WASHINGTON -- The Bush administration has revised the charter of a federal advisory committee concerned with the safety of research volunteers to specify that embryos and fetuses in experiments are "human subjects" whose welfare deserves special attention.
The change does not give embryos used in research any particular protections or have any direct impact on federal policy. But it is another indication that the administration considers embryos and fetuses to have special rights.
The committee, whose members have yet to be appointed, will offer recommendations to the Health and Human Services Department. The agency would have to propose regulations or encourage legislation if it wanted to put new protections in place.
The change was made to recognize that certain populations are particularly vulnerable in today's research, said Arthur J. Lawrence, deputy assistant secretary for health operations, who oversaw the rewriting of the charter. He noted that more women are being included in research studies, and some of them are likely to be pregnant.
The charter now directs the committee to provide advice concerning "research involving human subjects" including "pregnant women, embryos and fetuses."
"It's very important to focus in on the risks to women who are pregnant and their embryos and fetuses," Lawrence said Wednesday. "It was the intent of the revision of the charter to insert specifically within the charter the populations that needed to get special consideration."
Other groups mentioned in the charter include newborns, children, prisoners and the "decisionally impaired," meaning those unable to give informed consent.
The reference to embryos could apply to research using embryos left over from in vitro fertilization treatments or to those cloned for research.
Government guidelines only apply to research that is federally funded and none of this research currently qualifies, noted Rebecca Dresser, an expert on human subject protections who teaches law and medicine at Washington University in St. Louis.
Despite the restrictions, scientists increasingly are turning to embryos to help understand birth defects and infertility, and as a source of embryonic stem cells, which researchers hope to turn into therapies for a variety of degenerative diseases.
Dresser said that if the directive applied simply to embryos developing inside pregnant women, that would not be a departure from current thinking on research protections.
HHS spokesman Bill Pierce said that there is no significance to specifically extending the charter to cover fetuses and embryos.