United Nations Educational,
Scientific and Cultural Organization
Organisation des Nations Unies pour
l’éducation, la science et la culture
Universal Declaration on
Bioethics and Human Rights
(Adopted by acclamation on
19 October 2005 by the 33rd session of the General Conference of UNESCO)
The General Conference,
Conscious
of the unique capacity of human beings to reflect upon
their own existence and on their environment, to perceive injustice, to avoid
danger, to assume responsibility, to seek cooperation and to exhibit the moral
sense that gives expression to ethical principles,
Reflecting
on the rapid developments in science and technology,
which increasingly affect our understanding of life and life itself, resulting
in a strong demand for a global response to the ethical implications of such
developments,
Recognizing
that ethical issues raised by the rapid advances in
science and their technological applications should be examined with due respect
to the dignity of the human person and universal respect for, and observance of,
human rights and fundamental freedoms,
Resolving
that it is necessary and timely for the international
community to state universal principles that will provide a foundation for
humanity’s response to the ever-increasing dilemmas and controversies that
science and technology present for humankind and for the environment,
Recalling
the Universal Declaration of Human Rights of 10
December 1948, the Universal Declaration on the Human Genome and Human Rights
adopted by the General Conference of UNESCO on 11 November 1997 and the
International Declaration on Human Genetic Data adopted by the General
Conference of UNESCO on 16 October 2003,
Noting
the United Nations International Covenant on Economic, Social and
Cultural Rights and the International Covenant on Civil and Political Rights of
16 December 1966, the United Nations International Convention on the Elimination
of All Forms of Racial Discrimination of 21 December 1965, the United Nations
Convention on the Elimination of All Forms of Discrimination against Women of 18
December 1979, the United Nations Convention on the Rights of the Child of 20
November 1989, the United Nations Convention on Biological Diversity of 5 June
1992, the Standard Rules on the Equalization of Opportunities for Persons with
Disabilities adopted by the General Assembly of the United Nations in 1993, the
UNESCO Recommendation on the Status of Scientific Researchers of 20 November
1974, the UNESCO Declaration on Race and Racial Prejudice of 27 November 1978,
the UNESCO Declaration on the Responsibilities of the Present Generations
Towards Future Generations of 12 November 1997, the UNESCO Universal Declaration
on Cultural Diversity of 2 November 2001, the ILO Convention 169 concerning
Indigenous and Tribal Peoples in Independent Countries of 27 June 1989, the
International Treaty on Plant Genetic Resources for Food and Agriculture which
was adopted by the FAO Conference on 3 November 2001 and entered into force on
29 June 2004, the Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS) annexed to the Marrakech Agreement establishing the World Trade
Organization, which entered into force on 1 January 1995, the Doha Declaration
on the TRIPS Agreement and Public Health of 14 November 2001 and other relevant
international instruments adopted by the United Nations and the specialized
agencies of the United Nations system, in particular the Food and Agriculture
Organization of the United Nations (FAO) and the World Health Organization (WHO),
Also noting
international and regional instruments in the field of
bioethics, including the Convention for the Protection of Human Rights and
Dignity of the Human Being with regard to the Application of Biology and
Medicine: Convention on Human Rights and Biomedicine of the Council of Europe,
which was adopted in 1997 and entered into force in 1999, together with its
Additional Protocols, as well as national legislation and regulations in the
field of bioethics and the international and regional codes of conduct and
guidelines and other texts in the field of bioethics, such as the Declaration of
Helsinki of the World Medical Association on Ethical Principles for Medical
Research Involving Human Subjects, adopted in 1964 and amended in 1975, 1983,
1989, 1996 and 2000 and the International Ethical Guidelines for Biomedical
Research Involving Human Subjects of the Council for International Organizations
of Medical Sciences, adopted in 1982 and amended in 1993 and 2002,
Recognizing
that this Declaration is to be understood in a manner
consistent with domestic and international law in conformity with human rights
law,
Recalling
the Constitution of UNESCO adopted on 16 November 1945,
Considering
UNESCO’s role in identifying universal principles
based on shared ethical values to guide scientific and technological development
and social transformation in order to identify emerging challenges in science
and technology taking into account the responsibility of the present generations
towards future generations, and that questions of bioethics, which necessarily
have an international dimension, should be treated as a whole, drawing on the
principles already stated in the Universal Declaration on the Human Genome and
Human Rights and the International Declaration on Human Genetic Data and taking
account not only of the current scientific context but also of future
developments,
Aware
that human beings are an integral part of the biosphere, with an
important role in protecting one another and other forms of life, in particular
animals,
Recognizing
that, based on the freedom of science and research,
scientific and technological developments have been, and can be, of great
benefit to humankind in increasing,
inter alia, life expectancy and improving the quality of life, and
