Oversight of Fetal Tissue Research

The Deputy Director for Intramural Research is responsible for oversight of all research that uses fetal tissue conducted by intramural scientists at the NIH, whether they are working in NIH facilities or with collaborators outside of NIH. All intramural scientists are informed of the policies and legal requirements applying to fetal tissue research. Oversight of fetal tissue research conducted by intramural investigators is summarized below.

NIH Office of Human Subjects Research Protections (OHSRP)

The Office of Human Subjects Research Protections (OHSRP) provides first-line advice and guidance to intramural investigators who are using or contemplate using fetal tissue. The DDIR directs that all experiments using human fetal tissue must be reviewed and approved either by OHSRP or an NIH IRB. See the Reminder for Intramural Investigators of Legal Requirements Regarding Acquisition and Use of Human Fetal Tissue for Research Purposes for additional information or the FAQs on the Policy and Procedures for Research Using Human Fetal Tissue in the IRP. If still unsure contact OHSRP directly (301-402-3444).

Annual Reports

Intramural investigators with NIH supported projects must file annual reports on their research. The text of these reports are available electronically, fully searchable and publicly accessible (http://intramural.nih.gov/search/index.taf). The Office of Intramural Research and the Scientific Directors of each Institute/Center directs investigators to specifically identify when human fetal tissue is used during the reporting period.

Scientific Directors

The Scientific Directors (SD), who provide immediate oversight of intramural research in each institute, are aware of the legal requirements governing acquisition and use of fetal tissue. They are directed to insure that all scientists who use human fetal tissue in their research assure fetal tissue is use and acquired in accordance with the legal requirements.

Management Controls

In the annual Management Controls review, each Scientific Director will be asked to verify that he or she has reviewed the legal requirements regarding fetal tissue acquisition and use for research in their intramural program, and to identify and correct any potential problem areas.