Statute on Fetal Tissue Transplantation Research (1993)
PUBLIC LAW 103-43; JUNE 10, 1993
NATIONAL INSTITUTES OF HEALTH REVITALIZATION ACT OF 1993
TITLE I - GENERAL PROVISIONS REGARDING TITLE IV
of PUBLIC HEALTH SERVICE ACT
Subtitle A - Research Freedom
PART II - RESEARCH ON TRANSPLANTATION OF FETAL TISSUE
SEC. 111. ESTABLISHMENT OF AUTHORITIES.
Part G of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.)
is amended by inserting after section 498 the following section:
RESEARCH ON TRANSPLANTATION OF FETAL TISSUE SEC. 498A.
(a) ESTABLISHMENT OF PROGRAM-
(1) IN GENERAL - The Secretary may conduct or support research on the transplantation of human fetal tissue for therapeutic purposes.
(2) SOURCE OF TISSUE - Human fetal tissue may be used in research carried out under paragraph (1) regardless of whether the tissue is obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth.
(b) INFORMED CONSENT OF DONOR-
(1) IN GENERAL - In research carried out under subsection (a), human fetal tissue may be used only if the woman providing the tissue makes a statement, made in writing and signed by the woman, declaring that–
(A) the woman donates the fetal tissue for use in research described in subsection (a);
(B) the donation is made without any restriction regarding the identity of individuals who may be the recipients of transplantations of the tissue; and
(C) the woman has not been informed of the identity of any such individuals.
(2) ADDITIONAL STATEMENT - In research carried out under subsection (a), human fetal tissue may be used only if the attending physician with respect to obtaining the tissue from the woman involved makes a statement, made in writing and signed by the physician, declaring that–
(A) in the case of tissue obtained pursuant to an induced abortion–
(i) the consent of the woman for the abortion was obtained prior to requesting or obtaining consent for a donation of the tissue for use in such research;
(ii) no alteration of the timing, method, or procedures used to terminate the pregnancy was made solely for the purposes of obtaining the tissue; and
(iii) the abortion was performed in accordance with applicable State law;
(B) the tissue has been donated by the woman in accordance with paragraph (1); and
(C) full disclosure has been provided to the woman with regard to–
(i) such physician's interest, if any, in the research to be conducted with the tissue; and
(ii) any known medical risks to the woman or risks to her privacy that might be associated with the donation of the tissue and that are in addition to risks of such type that are associated with the woman's medical care.
(c) INFORMED CONSENT OF RESEARCHER AND DONEE - In research carried out under subsection (a), human fetal tissue may be used only if the individual with the principal responsibility for conducting the research involved makes a statement, made in writing and signed by the individual, declaring that the individual–
(1) is aware that
(A) the tissue is human fetal tissue;
(B) the tissue may have been obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth; and
(C) the tissue was donated for research purposes;
(2) has provided such information to other individuals with responsibilities regarding the research;
(3) will require, prior to obtaining the consent of an individual to be a recipient of a transplantation of the tissue, written acknowledgment of receipt of such information by such recipient; and
(4) 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.
(d) AVAILABILITY OF STATEMENTS FOR AUDIT-
(1) IN GENERAL - In research carried out under subsection (a), human fetal tissue may be used only if the head of the agency or other entity conducting the research involved certifies to the Secretary that the statements required under subsections (b)(2) and (c) will be available for audit by the Secretary.
(2) CONFIDENTIALITY OF AUDIT - Any audit conducted by the Secretary pursuant to paragraph (1) shall be conducted in a confidential manner to protect the privacy rights of the individuals and entities involved in such research, including such individuals and entities involved in the donation, transfer, receipt, or transplantation of human fetal tissue. With respect to any material or information obtained pursuant to such audit, the Secretary shall–
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