emphasizing
that such developments should always seek to promote
the welfare of individuals, families, groups or communities and humankind as a
whole in the recognition of the dignity of the human person and universal
respect for, and observance of, human rights and fundamental freedoms,
Recognizing
that health does not depend solely on scientific and
technological research developments but also on psychosocial and cultural
factors,
Also recognizing
that decisions regarding ethical issues in medicine,
life sciences and associated technologies may have an impact on individuals,
families, groups or communities and humankind as a whole,
Bearing in mind
that cultural diversity, as a source of exchange,
innovation and creativity, is necessary to humankind and, in this sense, is the
common heritage of humanity, but
emphasizing
that it may not be invoked at the expense of human
rights and fundamental freedoms,
Also bearing in mind
that a person’s identity includes biological,
psychological, social, cultural and spiritual dimensions,
Recognizing
that unethical scientific and technological conduct has
had a particular impact on indigenous and local communities,
Convinced
that moral sensitivity and ethical reflection should be
an integral part of the process of scientific and technological developments and
that bioethics should play a predominant role in the choices that need to be
made concerning issues arising from such developments,
Considering
the desirability of developing new approaches to social
responsibility to ensure that progress in science and technology contributes to
justice, equity and to the interest of humanity,
Recognizing
that an important way to evaluate social realities and
achieve equity is to pay attention to the position of women,
Stressing
the need to reinforce international cooperation in the
field of bioethics, taking into account, in particular, the special needs of
developing countries, indigenous communities and vulnerable populations,
Considering
that all human beings, without distinction, should
benefit from the same high ethical standards in medicine and life science
research,
Proclaims
the principles that follow and
adopts
the present Declaration.
General
provisions
Article
1 – Scope
1. This Declaration addresses
ethical issues related to medicine, life sciences and associated technologies as
applied to human beings, taking into account their social, legal and
environmental dimensions.
2. This Declaration is addressed
to States. As appropriate and relevant, it also provides guidance to decisions
or practices of individuals, groups, communities, institutions and corporations,
public and private.
Article
2 – Aims
The aims of this Declaration are:
(a) to provide a universal
framework of principles and procedures to guide States in the formulation of
their legislation, policies or other instruments in the field of bioethics;
(b) to guide the actions of
individuals, groups, communities, institutions and corporations, public and
private;
(c)
to promote respect for human dignity and protect human rights, by ensuring
respect for the life of human beings, and fundamental freedoms, consistent with
international human rights law;
(d) to recognize the importance
of freedom of scientific research and the benefits derived from scientific and
technological developments, while stressing the need for such research and
developments to occur within the framework of ethical principles set out in this
Declaration and to respect human dignity, human rights and fundamental freedoms;
(e) to foster multidisciplinary
and pluralistic dialogue about bioethical issues between all stakeholders and
within society as a whole;
(f) to promote equitable access
to medical, scientific and technological developments as well as the greatest
possible flow and the rapid sharing of knowledge concerning those developments
and the sharing of benefits, with particular attention to the needs of
developing countries;
(g) to safeguard and promote the
interests of the present and future generations;
(h) to underline the importance
of biodiversity and its conservation as a common concern of humankind.
Principles
Within
the scope of this Declaration, in decisions or practices taken or carried out by
those to whom it is addressed, the following principles are to be respected.
Article
3 – Human dignity and human rights
1. Human dignity, human rights
and fundamental freedoms are to be fully respected.
2. The interests and welfare of
the individual should have priority over the sole interest of science or
society.
Article
4 – Benefit and harm
In applying and advancing
scientific knowledge, medical practice and associated technologies, direct and
indirect benefits to patients, research participants and other affected
individuals should be maximized and any possible harm to such individuals should
be minimized.
Article
5 – Autonomy and individual responsibility
The autonomy of persons to make
decisions, while taking responsibility for those decisions and respecting the
autonomy of others, is to be respected. For persons who are not capable of
exercising autonomy, special measures are to be taken to protect their rights
and interests.
Article
6 – Consent
1. Any preventive, diagnostic and
therapeutic medical intervention is only to be carried out with the prior, free
and informed consent of the person concerned, based on adequate information. The
consent should, where appropriate, be express and may be withdrawn by the person
concerned at any time and for any reason without disadvantage or prejudice
2. Scientific research should
only be carried out with the prior, free, express and informed consent of the
person concerned. The information should be adequate, provided in a
comprehensible form and should include modalities for withdrawal of consent.
