Universal Declaration
on Bioethics
and Human Rights
Foreword
In October 2005, the General Conference of UNESCO adopted by acclamation
the Universal Declaration on Bioethics and Human Rights. For the first time
in the history of bioethics, Member States committed themselves and the
international community to respect and apply the fundamental principles
of bioethics set forth within a single text.
In dealing with ethical issues raised by medicine, life sciences and associated
technologies as applied to human beings, the Declaration, as reflected in its title,
anchors the principles it endorses in the rules that govern respect for human
dignity, human rights and fundamental freedoms. By enshrining bioethics
in international human rights and by ensuring respect for the life of human beings,
the Declaration recognizes the interrelation between ethics and human rights
in the specific field of bioethics.
Together with the Declaration, the General Conference of UNESCO adopted
a resolution which calls upon Member States to make every effort to give effect
to the principles set out in the Declaration and invites me to take appropriate steps
to ensure the follow-up to the Declaration, including its widest possible
dissemination.
This brochure constitutes a first tool for the dissemination of the Declaration
and is aimed at contributing significantly to knowledge of the Declaration
worldwide and to understanding of the principles set out therein, so that human
beings everywhere can benefit from the advances of science and technology
within the framework of respect for human rights and fundamental freedoms.
Koïchiro Matsuura
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)
The General Conference,
Universal Declaration
on Bioethics and
Human Rights*
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.
* Adopted by acclamation on 19 October 2005
by the 33 rd session of the General Conference of UNESCO
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.
United Nations Educational, Scientific and Cultural Organization
Division of Ethics of Science and Technology
Social and Human Science Sector
1, rue Miollis - 75732 Paris Cedex 15 - France
www.unesco.org/shs/ethics
SHS/EST/BIO/06/1
© UNESCO, 2006
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