NIH INTERIM GUIDELINES FOR THE SUPPORT AND CONDUCT OF THERAPEUTIC HUMANFETAL TISSUE TRANSPLANTATION RESEARCH



NIH GUIDE, Volume 22, Number 11, March 19, 1993



P.T. 34



Keywords:

  Human Subjects Policy 

  Abortion (Induced) 

  Biological Resources 



National Institutes of Health



The National Institutes of Health (NIH), in implementing the directive

set forth in the following memorandum, announces interim guidelines for

the support and conduct of therapeutic human fetal tissue

transplantation research.



quote:



                           THE WHITE HOUSE

                             WASHINGTON



                          January 22, 1993



MEMORANDUM FOR THE SECRETARY OF HEALTH AND HUMAN SERVICES



SUBJECT:  Federal Funding of Fetal Tissue Transplantation Research



On March 22, 1988, the Assistant Secretary for Health of Health and

Human Services ("HHS") imposed a temporary moratorium on Federal

funding of research involving transplantation of fetal tissue from

induced abortions.  Contrary to the recommendations of a National

Institutes of Health advisory panel, on November 2, 1989, the Secretary

of Health and Human Services extended the moratorium indefinitely.

This moratorium has significantly hampered the development of possible

treatments for individuals afflicted with serious diseases and

disorders, such as Parkinson's disease, Alzheimer's disease, diabetes,

and leukemia.  Accordingly, I hereby direct that you immediately lift

the moratorium.



You are hereby authorized and directed to publish this memorandum in

the Federal Register.



                              (signed)

                         William J. Clinton

endquote



On February 1, 1993, the Secretary of Health and Human Services carried

out the President's directive ending the moratorium.  The Secretary

further directed the NIH to develop interim guidelines, based on the

recommendations of the 1988 Human Fetal Tissue Transplantation Research

Panel, to ensure that Federal funding of therapeutic human fetal tissue

transplantation research does not encourage the choice of abortion.

Accordingly, the National Institutes of Health has developed the

following interim policy guidance to ensure that therapeutic human

fetal tissue transplantation research projects supported or conducted

by the NIH are carried out in accordance with the guidance provided by

the Human Fetal Tissue Transplantation Research Panel and the Advisory

Committee to the Director.  Relevant citations of Federal regulations

governing the protection of human subjects in research (45 CFR 46) are

in parentheses.



INTERIM GUIDELINES FOR THE CONDUCT OF THERAPEUTIC HUMAN FETAL TISSUE

TRANSPLANTATION RESEARCH



Separating Abortion from Research.



o  The decision to terminate a pregnancy and the abortion procedures

should be kept independent from the retrieval and use of fetal tissue.

(45 CFR 46 Subpart B)



o  The timing and method of abortion should not be influenced by the

potential uses of fetal tissue for transplantation or medical research.

(45 CFR 46 Subpart B)



Prohibiting Payments and Other Inducements.



o  Payments and any other forms of remuneration, compensation or

benefit associated with the procurement of fetal tissue should be

prohibited, except payment for reasonable expenses occasioned by the

actual retrieval, storage, preparation, and transportation of the

tissues.  (45 CFR 46 Subpart B;  Also addressed in the National Organ

Transplant Act).



Informed Consent.



o  Potential recipients of such tissues, as well as research and health

care participants, should be properly informed about the source of the

tissues in question.



o  The decision and consent to abort must precede discussion of the

possible use of the fetal tissue and any request for such consent that

might be required for that use.



o  Fetal tissue from induced abortions should not be used in medical

research without the prior consent of the pregnant woman.  Her decision

to donate fetal material is sufficient for the use of tissue, unless

the father objects (except in the cases of incest or rape).  (Uniform

Anatomical Gift Act; also 45 CFR 46 Subparts A and B contain general

requirements for informed consent, which may be relevant)



o  Consent should be obtained in compliance with State law and with the

Uniform Anatomical Gift Act. (45 CFR 46 Subpart B)



Prohibiting Directed Donations.



o  The pregnant woman should be prohibited from designating the

transplant-recipient of the fetal tissue.



o  Anonymity between donor and recipient should be maintained, so that

the donor does not know who will receive the tissue, and the identity

of the donor is concealed from the recipient and transplant team.



o Experimental transplants performed with fetal tissue from induced

abortions provided by a family member, friend or acquaintance should be

prohibited.



Abiding by State Laws.



o  Researchers in States with statutes appearing to ban fetal tissue

transplants should seek clarification of the law. (45 CFR 46 Subpart B,

which also requires adherence to local laws)



Ethical Review of Research.



o  Customary review procedures should apply to research involving

transplantation of tissue from induced abortions. (45 CFR 46)



Determining When Progress to Clinical Studies Is Justified.



o  Sufficient evidence from animal experimentation is needed to justify

proceeding to human clinical trials.  Acceptable preliminary data must

be presented to an appropriate Institutional Review Board, NIH Initial

Review Group, and National Advisory Council before Public Health

Service funds would be available. (45 CFR 46 and current peer review

process)



DEVELOPMENT OF FINAL GUIDELINES



The NIH is beginning to develop formal guidelines for this area of

research.  Until final guidelines are issued, the provisions outlined

above will constitute the NIH's interim policy guidance for the support

and conduct of therapeutic human fetal tissue transplantation research.

Comments on this interim policy will be considered in the preparation

of the final guidelines.  This interim policy will be published in the

Federal Register in the near future with a request for public comment.

If the NIH reauthorization legislation now pending before Congress is

enacted in its present form, additions to this interim policy would be

necessary.



INQUIRIES



Comments and questions about the interim guidelines may be directed to:



F. William Dommel, Jr., J.D.

Senior Policy Advisor

Office for Protection from Research Risks

Building 31, Room 5B59

Bethesda, MD  20892

Telephone:  (301) 496-7005



.

Return to 1993 Index

Return to NIH Guide Main Index

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)