II

103D CONGRESS

1ST SESSION S. 1042

To amend the Public Health Service Act to establish an Ethical Advisory

Board, and for other purposes.

IN THE SENATE OF THE UNITED STATES

MAY 27 (legislative day, APRIL 19), 1993

Mr. HATFIELD introduced the following bill; which was read twice and

referred to the Committee on Labor and Human Resources

A BILL

To amend the Public Health Service Act to establish an

Ethical Advisory Board, 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. ESTABLISHMENT OF ETHICAL ADVISORY

4 BOARD.

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

6 (42 U.S.C. 289 et seq.) is amended by inserting after sec7 tion 492 the following new section:
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1 ‘‘CERTAIN PROVISIONS REGARDING REVIEW AND

2 APPROVAL OF PROPOSALS FOR RESEARCH

3 ‘‘SEC. 492A. (a) REVIEW AS PRECONDITION TO RE4 SEARCH.—

5 ‘‘(1) PROTECTION OF HUMAN RESEARCH SUB6 JECTS.—

7 ‘‘(A) In the case of any application submit8 ted to the Secretary for financial assistance to

9 conduct research, the Secretary may not ap10 prove or fund any application that is subject to

11 review under section 491(a) by an Institutional

12 Review Board unless the application has under13 gone review in accordance with such section and

14 has been recommended for approval by a major15 ity of the members of the Board conducting

16 such review.

17 ‘‘(B) In the case of research that is subject

18 to review under procedures established by the

19 Secretary for the protection of human subjects

20 in clinical research conducted by the National

21 Institutes of Health, the Secretary may not au22 thorize the conduct of the research unless the

23 research has, pursuant to such procedures, been

24 recommended for approval.
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1 ‘‘(2) PEER REVIEW.—In the case of any appli2 cation submitted to the Secretary for financial as3 sistance to conduct research, the Secretary may not

4 approve or fund any application that is subject to

5 technical and scientific peer review under section

6 492(a) unless the application has undergone peer re7 view in accordance with such section and has been

8 recommended for approval by a majority of the

9 members of the entity conducting such review.

10 ‘‘(b) ETHICAL REVIEW OF RESEARCH.—

11 ‘‘(1) ESTABLISHMENT OF A STANDING ETHICAL

12 ADVISORY BOARD.—

13 ‘‘(A) Not later than 180 days after the

14 date of enactment of this Act, the Secretary, in

15 accordance with subpart B of part 46 of title

16 45, Code of Federal Regulations, and with the

17 recommendations of the National Commission

18 for the Protection of Human Subjects of Bio19 medical and Behavioral Research, shall estab20 lish a standing Ethical Advisory Board (here21 after referred to in this section as the ‘Board’).

22 ‘‘(B) The Board shall advise, report on,

23 and make recommendations to the Secretary

24 and the Congress regarding the ethical, legal,

25 and social acceptability of supporting specific
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1 biomedical and behavioral research designs, ap2 plications, or proposals submitted to it by the

3 Secretary or any Agency Head within the De4 partment, and shall prepare reports and make

5 recommendations concerning ethical policies re6 lating to biomedical and behavioral research re7 ferred to it by the Secretary, Agency Heads, or

8 Congressional Committees. With the approval of

9 the Secretary, the Board may develop reports

10 and make recommendations concerning other

11 matters that it considers of major importance

12 to the general public.

13 ‘‘(C)(i) The Board shall be composed of 15

14 individuals who are not officers or employees of

15 the United States to be appointed as follows:

16 ‘‘(I) Five individuals shall be ap17 pointed by the President.

18 ‘‘(II) Five individuals shall be ap19 pointed by the Speaker of the House of

20 Representatives in consultation with the

21 Minority Leader.

22 ‘‘(III) Five individuals shall be ap23 pointed by the Majority Leader of the

24 Senate in consultation with the Minority

25 Leader.
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1 ‘‘(ii) In appointing individuals under clause

2 (i), the appointing authority shall ensure that

3 such individuals possess special qualifications

4 and competence to provide advice and rec5 ommendations regarding ethical matters in bio6 medical and behavioral research. Of the mem7 bers of the Board—

8 ‘‘(I) at least one shall be an attorney;

9 ‘‘(II) at least one shall be a profes10 sional ethicist;

11 ‘‘(III) at least one shall be a practic12 ing physician;

13 ‘‘(IV) at least one shall be a theolo14 gian; and

15 ‘‘(V) at least one-third, and no more

16 than one-half, of all such members shall be

17 scientists who have made significant con18 tributions to the advancement of bio19 medical or behavioral science.

