[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 3060 Introduced in Senate (IS)]







107th CONGRESS
  2d Session
                                S. 3060

To amend the Public Health Service Act to provide protections for human 
                       participants in research.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            October 4, 2002

  Mr. Kennedy introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act to provide protections for human 
                       participants 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 ``Research Revitalization Act of 
2002''.

SEC. 2. FINDINGS AND PURPOSES.

    (a) Findings.--The Congress finds as follows:
            (1) In 1948, through adoption of the Universal Declaration 
        of Human Rights, the nations of the world affirmed the 
        Nuremberg Code which required the ethical treatment of persons 
        who serve as human subjects in research.
            (2) In response to findings of intolerable ethical abuses 
        of human subjects in research sponsored by the Public Health 
        Service and other Federal agencies, Congress enacted the 
        National Research Act (Public Law 93-348) to provide ethical 
        protections for human subjects in Federally sponsored research 
        and to create the National Commission for the Protection of 
        Human Subjects of Biomedical and Behavioral Research.
            (3) The National Commission for the Protection of Human 
        Subjects of Biomedical and Behavioral Research issued the 
        Belmont Report, which stated that the treatment of human 
        subjects in research should be based on the principles of 
        respect for persons, beneficence, and justice.
            (4) In 1981, the Department of Health and Human Services 
        published regulations (part 46 of title 45, Code of Federal 
        Regulations) to protect human participants in research that 
        were based on the principles developed by the Commission.
            (5) Some agencies of the Federal government sponsor 
        research involving human participants, but these agencies have 
        not adopted human participant protections or vulnerable-
        populations protections as provided for in part 46 of title 45, 
        Code of Federal Regulations, specifically subparts B, C, and D.
            (6) Research institutions that receive Federal funds for 
        conducting research involving human participants 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.
            (7) No provision of United States law explicitly requires 
        that informed consent and independent review of all research 
        involving human participants be obtained.
            (8) Numerous experts report and reviews have found that the 
        current system of protections for human participants needs to 
        be revitalized and enhanced to keep pace with the changing 
        nature of research.
            (9) 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 participants. In particular, the Committee 
        found that some consent forms currently in use are flawed in 
        morally significant aspects.
            (10) In 1998 and 2000, the Department of Health and Human 
        Services's Inspector General found that the effectiveness of 
        the Institutional Review Board system was ``in jeopardy'' and 
        attention needed to be directed to enhancing human participant 
        protections for a widening scope of clinical investigation.
            (11) The Inspector General found that Institutional Review 
        Boards ``review too much, too quickly, with too little 
        expertise''.
            (12) In its report on research conducted within the United 
        States, the National Bioethics Advisory Commission recommended 
        significant revisions to the current oversight structure for 
        the protection of research participants. Among other 
        recommendations, the Commission recommended establishing a 
        central office for Federal policy on research participant 
        protections, enacting legislation to ensure that all human 
        participants are covered by ethical protections regardless of 
        the funding source that supports the research, as well as new 
        policies to revitalize Institutional Review Boards.
            (13) In its report on international research, the National 
        Bioethics Advisory Commission found that investigators have 
        special responsibilities when conducting research on 
        participants from economically less developed communities. 
        These responsibilities include the need to ensure adequately 
        the provision of informed consent in diverse communities and 
        the consideration of whether participants will benefit from the 
        results of such research when it is concluded.
            (14) In light of this and other evidence, legislation is 
        required to enhance the current system for protecting research 
        participants so that--
                    (A) the safety and wellbeing of human participants 
                is properly safeguarded; and
                    (B) research involving human participants can 
                continue to enhance knowledge and progress.
            (15)(A) Entities conducting and sponsoring research 
        involving human participants engage in and affect interstate 
        commerce.
            (B) Information obtained through research involving human 
        participants affects products and services that move in 
        interstate commerce.
            (C) Human participants travel regularly across State lines 
        in order to become involved in research involving human 
        participants.
            (D) Institutions at which research involving human 
        participants is conducted employ scientists, doctors, 
        researchers, and other staff in an interstate market, and 
        contract for research and supplies in an interstate market.
            (E) Sponsors of research involving human participants buy 
        and sell products and services in an interstate market.
    (b) Purpose.--The purposes of this Act are--
            (1) to provide a comprehensive set of protections for human 
        participants in research;
            (2) to promote more effective oversight of research 
        involving human participants;
            (3) to prevent improper financial conflicts of interest by 
        those conducting or providing for the ethical oversight of 
        research; and
            (4) to provide effective oversight of research involving 
        human participants that is conducted outside the borders of the 
        United States, but is otherwise subject to the regulatory 
        authority of the United States.

