Oversight of Intramural Fetal Tissue Research - September 20, 2000

As holder of the NIH Multiple Project Assurance, the Deputy Director for Intramural Research is responsible for oversight of all human subjects research, including research that uses fetal tissue. This oversight covers all scientists at the NIH, whether they are working in NIH facilities or with collaborators outside of NIH. All intramural scientists are trained in the policies applying to human subjects research via computer-based training. Oversight of fetal tissue research is accomplished through these steps:

1. The Office of Human Subjects Research (OHSR) provides first-line advice and guidance to intramural investigators who are using or contemplate using fetal tissues. The DDIR directs such scientists to contact OHSR, which in turn directs them to submit their research plans to their Institutional Review Board (IRB). The IRB inspects the plans to assure that the investigator has appropriately considered the provisions governing acquisition and use of fetal tissue. (See attachment)

2. All intramural laboratories must provide annual reports on their research. The text of these reports is fully searchable electronically. As needed, the Office of Intramural Research and other administrators may search all reports for reference to human fetal tissue and then contact the investigators who are conducting this research to be sure they have addressed the provisions pertaining to fetal tissue.

3. The scientific directors, who provide immediate oversight of intramural research in each institute, have been alerted to the provisions governing acquisition and use of fetal tissue. They have been directed to discuss these with all principal investigators. They have worked to identify any scientists who use human fetal tissue in their research and to check that all fetal tissue acquisition and use is done in accordance with the legal requirements.

4. In their bi-annual Management Controls review, each scientific director will be asked to verify that he or she has addressed the provisions regarding fetal tissue acquisition and use for research in their intramural program, and to detail any potential problem areas.