Page:United States Statutes at Large Volume 107 Part 1.djvu/156

 107 STAT. 130 PUBLIC LAW 103-43—JUNE 10, 1993 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— "(A) use such material or information only for the purposes of verifying compliance with the requirements of this section; "(B) not disclose or publish such material or information, except where required by Federal law, in which case such material or information shall be coded in a manner such that the identities of such individuals and entities are protected; and "(C) not maintain such material or information after completion of such audit, except where necessary for the purposes of such audit. " (e) APPLICABILITY OF STATE AND LOCAL LAW.— " (1) RESEARCH CONDUCTED BY RECIPIENTS OF ASSISTANCE,— The Secretary may not provide support for reseeirch under subsection (a) luiless the applicsint for the financial assistance involved agrees to conduct the research in accordance with applicable State law. "(2) RESEARCH CONDUCTED BY SECRETARY.—The Secretary may conduct research under subsection (a) only in accordance with applicable State and local law.

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