Beginning with the inhumane research described at Nuremberg, there has been increasing sensitivity to the importance of ethical oversight of research when human subjects are involved. The Declaration of Helsinki was formulated by the World Medical Association in 1964 (and subsequently revised several times) to guide physicians in their roles in such research. The Council of International Organizations for Medical Sciences (CIOMS) developed International Ethical Guidelines for Research Involving Human Subjects in 1982, revised in 1992, and now being revised again, in support of the Helsinki Declaration. These, and other guidelines, provide explicit ethical principles and procedures for those planning, carrying out and reviewing such research. However, there has remained limited guidance for the setting up and functioning of the ethics committees that would actually carry out the review process. In response to this need, WHO’s Program for Tropical Diseases Research (TDR), in collaboration with CIOMS, has brought together researchers, ethicists and policy makers from around the world, most recently in Bangkok, to formulate Operational Guidelines for Ethics Committees That Review Biomedical Research. These Operational Guidelines provide detailed instructions on how to constitute such committees, the requirements they should apply to researchers, and the elements of the review process. Plans are now underway for reaching out to country levels to help in the building of capacities for establishing and managing ethical review committees.
Learning Objectives: To appreciate the challenges to those involved in research ethics to help in building the capacities of developing countries for establishing ethics committees for reviewing biomedical research
Keywords: Ethics, Research Ethics
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: The Council of International Organizations for Medical Sciences, an NGO founded by WHO and UNESCO and located at WHO Geneva
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.