[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 1042 Introduced in Senate (IS)]
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. ESTABLISHMENT OF ETHICAL ADVISORY BOARD.
Part G of title IV of the Public Health Service Act (42 U.S.C. 289
et seq.) is amended by inserting after section 492 the following new
section:
``certain provisions regarding review and approval of proposals for
research
``Sec. 492A. (a) Review as Precondition to Research.--
``(1) Protection of human research subjects.--
``(A) In the case of any application submitted to
the Secretary for financial assistance to conduct
research, the Secretary may not approve or fund any
application that is subject to review under section
491(a) by an Institutional Review Board unless the
application has undergone review in accordance with
such section and has been recommended for approval by a
majority of the members of the Board conducting such
review.
``(B) In the case of research that is subject to
review under procedures established by the Secretary
for the protection of human subjects in clinical
research conducted by the National Institutes of
Health, the Secretary may not authorize the conduct of
the research unless the research has, pursuant to such
procedures, been recommended for approval.
``(2) Peer review.--In the case of any application
submitted to the Secretary for financial assistance to conduct
research, the Secretary may not approve or fund any application
that is subject to technical and scientific peer review under
section 492(a) unless the application has undergone peer review
in accordance with such section and has been recommended for
approval by a majority of the members of the entity conducting
such review.
``(b) Ethical Review of Research.--
``(1) Establishment of a standing ethical advisory board.--
``(A) Not later than 180 days after the date of
enactment of this Act, the Secretary, in accordance
with subpart B of part 46 of title 45, Code of Federal
Regulations, and with the recommendations of the
National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research, shall
establish a standing Ethical Advisory Board (hereafter
referred to in this section as the `Board').
``(B) The Board shall advise, report on, and make
recommendations to the Secretary and the Congress
regarding the ethical, legal, and social acceptability
of supporting specific biomedical and behavioral
research designs, applications, or proposals submitted
to it by the Secretary or any Agency Head within the
Department, and shall prepare reports and make
recommendations concerning ethical policies relating to
biomedical and behavioral research referred to it by
the Secretary, Agency Heads, or Congressional
Committees. With the approval of the Secretary, the
Board may develop reports and make recommendations
concerning other matters that it considers of major
importance to the general public.
``(C)(i) The Board shall be composed of 15
individuals who are not officers or employees of the
United States to be appointed as follows:
``(I) Five individuals shall be appointed
by the President.
``(II) Five individuals shall be appointed
by the Speaker of the House of Representatives
in consultation with the Minority Leader.
``(III) Five individuals shall be appointed
by the Majority Leader of the Senate in
consultation with the Minority Leader.
``(ii) In appointing individuals under clause (i),
the appointing authority shall ensure that such
individuals possess special qualifications and
competence to provide advice and recommendations
regarding ethical matters in biomedical and behavioral
research. Of the members of the Board--
``(I) at least one shall be an attorney;
``(II) at least one shall be a professional
ethicist;
``(III) at least one shall be a practicing
physician;
``(IV) at least one shall be a theologian;
and
``(V) at least one-third, and no more than
one-half, of all such members shall be
scientists who have made significant
contributions to the advancement of biomedical
or behavioral science.
``(D) The terms of service of members of the Board
shall be for 3 years. The initial members of the Board
shall be appointed to serve staggered terms of 1, 2 or
3 years. If a member does not complete a full term of
service, the individual appointed to fill the resulting
vacancy shall be appointed for the remainder of the
term of the predecessor of the individual. A member may
be reappointed to serve no more than two consecutive
full terms.
``(E) A member of the Board shall be subject to
removal from the Board by the Secretary for neglect of
duty, malfeasance, or for other good cause as
demonstrated by the Secretary.
``(F) The members of the Board shall select one
member to serve as the chairperson of the Board. The
chairperson shall serve not more than one consecutive
3-year term.
``(G) In carrying out its responsibilities as
described in subparagraph (B), the Board shall hold
such inquiries, hold public hearings, enter into
contracts the aggregate of which shall not exceed
$300,000 per year, and report to the Secretary and to
the Congress the results and recommendations that
result from its deliberations.
``(H) With respect to information relevant to the
duties described in subparagraph (B), the Board shall
have access to all such information possessed by the
Department of Health and Human Services, or available
to the Secretary from other sources.
``(I) With respect to the duties described in
subparagraph (B), the members of the Board shall
receive compensation for each day they are engaged in
carrying out the purposes of the Board, including time
engaged in traveling for such purposes. Such
compensation may not be provided in an amount in excess
of the maximum rate of basic pay accorded for
individuals GS-18 of the General Schedule.
``(J) The Secretary, acting through the Director of
the National Institutes of Health, shall provide the
Board with staff and such other assistance necessary to
carrying out the duties of the Board.
``(K) Prior to reconstituting the Board, the
Secretary shall, through a statement published in the
Federal Register, announce the intention of the
Secretary to constitute the Board.
``(L) A statement issued under subparagraph (K)
shall include a request that interested parties submit
to the Secretary recommendations specifying the
particular individuals who should be appointed to the
Board. The Secretary shall consider such
recommendations in making appointments to the Board.
``(M) The appointments to the Board under
subparagraph (C) shall not take effect until the
expiration of the 30-day period beginning with the date
on which the statement required in subparagraph (K) is
made with respect to the Board.
``(2) Procedures regarding the withholding of funds.--
``(A) If research has been recommended for approval
for purposes of subsection (a), the Secretary may not
withhold funding for the research on ethical grounds
unless--
``(i) the Secretary refers the proposal
within 30 days to the Board in accordance with
paragraph (1) to study the ethical implications
of the research; and
``(ii)(I) the majority of the Board
recommends that, on ethical grounds, the
Secretary withhold funds for the research; or
``(II) the majority of the Board recommends
that the Secretary not withhold funds for the
research on ethical grounds, but the Secretary
determines, on the basis of the report
submitted under subparagraph (D) that there is
a reasonable basis for overruling the Board's
recommendations.
``(B) The limitation established in subparagraph
(A) regarding the authority to withhold funds on
ethical grounds shall apply without regard to whether
the withholding such funds is characterized as a
disapproval, a moratorium, a prohibition, or other
description.
``(C) Not later than 180 days after the date on
which the matter is referred under subparagraph (A) to
the Board, the Board shall submit to the Secretary, and
to the Committee on Energy and Commerce of the House of
Representatives and the Committee on Labor and Human
Resources of the Senate, a report describing the
findings of the Board regarding the project of research
involved and making a recommendation under subparagraph
(A)(ii) of whether the Secretary should or should not
withhold funds for the project. The report shall
include the information considered in making the
findings.''.
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