchers, where the framework conditions allow
for recruiting and retaining high quality researchers in environments
conducive to effective performance and productivity.
(9) Member States should endeavour to offer researchers sustainable
career development systems at all career stages, regardless of their
contractual situation and of the chosen R&D career path, and they
3
COM (2003) 226 final and SEC(2003) 489 of 30.4.2003.
4
SEC (2005) 260.
5
should endeavour to ensure that researchers are treated as professionals
and as an integral part of the institutions in which they work.
(10) Even though Member States have made considerable efforts to overcome
administrative and legal obstacles to geographical and intersectoral
mobility, many of these obstacles still remain.
(11) All forms of mobility should be encouraged as part of a comprehensive
human resource policy in R&D at national, regional and institutional
level.
(12) The value of all forms of mobility needs to be fully recognised in the
career appraisal and career advancement systems for researchers,
thus guaranteeing that such an experience is conducive to their professional
development.
(13) The development of a consistent career and mobility policy for
researchers to 5
and from the European Union should be considered
with regard to the situation in developing countries and regions within
and outside Europe, so that building research capacities within the
European Union does not occur at the expense of less developed
countries or regions.
(14) Funders or employers of researchers in their role as recruiters should
be responsible for providing researchers with open, transparent and
internationally comparable selection and recruitment procedures.
(15) Society should appreciate more fully the responsibilities and the professionalism
that researchers demonstrate in executing their work at
different stages of their careers and in their multi-faceted role as
knowledge workers, leaders, project coordinators, managers, supervisors,
mentors, career advisors or science communicators.
5
COM(2004) 178 final of 16.3.2004.
6
(16) This Recommendation takes as its premise that employers or funders
of researchers have an overriding obligation to ensure that they meet
respective national, regional or sectoral legislation requirements.
(17) This Recommendation provides Member States, employers, funders
and researchers with a valuable instrument to undertake, on a voluntary
basis, further initiatives for the improvement and consolidation
of researchers’ career prospects in the European Union and for the
creation of an open labour market for researchers.
(18) The general principles and requirements outlined in this Recommendation
are the fruits of a public consultation process to which the
members of the Steering Group on Human Resources and Mobility
have been fully associated,
Hereby recommends:
1. That Member States endeavour to undertake the necessary steps to
ensure that employers or funders of researchers develop and maintain
a supportive research environment and working culture, where
individuals and research groups are valued, encouraged and supported,
and provided with the necessary material and intangible support
to enable them to fulfil their objectives and tasks. Within this
context, particular priority should be given to the organisation of
working and training conditions in the early stage of the researchers’
careers, as it contributes to the future choices and attractiveness of
a career in R&D.
2. That Member States endeavour to take, wherever necessary, the crucial
steps to ensure that employers or funders of researchers improve
the recruitment methods and career evaluation/appraisal systems in
order to create a more transparent, open, equal and internationally
accepted system of recruitment and career development as a prerequisite
for a genuine European labour market for researchers.
7
3. That Member States - as they formulate and adopt their strategies
and systems for developing sustainable careers for researchers - take
duly into account and are guided by the general principles and
requirements, referred to as The European Charter for Researchers
and the Code of Conduct for the Recruitment of Researchers outlined
in the Annex.
4. That Member States endeavour to transpose these general principles
and requirements within their area of responsibility into national regulatory
frameworks or sectoral and/or institutional standards and
guidelines (charters and/or codes for researchers). In so doing they
should take into account the great diversity of the laws, regulations
and practices which, in different countries and in different sectors,
determine the path, organisation and working conditions of a career
in R&D.
5. That Member States consider such general principles and requirements
as an integral part of institutional quality assurance mechanisms
by regarding them as a means for establishing funding criteria
for national/regional funding schemes, as well as adopting them for
the auditing, monitoring and evaluation processes of public bodies.
6. That Member States continue their efforts to overcome the persisting
legal and administrative obstacles to mobility, including those related
to intersectoral mobility and mobility between and within different
functions, taking into account an enlarged European Union.
7. That Member States endeavour to ensure that researchers enjoy adequate
social security coverage according to their legal status. Within
this context, particular attention should be paid to the portability of
pension rights, either statutory or supplementary, for researchers
moving within the public and private sectors in the same country and
also for those moving across borders within the European Union.
Such regimes should guarantee that researchers who, in the course
8
of their lives, change jobs or interrupt their careers do not unduly suffer
a loss of social security rights.
8. That Member States put in place the necessary monitoring structures
to review this Recommendation regularly, as well as to measure the
extent to which employers, funders and researchers have applied the
European Charter for Researchers and the Code of Conduct for the
Recruitment of Researchers.
9. That the criteria for measuring this will be established and agreed
with the Member States within the context of the work undertaken by
the Steering Group on Human Resources and Mobility.
10. That Member States in their role as representatives in the international
organisations established at intergovernmental level take due
account of this Recommendation when proposing strategies and taking
decisions concerning the activities of those organisations.