Consent may be withdrawn by the person concerned at any time and for any reason
without any disadvantage or prejudice. Exceptions to this principle should be
made only in accordance with ethical and legal standards adopted by States,
consistent with the principles and provisions set out in this Declaration, in
particular in Article 27, and international human rights law.
3. In appropriate cases of
research carried out on a group of persons or a community, additional agreement
of the legal representatives of the group or community concerned may be sought.
In no case should a collective community agreement or the consent of a community
leader or other authority substitute for an individual’s informed consent.
Article
7 – Persons without the capacity to consent
In accordance with domestic law,
special protection is to be given to persons who do not have the capacity to
consent:
(a)
authorization for research and medical practice should be obtained in accordance
with the best interest of the person concerned and in accordance with domestic
law. However, the person concerned should be involved to the greatest extent
possible in the decision-making process of consent, as well as that of
withdrawing consent;
(b)
research should only be carried out for his or her direct health benefit,
subject to the authorization and the protective conditions prescribed by law,
and if there is no research alternative of comparable effectiveness with
research participants able to consent. Research which does not have potential
direct health benefit should only be undertaken by way of exception, with the
utmost restraint, exposing the person only to a minimal risk and minimal burden
and if the research is expected to contribute to the health benefit of other
persons in the same category, subject to the conditions prescribed by law and
compatible with the protection of the individual’s human rights. Refusal of
such persons to take part in research should be respected.
Article
8 – Respect for human vulnerability and personal integrity
In applying and advancing
scientific knowledge, medical practice and associated technologies, human
vulnerability should be taken into account. Individuals and groups of special
vulnerability should be protected and the personal integrity of such individuals
respected.
Article
9 – Privacy and confidentiality
The privacy of the persons
concerned and the confidentiality of their personal information should be
respected. To the greatest extent possible, such information should not be used
or disclosed for purposes other than those for which it was collected or
consented to, consistent with international law, in particular international
human rights law.
Article
10 – Equality, justice and equity
The fundamental equality of all
human beings in dignity and rights is to be respected so that they are treated
justly and equitably.
Article
11 – Non-discrimination and non-stigmatization
No individual or group should be
discriminated against or stigmatized on any grounds, in violation of human
dignity, human rights and fundamental freedoms.
Article
12 – Respect for cultural diversity and pluralism
The importance of cultural
diversity and pluralism should be given due regard. However, such considerations
are not to be invoked to infringe upon human dignity, human rights and
fundamental freedoms, nor upon the principles set out in this Declaration, nor
to limit their scope.
Article
13 – Solidarity and cooperation
Solidarity among human beings and
international cooperation towards that end are to be encouraged.
Article
14 – Social responsibility and health
1. The promotion of health and
social development for their people is a central purpose of governments that all
sectors of society share.
2. Taking into account that the
enjoyment of the highest attainable standard of health is one of the fundamental
rights of every human being without distinction of race, religion, political
belief, economic or social condition, progress in science and technology should
advance:
(a)
access to quality health care and essential medicines, especially for the health
of women and children, because health is essential to life itself and must be
considered to be a social and human good;
(b)
access to adequate nutrition and water;
(c)
improvement of living conditions and the environment;
(d)
elimination of the marginalization and the exclusion of persons on the basis of
any grounds;
(e)
reduction of poverty and illiteracy.
Article
15 – Sharing of benefits
1. Benefits resulting from any
scientific research and its applications should be shared with society as a
whole and within the international community, in particular with developing
countries. In giving effect to this principle, benefits may take any of the
following forms:
(a)
special and sustainable assistance to, and acknowledgement of, the persons and
groups that have taken part in the research;
(b)
access to quality health care;
(c)
provision of new diagnostic and therapeutic modalities or products stemming from
research;
(d)
support for health services;
(e)
access to scientific and technological knowledge;
(f)
capacity-building facilities for research purposes;
(g)
other forms of benefit consistent with the principles set out in this
Declaration.
2. Benefits should not constitute
improper inducements to participate in research.
Article
16 – Protecting future generations
The impact of life sciences on
future generations, including on their genetic constitution, should be given due
regard.
Article
17 – Protection of the environment, the biosphere and biodiversity
Due regard is to be given to the
interconnection between human beings and other forms of life, to the importance
of appropriate access and utilization of biological and genetic resources, to
respect for traditional knowledge and to the role of human beings in the
protection of the environment, the biosphere and biodiversity.
Application of the principles
Article
18 – Decision-making and addressing bioethical issues
1. Professionalism, honesty,
integrity and transparency in decision-making should be promoted, in particular
declarations of all conflicts of interest and appropriate sharing of knowledge.
