[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4605 Introduced in House (IH)]







106th CONGRESS
  2d Session
                                H. R. 4605

 To amend the Public Health Service Act with respect to the protection 
                     of human subjects in research.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              June 8, 2000

Ms. DeGette (for herself, Mr. Mica, Mr. Waxman, Mr. Dingell, Mr. Brown 
   of Ohio, Mr. LaTourette, Mr. Towns, Mr. Stark, and Mr. Kucinich) 
 introduced the following bill; which was referred to the Committee on 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act with respect to the protection 
                     of human subjects in research.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Human Research Subject Protections 
Act of 2000''.

SEC. 2. FINDINGS AND PURPOSES.

    (a) Findings.--The Congress finds as follows:
            (1) The first principle of the Nuremberg code states that 
        with respect to human research, the voluntary consent of the 
        human subject is absolutely essential. The Nuremberg code 
        further asserts that such consent must be competent, informed 
        and comprehending.
            (2) In 1974, the Department of Health, Education and 
        Welfare published regulations (45 CFR 46) governing the 
        protection of human subjects in research. These regulations 
        applied only to research sponsored by the Department. In 1991, 
        subpart A of these regulations was adopted by 16 additional 
        Federal agencies to apply to any research which these agencies 
        may conduct or sponsor.
            (3) Between 1974 and 1983, Congress enacted two Public Laws 
        that established ethical advisory bodies. Public Law 91-348 
        established the National Commission for the Protection of Human 
        Subjects of Biomedical and Behavioral Research and Public Law 
        95-622 established the President's Commission for the Study of 
        Ethical Problems in Medicine and Biomedical and Behavioral 
        Research. Each of these advisory bodies made recommendations to 
        the President and Congress to expand protections for human 
        research subjects. Some of these recommendations have been 
        incorporated into the Federal regulation (45 CFR 46).
            (4) In 1995, the President's Advisory Committee on Human 
        Radiation Experiments found that there are significant 
        deficiencies in some aspects of the current system for the 
        protection of human subjects. In particular, the Committee 
        found that some consent forms currently in use are flawed in 
        morally significant aspects.
            (5) The President's Advisory Committee on Human Radiation 
        Experiments recommended the adoption of a Federal policy 
        requiring the informed consent of all human subjects of 
        classified research and that this requirement not be subject to 
        exemption or waiver. The Committee further recommended that in 
        all cases, potential subjects should be informed of the 
        identity of the sponsoring Federal agency and that the project 
        involves classified information.
            (6) In 1996, Congress enacted the Health Insurance 
        Portability and Accountability Act, which established an August 
        21, 1999, deadline to enact comprehensive health privacy rules. 
        Failure to meet that deadline triggered a requirement for the 
        Secretary of Health and Human Services to issue final health 
        privacy regulations by February 2000.
            (7) In 1998 and 2000, the Department of Health and Human 
        Services's Inspector General found that the effectiveness of 
        Institutional Review Board was ``in jeopardy'' and attention 
        needed to be directed to enhancing human subject protections 
        for a widening scope of clinical investigation.
            (8) In 1998 and 1999, the National Bioethics Advisory 
        Commission found that Federal protections do not always contain 
        specific protections for certain vulnerable populations and 
        that existing regulations do not adequately address issues 
        involving human biological materials.
            (9) Some agencies of the Federal government sponsor 
        research involving human subjects, but these agencies have not 
        adopted the Common Rule or vulnerable-populations protections 
        as provided for in part 46 of title 45, Code of Federal 
        Regulations, specifically subparts B, C, and D.
            (10) Private individuals or institutions that do not 
        receive any Federal funding or that are not seeking the 
        approval of the Food and Drug Administration for a drug, 
        device, or biologic and that sponsor research involving human 
        subjects, do not need to abide by the requirements of part 46 
        of title 45, Code of Federal Regulations.
            (11) Research institutions that receive Federal funds for 
        conducting research involving human subjects are not required 
        to apply the protections of part 46 of title 45, Code of 
        Federal Regulations, to all research conducted at the 
        institution. Many, but not all, research institutions have 
        voluntarily made this commitment.
            (12) Notwithstanding paragraphs (1) through (8), no 
        provision of United States law explicitly requires that 
        informed consent and independent review of all research 
        involving human subjects be obtained.
            (13) The human research subject activities described in 
        this section are either in interstate (or foreign) commerce or 
        substantially affect such commerce or the free flow thereof, 
        and the regulation of those activities as provided for in this 
        Act is necessary to prevent and eliminate burdens upon such 
        commerce and to effectively regulate such commerce, in order to 
        insure that the rights and welfare of human research subjects 
        are protected.
    (b) Purpose.--The purposes of this Act are--
            (1) to apply Common Rule and vulnerable-populations 
        protections to all human research subjects independent of 
        setting and funding source;
            (2) to prohibit the provision of Federal support for 
        classified research that is not approved by an institutional 
        review board and require disclosure to human research subjects 
        of certain information regarding classified research; and
            (3) to enhance regulatory oversight of human subject 
        research by formally establishing an Office for Protection of 
        Research Subjects within the Office of the Secretary of Health 
        and Human Services.

