Purpose In October 2005, the member states of the United Nations Educational, Scientific, and Cultural Organization (UNESCO) unanimously adopted the Universal Declaration on Bioethics and Human Rights

After two years of intense work, the Member States adopted, unanimously and by acclamation on 19 October 2005, the Universal Declaration on Bioethics and Human Rights, thus solemnly affirming the commitment of the international community to respect a certain number of uni- versal principles for humanity in the development and application of science and technology. The full text of the Declaration is reproduced in this section.

Introduction Due to globalization, not only scientific and technological advances, but also bioethical issues, spread around the globe. As the example of human cloning demonstrates, when a new technology has been developed in one country, it can be applied elsewhere, even if some countries want to ban its use. Medical research is increas- ingly multi-centred and international, with more and more research subjects recruited in devel- oping countries. In addition, healthcare prac- tices are global but guidelines and legal contexts differ and are sometimes absent. Rules for transplantation and procedures for organ dona- tion, for example, are varying among countries and these different approaches have led to abuses such as organ trafficking and commer- cialization of transplantation practices.

Many countries, however, only have a limited infrastructure in bioethics, lacking expertise, educational programmes, bioethics committeesand legal frameworks. The global nature of science and technology implies the need for a global approach to bioethics. Member States have mandated UNESCO to set universal ethical benchmarks covering issues raised within the field of bioethics. They want to work together towards identifying basic principles and shared values regarding science, technology and health care.

Standard-setting action in the field of bioethics has become a necessity that is felt throughout the world, often expressed by scientists and practi- tioners themselves, as well as by legislators, policy-makers and citizens.

It was in this context that UNESCO was mandated by its Member States to draw up a declaration setting out fundamental principles in the field of bioethics. With the new Declaration, adopted unanimously and by acclamation on 19 October 2005, UNESCO strives to respond in particular to the needs of developing countries, indigenous communities and vulnerable groups or persons, all of whom are the object of special mention throughout the text.

If UNESCO was considered by States to be the most appropriate forum for the elaboration of such a text, it is without doubt because the Organization has been able to confirm its standard-setting role in the field of bioethics.

UNESCO, the only specialized body within the United Nations system that combines educa- tion, culture, science and social sciences in its field of competence, has developed a bioethics programme over the past ten years that reflects the multidisciplinary and transcultural dimen- sion of this debate. UNESCO is engaged in carrying out actions that involve all countries in this international discussion in order to bring out fundamental principles common to all, with ISSJ 186r UNESCO 2005. Published by Blackwell Publishing Ltd., 9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden, MA 02148, USA. respect for the cultural diversity of our societies.

The success of the Universal Declaration on the Human Genome and Human Rights adopted in 1997 and of the International Declaration on Human Genetic Data adopted in 2003 has reinforced UNESCO in its standard-setting action in the field of bioethics and allowed States to place confidence in the Organization to finalize the Universal Declaration.

Under the aegis of respect for human dignity, human rights and fundamental free- doms, the Universal Declaration deals with ethical issues raised by medicine, life sciences and associated technologies as applied to human beings, taking into account their social, legal and environmental dimensions.

The Universal Declaration aims to define the universally acceptable norms, principles and procedures in the field of bioethics, in confor- mity with human rights as enshrined in interna- tional law. It is thus conceived as a group of general provisions and principles that allow for a better evaluation of the implications of the ethical issues at stake in specific decisions and provide assistance in decision-making. The De- claration does not claim to resolve all the bioethical issues presently raised, which in any case evolve each day. Its aim is rather to constitute a basis for States wishing to endow themselves with legislation or policies in the field of bioethics. It also aims, as far as possible, to inscribe scientific decisions and practices within the framework of, and respect for, a certain number of general principles common to all.

And it aims to foster dialogue within societies on the implications of bioethics and the sharing of knowledge in the field of science and technology.

In order to achieve these goals, the Uni- versal Declaration presents a vested right which is reflected in its title: it anchors the principles it endorses in the rules that govern respect for human dignity, human rights and funda- mental freedoms. By drawing on the 1948 Uni- versal Declaration of Human Rights, it clearly sets bioethics within international human rights law in order to apply human rights to bioethical concerns.

