Global inequities in access to health care, combined with a substantial increase in biomedical research conducted in resource-poor settings, have created a situation where the potential for exploitation of human research subjects is a real concern. As a result, since May 2000, four major bioethics documents have been or will soon be released that specifically address the conduct of biomedical research in developing country settings with sponsorship by industrialized countries. The documents were written by (1) UNAIDS (Ethical Considerations in HIV Preventive Vaccine Research, May 2000), (2) World Medical Association (Declaration of Helsinki, revised October 2000), (3) U.S. National Bioethics Advisory Commission (Ethical and Policy Issues in International Research, anticipated release date April 2001), and (4) Council for International Organizations of Medical Sciences (International Ethical Guidelines for Biomedical Research Involving Human Subjects, revisions in progress). A direct comparison of the specific guidance provided by each document highlights several areas where universalist and relativist perspectives clash. First, there is a lack of consensus with regard to the appropriate use of placebos in clinical trials. Second, researcher obligations with regard to overall provision of care are differentially described. Third, the extent to which researchers and sponsors are considered obligated to insure participant, local community, and host country benefits is highly variable. Each of these issues highlights areas where the goals of public health research may differ from those of clinical research, suggesting that additional public discussion of the ethical implications of those differing goals is urgently needed.
Learning Objectives: 1. List four recent ethics documents that offer guidance for conducting research in developing countries. 2. Recognize areas where the goals of public health research may differ from those of clinical research. 3. Discuss the ethical implications of the differing goals of public health and clinical research.
Keywords: Policy/Policy Development, Research Ethics
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: (1) UNAIDS; (2) National Bioethics Advisory Commission (NBAC); (3) Council for International Organizations of Medical Sciences (CIOMS); (4) World Medical Association (WMA)
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.