                   TITLE I--HUMAN SUBJECT PROTECTIONS

SEC. 101. PROTECTION OF HUMAN SUBJECTS IN RESEARCH; UNIFORM NATIONAL 
              APPLICABILITY OF COMMON RULE AND PROVISIONS PROTECTING 
              VULNERABLE POPULATIONS.

    Part H of title IV of the Public Health Service Act (42 U.S.C. 289 
et seq.) is amended by inserting after section 491 the following 
section:

   ``protection of human subjects; uniform national applicability of 
      common rule and provisions protecting vulnerable populations

    ``Sec. 491A. (a) In General.--All human-subject research shall be 
conducted in accordance with the provisions of subpart A of part 46 of 
title 45, Code of Federal Regulations (referred to in this section as 
the `common rule'), and as applicable to the human subjects used in 
such research, with the provisions of subparts B through D of such part 
46 (referred to in this section as `vulnerable-populations rules'), 
except to the extent that such provisions are in conflict with this 
section.
    ``(b) Definitions.--
            ``(1) Human-subject research.--For purposes of this 
        section, the term `human-subject research' means research that 
        is conducted with one or more human subjects and--
                    ``(A) is conducted, supported, or otherwise subject 
                to regulation under a provision of Federal law (other 
                than this section), without regard to whether the 
                Federal agency that administers such law has taken 
                administrative action to make the common rule 
                applicable to the agency; or
                    ``(B) is not described in subparagraph (A) and has 
                activities that are in or that affect interstate 
                commerce.
            ``(2) Other definitions.--For purposes of this section:
                    ``(A) The term `common rule' has the meaning 
                indicated for such term in subsection (a).
                    ``(B) The term `Federal agency' has the meaning 
                given the term `Executive agency' in section 105 of 
                title 5, United States Code.
                    ``(C) The term `human subject' has the meaning 
                given such term in section 46.102 of title 45, Code of 
                Federal Regulations.
                    ``(D) The term `research' has the meaning given 
                such term in section 46.102 of title 45, Code of 
                Federal Regulations.
                    ``(E) The term `vulnerable-populations rules' has 
                the meaning indicated for such term in subsection 
                (a).''.

SEC. 102. SCOPE OF AUTHORITY OF SECRETARY.

    Section 491A of the Public Health Service Act, as added by section 
101 of this Act, is amended by adding at the end the following 
subsections:
    ``(c) Scope of Authority of Secretary.--
            ``(1) In general.--The common rule (including the 
        exemptions described in section 46.101(b) of title 45, Code of 
        Federal Regulations) and the vulnerable-populations rules, as 
        in effect on the day before the date of the enactment of the 
        Human Research Subject Protections Act of 2000, continue to be 
        in effect on and after such date, subject to paragraph (2).
            ``(2) Modifications.--
                    ``(A) In general.--This section may not be 
                construed as affecting the authority of the Secretary 
                to modify the provisions of the common rule or the 
                vulnerable-populations rules, except to the extent that 
                any such modification is in conflict with this section. 
                Any such modification shall be made by regulation.
                    ``(B) Agency-specific additional protections.--With 
                respect to human-subject research that is conducted, 
                supported, or otherwise subject to regulation under a 
                provision of Federal law (other than this section), the 
                Secretary may under subparagraph (A) permit the Federal 
                agency involved to establish additional protections for 
                the protection of human subjects if the Secretary 
                determines that such additional protections are not in 
                conflict with protections established under this 
                section.
            ``(3) Suspension and revocation.--After providing notice 
        and an opportunity for a hearing, the Secretary may suspend or 
        revoke the registration, impose restrictions during a 
        corrective action period, or withhold Federal funding to an 
        Institutional Review Board described under subsection 
        (e)(1)(F).

