I

103D CONGRESS

2D SESSION H. R. 3878

To amend the Public Health Service Act to establish a requirement of informed consent regarding the use of human subjects in research conducted or supported by the Federal Government, and for other purposes.

IN THE HOUSE OF REPRESENTATIVES

FEBRUARY 23, 1994

Mr. COOPER (for himself, Mr. CLEMENT, Mr. TANNER, Mr. GORDON, Mr.

DUNCAN, Mr. QUILLEN, Mr. FORD of Tennessee, Mrs. LLOYD, and Mr.

SUNDQUIST) 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 a requirement of informed consent regarding the use of

human subjects in research conducted or supported by

the Federal Government, and for other purposes.

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 ‘‘Federal Research In5 formed Consent Act’’.
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1 SEC. 2. REQUIREMENT OF INFORMED CONSENT REGARD2 ING USE OF HUMAN SUBJECTS IN FEDER3 ALLY QUALIFIED RESEARCH.

4 (a) IN GENERAL.—Section 491 of the Public Health

5 Service Act (42 U.S.C. 289) is amended by adding at the

6 end the following subsection:

7 ‘‘(c) REQUIREMENT OF INFORMED CONSENT RE8 GARDING HUMAN SUBJECTS.—

9 ‘‘(1) IN GENERAL.—Subject to paragraph (2),

10 the Secretary shall by regulation establish the re11 quirement that, in federally qualified research in

12 which any human subject is to be used, an individual

13 may not be used as a subject unless the principal re14 searcher obtains the informed consent of the individ15 ual to serve as a subject.

16 ‘‘(2) EXEMPTED CATEGORIES OF RESEARCH.—

17 ‘‘(A) With respect to the requirement of

18 paragraph (1) that informed consent be ob19 tained, the Secretary may, in issuing regula20 tions under such paragraph, establish such ex21 empted categories of research as the Secretary

22 determines to be appropriate. The regulations

23 may not authorize any waiver of the applicabil24 ity of the requirement to a research activity

25 that is not within such a category.
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1 ‘‘(B) In the case of a particular research

2 activity, the Secretary is responsible for approv3 ing or disapproving the activity as qualifying

4 for an exemption under subparagraph (A).

5 ‘‘(C) If under subparagraph (B) the Sec6 retary approves an exemption, the Secretary

7 shall submit to the congressional committees of

8 jurisdiction a notification that the exemption

9 has been approved (together with a description

10 of the circumstances). In the case of classified

11 materials, the notification shall be submitted to

12 the committees, and reviewed by the commit13 tees, in accordance with any applicable require14 ments for such materials.

15 ‘‘(D) An exemption approved by the Sec16 retary under subparagraph (B) takes effect

17 upon the expiration of the 60-day period begin18 ning on the date on which the notification re19 garding the exemption is submitted under sub20 paragraph (C).

21 ‘‘(3) CRITERIA REGARDING PROVISION OF CON22 SENT.—In issuing regulations under paragraph (1),

23 the Secretary shall establish requirements for ob24 taining informed consent, including requirements re25 garding the information to be provided to the pro-
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1 spective research subject and requirements regarding

2 documentation of the informed consent of such sub3 ject.

4 ‘‘(4) NONCOMPLIANCE.—

5 ‘‘(A) An individual aggrieved as a result of

6 a violation of the requirement under paragraph

7 (1) may obtain appropriate relief through a civil

8 action, including damages, equitable relief, and

9 a reasonable attorney’s fees and costs. Damages

10 in such an action may include damages other

11 than actual damages.

12 ‘‘(B) With respect to a civil action under

13 subparagraph (A), if the research involved al14 legedly was conducted by the United States, the

15 defendant shall be the United States. The Unit16 ed States district courts have exclusive original

17 jurisdiction of actions described in the preced18 ing sentence, and such actions may be com19 menced in a judicial district only in accordance

20 with applicable law on the venue of civil actions.

21 ‘‘(C) With respect to a civil action under

22 subparagraph (A), if the research involved al23 legedly was conducted by a State, the defendant

24 shall be the head of the State agency involved.

25 Actions described in the preceding sentence
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1 may be commenced in any court of competent

2 jurisdiction. For purposes of this subparagraph,

3 a State is not immune under the Eleventh

4 Amendment of the Constitution of the United

5 States from a civil action under subparagraph

6 (A) in Federal court.

7 ‘‘(D) With respect to a civil action under

8 subparagraph (A), if the research involved al9 legedly was not conducted by the United States

10 or by a State, the entity that allegedly did con11 duct the research shall be the defendant. Ac12 tions described in the preceding sentence may

13 be commenced in any court of competent juris14 diction.