11. This Recommendation is addressed to the Member States but it is
also intended as an instrument to encourage social dialogue, as well
as dialogue among researchers, stakeholders and society at large.
12. The Member States are invited to inform the Commission, as far as
possible, by 15th December 2005 and annually thereafter of any
measures they have taken further to this Recommendation, and to
inform it of the first results of its application as well as to provide
examples of good practice.
13. This Recommendation will be reviewed periodically by the Commission
in the context of the Open Method of Coordination.
Done at Brussels, 11 March 2005
For the Commission
Janez Potočnik
Member of the Commission
9
The European Charter for Researchers is a set of general principles and
requirements which specifies the roles, responsibilities and entitlements
of researchers as well as of employers and/or funders of researchers 6
.
The aim of the Charter is to ensure that the nature of the relationship
between researchers and employers or funders is conducive to successful
performance in generating, transferring, sharing and disseminating
knowledge and technological development, and to the career development
of researchers. The Charter also recognizes the value of all forms of
mobility as a means for enhancing the professional development of
researchers.
In this sense, the Charter constitutes a frameworkfor researchers, employers
and funders which invites them to act responsibly and as professionals
within their working environment, and to recognise each other as such.
The Charter addresses all researchers in the European Union at all stages
of their career and covers all fields of research in the public and private
sectors, irrespective of the nature of the appointment or employment 7
, the
legal status of their employer or the type of organisation or establishment
in which the work is carried out. It takes into account the multiple roles of
researchers, who are appointed not only to conduct research and/or to
carry out development activities but are also involved in supervision, mentoring,
management or administrative tasks.
ANNEX
Section 1
The European Charter for Researchers
6
See definition in Section 3.
7
See definition in Section 3.
10
This Charter takes as its premise that researchers as well as employers
and/or funders of researchers have an overriding obligation to ensure that
they meet the requirements of the respective national or regional legislation.
Where researchers enjoy a status and rights which are, in certain
respects, more favourable than those provided for in this Charter, its terms
should not be invoked to diminish the status and rights already acquired.
Researchers, as well as employers and funders, who adhere to this Charter
will also be respecting the fundamental rights and observe the principles
recognised by the Charter of Fundamental Rights of the European
Union 8
.
8
Official Journal C 364, 18.12.2000 p. 0001-0022.
11
General Principles and Requirements
applicable to Researchers:
Research Freedom
Researchers should focus their research for the good of mankind and for
expanding the frontiers of scientific knowledge, while enjoying the freedom
of thought and expression, and the freedom to identify methods by
which problems are solved, according to recognised ethical principles and
practices.
Researchers should, however, recognise the limitations to this freedom
that could arise as a result of particular research circumstances (including
supervision/guidance/management) or operational constraints, e.g. for
budgetary or infrastructural reasons or, especially in the industrial sector,
for reasons of intellectual property protection. Such limitations should
not, however, contravene recognised ethical principles and practices, to
which researchers have to adhere.
Ethical principles
Researchers should adhere to the recognised ethical practices and fundamental
ethical principles appropriate to their discipline(s) as well as to
ethical standards as documented in the different national, sectoral or institutional
Codes of Ethics.
Professional responsibility
Researchers should make every effort to ensure that their research is relevant
to society and does not duplicate research previously carried out
elsewhere.
12
They must avoid plagiarism of any kind and abide by the principle of intellectual
property and joint data ownership in the case of research carried
out in collaboration with a supervisor(s) and/or other researchers. The
need to validate new observations by showing that experiments are reproducible
should not be interpreted as plagiarism, provided that the data to
be confirmed are explicitly quoted.
Researchers should ensure, if any aspect of their work is delegated, that
the person to whom it is delegated has the competence to carry it out.
Professional attitude
Researchers should be familiar with the strategic goals governing their
research environment and funding mechanisms, and should seek all necessary
approvals before starting their research or accessing the resources
provided.
They should inform their employers, funders or supervisor when their
research project is delayed, redefined or completed, or give notice if it is
to be terminated earlier or suspended for whatever reason.
Contractual and legal obligations
Researchers at all levels must be familiar with the national, sectoral or
institutional regulations governing training and/or working conditions.
This includes Intellectual Property Rights regulations, and the requirements
and conditions of any sponsor or funders, independently of the
nature of their contract. Researchers should adhere to such regulations by
delivering the required results (e.g. thesis, publications, patents, reports,
new products development, etc) as set out in the terms and conditions of
the contract or equivalent document.
13
Accountability
Researchers need to be aware that they are accountable towards their
employers, funders or other related public or private bodies as well as, on
more ethical grounds, towards society as a whole. In particular,
researchers funded by public funds are also accountable for the efficient
use of taxpayers’ money. Consequently, they should adhere to the principles
of sound, transparent and efficient financial management and cooperate
with any authorised audits of their research, whether undertaken
by their employers/funders or by ethics committees.