SEC. 103. ENHANCED HUMAN SUBJECT PROTECTIONS FOR PEOPLE WITH DIMINISHED 
              DECISIONMAKING CAPACITY.

    Not later than 180 days after the date of the enactment of this 
Act, the Secretary of Health and Human Services shall, for purposes of 
section 491A of the Public Health Service Act, promulgate regulations 
to enhance the protection of people with diminished decisionmaking 
capacity with respect to their participation as subjects in clinical 
research.

                       TITLE II--INFORMED CONSENT

SEC. 201. RIGHT OF INFORMED CONSENT.

    Section 491A of the Public Health Service Act, as added by section 
102 of this Act, is amended by adding at the end the following 
subsection:
    ``(d) Right of Informed Consent.--
            ``(1) In general.--Except as provided by the Secretary by 
        regulation, no investigator may involve a living human being as 
        a subject in research unless the investigator has obtained the 
        legally effective informed consent of the subject or the 
        subject's legally authorized representative.
            ``(2) Disclosure and understanding.--During the informed 
        consent process, all human subjects shall be given full and 
        complete information relevant to the proposed research in 
        language and in a manner that allows them to understand the 
        information and make an informed decision, free of coercion, 
        regarding their participation in research. An individual 
        knowledgeable about the proposed research must provide this 
        information such that any questions the potential subject has 
        can be answered.
            ``(3) Consent form.--A human subject of research shall be 
        given a consent form that includes, at a minimum, the basic 
        elements of informed consent, including the purpose of the 
        study, the potential risks, benefits and alternatives to 
        participation, the distinction between research and therapeutic 
        treatment, the right to withdraw participation at any time, 
        investigator financial interest under paragraph (4)(B), and the 
        sponsor of the study. A copy of the signed consent form shall 
        be given to the human subject and contact information for the 
        Office for Protection of Research Subjects for questions or to 
        report concerns.''.

SEC. 202. WRITTEN ATTESTATION AND DISCLOSURE.

    Section 491A(d) of the Public Health Service Act, as added by 
section 201 of this Act, is amended by adding at the end the following 
paragraph:
            ``(4) Written attestation and disclosure.--
                    ``(A) In general.--An investigator engaged in 
                research involving human subjects shall file a written 
                attestation of familiarity with and agreement to comply 
                with the requirements of human subject research 
                protections, including informed consent.
                    ``(B) Financial interest.--An investigator engaged 
                in research involved in human subjects shall disclose 
                to the subjects investigator financial interest in the 
                research, including capitation payments, disclosure of 
                sponsors of the research and any conflict deemed 
                necessary by the Institutional Review Board.''.

                 TITLE III--INSTITUTIONAL REVIEW BOARDS

SEC. 301. REQUIREMENTS FOR BOARD.