                 TITLE I--HUMAN PARTICIPANT PROTECTIONS

SEC. 101. CONSISTENT NATIONAL APPLICABILITY OF STANDARDS TO PROTECT 
              HUMAN PARTICIPANT IN RESEARCH, ESTABLISHMENT OF A 
              NATIONAL OFFICE OF HUMAN RESEARCH PROTECTIONS.

    Section 491 of the Public Health Service Act (42 U.S.C. 289) is 
amended to read as follows:

``SEC. 491. CONSISTENT NATIONAL APPLICABILITY OF STANDARDS TO PROTECT 
              HUMAN PARTICIPANT IN RESEARCH, ESTABLISHMENT OF A 
              NATIONAL OFFICE OF HUMAN RESEARCH PROTECTIONS.

    ``(a) Ethical Principles for the Conduct of Research Involving 
Human Participants.--It is the policy of Congress that all research 
involving human subjects (that is conducted in the United States, 
funded by the United States Government, or that is subject to Federal 
regulatory review) should be conducted so as to ensure that--
            ``(1) the foreseeable risks have been weighed against the 
        anticipated benefits and the risks are determined to be 
        reasonable and justified by the potential benefits that may 
        result;
            ``(2) the rights and welfare of the participant, including 
        privacy and the protection of the data concerning such 
        participant, are safeguarded;
            ``(3) in the case of research that involves more than 
        minimal risk to a human participant or participants enrolled in 
        such research, there is a reasonable likelihood that the 
        populations in which the covered research is conducted will 
        benefit from the results of the research;
            ``(4) the participant may, without any resulting reprisal, 
        withdraw from the covered research at any time by revoking his 
        or her informed consent;
            ``(5) informed consent in the appropriate manner has been 
        obtained;
            ``(6) situations that may render a participant vulnerable 
        to harm or coercion are identified and minimized; and
            ``(7) those with responsibility for ensuring the welfare of 
        research participants are not subject to conflicts of interest 
        that may impair their ability to discharge that responsibility 
        effectively.
    ``(b) Consistent National Applicability of Standards To Protect 
Human Participants in Research.--Effective beginning on June 1, 2005, 
no covered research may be conducted unless it is in accordance with--
            ``(1) the provisions of part 46 (including all subparts) of 
        title 45, Code of Federal Regulations (referred to in this part 
        as `the common rule'), as in effect on June 1, 2003; and
            ``(2) any amendments to such provisions under subsection 
        (d).
    ``(c) Office of Human Research Protections.--
            ``(1) Establishment.--There is established within the 
        Department of Health and Human Services an office to be known 
        as the Office of Human Research Protections (in this section 
        referred to as the `Office').
            ``(2) Director.--The Office shall be headed by a Director 
        who shall be appointed by the Secretary, with the advice and 
        consent of the Senate including submission of the nomination to 
        the Committee on Health, Education, Labor, and Pensions of the 
        Senate for appropriate hearings. The term of office of the 
        Director shall be 6 years, except that the Secretary may remove 
        a Director who fails to carry out the duties of the Director in 
        good conduct. An individual may be appointed to the office of 
        Director for no more than 2 terms.
    ``(d) Amendments to the Common Rule.--
            ``(1) In general.--The Director may by regulation amend the 
        provisions of the common rule, except to the extent that any 
        such amendment is in conflict with this section or any of 
        sections 491A, 491B, 492B, and 492C.
            ``(2) Consultations.--In promulgating regulations under 
        paragraph (1), the Director shall, to the maximum extent 
        practicable, consult with--
                    ``(A) the Advisory Committee under subsection (e); 
                and
                    ``(B) the Human Subjects Research Subcommittee of 
                the National Science and Technology Council (or any 
                successor to such Subcommittee) to the extent that such 
                subcommittee is conducting business or meetings.
            ``(3) Authority for determinations.--The Director may 
        promulgate regulations under this subsection regarding--
                    ``(A) whether research is covered research under 
                the meaning given that term under section 492B(h)(2); 
                and
                    ``(B) whether covered research involves greater 
                than minimal risk under the meaning given that term 
                under section 492B(h)(8) and  is therefore eligible for 
administrative review as specified in section 491A(c)(1).
            ``(4) Congressional findings.--
                    ``(A) Finding regarding research that involves less 
                than minimal risk.--Congress finds that much--
                            ``(i) social science research; and
                            ``(ii) other research that does not 
                        involve--
                                    ``(I) the introduction of foreign 
                                substances into the body of a human 