Methods of collection and analysis, the outputs and, where applicable,
details of the data should be open to internal and external scrutiny, whenever
necessary and as requested by the appropriate authorities.
Good practice in research
Researchers should at all times adopt safe working practices, in line with
national legislation, including taking the necessary precautions for health
and safety and for recovery from information technology disasters, e.g. by
preparing proper back-up strategies. They should also be familiar with the
current national legal requirements regarding data protection and confidentiality
protection requirements, and undertake the necessary steps to
fulfil them at all times.
Dissemination, exploitation of results
All researchers should ensure, in compliance with their contractual
arrangements, that the results of their research are disseminated and
exploited, e.g. communicated, transferred into other research settings or,
if appropriate, commercialised. Senior researchers, in particular, are
expected to take a lead in ensuring that research is fruitful and that results
14
are either exploited commercially or made accessible to the public (or
both) whenever the opportunity arises.
Public engagement
Researchers should ensure that their research activities are made known
to society at large in such a way that they can be understood by non-specialists,
thereby improving the public’s understanding of science. Direct
engagement with the public will help researchers to better understand
public interest in priorities for science and technology and also the public’s
concerns.
Relation with supervisors
Researchers in their training phase should establish a structured and regular
relationship with their supervisor(s) and faculty/departmental representative(s)
so as to take full advantage of their relationship with them.
This includes keeping records of all work progress and research findings,
obtaining feedback by means of reports and seminars, applying such feedback
and working in accordance with agreed schedules, milestones, deliverables
and/or research outputs.
Supervision and managerial duties
Senior researchers should devote particular attention to their multi-faceted
role as supervisors, mentors, career advisors, leaders, project coordinators,
managers or science communicators. They should perform these
tasks to the highest professional standards. With regard to their role as
supervisors or mentors of researchers, senior researchers should build up
a constructive and positive relationship with the early-stage researchers,
in order to set the conditions for efficient transfer of knowledge and for the
further successful development of the researchers’ careers.
15
Continuing Professional Development
Researchers at all career stages should seek to continually improve themselves
by regularly updating and expanding their skills and competencies.
This may be achieved by a variety of means including, but not restricted to,
formal training, workshops, conferences and e-learning.
16
General Principles and Requirements applicable to Employers and
Funders:
Recognition of the profession
All researchers engaged in a research career should be recognised as professionals
and be treated accordingly. This should commence at the
beginning of their careers, namely at postgraduate level, and should
include all levels, regardless of their classification at national level (e.g.
employee, postgraduate student, doctoral candidate, postdoctoral fellow,
civil servants).
Non-discrimination
Employers and/or funders of researchers will not discriminate against
researchers in any way on the basis of gender, age, ethnic, national or
social origin, religion or belief, sexual orientation, language, disability,
political opinion, social or economic condition.
Research environment
Employers and/or funders of researchers should ensure that the most
stimulating research or research training environment is created which
offers appropriate equipment, facilities and opportunities, including for
remote collaboration over research networks, and that the national or sectoral
regulations concerning health and safety in research are observed.
Funders should ensure that adequate resources are provided in support of
the agreed work programme.
17
Working conditions
Employers and/or funders should ensure that the working conditions for
researchers, including for disabled researchers, provide where appropriate
the flexibility deemed essential for successful research performance in
accordance with existing national legislation and with national or sectoral
collective-bargaining agreements. They should aim to provide working
conditions which allow both women and men researchers to combine family
and work, children and career 9
. Particular attention should be paid,
inter alia, to flexible working hours, part-time working, tele-working and
sabbatical leave, as well as to the necessary financial and administrative
provisions governing such arrangements.
Stability and permanence of employment
Employers and/or funders should ensure that the performance of
researchers is not undermined by instability of employment contracts, and
should therefore commit themselves as far as possible to improving the
stability of employment conditions for researchers, thus implementing
and abiding by the principles and terms laid down in the EU Directive on
Fixed-Term Work 10
.
9
See SEC (2005) 260, Women and Science: Excellence and Innovation – Gender Equality in
Science.
10
Which aims to prevent fixed-term employees from being treated less favourably than similar
permanent employees, to prevent abuse arising from the use of successive fixed-term contracts,
to improve access to training for fixed-term employees and to ensure that fixed-term
employees are informed about available permanent jobs. Council Directive 1999/70/EC concerning
the “Framework Agreement on fixed-term work” concluded by ETUC, UNICE and CEEP,
adopted on 28 June 1999.
18
Funding and salaries
Employers and/or funders of researchers should ensure that researchers
enjoy fair and attractive conditions of funding and/or salaries with adequate
and equitable social security provisions (including sickness and
parental benefits, pension rights and unemployment benefits) in accordance
with existing national legislation and with national or sectoral collective
bargaining agreements. This must include researchers at all career
stages including early-stage researchers, commensurate with their legal
status, performance and level of qualifications and/or responsibilities.