    Section 491A of the Public Health Service Act, as added by section 
201 of this Act, is amended by adding at the end the following 
subsection:
    ``(e) Institutional Review Boards.--
            ``(1) Requirements for boards.--Human-subject research may 
        not be conducted unless an Institutional Review Board 
        established pursuant to this section has, for purposes of the 
        common rule (and the vulnerable-populations rules, as 
        applicable), approved the proposal for such research. The 
        approval by the Board of the proposal for the research is not 
        effective unless, in addition to conditions established by the 
        Secretary, the following conditions are met:
                    ``(A) Of the membership of such Board:
                            ``(i) Not fewer than 2 members or 20 
                        percent of all members (whichever is greater) 
                        are individuals whose primary expertise is in 
                        scientific areas.
                            ``(ii) Not fewer than 2 members or 20 
                        percent of all members (whichever is greater) 
                        are individuals whose primary expertise is in 
                        nonscientific areas.
                            ``(iii) Not fewer than 2 members or 20 
                        percent of all members (whichever is greater) 
                        are individuals who are not affiliated with the 
                        institution with respect to which the Board is 
                        established (other than by serving on the 
                        Board), who are not immediate family members of 
                        any individual who is affiliated with the 
                        institution, and who do not have a conflict of 
                        interest (including nonproprietary interest).
                    ``(B) When reviewing a proposal that will include 
                as a subject an individual who is a member of a 
                vulnerable population, the Board shall include members 
                who are experts in the issues involving such 
                population. Such members shall be allowed to fully 
                participate in the Board review process and have the 
                same voting rights as other Board members.
                    ``(C) With respect to the review by the Board of a 
                proposal for human-subject research, the Board does not 
                consider a quorum to have been established for a 
                meeting unless the members present at the meeting 
                include one or more members who are individuals 
                described in clauses (i) and (ii) of subparagraph (A) 
                and one or more members who are individuals described 
                in clause (iii) of such subparagraph.
                    ``(D) The institution with respect to which the 
                Board is employed by ensures that the Board has an 
                orientation and continuing education program for new 
                members of the Board, and with respect to ethical 
                matters that relate to research, a continuing education 
                program for all members of the Board.
                    ``(E) The institution with respect to which the 
                Board is employed by is in compliance with such 
                conditions as the Secretary may by regulation establish 
                for purposes of ensuring that the institution is 
                providing to the Board and recovering resources from 
                the research sponsor sufficient to carry out the 
                responsibilities of the Board pursuant to this section.
                    ``(F) The Board has submitted to the Secretary a 
                registration informing the Secretary of the existence 
                of the Board, and the registration was is in such form, 
                was made in such manner, and contained such agreements, 
                assurances, and information as the Secretary requested 
                regarding functions of the Board under this section.
                    ``(G) The Board has submitted to the Secretary such 
                reports regarding the Board as the Secretary has 
                requested.''.

SEC. 302. NOTIFICATION OF INSTITUTIONAL REVIEW BOARD.

    Section 491A(e) of the Public Health Service Act, as added by 
section 301 of this Act, is amended by adding at the end the following 
paragraph:
            ``(2) Notification of institutional review board.--In 
        submitting to an Institutional Review Board a proposal for 
        human-subject research, the sponsors and investigators for the 
        research shall notify the Board--
                    ``(A) whether the proposal has been submitted to 
                any other Institutional Review Board;
                    ``(B) as applicable, of the findings of the review 
                made by such other Board, to the extent the findings 
                are available; and
                    ``(C) whether the sponsors, investigators, or 
                institutions have been disqualified or restricted by 
                any Federal entity in their ability to participate in 
                human subject research, or are ineligible to receive 
                investigational new drugs, or have agreed to some 
                restriction.''.

SEC. 303. ACTIVITIES.

    Section 491A(e) of the Public Health Service Act, as amended by 
section 302 of this Act, is amended by adding at the end the following 
subparagraph:
            ``(3) Activities.--
                    ``(A) Data collection.--An Institutional Review 
                Board shall compile annual data on the number of new 
                research proposals reviewed, the number of continuing 
                research projects reviewed, the number of human 
                subjects involved in approved research, and other 
                information to be determined by the Secretary, and 
                report such data to the Office for Protection of 
                Research Subjects.
                    ``(B) Improved monitoring.--The Secretary shall 
                promulgate regulations regarding data safety and 
                monitoring boards and clinical trial monitoring plans. 
                Such regulations shall specify minimum reporting 
                requirements to Institutional Review Boards and the 
                Office for Protection of Research Subjects.
                    ``(C) Multiple site research.--The Secretary shall 
                promulgate regulations regarding the conduct of 
                research at multiple research sites, including 
                international sites. Such regulations shall specify 
                minimum reporting requirements to Institutional Review 
                Boards and the Office for Protection of Research 
                Subjects, conditions requiring the establishment of 
                data safety and monitoring boards, and other 
                requirements necessary to assure compliance with this 
                section.''.

SEC. 304. DISCLOSURE OF INTERESTS.