                                participant or participants;
                                    ``(II) significant alterations of 
                                the physical or sensory environment of 
                                a human participant or participants; or
                                    ``(III) significant risks to the 
                                privacy, dignity, or economic wellbeing 
                                of a human participant or participants;
                is likely to involve less than minimal risk under the 
                meaning of that term under section 492B(h)(8).
                    ``(B) Finding regarding research involving 
                individuals who have undergone trauma.--Congress finds 
                that--
                            ``(i) in circumstances in which an 
                        individual has undergone trauma, research 
                        involving the individual often cannot 
                        practically be carried out with the consent of 
                        the individual; and
                            ``(ii) in such limited circumstances, there 
                        are acceptable alternative means of obtaining 
                        consent, as described in section 50.24 of title 
                        21, Code of Federal Regulations (as in effect 
                        on the day before the date of enactment of the 
                        Research Revitalization Act of 2001).
            ``(5) Recognition of finding.--The Director shall 
        consider--
                    ``(A) the finding under paragraph (4)(A) in 
                promulgating regulations under paragraph (3)(B); and
                    ``(B) the finding under paragraph (4)(B) in 
                promulgating regulations regarding informed consent 
                under paragraph (1).
    ``(e) Advisory Committee.--The Secretary shall establish a National 
Human Research Protections Advisory Committee to serve as an Advisory 
Committee for purposes of providing expert advice and counsel to the 
Secretary on issues relating to or associated with the protection of 
human research participants.
    ``(f) Certain Administrative Authorities.--In carrying out this 
section and sections 491A and 491B, the Director of the Office may--
            ``(1) appoint and fix the compensation of officers and 
        employees for the Office in accordance with chapter 51 of title 
        5, United States Code, and subchapter III of chapter 53 of such 
        title;
            ``(2) acquire, without regard to the Act of March 3, 1877 
        (40 U.S.C. 34), by lease or otherwise through the Administrator 
        of General Services, buildings or portions of buildings in the 
        District of Columbia or communities located adjacent to the 
        District of Columbia for use for a period not to exceed 10 
        years;
            ``(3) enter into contracts, subject to the availability of 
        amounts made available in appropriations Acts, including 
        contracts for financial and administrative services (such as 
        budget and accounting, financial reporting, personnel, and 
        procurement), with the General Services Administration, or such 
        other Federal agencies as the Director of the Office determines 
        to be appropriate;
            ``(4) use, with their consent, the services, equipment, 
        personnel, information, and facilities of other Federal, State, 
        or local public agencies, with or without reimbursement;
            ``(5) in accordance with section 3109 of title 5, United 
        States Code, obtain the assistance and advice of experts and 
        consultants;
            ``(6) accept voluntary and uncompensated service; and
            ``(7) award grants or enter into cooperative agreements 
        to--
                    ``(A) improve the training of investigators in the 
                principles or practice of human participant 
                protections;
                    ``(B) enhance the function of Institutional Review 
                Boards; or
                    ``(C) otherwise improve human participant 
                protections.
    ``(g) Rule of Construction.--
            ``(1) Effect on existing law.--Effective beginning on June 
        1, 2005, the provisions of part 46 (including all subparts) of 
        title 45, Code of Federal Regulations, as amended under 
        subsection (d), shall be construed to supersede such other 
        Federal laws or regulations relating to the protection of human 
        participants in research as may have been in effect prior to 
        such date.
            ``(2) Office or administrative units.--The provisions of 
        this section, and sections 491A and 491B, shall allow for, but 
        not be construed as requiring, the termination of any office or 
        other administrative unit in a Federal agency that, on the day 
        before the date of the enactment of the Research Revitalization 
        Act of 2002, had duties relating to the protection of human 
        participants in research conducted, supported, or otherwise 
        subject to regulation under Federal law.
    ``(h) Authorization of Appropriations.--For the purposes of 
carrying out this section, there are authorized to be appropriated 
$20,000,000 for fiscal year 2003, and such sums as may be necessary for 
each subsequent fiscal year.''.

