Research on Human Fetal Tissue Amendments of 1993

Summary: Research on Human Fetal Tissue Amendments of 1993 - Amends the Public Health Service Act to authorize and regulate research on human fetal tissue transplantation without regard to whether the tissue is obtained after a spontaneous or induced abortion or a stillbirth in accordance with State law. 
Imposes criminal penalties for:  (1) transferring such tissue for valuable consideration affecting interstate commerce; or (2) soliciting or receiving a directed donation.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Research on Human Fetal Tissue 
Amendments of 1993''.

SEC. 2. ESTABLISHMENT OF AUTHORITIES AND PROTECTIONS REGARDING 
              TRANSPLANTATION OF HUMAN FETAL TISSUE.

    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 new 
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 the tissue to be used in 
                        such research; and
                            ``(ii) no alteration of the timing, method, 
                        or procedures used to terminate the pregnancy 
                        was made solely for the purposes of obtaining 
                        the tissue;
                    ``(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 subsequent 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 research under subsection 
        (a) unless the applicant for the financial assistance involved 
        agrees to conduct the research in accordance with applicable 
        State and local law.
            ``(2) Research conducted by secretary.--The Secretary may 
        conduct research under subsection (a) only in accordance with 
        applicable State and local law.
    ``(f) Definition.--For purposes of this section, the term `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.''.

SEC. 3. PURCHASE OF HUMAN FETAL TISSUE; SOLICITATION OR ACCEPTANCE OF 
              TISSUE AS DIRECTED DONATION FOR USE IN TRANSPLANTATION.

    Part G of title IV of the Public Health Service Act, as amended by 
section 2 of this Act, is amended by inserting after section 498A the 
following new section:

              ``prohibitions regarding human fetal tissue

    ``Sec. 498B. (a) Purchase of Tissue.--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.
    ``(b) Solicitation or Acceptance of Tissue as Directed Donation for 
Use in Transplantation.--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.
    ``(c) Criminal Penalties for Violations.--
            ``(1) In general.--Any person who violates subsection (a) 
        or (b) shall be fined in accordance with title 18, United 
        States Code, subject to paragraph (2), or imprisoned for not 
        more than 10 years, or both.
            ``(2) Penalties applicable to persons receiving 
        consideration.--With respect to the imposition of a fine under 
        paragraph (1), if the person involved violates subsection (a) 
        or (b)(3), a fine shall be imposed in an amount not less than 
        twice the amount of the valuable consideration received.
    ``(d) Definitions.--For purposes of this section:
            ``(1) The term `human fetal tissue' has the meaning given 
        such term in section 498A(f).
            ``(2) The term `interstate commerce' has the meaning given 
        such term in section 201(b) of the Federal Food, Drug, and 
        Cosmetic Act.
            ``(3) The term `valuable consideration' does not include 
        reasonable payments associated with the transportation, 
        implantation, processing, preservation, quality control, or 
        storage of human fetal tissue.''.

SEC. 4. REPORT BY GENERAL ACCOUNTING OFFICE ON ADEQUACY OF PROTECTIONS.

    (a) In General.--With respect to research on the transplantation of 
human fetal tissue for therapeutic purposes, the Comptroller General of 
the United States shall conduct an audit for the purpose of 
determining--
            (1) whether and to what extent such research conducted or 
        supported by the Secretary of Health and Human Services has 
        been conducted in accordance with section 498A of the Public 
        Health Service Act (as added by section 2 of this Act); and
            (2) whether and to what extent there have been violations 
        of section 498B of such Act (as added by section 3 of this 
        Act).
    (b) Report.--Not later than May 19, 1995, the Comptroller General 
of the United States shall complete the audit required in subsection 
(a) and submit to the Congress a report describing the findings made 
pursuant to the audit.