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.