The CIOMS International Ethical Guidelines for Research Involving Human Subjects were formulated in 1982 and revised in 1993. Their purpose is to deepen understanding of how fundamental ethical principles guide the conduct of biomedical research involving human subjects. The Guidelines are used and cited widely around the world. However, there are indications of need for revision, prompted in part by the controversial ethical issues arising out of large-scale vaccine and drug trials, and transnational research involving members of so-called vulnerable groups. Accordingly, CIOMS, in collaboration with WHO and UNAIDS, held a consultation in March, 2000 to consider draft revisions. The consultation included formal presentations by leading ethicists and researchers on subjects pertinent to new questions that are arising, and included commentary by leading ethicists and other scholars, mainly from the developing world. The subjects included: reproductive technology; research in human genetics; randomized clinical trials; global aspects of justice; human rights and their proper role in international codes of research ethics; anthropological perspectives including language and communications; and capacity building in the field of research ethics in developing countries. The outcome of the consultation was a further draft to be circulated widely before it is finalized, approved, and issued. This presentation will review the conceptual history of this project, summarize its philosophical aspects, and report on their status as of the time of the APHA meeting.
Learning Objectives: To appreciate the changes underway in the field of ethics related to research. Here, international ethical guidelines, which have been long established and respected, are being revised because of changes underway in the fields of ethics and research
Keywords: Research Ethics, Developing Countries
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
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.