The National Bioethics Advisory Commission: Contributing to Public Policy

Over the past ten years or more, there has been a significant increase in the amount of clinical research that the United States conducts or sponsors in other countries, particularly in developing countries. As the pace and scope of international research have increased, adequate protection of the rights and welfare of individuals who participate in clinical trials has emerged as a critical issue in international research ethics.

This issue came to light in 1997 when controversy arose over a series of clinical trials conducted in Africa, Asia, and the Caribbean that were aimed at finding a less-complicated, less-expensive, and shorter treatment regimen to lower the rate of maternal-to-infant transmission of HIV in developing countries (Angell, 1997; Lurie and Wolfe, 1997). The concern with these trials was that participants in the control group were given a placebo instead of the existing effective treatment (continuously administered AZT, generic name zidovudine or ZDV, a class of anti-HIV drugs) and were being treated differently than control groups in developed countries where it would be considered unethical to withhold an effective treatment.

In addition, several international efforts were underway in recent years to revise and develop guidelines on the ethical conduct of international research. These efforts included revisions of the World Medical Association's Declaration of Helsinki, the WHO's Operational Guidelines for Ethics Committees That Review Biomedical Research, and the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects.

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