[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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