    Section 491A(e) of the Public Health Service Act, as amended by 
section 303 of this Act, is amended by adding at the end the following 
paragraph:
            ``(4)(A) All researchers shall disclose to an Institutional 
        Review Board any actual, perceived, or potential conflicts of 
        interest. All researchers shall disclose to potential subjects 
        financial interests they have in research for which the 
        subjects are being recruited, including capitation payments, 
        disclosure of sponsors of the research and any conflict deemed 
        necessary by the Institutional Review Board.
            ``(B) All Board members shall disclose any actual, 
        perceived, or potential conflicts of interest to the Board, 
        including but not limited to--
                    ``(i) involvement as researchers in research 
                projects being reviewed by the Board;
                    ``(ii) ownership interests in the research projects 
                being reviewed by the Board; and,
                    ``(iii) financial relationships or arrangements 
                with private sponsors of research projects being 
                reviewed by the Board and provide that information to 
                the Office for Protection of Research Subjects.
            ``(C) No Board member may participate in the review of any 
        research protocol under consideration by the Board in which the 
        member has a conflict of interest (including nonproprietary 
        interest).''.

SEC. 305. ACCREDITATION.

    (a) In General.--Section 491A(e)(1) of the Public Health Service 
Act, as added by section 301 of this Act, is amended by adding at the 
end the following subparagraph:
                    ``(H)(i) Effective two years after the date of the 
                enactment of the Human Research Subject Protections Act 
                of 2000, the Board has been accredited by a nonprofit 
                private entity approved by the Secretary for purposes 
                of this subparagraph.''.
    (b) Requirements of Accrediting Body.--Section 491A(e)(1)(H) of the 
Public Health Service Act, as added by subsection (a) of this section, 
is amended by adding at the end the following clauses:
                    ``(ii) The accrediting body must meet standards for 
                accreditation established by the Secretary.
                    ``(iii) The accrediting body shall provide 
                satisfactory assurances that it will comply with such 
                standards.
                    ``(iv) The Secretary shall evaluate annually the 
                performance of the accrediting body.
                    ``(v) The Secretary may withdraw approval of the 
                accrediting body if the Secretary determines that the 
                accrediting body does not meet the standards under 
                clause (ii).''.

SEC. 306. COST RECOVERY.

    Section 491A(e) of the Public Health Service Act, as amended by 
section 304 of this Act, is amended by adding at the end the following 
paragraph:
            ``(5) Cost recovery.--Institutions may recover costs 
        associated with compliance for human subject protections under 
        this Act from government sponsors of research as direct 
        costs.''.

SEC. 307. APPLICABILITY OF REQUIREMENTS.

    Section 491A of the Public Health Service Act, as amended by 
section 301 of this Act, is amended by adding at the end the following 
subsection:
    ``(f) Applicability of Requirements.--The requirements of this 
section apply on and after the date of the enactment of the Human 
Research Subject Protections Act of 2000.''.

                      TITLE IV--FEDERAL OVERSIGHT

SEC. 401. ESTABLISHMENT OF OFFICE FOR PROTECTION OF RESEARCH SUBJECTS.

    (a) In General.--Section 491 of the Public Health Service Act (42 
U.S.C. 289) is amended--
            (1) by redesignating subsection (b) as subsection (c);
            (2) by striking ``Sec. 491. (a) The Secretary shall by 
        regulation require'' and inserting the following:
    ``(b) Requirement Regarding Institutional Review Boards.--The 
Secretary shall by regulation require''; and
            (3) by inserting before subsection (b) (as redesignated by 
        paragraph (2) of this subsection) the following:
    ``Sec. 491. (a) Office for Protection of Research Subjects.--There 
is established within the Office of the Secretary an office to be known 
as the Office for Protection of Research Subjects (in this section 
referred to as the `Office'). The Office shall be headed by a director, 
who shall be appointed by the Secretary. The Secretary shall carry out 
this section acting through the Director of the Office.''.
    (b) Conforming Amendments.--Section 491 of the Public Health 
Service Act (42 U.S.C. 289) is amended in subsection (c) (as 
redesignated by subsection (a)(1) of this section)--
            (1) by striking ``(c)(1) The Secretary shall'' and 
        inserting the following:
    ``(c) Ethics Guidance Program.--
            ``(1) In general.--The Secretary shall''; and
            (2) by striking ``(2) The Secretary shall'' and inserting 
        the following:
            ``(2) Process regarding violations.--The Secretary shall''.

SEC. 402. AUTHORIZATION OF APPROPRIATIONS.

