I

103D CONGRESS

1ST SESSION H. R. 1175

To amend the Public Health Service Act to establish authorities and

protections regarding the transplantation of human fetal tissue.

IN THE HOUSE OF REPRESENTATIVES

MARCH 2, 1993

Mr. OBEY introduced the following bill; which was referred to the Committee

on Energy and Commerce

A BILL

To amend the Public Health Service Act to establish authorities and protections regarding the transplantation of

human fetal tissue.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Research on Human

5 Fetal Tissue Amendments of 1993’’.
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1 SEC. 2. ESTABLISHMENT OF AUTHORITIES AND PROTEC2 TIONS REGARDING TRANSPLANTATION OF

3 HUMAN FETAL TISSUE.

4 Part G of title IV of the Public Health Service Act

5 (42 U.S.C. 289 et seq.) is amended by inserting after sec6 tion 498 the following new section:

7 ‘‘RESEARCH ON TRANSPLANTATION OF FETAL TISSUE

8 ‘‘SEC. 498A. (a) ESTABLISHMENT OF PROGRAM.—

9 ‘‘(1) IN GENERAL.—The Secretary may conduct

10 or support research on the transplantation of human

11 fetal tissue for therapeutic purposes.

12 ‘‘(2) SOURCE OF TISSUE.—Human fetal tissue

13 may be used in research carried out under para14 graph (1) regardless of whether the tissue is ob15 tained pursuant to a spontaneous or induced abor16 tion or pursuant to a stillbirth.

17 ‘‘(b) INFORMED CONSENT OF DONOR.—

18 ‘‘(1) IN GENERAL.—In research carried out

19 under subsection (a), human fetal tissue may be

20 used only if the woman providing the tissue makes

21 a statement, made in writing and signed by the

22 woman, declaring that—

23 ‘‘(A) the woman donates the fetal tissue

24 for use in research described in subsection (a);

25 ‘‘(B) the donation is made without any re26 striction regarding the identity of individuals
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1 who may be the recipients of transplantations

2 of the tissue; and

3 ‘‘(C) the woman has not been informed of

4 the identity of any such individuals.

5 ‘‘(2) ADDITIONAL STATEMENT.—In research

6 carried out under subsection (a), human fetal tissue

7 may be used only if the attending physician with re8 spect to obtaining the tissue from the woman in9 volved makes a statement, made in writing and

10 signed by the physician, declaring that—

11 ‘‘(A) in the case of tissue obtained pursu12 ant to an induced abortion—

13 ‘‘(i) the consent of the woman for the

14 abortion was obtained prior to requesting

15 or obtaining consent for the tissue to be

16 used in such research; and

17 ‘‘(ii) no alteration of the timing,

18 method, or procedures used to terminate

19 the pregnancy was made solely for the pur20 poses of obtaining the tissue;

21 ‘‘(B) the tissue has been donated by the

22 woman in accordance with paragraph (1); and

23 ‘‘(C) full disclosure has been provided to

24 the woman with regard to—
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1 ‘‘(i) such physician’s interest, if any,

2 in the research to be conducted with the

3 tissue; and

4 ‘‘(ii) any known medical risks to the

5 woman or risks to her privacy that might

6 be associated with the donation of the tis7 sue and that are in addition to risks of

8 such type that are associated with the

9 woman’s medical care.

10 ‘‘(c) INFORMED CONSENT OF RESEARCHER AND

11 DONEE.—In research carried out under subsection (a),

12 human fetal tissue may be used only if the individual with

13 the principal responsibility for conducting the research in14 volved makes a statement, made in writing and signed by

15 the individual, declaring that the individual—

16 ‘‘(1) is aware that—

17 ‘‘(A) the tissue is human fetal tissue;

18 ‘‘(B) the tissue may have been obtained

19 pursuant to a spontaneous or induced abortion

20 or subsequent to a stillbirth; and

21 ‘‘(C) the tissue was donated for research

22 purposes;

23 ‘‘(2) has provided such information to other in24 dividuals with responsibilities regarding the research;
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1 ‘‘(3) will require, prior to obtaining the consent

2 of an individual to be a recipient of a transplan3 tation of the tissue, written acknowledgment of re4 ceipt of such information by such recipient; and

5 ‘‘(4) has had no part in any decisions as to the

6 timing, method, or procedures used to terminate the

7 pregnancy made solely for the purposes of the re8 search.

9 ‘‘(d) AVAILABILITY OF STATEMENTS FOR AUDIT.—

10 ‘‘(1) IN GENERAL.—In research carried out

11 under subsection (a), human fetal tissue may be

12 used only if the head of the agency or other entity

13 conducting the research involved certifies to the Sec14 retary that the statements required under sub15 sections (b)(2) and (c) will be available for audit by

16 the Secretary.

17 ‘‘(2) CONFIDENTIALITY OF AUDIT.—Any audit

18 conducted by the Secretary pursuant to paragraph

19 (1) shall be conducted in a confidential manner to

20 protect the privacy rights of the individuals and enti21 ties involved in such research, including such indi22 viduals and entities involved in the donation, trans23 fer, receipt, or transplantation of human fetal tissue.

