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A world of research subjects.

In recent years, concerns about research with the decisionally impaired and children, genetic research involving identifiable communities and stored tissues, and the quality of the IRB review process and subjects' informed consent have all compelled reappraisal of both the fundamental ethical norms and the guiding documents of human subjects research, including the Declaration of Helsinki, the Belmont Report, and the "Common Rule." Controversy surrounding American-sponsored trials to prevent maternal-fetal transmission of HIV infection in Asian and African developing countries has emphasized the frequently neglected area of justice. The controversy is not about the universality or relativity of ethical norms. It is about the interpretation or conception of justice, including the obligations imposed by the principles of international distributive justice, that is appropriate for the protection of human subjects. By focusing on the role of justice, reflection on international biomedical research should illuminate more general ethical challenges of research that entail trade-offs of efficacy and cost savings even in developed countries. "Best Proven" Therapy The second section of the Declaration of Helsinki states that "[i]n any medical study, every patient--including those of a Control group, if any--should be assured of the best proven diagnostic and therapeutic method."[1] Part of the current controversy surrounding the maternal-fetal HIV transmission studies is whether "best proven" therapy refers to the best available in the sponsoring nation, such as the United States, or the best available in the country where the research is being conducted. Critics charge, in essence, that because the NIH- and CDC-sponsored trials did not provide control groups with the most effective therapy available in developed countries they were unethical. "Reasonable Availability" Guideline 8 of the CIOMS International Guidelines for Biomedical Research Involving Human Subjects states that "[a]s a general rule, the sponsoring agency should ensure that, at the completion of successful testing, any product developed will be made reasonably available to inhabitants of the underdeveloped community in which the research was carried out." If the people in a developing country assume risks by participating in biomedical research, but cannot afford the drugs, vaccines, and other biomedical products when they become available, then they may be exploited for the benefit of people in the developed countries that sponsored the research. …