    Section 491 of the Public Health Service Act (42 U.S.C. 289), as 
amended by section 401 of this Act, is amended by adding at the end the 
following subsection:
    ``(d) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $20,000,000 
for fiscal year 2001, and such sums as may be necessary for fiscal year 
2002 and each subsequent fiscal year.''.

SEC. 403. INSTITUTIONAL PROGRAMS FOR PROVIDING EDUCATION ON PROTECTION 
              OF HUMAN SUBJECTS IN RESEARCH.

    Section 491 of the Public Health Service Act (42 U.S.C. 289), as 
amended by section 402 of this Act, is amended by adding at the end the 
following subsection:
    ``(e) Institutional Programs of Education.--For fiscal year 2001 
and subsequent fiscal years, the Secretary may not make an award of a 
grant, cooperative agreement, or contract under this Act to a public 
entity or a private academic institution, or make an award of a grant, 
cooperative agreement, or contract under this Act for the conduct of 
research at or through or in affiliation with a public entity or a 
private academic institution, unless the public entity or private 
academic institution (as the case may be) has a comprehensive and 
ongoing program to educate investigators and Board members on the 
protection of human subjects in research.''.

SEC. 404. CERTAIN CLASSIFIED HUMAN-SUBJECT RESEARCH.

    Section 491 of the Public Health Service Act (42 U.S.C. 289), as 
amended by section 403 of this Act, is amended by adding at the end the 
following subsection:
    ``(f) Certain Classified Human-Subject Research.--
            ``(1) In general.--Notwithstanding any other provision of 
        law, Federal funds may not be expended for the conduct of 
        classified human-subject research if--
                    ``(A) the Institutional Review Board reviewing the 
                proposal for the research pursuant to this section has 
                under the common rule waived the requirement to obtain 
                the informed consent of the human subjects in the 
                research; or
                    ``(B) the research is exempt from the requirement 
                under the common rule that the proposal for the 
                research be reviewed by such a Board.
            ``(2) Definitions.--For purposes of this subsection:
                    ``(A) The term `classified', with respect to human-
                subject research, refers to research that, within the 
                meaning of section 552(b)(1)(A) of title 5, United 
                States Code, is--
                            ``(i) specifically authorized under 
                        criteria established by an Executive order to 
                        be kept secret in the interest of national 
                        defense or foreign policy; and
                            ``(ii) is in fact properly classified 
                        pursuant to such Executive order.
                    ``(B) The terms `common rule' and `human-subject 
                research' have the meanings given such terms in section 
                491A.''.

SEC. 405. RULE OF CONSTRUCTION REGARDING INDIVIDUAL AGENCY OFFICES.

    The amendments made by this Act may not be construed as terminating 
any office or other administrative unit in a Federal agency that, on 
the day before the date of the enactment of this Act, had duties 
relating to the protection of human subjects in research conducted, 
supported, or otherwise subject to regulation under Federal law.

SEC. 406. NATIONAL BIOETHICS ADVISORY COMMISSION.

    (a) In General.--Title XVIII of the Public Health Service Act (42 
U.S.C. 300v et seq.) is amended to read as follows:

         ``TITLE XVIII--NATIONAL BIOETHICS ADVISORY COMMISSION

``SEC. 1801. NATIONAL BIOETHICS ADVISORY COMMISSION.

