Federal Advisory Committee To Consider Embryos ‘Human Subjects’ in Research

The Bush administration has directed a federal advisory committee that addresses the safety of human medical research subjects to consider embryos "'human subjects' whose welfare should be considered along with that of fetuses, children and adults," the Washington Post reports. The National Human Research Protections Advisory Committee, created under the Clinton administration, was "allowed to expire" last month after HHS officials said that they wanted to broaden the scope of the committee. The panel was officially "reincarnated" on Oct. 1 as the Secretary's Advisory Committee on Human Research Protections. Its new charter states that the committee "will provide [to HHS] advice relating to the responsible conduct of research involving human subjects with particular emphasis on ... pregnant women, embryos and fetuses." Arthur Lawrence, deputy assistant secretary for health operations at HHS and assistant surgeon general, said that the directive to the advisory committee mainly aims to address the safety of pregnant women in research trials. Lawrence added that the word "embryos" was included in the charter because some research might harm a developing fetus and "some people use the two words [embryo and fetus] interchangeably." The administration's directive does not immediately require that embryos be granted the same protections as fetuses, children and adults in medical trials; the committee is tasked only with making recommendations to HHS on how to provide such safeguards. According to the Post, HHS would have to issue a regulation or encourage legislation explicitly outlining protections for embryos if the department wished to implement specific safeguards. Some experts have noted that although the committee will include embryos in its analyses, it may not recommend any changes to experiments involving embryos.

Experts in the field said that stricter rules regarding studies involving embryos could have a negative effect on both medical research and fertility treatments. Tighter rules could require researchers working with embryos to obtain approval from review boards that currently do not have to address such studies, and some researchers have speculated that the rules might forbid medical experiments that do "not promise a direct benefit to the embryo itself," the Post reports (Weiss, Washington Post, 10/30). In addition, although the committee's directive does not apply directly to privately funded research, an HHS official said that the changes could affect some private research conducted on medicines or medical devices that are under consideration for FDA approval (Zitner, Los Angeles Times, 10/30).