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WHO Guideline TDR/PRD/Ethics/2000.1 – Ethics Committees
All international guidelines require the ethical and scientific review of biomedical research alongside informed consent and the appropriate protection of those unable to consent as essential measures to protect the individual person and the communities who participate in research. For the purposes of these Guidelines, biomedical research includes re-search on pharmaceuticals, medical devices, medical radiation and imaging, surgical procedures, medical records, and biological samples, as well as epidemiological, social, and psychological investigations.
These Guidelines are intended to facilitate and support ethical re-view in all countries around the world. They are based on a close examination of the requirements for ethical review as established in international guidelines, as well as on an evaluation of existing practices of ethical review in countries around the world. They do not, however, purport to replace the need for national and local guide-lines for the ethical review of biomedical research, nor do they in-tend to supersede national laws and regulations.
The majority of biomedical research has been predominantly motivated by concern for the benefit of already privileged communities. This is reflected by the fact that the WHO estimates that 90% of the resources devoted to research and development on medical problems are applied to diseases causing less than 10% of the present global suffering. The establishment of international guidelines that assist in strengthening the capacity for the ethical review of biomedical research in all countries contributes to redressing this imbalance.
1 OBJECTIVE
The objective of these Guidelines is to contribute to the development of quality and consistency in the ethical review of biomedical research. The Guidelines are intended to complement existing laws, regulations, and practices, and to serve as a basis upon which ethics committees (ECs) can develop their own specific written procedures for their functions in biomedical research. In this regard, the Guidelines establish an international standard for ensuring quality in ethical review. The Guidelines should be used by national and local bodies in developing, evaluating, and progressively re-fining standard operating procedures for the ethical review of biomedical research.
2 THE ROLE OF AN EC
The purpose of an EC in reviewing biomedical research is to con-tribute to safeguarding the dignity, rights, safety, and well-being of all actual or potential research participants. A cardinal principle of research involving human participants is ‘respect for the dignity of persons’. The goals of research, while important, should never be permitted to override the health, well-being, and care of research participants. ECs should also take into consideration the principle of justice. Justice requires that the benefits and burdens of research be distributed fairly among all groups and classes in society, taking into account age, gender, economic status, culture, and ethnic considerations.
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