Gender balance 11
Employers and/or funders should aim for a representative gender balance
at all levels of staff, including at supervisory and managerial level. This
should be achieved on the basis of an equal opportunity policy at recruitment
and at the subsequent career stages without, however, taking precedence
over quality and competence criteria. To ensure equal treatment,
selection and evaluation committees should have an adequate gender
balance.
Career development
Employers and/or funders of researchers should draw up, preferably within
the framework of their human resources management, a specific career
development strategy for researchers at all stages of their career, regardless
of their contractual situation, including for researchers on fixed-term
contracts. It should include the availability of mentors involved in providing
support and guidance for the personal and professional development
of researchers, thus motivating them and contributing to reducing any
11
See SEC (2005) 260, Women and Science: Excellence and Innovation – Gender Equality in
Science.
19
insecurity in their professional future. All researchers should be made
familiar with such provisions and arrangements.
Value of mobility
Employers and/or funders must recognise the value of geographical, intersectoral,
inter- and trans-disciplinary and virtual 12
mobility as well as mobility
between the public and private sector as an important means of
enhancing scientific knowledge and professional development at any stage
of a researcher’s career. Consequently, they should build such options into
the specific career development strategy and fully value and acknowledge
any mobility experience within their career progression/appraisal system.
This also requires that the necessary administrative instruments be put in
place to allow the portability of both grants and social security provisions,
in accordance with national legislation.
Access to research training and continuous development
Employers and/or funders should ensure that all researchers at any stage
of their career, regardless of their contractual situation, are given the
opportunity for professional development and for improving their employability
through access to measures for the continuing development of skills
and competencies.
Such measures should be regularly assessed for their accessibility, takeup
and effectiveness in improving competencies, skills and employability.
12
i.e. remote collaboration over electronic networks.
20
Access to career advice
Employers and/or funders should ensure that career advice and job placement
assistance, either in the institutions concerned, or through collaboration
with other structures, is offered to researchers at all stages of their
careers, regardless of their contractual situation.
Intellectual Property Rights
Employers and/or funders should ensure that researchers at all career
stages reap the benefits of the exploitation (if any) of their R&D results
through legal protection and, in particular, through appropriate protection
of Intellectual Property Rights, including copyrights.
Policies and practices should specify what rights belong to researchers
and/or, where applicable, to their employers or other parties, including
external commercial or industrial organisations, as possibly provided for
under specific collaboration agreements or other types of agreement.
Co-authorship
Co-authorship should be viewed positively by institutions when evaluating
staff, as evidence of a constructive approach to the conduct of research.
Employers and/or funders should therefore develop strategies, practices
and procedures to provide researchers, including those at the beginning
of their research careers, with the necessary framework conditions so that
they can enjoy the right to be recognised and listed and/or quoted, in the
context of their actual contributions, as co-authors of papers, patents, etc,
or to publish their own research results independently from their supervi-
sor(s).
21
Supervision
Employers and/or funders should ensure that a person is clearly identified
to whom early-stage researchers can refer for the performance of their professional
duties, and should inform the researchers accordingly.
Such arrangements should clearly define that the proposed supervisors
are sufficiently expert in supervising research, have the time, knowledge,
experience, expertise and commitment to be able to offer the research
trainee appropriate support and provide for the necessary progress and
review procedures, as well as the necessary feedback mechanisms.
Teaching
Teaching is an essential means for the structuring and dissemination of
knowledge and should therefore be considered a valuable option within
the researchers’ career paths. However, teaching responsibilities should
not be excessive and should not prevent researchers, particularly at the
beginning of their careers, from carrying out their research activities.
Employers and/or funders should ensure that teaching duties are adequately
remunerated and taken into account in the evaluation/appraisal
systems, and that time devoted by senior members of staff to the training
of early stage researchers should be counted as part of their teaching commitment.
Suitable training should be provided for teaching and coaching
activities as part of the professional development of researchers.
Evaluation/appraisal systems
Employers and/or funders should introduce for all researchers, including
senior researchers, evaluation/appraisal systems for assessing their professional
performance on a regular basis and in a transparent manner by
an independent (and, in the case of senior researchers, preferably international)
committee.
22
Such evaluation and appraisal procedures should take due account of
their overall research creativity and research results, e.g. publications,
patents, management of research, teaching/lecturing, supervision, mentoring,
national or international collaboration, administrative duties, public
awareness activities and mobility, and should be taken into
consideration in the context of career progression.
Complaints/appeals
Employers and/or funders of researchers should establish, in compliance
with national rules and regulations, appropriate procedures, possibly in
the form of an impartial (ombudsman-type) person to deal with complaints/appeals
of researchers, including those concerning conflicts
between supervisor(s) and early-stage researchers. Such procedures
should provide all research staff with confidential and informal assistance
in resolving work-related conflicts, disputes and grievances, with the aim
of promoting fair and equitable treatment within the institution and
improving the overall quality of the working environment.
