HHS Creates New Department to Oversee Foreign Clinical Trials

The Department of Health and Human Services announced yesterday the creation of a new office that will oversee U.S.-funded medical research in foreign countries and address the ethical concerns such studies raise, the Washington Post reports. The Office of International Activities was created "to make sure [foreign research] is not exploitative ... that it leaves something of value behind," E. Greg Koski, director of the HHS Office for Human Research Protections, said. Koski's office has no authority over studies being carried out by private companies, but is charged with enforcing "human subject protections" in federally funded trials. The new office will "tackle" issues such as those raised in a December Post series, "The Body Hunters," which profiled "risky and exploitative" medical research carried out by U.S. companies and institutions in developing countries such as Thailand, where HIV-positive pregnant women participating in a clinical trial did not receive drugs known to prevent vertical transmission to their fetuses, and 59 infants were born HIV-positive. The Post series also "sparked concern" in Congress, where Rep. Sherrod Brown (D-Ohio), a ranking member of the House health subcommittee, yesterday called for hearings on how to "protect foreign test subjects." Sen. Edward Kennedy (Mass.), the senior Democrat on the Senate health committee, echoed Brown's concern, calling for similar evaluation. In addition to the new office, Koski also has suggested the creation of independent "specialized ethics panels," consisting of members of the international research community and the host country, to review proposals for research abroad that involve "vulnerable foreign populations." Currently, an institution "must conduct its own ethics review" prior to undertaking any taxpayer-supported human research in the United States or abroad. The National Bioethics Advisory Commission has been drafting ethical guidelines on foreign trials "for months," with special attention on whether foreign subjects in developing nations should be considered "vulnerable populations" that need "added protections such as those afforded children or mentally disabled patients" (Nelson/Flaherty, Washington Post, 1/24).