NIH-Funded Research:

Therapeutic Human Fetal Tissue Transplantation Projects Meet Federal Requirements

HEHS-97-61: Published: Mar 10, 1997. Publicly Released: Mar 10, 1997.

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Pursuant to a legislative requirement, GAO reviewed the fetal tissue transplantation research funded by the National Institutes of Health (NIH) under the NIH Revitalization Act, focusing on: (1) compliance with informed consent and other documentation; and (2) any violations occurring in the acquisition of human fetal tissue for use in transplantation.

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.

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