Apart from principles already well-estab- lished in the scientific community, such as informed consent, autonomy and individual responsibility, and respect for privacy and confidentiality, the Declaration raises the issuesof access to quality health care and essential medicines, nutrition and provision of clean water, improvement of living conditions, and the environment and the reduction of poverty.

The Universal Declaration thus opens perspec- tives for action that reach further than just medical ethics and reiterates the need to place bioethics within the context of reflection open to the political and social world. Today, bioethics goes far beyond the code of ethics of the various professional practices concerned. It implies reflection on the evolution of society and indeed on world stability, under the pressure of scientific and technological developments. The Universal Declaration paves the way for a new agenda of bioethics at the international level.

Although the Universal Declaration con- stitutes a non-binding instrument in the eyes of international law, its value and its strength are in no way diminished. For the first time in the history of bioethics, all States in the interna- tional community are solemnly committed to respect and to implement the basic principles of bioethics, set forth within a single text. The Universal Declaration helps put bioethics on the agenda of States. Furthermore, the elaboration process of the Universal Declaration, character- ized by the transparency and the active partici- pation of all the actors concerned, and involving extensive consultations, has already largely contributed to the visibility and general accep- tance of the text. The innovative dimension of the Declaration is that it constitutes, for the first time, a commitment of governments to a set of bioethical principles. Previous international declarations, although sometimes very influen- tial, such as the Helsinki Declaration, were adopted by professional organizations (such as the World Medical Association).

The timetable set out for the elaboration of the Declaration planned a first year devoted to the drafting work of the International Bioethics Committee of UNESCO (IBC)Fa UNESCO advisory committee composed of independent expertsFand a second year devoted to intergovernmental negotiations on the basis of the text drawn up by the IBC. Nevertheless, broad consultations, hearings and conferences were carried out world wide throughout the process of elaboration in order to associate States, other specialized agencies of the United Nations system and other intergovernmental 746Documents rUNESCO 2005. organizations, non-governmental organizations voicing in particular vulnerable persons and groups, relevant national bodies and specialists.

By means of the web site which made it possible to post regularly, and thereby make public, the results of each meeting or consultation held, all were free to present their views, remarks and comments to IBC on the different versions of the text. Thus, from the very beginning of the elaboration process, the Universal Declaration has promoted general recognition of bioethical concerns and has stimulated the bioethics debate in the four corners of the world, involving and nourishing intercultural dialogue on these issues.

The Universal Declaration on Bioethics and Human Rights should be seen therefore not as the fruit of the reflection of just a few but as the result of a long and sustained common effort in which all actors have been involved.

Henk ten Have Director Division of Ethics of Science and Technology Sector for Social and Human Sciences UNESCO Further information on the Universal Declaration and on the process of its elabora- tion can be found on Internet at the following address: www.unesco.org/bioethics. The Edi- tor encourages comment on the Declaration and on the social science implications of bioethics and bioethical standard-setting.

Relevant contributions will be considered for publication in the Debate section of the forthcoming issues.

Universal Declaration on Bioethics and Human Rights n The General Conference Consciousof 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 co- operation and to exhibit the moral sense that gives expression to ethical principles, Reflectingon 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, Recognizingthat 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, Resolvingthat 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 dilem- mas and controversies that science and technology present for humankind and for the environment, Recallingthe Universal Declaration of Hu- man 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, Notingthe 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 Dis- crimination 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 Genera- tions 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 Re- sources for Food and Agriculture which was adopted by the FAO Conference on 3 November The Universal Declaration on Bioethics and Human Rights747 rUNESCO 2005. 2001 and entered into force on 29 June 2004, the Agreement on Trade-Related Aspects of Intel- lectual 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 interna- tional 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 Organi- zation (WHO), Also notinginternational and regional in- struments 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: Con- vention 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, 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, Recognizingthat this Declaration is to be understood in a manner consistent with domes- tic and international law in conformity with human rights law, Recallingthe Constitution of UNESCO adopted on 16 November 1945, ConsideringUNESCO’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 HumanGenome 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, Awarethat 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, Recognizingthat, 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 indivi- duals, 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, Recognizingthat health does not depend solely on scientific and technological research developments but also on psychosocial and cultural factors, Also recognizingthat 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 mindthat cultural diversity, as a source of exchange, innovation and creativity, is necessary for humankind and, in this sense, is the common heritage of humanity, butempha- sizingthat it may not be invoked at the expense of human rights and fundamental freedoms, Also bearing in mindthat a person’s identity includes biological, psychological, social, cultur- al and spiritual dimensions, Recognizingthat 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, Consideringthe desirability of developing new approaches to social responsibility to ensure that progress in science and technology con- tributes to justice, equity and to the interest of humanity, 748Documents rUNESCO 2005. Recognizingthat an important way to evaluate social realities and achieve equity is to pay attention to the position of women, Stressingthe 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, Consideringthat all human beings, without distinction, should benefit from the same high ethical standards in medicine and life science research, Proclaimsthe principles that follow and adoptsthe present Declaration. General Provisions Article 1 – Scope a) This Declaration addresses ethical issues related to medicine, life sciences and asso- ciated 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 indivi- duals, groups, communities, institutions and corporations, public and private.

