NIH-Funded ResearchTherapeutic Human Fetal Tissue Transplantation Projects Meet Federal Requirements Gao ID: HEHS-97-61 March 10, 1997
Therapeutic human fetal tissue transplantation holds promise for treating a host of disease, such as juvenile diabetes and leukemia. Ongoing federally funded research is using fetal tissue from aborted fetuses to treat patients with Parkinson's disease. Ethical concerns have been raised, however, that some women might choose to abort their fetuses to treat family members or to supply fetal tissue for financial gain. In June 1993, legislation was enacted to address these concerns. The bill established guidelines under which federally funded therapeutic human fetal tissue transplantation research can take place. In general, GAO found that the requirements of the law are being complied with. The legislation's documentation requirements--pertaining to informed consent of donors and recipients and compliance statement made by institutions, researched, and attending physicians--were met. The Department of Health and Human Services did not submit required annual reports on the program's activities, although it did issue a combined report in January 1997 described activities from fiscal year 1993 onward. There have been no reported violations in the acquisition of human fetal tissue for use in transplantation, according to the National Institutes of Health and GAO.
GAO noted that: (1) in general, the requirements of the act are being complied with; (2) the act's documentation requirements, pertaining to informed consent of donors and "donees" (recipients) and compliance statements made by institutions, researchers, and attending physicians, were met; (3) the Department of Health and Human Services did not submit annual reports on the program's activities, however, as required by the act; (4) but the agency did submit a combined report describing the activities from fiscal years 1993 through 1995; and (5) there have been no reported violations in the acquisition of human fetal tissue for use in transplantation, according to NIH and GAO's verification efforts.