    ``(a) Establishment.--There is established the National Bioethics 
Advisory Commission (in this title referred to as the `Commission'), 
which shall provide advice and make recommendations to the President, 
Federal agencies, other appropriate entities, and the public on 
bioethical issues arising from the delivery of health care; research on 
human biology and behavior; and the applications, including the 
clinical applications, of that research. The Commission is governed by 
the provisions of the Federal Advisory Committee Act.
    ``(b) Function.--(1) The National Bioethics Advisory Commission 
shall advise, consult with, and make recommendations to the President, 
Federal agencies, and other appropriate entities, and also make 
available to the public the Commission's advice and recommendations. 
The Commission's purview includes the appropriateness of departmental, 
agency, or other governmental programs, policies, assignments, 
missions, guidelines, and regulations as they relate to bioethical 
issues arising from the delivery of health care; research on human 
biology and behavior; and applications, including the clinical 
applications, of that research. The Commission shall identify broad, 
overarching principles to govern the ethical conduct of research and 
the delivery of health care, citing individual projects only as 
illustrations for such principles. The Commission shall not be 
responsible for the review and approval of individual research 
projects.
    ``(2) In addition to responding to requests for advice and 
recommendations from the President, the Commission also may accept 
suggestions for issues for consideration from the Congress, Federal 
agencies, and the public. The Commission also may identify other 
bioethical issues for the purpose of providing advice and 
recommendations.
    ``(3) The Commission shall consider the following four criteria in 
establishing priority for its activities:
            ``(A) The public health or public policy urgency of the 
        bioethical issue.
            ``(B) The relation of the bioethical issue to the goals for 
        Federal investment in science and technology.
            ``(C) The absence of another body able to deliberate 
        fruitfully on the bioethical issue.
            ``(D) The extent of interest in the issue across the 
        Government.
In order to avoid duplication of effort, the Commission is encouraged 
to review the deliberations of other entities. The Commission may 
incorporate or otherwise use the results of the deliberations of other 
entities, as it deems appropriate.
    ``(c) Structure.--(1) The National Bioethics Advisory Commission 
shall consist of not more than 18 members including the Chairperson. 
Appointments shall be made by the President, who shall select from 
knowledgeable non-Government experts and community representatives with 
special qualifications and competence to deal effectively with 
bioethical issues. At least one member shall be selected from each of 
the following categories of primary expertise:
            ``(A) Philosophy/theology.
            ``(B) Social/behavioral science.
            ``(C) Law.
            ``(D) Medicine/allied health professions.
            ``(E) Biological research.
At least three members shall be selected from the general public, 
bringing to the Commission expertise other than that listed. The 
membership shall be approximately evenly balanced between scientists 
and nonscientists. Close attention will be given to equitable 
geographic distribution and to ethnic and gender representation.
    ``(2) Members of the Commission will serve for terms of 3 years and 
no more than 2 consecutive terms and may continue to serve after the 
expiration of their term until a successor is appointed. A member 
appointed to fill an unexpired term will be appointed to the remainder 
of such term. The Chairperson shall be appointed by the President. The 
term of office for the Chairperson shall be two years, renewable by 
appropriate action of the President. If a vacancy occurs on the 
Commission, the President shall make an appointment to fulfill the 
term. Any member appointed to fill a vacancy occurring prior to 
expiration of the term for which his or her predecessor was appointed 
shall serve for the remainder of such term. Members may serve after the 
expiration of their terms until their successors have taken office.
    ``(d) Administrative Provisions.--(1) The Commission may conduct 
inquiries, hold hearings and establish subcommittees, as necessary. The 
Commission is authorized to solicit information from relevant groups.
    ``(2) The Commission may appoint and fix the pay of such staff 
personnel as it deems desirable. Such personnel shall be appointed 
subject to the provisions of title 5, United States Code, governing 
appointments in the competitive service, and shall be paid in 
accordance with the provision of chapter 51 and subchapter III of 
chapter 53 of such title relating to classification and General 
Schedule pay rates.
    ``(3) The Commission shall appoint an Executive Director, who shall 
be paid at the level of the Senior Executive Service.
    ``(4) The Commission may procure temporary and intermittent 
services to the same extent as is authorized by section 3109(b) of 
title 5 of the United States Code, but at rates for individuals not to 
exceed the daily equivalent of the annual rate of basis pay in effect 
for grade GS-15 of the General Schedule.
    ``(5) Upon request of the Commission, the head of any Federal 
agency is authorized to detail, on a reimbursable basis, any of the 
personnel of such agency to the Commission to assist it in carrying out 
its duties under this title.
    ``(6) The Commission is authorized to conduct analyses and develop 
reports or other materials. In order to augment the expertise present 
on the Commission, the Commission is also authorized to contract for 
