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President's Bioethics Commission Names International Panel to Review Whether U.S. Rules Protect Clinical Trial Participants in U.S., Abroad

March 3, 2011

"Prompted by concerns about an unethical U.S.-sponsored study in the 1940s," the Presidential Commission for the Study of Bioethical Issues on Tuesday announced the formation of an international panel "that will examine whether current rules adequately protect volunteers in global clinical trials," Science's "ScienceInsider" blog reports (Kaiser, 3/1).

"In the wake of revelations last October about U.S. Public Health Service-supported research on sexually transmitted diseases in Guatemala from 1946 to 1948, which involved the intentional infection of vulnerable human populations," President Barack Obama called on his advisers to form a panel to evaluate "the effectiveness of current U.S. rules and international standards for the protection of human subjects in scientific studies supported by the Federal Government and to assure him that 'the current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally,'" according to a Commission press release (3/1). Obama also asked the group to conduct a "thorough fact-finding investigation into the specifics of the U.S. Public Health Service Sexually Transmitted Diseases Inoculation Study," Nature's "The Great Beyond" blog reports (Wadman, 3/1).

The panel, comprising four members of the bioethics commission and 12 other experts from 10 countries, "will look at the 'adequacy' of standards 'across the field of international research today,'" Amy Gutmann, chair of the Presidential Commission for the Study of Bioethical Issues, said, "ScienceInsider" reports. The panel is charged with examining clinical trials funded by the U.S. government, though they "are free to move beyond that" and examine trials run by pharmaceutical companies or other entities, Gutmann said. A report is expected by the end of the year, according to "ScienceInsider" (3/1).

The president's request of the Commission is "highly relevant at a time when expense and red tape have driven U.S. clinical trials, including many funded by the NIH, increasingly offshore, often to poorer countries," the "The Great Beyond" reports (3/1). "Last year, the U.S. Department of Health and Human Services' inspector general reported that between 40 and 65 percent of clinical studies of federally regulated medical products were done in other countries in 2008, and that proportion probably has grown. The report also noted that U.S. regulators inspected fewer than 1 percent of foreign clinical trial sites," the Associated Press reports in a piece examining the history of medical testing first on prison inmates and minority groups in the U.S. and the growth of U.S.-run clinical studies abroad.

"Monitoring research is complicated, and rules that are too rigid could slow new drug development. But it's often hard to get information on international trials, sometimes because of missing records and a paucity of audits," Kevin Schulman, a Duke University professor of medicine who has written on international study ethics, said, according to the news service. Arthur Caplan, director of the University of Pennsylvania Center for Bioethics, Laura Stark, a Wesleyan University assistant professor of science in society, and a former inmate who was experimented on in a U.S. prison are quoted in the article (Stobbe, 2/28).

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