Participation in decision-making bodies
Employers and/or funders of researchers should recognise it as wholly
legitimate, and indeed desirable, that researchers be represented in the
relevant information, consultation and decision-making bodies of the institutions
for which they work, so as to protect and promote their individual
and collective interests as professionals and to actively contribute to the
workings of the institution 13
.
13
In this context see also EU Directive 2002/14/EC.
23
Recruitment
Employers and/or funders should ensure that the entry and admission
standards for researchers, particularly at the beginning at their careers, are
clearly specified and should also facilitate access for disadvantaged
groups or for researchers returning to a research career, including teachers
(of any level) returning to a research career.
Employers and/or funders of researchers should adhere to the principles
set out in the Code of Conduct for the Recruitment of Researchers when
appointing or recruiting researchers.
24
Section 2
The Code of Conduct for the Recruitment of Researchers
The code of conduct for the recruitment of researchers consists of a set of
general principles and requirements that should be followed by employers
and/or funders when appointing or recruiting researchers. These principles
and requirements should ensure observance of values such as
transparency of the recruitment process and equal treatment of all applicants,
in particular with regard to the development of an attractive, open
and sustainable European labour market for researchers, and are complementary
to those outlined in the European Charter for Researchers.
Institutions and employers adhering to the Code of Conduct will openly
demonstrate their commitment to act in a responsible and respectable
way and to provide fair framework conditions to researchers, with a clear
intention to contribute to the advancement of the European Research Area.
General Principles and Requirements for the Code of Conduct
Recruitment
Employers and/or funders should establish recruitment procedures which
are open 14
, efficient, transparent, supportive and internationally comparable,
as well as tailored to the type of positions advertised.
14
All available instruments should be used, in particular international or globally accessible
web-based resources such as the pan-European Researcher’s Mobility Portal:
http://europa.eu.int/eracareers.
25
Advertisements should give a broad description of knowledge and competencies
required, and should not be so specialised as to discourage
suitable applicants. Employers should include a description of the working
conditions and entitlements, including career development prospects.
Moreover, the time allowed between the advertisement of the vacancy or
the call for applications and the deadline for reply should be realistic.
Selection
Selection committees should bring together diverse expertise and competences
and should have an adequate gender balance and, where appropriate
and feasible, include members from different sectors (public and private)
and disciplines, including from other countries and with relevant experience
to assess the candidate. Whenever possible, a wide range of selection practices
should be used, such as external expert assessment and face-to-face
interviews. Members of selection panels should be adequately trained.
Transparency
Candidates should be informed, prior to the selection, about the recruitment
process and the selection criteria, the number of available positions and the
career development prospects. They should also be informed after the selection
process about the strengths and weaknesses of their applications.
Judging merit
The selection process should take into consideration the whole range of
experience 15
of the candidates. While focusing on their overall potential as
researchers, their creativity and level of independence should also be
considered.
15
See also The European Charter for Researchers: Evaluation/Appraisal systems in Section 1 of
this document.
26
This means that merit should be judged qualitatively as well as quantitatively,
focusing on outstanding results within a diversified career path and
not only on the number of publications. Consequently, the importance of
bibliometric indices should be properly balanced within a wider range of
evaluation criteria, such as teaching, supervision, teamwork, knowledge
transfer, management of research and innovation and public awareness
activities. For candidates from an industrial background, particular attention
should be paid to any contributions to patents, development or inventions.
Variations in the chronological order of CVs
Career breaks or variations in the chronological order of CVs should not be
penalised, but regarded as an evolution of a career, and consequently, as
a potentially valuable contribution to the professional development of
researchers towards a multidimensional career track. Candidates should
therefore be allowed to submit evidence-based CVs, reflecting a representative
array of achievements and qualifications appropriate to the post
for which application is being made.
Recognition of mobility experience
Any mobility experience, e.g. a stay in another country/region or in another
research setting (public or private) or a change from one discipline or sector
to another, whether as part of the initial research training or at a later stage
of the research career, or virtual mobility experience, should be considered
as a valuable contribution to the professional development of a researcher.
Recognition of qualifications
Employers and/or funders should provide for appropriate assessment and
evaluation of the academic and professional qualifications, including nonformal
qualifications, of all researchers, in particular within the context of
27
international and professional mobility. They should inform themselves
and gain a full understanding of rules, procedures and standards governing
the recognition of such qualifications and, consequently, explore
existing national law, conventions and specific rules on the recognition of
these qualifications through all available channels 16
.
Seniority
The levels of qualifications required should be in line with the needs of the
position and not be set as a barrier to entry. Recognition and evaluation
of qualifications should focus on judging the achievements of the person
rather than his/her circumstances or the reputation of the institution where
the qualifications were gained. As professional qualifications may be
gained at an early stage of a long career, the pattern of lifelong professional
development should also be recognised.