Every endeavour should be made to use the best available scientific knowledge
and methodology in addressing and periodically reviewing bioethical issues.
2. Persons and professionals
concerned and society as a whole should be engaged in dialogue on a regular
basis.
3. Opportunities for informed
pluralistic public debate, seeking the expression of all relevant opinions,
should be promoted.
Article
19 – Ethics committees
Independent, multidisciplinary
and pluralist ethics committees should be established, promoted and supported at
the appropriate level in order to:
(a)
assess the relevant ethical, legal, scientific and social issues related to
research projects involving human beings
(b)
provide advice on ethical problems in clinical settings;
(c)
assess scientific and technological developments, formulate recommendations and
contribute to the preparation of guidelines on issues within the scope of this
Declaration;
(d)
foster debate, education and public awareness of, and engagement in, bioethics.
Article
20 – Risk assessment and management
Appropriate assessment and
adequate management of risk related to medicine, life sciences and associated
technologies should be promoted.
Article
21 – Transnational practices
1. States, public and private
institutions, and professionals associated with transnational activities should
endeavour to ensure that any activity within the scope of this Declaration,
undertaken, funded or otherwise pursued in whole or in part in different States,
is consistent with the principles set out in this Declaration.
2. When research is undertaken or
otherwise pursued in one or more States (the host State(s)) and funded by a
source in another State, such research should be the object of an appropriate
level of ethical review in the host State(s) and the State in which the funder
is located. This review should be based on ethical and legal standards that are
consistent with the principles set out in this Declaration.
3. Transnational health research
should be responsive to the needs of host countries, and the importance of
research contributing to the alleviation of urgent global health problems should
be recognized.
4. When negotiating a research
agreement, terms for collaboration and agreement on the benefits of research
should be established with equal participation by those party to the negotiation.
5. States should take appropriate
measures, both at the national and international levels, to combat bioterrorism
and illicit traffic in organs, tissues, samples, genetic resources and
genetic-related materials.
Promotion of the Declaration
Article 22 – Role of States
1. States should take all
appropriate measures, whether of a legislative, administrative or other
character, to give effect to the principles set out in this Declaration in
accordance with international human rights law. Such measures should be
supported by action in the spheres of education, training and public information.
2. States should encourage the
establishment of independent, multidisciplinary and pluralist ethics committees,
as set out in Article 19.
Article
23 – Bioethics education, training and information
1. In order to promote the
principles set out in this Declaration and to achieve a better understanding of
the ethical implications of scientific and technological developments, in
particular for young people, States should endeavour to foster bioethics
education and training at all levels as well as to encourage information and
knowledge dissemination programmes about bioethics.
2. States should encourage the
participation of international and regional intergovernmental organizations and
international, regional and national non-governmental organizations in this
endeavour.
Article
24 – International cooperation
1. States should foster
international dissemination of scientific information and encourage the free
flow and sharing of scientific and technological knowledge.
2. Within the framework of
international cooperation, States should promote cultural and scientific
cooperation and enter into bilateral and multilateral agreements enabling
developing countries to build up their capacity to participate in generating and
sharing scientific knowledge, the related know-how and the benefits thereof.
3. States should respect and
promote solidarity between and among States, as well as individuals, families,
groups and communities, with special regard for those rendered vulnerable by
disease or disability or other personal, societal or environmental conditions
and those with the most limited resources.
Article
25 – Follow-up action by UNESCO
1. UNESCO shall promote and
disseminate the principles set out in this Declaration. In doing so, UNESCO
should seek the help and assistance of the Intergovernmental Bioethics Committee
(IGBC) and the International Bioethics Committee (IBC).
2. UNESCO shall reaffirm its
commitment to dealing with bioethics and to promoting collaboration between IGBC
and IBC.
Final provisions
Article 26 – Interrelation and complementarity of
the principles
This Declaration is to be
understood as a whole and the principles are to be understood as complementary
and interrelated. Each principle is to be considered in the context of the other
principles, as appropriate and relevant in the circumstances.
Article
27 – Limitations on the application of the principles
If the application of the
principles of this Declaration is to be limited, it should be by law, including
laws in the interests of public safety, for the investigation, detection and
prosecution of criminal offences, for the protection of public health or for the
protection of the rights and freedoms of others. Any such law needs to be
consistent with international human rights law.
Article
28 – Denial of acts contrary to human rights, fundamental
freedoms
and human dignity
Nothing in this Declaration may
be interpreted as implying for any State, group or person any claim to engage in
any activity or to perform any act contrary to human rights, fundamental
freedoms and human dignity.
