Bioethics Commission Recommends American Institutional Review Board Oversee International Research

A "majority" of the National Bioethics Advisory Commission on Friday said that foreign studies sponsored by the U.S. government and academic institutions should be reviewed by both an American and an international review board to ensure that studies meet ethical guidelines, Reuters Health reports. The commission met last week to review draft guidelines that aim to ensure that participants in U.S.-sponsored overseas studies are "given the same protections" as those who participate in U.S.-based studies. The commission had earlier considered excluding the American institutional review board from the review process, a move that Public Citizen's Health Research Group warned would be a "step backwards in ensuring protection of research subjects around the globe." Commissioner Bernard Lo, director of the University of California-San Francisco medical ethics program, concurred that taking away the American review board "sort of sends the wrong message" (Reuters Health, 12/11). Recent efforts to safeguard ethics in international AIDS research include an amendment to the Declaration of Helsinki stating that clinical trials should test new treatments against the "best current" treatments, instead of using placebos (Kaiser Daily HIV/AIDS Report, 10/17). In addition, UNAIDS guidelines on international HIV vaccine research, released earlier this year, urge that "care and treatment should be provided, with the ideal being to provide the best proven therapy, and the minimum to provide the highest level of care attainable in the host country." Dr. Peter Piot, executive director of UNAIDS, said, "It is our collective responsibility to ensure that all vaccine trials are conducted under the strictest possible ethical and scientific standards" (Kaiser Daily HIV/AIDS Report, 2/29). National Bioethics Advisory Commission Executive Director Eric Meslin said that the final guidelines may be issued by January, and will be available at http://bioethics.gov (Reuters Health, 12/11).