20 ‘‘(D) The terms of service of members of

21 the Board shall be for 3 years. The initial mem22 bers of the Board shall be appointed to serve

23 staggered terms of 1, 2 or 3 years. If a member

24 does not complete a full term of service, the in25 dividual appointed to fill the resulting vacancy
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1 shall be appointed for the remainder of the

2 term of the predecessor of the individual. A

3 member may be reappointed to serve no more

4 than two consecutive full terms.

5 ‘‘(E) A member of the Board shall be sub6 ject to removal from the Board by the Secretary

7 for neglect of duty, malfeasance, or for other

8 good cause as demonstrated by the Secretary.

9 ‘‘(F) The members of the Board shall se10 lect one member to serve as the chairperson of

11 the Board. The chairperson shall serve not

12 more than one consecutive 3-year term.

13 ‘‘(G) In carrying out its responsibilities as

14 described in subparagraph (B), the Board shall

15 hold such inquiries, hold public hearings, enter

16 into contracts the aggregate of which shall not

17 exceed $300,000 per year, and report to the

18 Secretary and to the Congress the results and

19 recommendations that result from its delibera20 tions.

21 ‘‘(H) With respect to information relevant

22 to the duties described in subparagraph (B),

23 the Board shall have access to all such informa24 tion possessed by the Department of Health
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1 and Human Services, or available to the Sec2 retary from other sources.

3 ‘‘(I) With respect to the duties described in

4 subparagraph (B), the members of the Board

5 shall receive compensation for each day they are

6 engaged in carrying out the purposes of the

7 Board, including time engaged in traveling for

8 such purposes. Such compensation may not be

9 provided in an amount in excess of the maxi10 mum rate of basic pay accorded for individuals

11 GS–18 of the General Schedule.

12 ‘‘(J) The Secretary, acting through the Di13 rector of the National Institutes of Health,

14 shall provide the Board with staff and such

15 other assistance necessary to carrying out the

16 duties of the Board.

17 ‘‘(K) Prior to reconstituting the Board, the

18 Secretary shall, through a statement published

19 in the Federal Register, announce the intention

20 of the Secretary to constitute the Board.

21 ‘‘(L) A statement issued under subpara22 graph (K) shall include a request that inter23 ested parties submit to the Secretary rec24 ommendations specifying the particular individ25 uals who should be appointed to the Board. The
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1 Secretary shall consider such recommendations

2 in making appointments to the Board.

3 ‘‘(M) The appointments to the Board

4 under subparagraph (C) shall not take effect

5 until the expiration of the 30-day period begin6 ning with the date on which the statement re7 quired in subparagraph (K) is made with re8 spect to the Board.

9 ‘‘(2) PROCEDURES REGARDING THE WITHHOLD10 ING OF FUNDS.—

11 ‘‘(A) If research has been recommended

12 for approval for purposes of subsection (a), the

13 Secretary may not withhold funding for the re14 search on ethical grounds unless—

15 ‘‘(i) the Secretary refers the proposal

16 within 30 days to the Board in accordance

17 with paragraph (1) to study the ethical im18 plications of the research; and

19 ‘‘(ii)(I) the majority of the Board rec20 ommends that, on ethical grounds, the Sec21 retary withhold funds for the research; or

22 ‘‘(II) the majority of the Board rec23 ommends that the Secretary not withhold

24 funds for the research on ethical grounds,

25 but the Secretary determines, on the basis
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1 of the report submitted under subpara2 graph (D) that there is a reasonable basis

3 for overruling the Board’s recommenda4 tions.

5 ‘‘(B) The limitation established in subpara6 graph (A) regarding the authority to withhold

7 funds on ethical grounds shall apply without re8 gard to whether the withholding such funds is

9 characterized as a disapproval, a moratorium, a

10 prohibition, or other description.

11 ‘‘(C) Not later than 180 days after the

12 date on which the matter is referred under sub13 paragraph (A) to the Board, the Board shall

14 submit to the Secretary, and to the Committee

15 on Energy and Commerce of the House of Rep16 resentatives and the Committee on Labor and

17 Human Resources of the Senate, a report de18 scribing the findings of the Board regarding the

19 project of research involved and making a rec20 ommendation under subparagraph (A)(ii) of

21 whether the Secretary should or should not

22 withhold funds for the project. The report shall

23 include the information considered in making

24 the findings.’’.

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