15 ‘‘(E) With respect to the death of an indi16 vidual who is aggrieved for purposes of sub17 paragraph (A), the cause of action survives the

18 individual and the civil action under such sub19 paragraph may be commenced only by a per20 sonal representative of the individual.

21 ‘‘(F) With respect to limitations on com22 mencing a civil action under subparagraph

23 (A)—

24 ‘‘(i) the civil action may not be com25 menced after the expiration of the 5-year
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1 period beginning on the date on which the

2 individual (or the personal representative,

3 as the case may be) receives notice of the

4 alleged facts with respect to which the in5 dividual is aggrieved; and

6 ‘‘(ii) notwithstanding clause (i), the

7 civil action may not be commenced after

8 the expiration of the 50-year period begin9 ning on the date on which the individual

10 dies.

11 ‘‘(5) PREEMPTION.—This subsection supersedes

12 any private cause of action under the laws of a State

13 arising as a result of the use of an individual as a

14 subject in federally qualified research without the

15 consent of the individual.

16 ‘‘(6) DEFINITIONS.—For purposes of this sub17 section:

18 ‘‘(A) The term ‘federally qualified re19 search’ means—

20 ‘‘(i) any research conducted or sup21 ported by the Federal Government; and

22 ‘‘(ii) any research regulated by the

23 Federal Government, other than research

24 which is only incidentally regulated.
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1 ‘‘(B) The term ‘principal researcher’, with

2 respect to federally qualified research, means

3 the individual with the principal responsibility

4 for conducting the research.’’.

5 (b) STYLISTIC CONFORMING AMENDMENTS.—Sec6 tion 491 of the Public Health Service Act (42 U.S.C. 289)

7 is amended—

8 (1) in subsection (a), by striking ‘‘(a) The Sec9 retary’’ and inserting ‘‘(a) INSTITUTIONAL REVIEW

10 BOARDS.—The Secretary’’; and

11 (2) in subsection (b)—

12 (A) by striking ‘‘(b)(1) The Secretary’’ and

13 inserting the following:

14 ‘‘(b) ETHICS GUIDANCE PROGRAM.—

15 ‘‘(1) IN GENERAL.—The Secretary’’; and

16 (B) in paragraph (2), by striking ‘‘(2) The

17 Secretary’’ and inserting the following:

18 ‘‘(2) RESPONSE RESPECTING VIOLATIONS.—

19 The Secretary’’.

20 SEC. 3. EFFECT ON EXISTING REGULATIONS; EFFECTIVE

21 DATE REGARDING CAUSES OF ACTION.

22 (a) EFFECT ON EXISTING REGULATIONS.—With re23 spect to the provisions of part 46 of title 45, Code of Fed24 eral Regulations (relating to the protection of human sub25 jects), as in effect on the date of the enactment of this
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1 Act, the legal status of such provisions is affected by the

2 amendment made by section 2(a) only to the extent that

3 any such provision is inconsistent with the amendment.

4 (b) EFFECTIVE DATE REGARDING CAUSES OF AC5 TION; APPLICABLE PROVISIONS.—The requirement estab6 lished under section 491(c)(1) of the Public Health Serv7 ice Act (as added by the amendment made by section 2(a)

8 of this Act) is effective in the case of any violation of the

9 requirement occurring on or after the date of the enact10 ment of this Act, without regard to the date on which final

11 regulations under such section take effect. For purposes

12 of the preceding sentence, in the case of a cause of action

13 accruing before such regulations take effect—

14 (1) a defendant is liable, subject to paragraphs

15 (2) and (3), if the principal researcher involved (as

16 defined under such amendment) failed to obtain in17 formed consent in accordance with the provisions of

18 part 46 of title 45, Code of Federal Regulations (re19 lating to the protection of human subjects), as in ef20 fect on the date of the enactment of this Act;

21 (2) it is a defense that the Secretary of Health

22 and Human Services—

23 (A) determined that the research activity

24 involved was within one of the categories of re-
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1 search described in section 46.101(b) of such

2 part;

3 (B) determined that the research activity

4 otherwise was not covered by the policy; or

5 (C) with respect to informed consent,

6 waived the applicability of the requirements in7 volved; and

8 (3) it is not a defense (except as provided in

9 paragraph (2)) that—

10 (A) for purposes of section 46.101(a) of

11 such part, the Federal department or agency in12 volved did not take action to make the policy

13 applicable;

14 (B) for purposes of section 46.101(c) of

15 such part, the department or agency head de16 termined that the research activity was not cov17 ered by the policy; or

18 (C) for purposes of section 46.101(i) of

19 such part, the department or agency head

20 waived the applicability of some or all of the

21 provisions of the policy.

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