Postdoctoral appointments
Clear rules and explicit guidelines for the recruitment and appointment of
postdoctoral researchers, including the maximum duration and the objectives
of such appointments, should be established by the institutions
appointing postdoctoral researchers. Such guidelines should take into
account time spent in prior postdoctoral appointments at other institutions
and take into consideration that the postdoctoral status should be
transitional, with the primary purpose of providing additional professional
development opportunities for a research career in the context of longterm
career prospects.
16
Look at http://www.enic-naric.net/ to find more detailed information about the NARIC Network
(National Academic Recognition Information Centres) and the ENIC Network (European Network
of Information Centres).
28
Section 3
Definitions
Researchers
For the purpose of this Recommendation the internationally recognised
Frascati definition of research 17
will be used. Consequently, researchers are
described as
“Professionals engaged in the conception or creation of new knowledge,
products, processes, methods and systems, and in the management of
the projects concerned.”
More specifically, this Recommendation relates to all persons professionally
engaged in R&D at any career stage 18
, regardless of their classification.
This includes any activities related to “basic research”, “strategic
research”, “applied research”, experimental development and “transfer of
knowledge” including innovation and advisory, supervisory and teaching
capacities, the management of knowledge and intellectual property rights,
the exploitation of research results or scientific journalism.
A distinction is made between Early-Stage Researcher and Experienced
Researchers:
• The term Early-Stage Researcher 19
refers to researchers in the first
four years (full-time equivalent) of their research activity, including
the period of research training.
17
In: Proposed Standard Practice for Surveys on Research and Experimental Development,
Frascati Manual, OECD, 2002.
18
COM (2003) 436 of 18.7. 2003: Researchers in the ERA: One profession, multiple careers.
19
See Work Programme Structuring the European Research Area Human Resources and Mobility
Marie Curie Actions, edition September 2004, page 41.
29
• Experienced Researchers 20
are defined as researchers having at
least four years of research experience (full-time equivalent) since
gaining a university diploma giving them access to doctoral studies,
in the country in which the degree/diploma was obtained or
researchers already in possession of a doctoral degree, regardless
of the time taken to acquire it.
Employers
In the context of this Recommendation “employers” refers to all those
public or private institutions which employ researchers on a contractual
basis or which host them under other types of contracts or arrangements,
including those without a direct financial relationship. The latter refers
particularly to institutions of higher education, faculty departments, laboratories,
foundations or private bodies where researchers either undergo
their research training or carry out their research activities on the basis of
funding provided by a third party.
Funders
“Funders” refers to all those bodies 21
which provide funding, (including
stipends, awards, grants and fellowships) to public and private research
institutions, including institutions for higher education. In this role they
might stipulate as a key condition for providing funding that the funded
institutions should have in place and apply effective strategies, practices
and mechanisms according to the general principles and requirements
presented in this Recommendation.
20
Idem, page 42.
21
The Community will endeavour to apply the commitments laid down in this Recommendation
to the receiver of funding in the context of the Framework Programme(s) for Research, Technological
Development and Demonstration Activities.
30
Appointment or employment
This refers to any type of contract or stipend or to a fellowship, grant or
awards financed by a third party including funding within the context of the
Framework Programme(s) 22
.
22
The Framework Programme(s) for Research, Technological Development and Demonstration
Activities.
European Commission
EUR 21620 — The European Charter for Researchers.
The Code of Conduct for the Recruitment
Luxembourg: Office for Official Publications of the European Communities
2005 — 32 pp. — 14.8 x 21 cm
ISBN 92-894-9311-9
SALES AND SUBSCRIPTIONS
Publications for sale produced by the Office for Official Publications of the European
Communities are available from our sales agents throughout the world.
How do I set about obtaining a publication?
Once you have obtained the list of sales agents, contact the sales agent of your choice and
place your order.
How do I obtain the list of sales agents?
• Go to the Publications Office website http://publications.eu.int/
• Or apply for a paper copy by fax (352) 2929 42758
15KI-NA-21620-EN-C
The European Commission has adopted the European Charter for
Researchers and a Code of Conduct for the Recruitment of
Researchers. These two documents are key elements in the EU’s
policy to make research an attractive career, which is a vital
feature of its strategy to stimulate economic and employment
growth. The Charter and Code of Conduct will give individual
researchers the same rights and obligations wherever they may
work throughout the EU. This should help counter the fact that
research careers in Europe are fragmented at local, regional,
national or sectoral level, and allow Europe to make the most of
its scientific potential.
1
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI
Ethical Principles for Medical Research Involving Human Subjects
Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by the:
29th WMA General Assembly, Tokyo, Japan, October 1975
35th WMA General Assembly, Venice, Italy, October 1983
41st WMA General Assembly, Hong Kong, September 1989
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996
52nd WMA General Assembly, Edinburgh, Scotland, October 2000
53rd WMA General Assembly, Washington 2002 (Note of Clarification on paragraph 29 added)
55th WMA General Assembly, Tokyo 2004 (Note of Clarification on Paragraph 30 added)
59th WMA General Assembly, Seoul, October 2008
A. INTRODUCTION
1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a
statement of ethical principles for medical research involving human subjects, including
research on identifiable human material and data.
