WITHDRAWAL OF INTERIM NIH GUIDELINES FOR THE SUPPORT AND CONDUCT OFTHERAPEUTIC HUMAN FETAL TISSUE TRANSPLANTATION RESEARCH IN LIGHT OF

SUPERSEDING PROVISIONS OF PUBLIC LAW 103-43, THE NATIONAL INSTITUTES OF

HEALTH REVITALIZATION ACT OF 1993



NIH GUIDE, Volume 22, Number 32, September 3, 1993



P.T. 34



Keywords:

  Human Subjects Policy 

  Abortion (Induced) 

  Biological Resources 



National Institutes of Health



SUMMARY:  The National Institutes of Health (NIH) is announcing the

withdrawal of its interim guidelines for the support and conduct of

therapeutic human fetal tissue transplantation research because of the

superseding provisions of P.L. 103-43, the National Institutes of

Health Revitalization Act of 1993.  A  summary of pertinent provisions

of the Act is provided below.



Background



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.  Secretary of Health and

Human Services Donna E. Shalala notified the National Institutes of

Health (NIH) of the President's action, and then formally revoked the

moratorium on February 1, 1993.  At the same time, the Secretary,

through the Acting Assistant Secretary for Health, 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 human fetal tissue transplantation research does not

encourage the choice of abortion.  Accordingly, the NIH prepared, and

transmitted to the Acting Assistant Secretary for Health, interim

policy guidelines based on the recommendations of the 1988 Human Fetal

Tissue Transplantation Research Panel and the Advisory Committee to the

Director, NIH.  Those interim guidelines were published in the NIH

Guide for Grants and Contracts on March 19, 1993 (Vol. 22, No. 11).



Action



The NIH Interim Guidelines for the Support and Conduct of Therapeutic

Human Fetal Tissue Transplantation Research are hereby withdrawn in

light of the comprehensive and superseding provisions of P.L. 103-43,

enacted June 10, 1993.  Final guidelines will not be issued.



Additional Information



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 NIH Revitalization Act of

1993.  The provisions of that section pertinent to research on

transplantation of fetal tissue are summarized as follows:



o  Human fetal tissue means tissue or cells obtained from a dead human

embryo or fetus after a spontaneous or induced abortion, or after a

stillbirth.



o  Human fetal tissue may be used regardless of whether the tissue is

obtained pursuant to a spontaneous or induced abortion or pursuant to

a stillbirth.



o  The Secretary of Health and Human Services may conduct or support

research on the transplantation of human fetal tissue for therapeutic

purposes.



o  The woman donating the human fetal tissue must sign a statement

declaring that the tissue is being donated for therapeutic

transplantation research, the donation is being made without any

restriction regarding the identity of individuals who may be the

recipients of transplantations of the tissue, and the donation is being

made without her (the donor) having been informed of the identity of

those individuals who may be the recipients.



o  The attending physician must sign a statement declaring that the

tissue has been obtained in accord with the donor's signed statement

and that full disclosure has been made to the donating woman of (1) the

attending physician's interest, if any, in the research to be conducted

with the tissue, and (2) any known medical risks to the donor or risks

to her privacy that might be associated with the donation of the tissue

and are in addition to the risks associated with the woman's medical

care.  In the case of tissue obtained pursuant to an induced abortion,

the attending physician's statement must also declare that the consent

of the woman for the abortion was obtained prior to requesting or

obtaining consent for donation, the abortion was conducted in accord

with applicable State Law, and no alteration of the timing, method, or

procedures used to terminate the pregnancy was made solely for the

purposes of obtaining the tissue.



o  The individual with the principal responsibility for conducting the

research must sign a statement declaring that the individual is aware

that the tissue is human fetal tissue donated for research purposes and

may have been obtained pursuant to a spontaneous or induced abortion or

pursuant to a stillbirth; that the principally responsible researcher

has provided such information to other individuals with

responsibilities regarding the research; that the principally

responsible researcher will require, prior to obtaining the consent of

a person to be a recipient of a transplantation of the tissue, written

acknowledgment of receipt of the foregoing information by such

recipient; and that the principally responsible researcher has had no

part in any decisions as to the timing, method, or procedures used to

terminate the pregnancy made solely for the purposes of the research.



o  Human fetal tissue may be used only if the head of the agency or

other entity conducting the research involved certifies to the

Secretary of Health and Human Services that the statements required

herein will be available for audit by the Secretary [HHS].



o  Research involving the transplantation of human fetal tissue for

therapeutic purposes must be conducted in accord with applicable State

law and the Secretary may not provide support for such research unless

the applicant for assistance agrees to so conduct the research.  The

conduct of such research by the Secretary must be in accord with

applicable State and local law.



The provisions of section 498B of the Public Health Service Act (42

U.S.C 289g-2), added by P.L. 103-43, the NIH Revitalization Act of

1993, are summarized as follows:



o  It shall be unlawful for any person to knowingly acquire, receive,

or otherwise transfer any human fetal tissue for valuable consideration

if the transfer affects interstate commerce.  (Valuable consideration

does not include reasonable payments associated with the

transportation, implantation, processing, preservation, quality

control, or storage of human fetal tissue.)



o  It shall be unlawful for any person to solicit or knowingly acquire,

receive, or accept a donation of human fetal tissue for the purpose of

transplantation of such tissue into another person if the donation

affects interstate commerce, the tissue will be or is obtained pursuant

to an induced abortion, and (1) the donation will be or is made

pursuant to a promise to the donating individual that the donated

tissue will be transplanted into a recipient specified by such

individual; (2) the donated tissue will be transplanted into a relative

of the donating individual; or (3) the person who solicits or knowingly

acquires, receives, or accepts the donation has provided valuable

consideration for the costs associated with such abortion.  (Valuable

consideration does not include reasonable payments associated with the

transportation, implantation, processing, preservation, quality

control, or storage of human fetal tissue.)



o  Any person who violates these provisions shall be (1) fined in

accordance with Title 18 United States Code, except that the fine shall

be not less than twice the amount of any valuable consideration

received, (2) imprisoned for not more than 10 years, or (3) penalized

as described in both (1) and (2).



INQUIRIES



Written comments may be mailed or delivered (between 9 a.m. and 5 p.m.

weekdays).  Comments received may be inspected at the same location

during these hours.



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

Senior Policy Advisor

Office for Protection from Research Risks

Building 31, Room 5B63

Bethesda, MD  20892

Telephone:  (301) 496-7005



.

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