/humansubjects/guidance/ documents

Withdrawal of Interim NIH guidelines for the Support and Conduct of Therapeutic Human Fetal Tissue Transplantation Research in Light of Superseding Provisions of Public Law 103-43, the National Institutes of Health Revitalization Act of 1993

AGENCY: National Institute of Health, PHS, HHS.

ACTION: Notice of new statutory requirements and of withdrawal of interim guidelines.

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SUMMARY: The National Institute 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 Public Law 103-43, the National Institutes of Health Revitalization Act of 1993. A summary of pertinent provisions of the Act is provided below.

ADDRESSES: Written comments should be mailed to F. William Dommel, Jr., J.D., Senior Policy Advisor, Office for Protection from Research Risks, NIH, Building 31, room 5B63, 9000 Rockville Pike, Bethesda, Maryland 20892, 301-496-7005, or delivered to the same location between 9 a.m. and 5 p.m. on weekdays, Federal holidays excepted. Comments received may be inspected at the same location during these hours.

FOR FURTHER INFORMATION CONTACT: Mr. F. William Dommel, Jr., 301-496-7005.

SUPPLEMENTARY INFORMATION:

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 Public Law 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 Public Law 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:

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.
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.
The Secretary of Health and Human Services may conduct or support research on the transplantation of human fetal tissue for therapeutic purposes.
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.
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 requiring 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.
The individual with the principal responsibility for conducting the research must sign a statement declaring that the individual is aware of 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.
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].
Research involving the transplantation of human fetal tissue for therapeutic purpose 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 Public Law 103-43, the NIH Revitalization Act of 1993, are summarized as follows:

It shall be unlawful for any person to knowingly acquire, received, 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.)
It shall be unlawful for any person to solicit or knowingly acquire, received, 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 denotation 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.)
Any person who violates these provisions shall be: (1) Fined in accordance with title 18 Untied Sates 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).

Dated: August 23, 1993.
Ruth L. Kirschstein,
Acting Director, NIH.

[FR Doc. 93-20977 Filed 8-27-93; 8:45 am]
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