the services of nongovernmental consultants who may conduct analyses, 
prepare reports and background papers, or prepare other materials for 
consideration by the Commission, as appropriate.
    ``(7) The Commission may secure directly from any Federal agency 
information necessary to enable it to carry out this title. Upon 
request of the Chairman of the Commission, the head of such agency 
shall furnish such information to the Commission.
    ``(8) The Commission shall promptly arrange for such security 
clearances for its members and appropriate staff as are necessary to 
obtain access to classified information needed to carry out its duties 
under this title.
    ``(9) The Commission shall not disclose any information reported to 
or otherwise obtained by the Commission which is exempt from disclosure 
under subsection (a) of section 552 of title 5, United States Code, by 
reasons of paragraphs (4) and (6) of subsection (b) of such section.
    ``(10) The Administrator of General Services shall provide to the 
Commission on a reimbursable basis such administrative support services 
as the Commission may request.
    ``(e) Meetings.--Meetings of the Commission shall be held up to 12 
times a year at the call of the Chairperson. Meetings of the 
subcommittee(s) shall be convened as necessary. A Federal Government 
official shall be present at all meetings. Meetings shall be open to 
the public except as determined otherwise by the President. Advance 
notice of all meetings shall be given to the public. Meetings shall be 
conducted, and records of proceedings kept, as required by applicable 
laws and Federal regulations.
    ``(f) Compensation.--Members may be compensated at a rate not to 
exceed the maximum pay authorized by section 3109 of title 5, United 
States Code, plus per diem and travel expenses as in accordance with 
standard government travel regulations.
    ``(g) Reports.--(1) Reports by the Commission on specific issues 
shall be submitted to the President, the Congress, appropriate Federal 
agencies, and other appropriate entities. Within 60 days of the date a 
Federal agency receives a recommendation from the Commission that the 
agency take any action with respect to its rules, policies, guidelines, 
or regulations, the agency shall publish such recommendation in the 
Federal Register and shall provide opportunity for interested persons 
to submit written data, views, and arguments with respect to adoption 
of the recommendation. Within the 180-day period beginning on the date 
of such publication, the agency shall determine whether the action 
proposed by such recommendation is appropriate, and to the extent that 
it determines that--
            ``(A) such action is not appropriate, the agency shall, 
        within such time period, provide the Commission with, and 
        publish in the Federal Register, a notice of such determination 
        (including an adequate statement of the reasons for the 
        determination); or
            ``(B) such action is appropriate, the agency shall 
        undertake such action as expeditiously as feasible and shall 
        notify the Commission of the determination and the action 
        undertaken.
Executive summaries of each report of the Commission shall be published 
in the Federal Register or on the World Wide Web. Such summaries shall 
specifically list the agency to which any recommendations are directed 
and the date by which such responses are required.
    ``(2) An annual report shall be submitted to the President, the 
Congress, and appropriate Federal agencies. It shall contain, at a 
minimum--
            ``(A) the Commission's function;
            ``(B) a list of members and their business addresses;
            ``(C) the dates and places of meetings;
            ``(D) a summary of the Commission's activities during the 
        year;
            ``(E) a summary of the Commission's recommendations made 
        during the year; and
            ``(F) a summary of responses made by Federal agencies to 
        the Commission's recommendations during the year.
    ``(h) Authorization of Appropriations.--For the purposes of 
carrying out this section, there are authorized to be appropriated 
$5,000,000 for fiscal year 2001, and such sums as may be necessary for 
fiscal year 2002 and each subsequent fiscal year.''.
    (b) Study on Research Involving Children.--The National Bioethics 
Advisory Commission under section 1801 of the Public Health Service Act 
shall conduct a thorough review and report on the research involving--
            (1) the process of obtaining informed consent from parents 
        and children, including (A) the definitions of `informed 
        consent' and `assent', and (B) substitute decisionmaking, 
        including who can serve as a legally authorized representative 
        (as defined in subpart A of part 46 of title 45, Code of 
        Federal Regulations);
            (2) the requirements for what elements of information 
        should be disclosed to parents and children (such as risks and 
        benefits of, and alternatives to participation in, the research 
        project, and data of prior adverse events);
            (3) determining comprehension by parents and children of 
        the informed consent document, including the distinction 
        between research and therapeutic treatment;
            (4) the requirements of what additional measures should be 
        undertaken with respect to protecting children from undue risk;
            (5) the appropriateness of the regulations for children of 
        different ages, from infants to adolescents and emancipated 
        minors;
            (6) payment (financial and other) for research 
        participation; and
            (7) the unique roles and responsibilities of IRBs in 
        reviewing research involving children, including membership 
        composition.
                                 <all>