The Declaration is intended to be read as a whole and each of its constituent paragraphs
should not be applied without consideration of all other relevant paragraphs.
2. Although the Declaration is addressed primarily to physicians, the WMA encourages
other participants in medical research involving human subjects to adopt these
principles.
3. It is the duty of the physician to promote and safeguard the health of patients, including
those who are involved in medical research. The physician's knowledge and conscience
are dedicated to the fulfilment of this duty.
4. The Declaration of Geneva of the WMA binds the physician with the words, “The
health of my patient will be my first consideration,” and the International Code of
Medical Ethics declares that, “A physician shall act in the patient's best interest when
providing medical care.”
5. Medical progress is based on research that ultimately must include studies involving
human subjects. Populations that are underrepresented in medical research should be
provided appropriate access to participation in research.
6. In medical research involving human subjects, the well-being of the individual research
subject must take precedence over all other interests.
7. The primary purpose of medical research involving human subjects is to understand the
causes, development and effects of diseases and improve preventive, diagnostic and
therapeutic interventions (methods, procedures and treatments). Even the best current
interventions must be evaluated continually through research for their safety,
effectiveness, efficiency, accessibility and quality.
8. In medical practice and in medical research, most interventions involve risks and
burdens.
DoH/Oct2008
2
9. Medical research is subject to ethical standards that promote respect for all human
subjects and protect their health and rights. Some research populations are particularly
vulnerable and need special protection. These include those who cannot give or refuse
consent for themselves and those who may be vulnerable to coercion or undue
influence.
10. Physicians should consider the ethical, legal and regulatory norms and standards for
research involving human subjects in their own countries as well as applicable
international norms and standards. No national or international ethical, legal or
regulatory requirement should reduce or eliminate any of the protections for research
subjects set forth in this Declaration.
B. PRINCIPLES FOR ALL MEDICAL RESEARCH
11. It is the duty of physicians who participate in medical research to protect the life, health,
dignity, integrity, right to self-determination, privacy, and confidentiality of personal
information of research subjects.
12. Medical research involving human subjects must conform to generally accepted
scientific principles, be based on a thorough knowledge of the scientific literature, other
relevant sources of information, and adequate laboratory and, as appropriate, animal
experimentation. The welfare of animals used for research must be respected.
13. Appropriate caution must be exercised in the conduct of medical research that may
harm the environment.
14. The design and performance of each research study involving human subjects must be
clearly described in a research protocol. The protocol should contain a statement of the
ethical considerations involved and should indicate how the principles in this
Declaration have been addressed. The protocol should include information regarding
funding, sponsors, institutional affiliations, other potential conflicts of interest,
incentives for subjects and provisions for treating and/or compensating subjects who are
harmed as a consequence of participation in the research study. The protocol should
describe arrangements for post-study access by study subjects to interventions identified
as beneficial in the study or access to other appropriate care or benefits.
15. The research protocol must be submitted for consideration, comment, guidance and
approval to a research ethics committee before the study begins. This committee must
be independent of the researcher, the sponsor and any other undue influence. It must
take into consideration the laws and regulations of the country or countries in which the
research is to be performed as well as applicable international norms and standards but
these must not be allowed to reduce or eliminate any of the protections for research
subjects set forth in this Declaration. The committee must have the right to monitor
ongoing studies. The researcher must provide monitoring information to the committee,
especially information about any serious adverse events. No change to the protocol may
be made without consideration and approval by the committee.
16. Medical research involving human subjects must be conducted only by individuals with
the appropriate scientific training and qualifications. Research on patients or healthy
DoH/Oct2008
3
volunteers requires the supervision of a competent and appropriately qualified physician
or other health care professional. The responsibility for the protection of research
subjects must always rest with the physician or other health care professional and never
the research subjects, even though they have given consent.
17. Medical research involving a disadvantaged or vulnerable population or community is
only justified if the research is responsive to the health needs and priorities of this
population or community and if there is a reasonable likelihood that this population or
community stands to benefit from the results of the research.
18. Every medical research study involving human subjects must be preceded by careful
assessment of predictable risks and burdens to the individuals and communities
involved in the research in comparison with foreseeable benefits to them and to other
individuals or communities affected by the condition under investigation.
19. Every clinical trial must be registered in a publicly accessible database before
recruitment of the first subject.
20. Physicians may not participate in a research study involving human subjects unless they
are confident that the risks involved have been adequately assessed and can be
satisfactorily managed. Physicians must immediately stop a study when the risks are
found to outweigh the potential benefits or when there is conclusive proof of positive
and beneficial results.
