Universal Draft Declaration on Bioethics and Human Rights (24 giugno 2005)
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 two United Nations International Covenants on Economic, Social and Cultural Rights
and 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 United Nations
General Assembly in 1993, 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 adopted by the FAO Conference on 3 November 2001 and entered into force
on 29 June 2004, the Recommendation of UNESCO 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 Trade Related Aspects of Intellectual Property Rights Agrements (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),
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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, 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, 1989, 1993,
1996, 2000 and 2002 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
generation 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 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 the 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 psycho-social 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 for 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 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,
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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
a) 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.
b) 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:
(i) 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;
(ii) to guide the actions of individuals, groups, communities, institutions and corporations,
public and private;
(iii) 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;
(iv) to recognize the importance of freedom of scientific research and the benefits derived
from scientific and technological developments, while stressing the need that such
research and developments occur within the framework of ethical principles set out in
this Declaration and that they respect human dignity, human rights and fundamental
freedoms;
(v) to foster multidisciplinary and pluralistic dialogue about bioethical issues between all
stakeholders and within society as a whole;
(vi) 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;
(vii) to safeguard and promote the interests of the present and future generations; and
(viii) to underline the importance of biodiversity and its conservation as a common concern
of humankind.
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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
a) Human dignity, human rights and fundamental freedoms are to be fully respected.
b) 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 techologies, 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
a) 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.
b) 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 the modalities for withdrawal of consent. The 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.
c) 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
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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
a) The promotion of health and social development for their people is a central purpose of
governments, that all sectors of society share.
b) 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:
(i) access to quality health care and essential medicines, including especially for the
health of women and children, because health is essential to life itself and must be
considered as a social and human good;
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(ii) access to adequate nutrition and water;
(iii) improvement of living conditions and the environment;
(iv) elimination of the marginalization and the exclusion of persons on the basis of any
grounds; and
(v) reduction of poverty and illiteracy.
Article 15 – Sharing of Benefits
a) 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:
(i) special and sustainable assistance to, and acknowledgement of, the persons and groups
that have taken part in the research;
(ii) access to quality health care;
(iii) provision of new diagnostic and therapeutic modalities or products stemming from
research;
(iv) support for health services;
(v) access to scientific and technological knowledge;
(vi) capacity-building facilities for research purposes; and
(vii) other forms of benefit consistent with the principles set out in this Declaration.
b) 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 the
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
a) 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.
b) Persons and professionals concerned and society as a whole should be engaged in dialogue
on a regular basis.
c) Opportunities for informed pluralistic public debate, seeking the expression of all relevant
opinions, should be promoted.
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Article 19 – Ethics Committees
Independent, multidisciplinary and pluralist ethics committees should be established, promoted and
supported at the appropriate level in order to:
(i) assess the relevant ethical, legal, scientific and social issues related to research projects
involving human beings;
(ii) provide advice on ethical problems in clinical settings;
(iii) assess scientific and technological developments, formulate recommendations and
contribute to the preparation of guidelines on issues within the scope of this
Declaration; and
(iv) 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
a) States, public and private institutions, and professionals associated with transnational
activities should endeavour to ensure that any activity within the scope of this Declaration, which is
undertaken, funded or otherwise pursued in whole or in part in different States, is consistent with
the principles set out in this Declaration.
b) 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.
c) Transnational health research should be responsive to the needs of host countries, and the
importance of research to contribute to the alleviation of urgent global health problems should be
recognized.
d) When negotiating a research agreement, terms for collaboration and agreement on benefits
of research should be established with equal participation by those party to the negotiation.
e) States should take appropriate measures, both at the national and the international level, to
combat bioterrorism, illicit traffic in organs, tissues and samples, genetic resources and geneticrelated
materials.
PROMOTION OF THE DECLARATION
Article 22 – Role of States
a) 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.
b) States should encourage the establishment of independent, multidisciplinary and pluralist
ethics committees, as set out in Article 19.
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Article 23 – Bioethics Education, Training and Information
a) 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.
b) 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
a) States should foster international dissemination of scientific information and encourage the
free flow and sharing of scientific and technological knowledge.
b) 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.
c) 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
a) 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).
b) 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
(emendata il 10 ottobre 2005)