NOTE: THIS GUIDANCE DOCUMENT HAS BEEN REPLACED BY THE FOLLOWING OHRP GUIDANCE: "Fetal Tissue Transplantation" CLICK > [HTML Format] [PDF Format]; THE NEW GUIDANCE HAS BEEN UPDATED FOR FORMAT, AND REFERENCE TO THE NIH REPORT OF THE HUMAN FETAL TISSUE TRANSPLANTATION RESEARCH PANEL HAS BEEN REMOVED.
This letter is being forwarded to Institutional Officials and
Institutional Review Board (IRB) Chairs throughout the country.
Its purpose is to acquaint you with the current protection-of
human-subject requirements for research involving the transplantation
of human fetal tissue.
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On January 22, 1993, President Clinton issued a directive to
the Secretary of Health and Human Services ending a
five-year moratorium on Federal funding of therapeutic transplantation
research that uses human fetal tissue derived from induced abortions. In March 1993, NIH published interim
guidelines for research involving human fetal tissue transplantation. These guidelines were based on the recommendations
of the 1988 Human Fetal Tissue Transplantation Research Panel
and were designed to ensure that Federal funding of human fetal
tissue transplantation research would not encourage the choice
of abortion. On June 10, 1993, the NIH Revitalization Act of
1993 (Public Law 103-43) was enacted, and, because of the superseding
provisions regarding fetal tissue transplantation contained in
the law, the interim guidelines were withdrawn.
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To this end, your attention is directed to section 498A of the
Public Health Service Act (42 U.S.C. 289g-1) added by
P.L. 103-43. The provisions of this section, pertinent to the
protection of human subjects in research involving the
therapeutic transplantation of fetal tissue, are summarized in
the enclosed notice (Federal Register
58, August 30, 1993).
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If your institution is conducting or planning to conduct research
involving the therapeutic transplantation of human fetal tissue,
or, if your IRB is reviewing or planning to review such research,
your attention to the requirements outlined in this letter is essential.
Adherence to your OPRR-approved Human Subject Assurance of Compliance
requires that this new
legislative mandate be met; certification of IRB review and approval
in accord with that Assurance is your institution's
guarantee that you are abiding by and will continue to abide
by the statute.
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Public Law 103-43 makes specific reference to a 1988 report,
the Report of the Human Fetal Tissue Transplantation
Research Panel, and deems the report to provide guidance on the
ethical status of such research. This report may be an especially
useful aid to investigators and IRBs. It is available at no charge
by sending your name and address to OPRR (attn: Darlene M. Ross,
Education Program Coordinator for Human Subject Protections).
I urge your careful review of these requirements as they may
apply to your institution's and your IRB's actions and procedures.
If you have any questions as you carry out this task, please
contact OPRR's Senior Policy Advisor F. William Dommel, Jr.,
at 301-496-7005. |