Article 2 – Aims The aims of this Declaration are:

(i) to provide a universal framework of princi- ples 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 corpora- tions, public and private; (iii) to promote respect for human dignity and protect human rights, by ensuring respect for the life of human beings, and funda- mental freedoms, consistent with interna- tional human rights law; (iv) to recognize the importance of freedom of scientific research and the benefits derived from scientific and technological develop- ments, while stressing the need that such research and developments occur withinthe framework of ethical principles set out in this Declaration and that they respect human dignity, human rights and funda- mental 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 biodiver- sity and its conservation as a common concern of humankind. Principles Within the scope of this Declaration, in deci- sions 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 funda- mental 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 – Bene t 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 The Universal Declaration on Bioethics and Human Rights749 rUNESCO 2005. 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 with- drawn 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 infor- mation should be adequate, provided in a comprehensible form and should include the modalities for withdrawal of consent. Con- sent may be withdrawn by the person concerned at any time and for any reason without any disadvantage or prejudice. Ex- ceptions to this principle should be made only in accordance with ethical and legal stan- dards 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 representa- tives 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 sub- stitute for an individual’s informed consent.

Article 7 – Persons without the capacity to consent In accordance with domestic law, special protec- tion is to be given to persons who do not have the capacity to consent:

a) authorization for research and medical prac- tice 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 tothe 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 under- taken 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 con dentiality 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 interna- tional 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. 750Documents rUNESCO 2005. 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 interna- tional cooperation towards that end are to be encouraged.

Article 14 – Social responsibility and health 1. The promotion of health and social develop- ment 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, 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; (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; and (e) reduction of poverty and illiteracy. Article 15 – Sharing of bene ts 1. Benefits resulting from any scientific research and its applications should be shared with society as a whole and within the interna- tional community, in particular with devel- oping 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 re- search; (d) support for health services; (e) access to scientific and technological knowl- edge; (f) capacity-building facilities for research pur- poses; and (g) other forms of benefit consistent with the principles set out in this Declaration.

2. Benefits should not constitute improper induce- ments 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. The Universal Declaration on Bioethics and Human Rights751 rUNESCO 2005. Application of the Principles Article 18 – Decision-making and addressing bioethical issues 1. Professionalism, honesty, integrity and trans- parency in decision-making should be pro- moted, 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, pro- moted 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 develop- ments, formulate recommendations and contribute to the preparation of guidelines on issues within the scope of this Declara- tion; and (d) foster debate, education, and public aware- ness of, and engagement in, bioethics.

Article 20 – Risk assessment and management Appropriate assessment and adequate manage- ment 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 transnationalactivities should endeavour to ensure that any activity within the scope of this Declara- tion, undertaken, funded or otherwise pur- sued 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 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, illicit traffic in organs, tissues and 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 effectto the principles set out in this Declaration in accordance with interna- tional 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 752Documents rUNESCO 2005. 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 dissemina- tion of scientific information and encourage the free flow and sharing of scientific and technological knowledge.

2. Within the framework of international co- operation, States should promote cultural and scientific cooperation and enter into bi- lateral and multilateral agreements enabling developing countries to build up their capa- city 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 indivi- duals, families, groups and communities, with special regard for those rendered vulner- able 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 BioethicsCommittee (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 protec- tion 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. Note nAdopted by acclamation on 19 October 2005 by the 33 rdsession of the General Conference of UNESCO. The Universal Declaration on Bioethics and Human Rights753 rUNESCO 2005.