24 With respect to any material or information obtained

25 pursuant to such audit, the Secretary shall—
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1 ‘‘(A) use such material or information only

2 for the purposes of verifying compliance with

3 the requirements of this section;

4 ‘‘(B) not disclose or publish such material

5 or information, except where required by Fed6 eral law, in which case such material or infor7 mation shall be coded in a manner such that

8 the identities of such individuals and entities

9 are protected; and

10 ‘‘(C) not maintain such material or infor11 mation after completion of such audit, except

12 where necessary for the purposes of such audit.

13 ‘‘(e) APPLICABILITY OF STATE AND LOCAL LAW.—

14 ‘‘(1) RESEARCH CONDUCTED BY RECIPIENTS

15 OF ASSISTANCE.—The Secretary may not provide

16 support for research under subsection (a) unless the

17 applicant for the financial assistance involved agrees

18 to conduct the research in accordance with applica19 ble State and local law.

20 ‘‘(2) RESEARCH CONDUCTED BY SECRETARY.—

21 The Secretary may conduct research under sub22 section (a) only in accordance with applicable State

23 and local law.

24 ‘‘(f) DEFINITION.—For purposes of this section, the

25 term ‘human fetal tissue’ means tissue or cells obtained
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1 from a dead human embryo or fetus after a spontaneous

2 or induced abortion, or after a stillbirth.’’.

3 SEC. 3. PURCHASE OF HUMAN FETAL TISSUE; SOLICITA4 TION OR ACCEPTANCE OF TISSUE AS DI5 RECTED DONATION FOR USE IN TRANSPLAN6 TATION.

7 Part G of title IV of the Public Health Service Act,

8 as amended by section 2 of this Act, is amended by insert9 ing after section 498A the following new section:

10 ‘‘PROHIBITIONS REGARDING HUMAN FETAL TISSUE

11 ‘‘SEC. 498B. (a) PURCHASE OF TISSUE.—It shall be

12 unlawful for any person to knowingly acquire, receive, or

13 otherwise transfer any human fetal tissue for valuable con14 sideration if the transfer affects interstate commerce.

15 ‘‘(b) SOLICITATION OR ACCEPTANCE OF TISSUE AS

16 DIRECTED DONATION FOR USE IN TRANSPLANTATION.—

17 It shall be unlawful for any person to solicit or knowingly

18 acquire, receive, or accept a donation of human fetal tissue

19 for the purpose of transplantation of such tissue into an20 other person if the donation affects interstate commerce,

21 the tissue will be or is obtained pursuant to an induced

22 abortion, and—

23 ‘‘(1) the donation will be or is made pursuant

24 to a promise to the donating individual that the do25 nated tissue will be transplanted into a recipient

26 specified by such individual;
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1 ‘‘(2) the donated tissue will be transplanted

2 into a relative of the donating individual; or

3 ‘‘(3) the person who solicits or knowingly ac4 quires, receives, or accepts the donation has provided

5 valuable consideration for the costs associated with

6 such abortion.

7 ‘‘(c) CRIMINAL PENALTIES FOR VIOLATIONS.—

8 ‘‘(1) IN GENERAL.—Any person who violates

9 subsection (a) or (b) shall be fined in accordance

10 with title 18, United States Code, subject to para11 graph (2), or imprisoned for not more than 10

12 years, or both.

13 ‘‘(2) PENALTIES APPLICABLE TO PERSONS RE14 CEIVING CONSIDERATION.—With respect to the im15 position of a fine under paragraph (1), if the person

16 involved violates subsection (a) or (b)(3), a fine shall

17 be imposed in an amount not less than twice the

18 amount of the valuable consideration received.

19 ‘‘(d) DEFINITIONS.—For purposes of this section:

20 ‘‘(1) The term ‘human fetal tissue’ has the

21 meaning given such term in section 498A(f).

22 ‘‘(2) The term ‘interstate commerce’ has the

23 meaning given such term in section 201(b) of the

24 Federal Food, Drug, and Cosmetic Act.
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1 ‘‘(3) The term ‘valuable consideration’ does not

2 include reasonable payments associated with the

3 transportation, implantation, processing, preserva4 tion, quality control, or storage of human fetal tis5 sue.’’.

6 SEC. 4. REPORT BY GENERAL ACCOUNTING OFFICE ON

7 ADEQUACY OF PROTECTIONS.

8 (a) IN GENERAL.—With respect to research on the

9 transplantation of human fetal tissue for therapeutic pur10 poses, the Comptroller General of the United States shall

11 conduct an audit for the purpose of determining—

12 (1) whether and to what extent such research

13 conducted or supported by the Secretary of Health

14 and Human Services has been conducted in accord15 ance with section 498A of the Public Health Service

16 Act (as added by section 2 of this Act); and

17 (2) whether and to what extent there have been

18 violations of section 498B of such Act (as added by

19 section 3 of this Act).

20 (b) REPORT.—Not later than May 19, 1995, the

21 Comptroller General of the United States shall complete

22 the audit required in subsection (a) and submit to the

23 Congress a report describing the findings made pursuant

24 to the audit.

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