21. Medical research involving human subjects may only be conducted if the importance of
the objective outweighs the inherent risks and burdens to the research subjects.
22. Participation by competent individuals as subjects in medical research must be
voluntary. Although it may be appropriate to consult family members or community
leaders, no competent individual may be enrolled in a research study unless he or she
freely agrees.
23. Every precaution must be taken to protect the privacy of research subjects and the
confidentiality of their personal information and to minimize the impact of the study on
their physical, mental and social integrity.
24. In medical research involving competent human subjects, each potential subject must be
adequately informed of the aims, methods, sources of funding, any possible conflicts of
interest, institutional affiliations of the researcher, the anticipated benefits and potential
risks of the study and the discomfort it may entail, and any other relevant aspects of the
study. The potential subject must be informed of the right to refuse to participate in the
study or to withdraw consent to participate at any time without reprisal. Special
attention should be given to the specific information needs of individual potential
subjects as well as to the methods used to deliver the information. After ensuring that
the potential subject has understood the information, the physician or another
appropriately qualified individual must then seek the potential subject’s freely-given
informed consent, preferably in writing. If the consent cannot be expressed in writing,
the non-written consent must be formally documented and witnessed.
DoH/Oct2008
4
25. For medical research using identifiable human material or data, physicians must
normally seek consent for the collection, analysis, storage and/or reuse. There may be
situations where consent would be impossible or impractical to obtain for such research
or would pose a threat to the validity of the research. In such situations the research may
be done only after consideration and approval of a research ethics committee.
26. When seeking informed consent for participation in a research study the physician
should be particularly cautious if the potential subject is in a dependent relationship
with the physician or may consent under duress. In such situations the informed consent
should be sought by an appropriately qualified individual who is completely
independent of this relationship.
27. For a potential research subject who is incompetent, the physician must seek informed
consent from the legally authorized representative. These individuals must not be
included in a research study that has no likelihood of benefit for them unless it is
intended to promote the health of the population represented by the potential subject,
the research cannot instead be performed with competent persons, and the research
entails only minimal risk and minimal burden.
28. When a potential research subject who is deemed incompetent is able to give assent to
decisions about participation in research, the physician must seek that assent in addition
to the consent of the legally authorized representative. The potential subject’s dissent
should be respected.
29. Research involving subjects who are physically or mentally incapable of giving
consent, for example, unconscious patients, may be done only if the physical or mental
condition that prevents giving informed consent is a necessary characteristic of the
research population. In such circumstances the physician should seek informed consent
from the legally authorized representative. If no such representative is available and if
the research cannot be delayed, the study may proceed without informed consent
provided that the specific reasons for involving subjects with a condition that renders
them unable to give informed consent have been stated in the research protocol and the
study has been approved by a research ethics committee. Consent to remain in the
research should be obtained as soon as possible from the subject or a legally authorized
representative.
30. Authors, editors and publishers all have ethical obligations with regard to the
publication of the results of research. Authors have a duty to make publicly available
the results of their research on human subjects and are accountable for the completeness
and accuracy of their reports. They should adhere to accepted guidelines for ethical
reporting. Negative and inconclusive as well as positive results should be published or
otherwise made publicly available. Sources of funding, institutional affiliations and
conflicts of interest should be declared in the publication. Reports of research not in
accordance with the principles of this Declaration should not be accepted for
publication.
DoH/Oct2008
5
C. ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH
MEDICAL CARE
31. The physician may combine medical research with medical care only to the extent that
the research is justified by its potential preventive, diagnostic or therapeutic value and if
the physician has good reason to believe that participation in the research study will not
adversely affect the health of the patients who serve as research subjects.
32. The benefits, risks, burdens and effectiveness of a new intervention must be tested
against those of the best current proven intervention, except in the following
circumstances:
• The use of placebo, or no treatment, is acceptable in studies where no current
proven intervention exists; or
• Where for compelling and scientifically sound methodological reasons the use of
placebo is necessary to determine the efficacy or safety of an intervention and the
patients who receive placebo or no treatment will not be subject to any risk of
serious or irreversible harm. Extreme care must be taken to avoid abuse of this
option.
33. At the conclusion of the study, patients entered into the study are entitled to be
informed about the outcome of the study and to share any benefits that result from it, for
example, access to interventions identified as beneficial in the study or to other
appropriate care or benefits.
34. The physician must fully inform the patient which aspects of the care are related to the
research. The refusal of a patient to participate in a study or the patient’s decision to
withdraw from the study must never interfere with the patient-physician relationship.
35. In the treatment of a patient, where proven interventions do not exist or have been
ineffective, the physician, after seeking expert advice, with informed consent from the
patient or a legally authorized representative, may use an unproven intervention if in the
physician's judgement it offers hope of saving life, re-establishing health or alleviating
suffering. Where possible, this intervention should be made the object of research,
designed to evaluate its safety and efficacy. In all cases, new information should be
recorded and, where appropriate, made publicly available.