Universal Declaration on Bioethics and Human Rights

UNESCO Declaration stating that "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"

 file of unspecified type  by UNESCO

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Subjects: vaccine, gene technology, medical ethics, human rights, UNESCO, bioethics
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Universal Declaration on Bioethics and Human Rights

Article 1 Scope

1.This Declaration addresses ethical issues related to medicine, life sciences andassociated technologies as applied to human beings, taking into account theirsocial, legal and environmental dimensions.

2.This Declaration is addressed to States. As appropriate and relevant, it alsoprovides 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

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 agreementsenabling 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 beby 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 Sector1, rue Miollis - 75732 Paris Cedex 15 - Francewww.unesco.org/shs/ethicsSHS/EST/BIO/06/1© UNESCO, 2006

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