  TITLE II--IMPROVING THE EFFECTIVENESS OF INSTITUTIONAL REVIEW BOARDS

SEC. 201. IMPROVING THE EFFECTIVENESS OF INSTITUTIONAL REVIEW BOARDS.

    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:

``SEC. 491A. IMPROVING THE EFFECTIVENESS OF INSTITUTIONAL REVIEW 
              BOARDS.

    ``(a) Institutional Review Boards.--Each institution at which 
covered research is conducted shall establish or enter into a 
contractual association with a board (to be known as an `Institutional 
Review Board') or boards under which the board will review covered 
research conducted or supported by such institution in order to protect 
the rights of the human participants enrolled in such research.
    ``(b) Requirement for Review.--No investigator shall conduct 
covered research unless--
            ``(1) such research shall have been reviewed by and 
        recommended for approval by an Institutional Review Board that 
        is established at or contractually associated with the 
        institution at which such covered research is to be conducted, 
        except as provided for in subsection (c); and
            ``(2) with respect to covered research involving greater 
        than minimal risk, policies and practices have been implemented 
        that effectively monitor such research and safeguard against 
        significant dangers to the health and welfare of a human 
        participant or participants due to participation in such 
        research.
    ``(c) Administrative Review.--
            ``(1) In general.--If a proposal to conduct covered 
        research that is submitted for review to an Institutional 
        Review Board conforms to conditions established by the Director 
        under section 491(d)(3), the chair of such Board may select a 
        member or members of such Board to review such proposal in lieu 
        of requiring review by the full Board.
            ``(2) Approval.--A proposal to conduct covered research 
        that is reviewed as provided for in paragraph (1) shall be 
        deemed to be in compliance with the requirements of subsection 
        (b)(1) if such proposal has been approved by the member of the 
        Board selected to review such research.
    ``(d) Accreditation of Institutional Review Boards.--Effective 
beginning on the date that is 6 years after the date of enactment of 
this section, no investigator shall conduct covered research unless 
such research shall have been approved by an Institutional Review Board 
that--
            ``(1) meets the requirements of subsection (b); and
            ``(2) is accredited--
                    ``(A) by the Director for the purposes of reviewing 
                such research pursuant to subsection (e); or
                    ``(B) by an accrediting body pursuant to subsection 
                (f).
    ``(e) Basis for Accreditation.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this section, the Director, in consultation with 
        the entities described in section 491(d)(2), shall by 
        regulation establish standards for the accreditation of 
        Institutional Review Boards.
            ``(2) Requirements.--In establishing standards pursuant to 
        paragraph (1), the Director shall require that, to be 
        accredited, an Institutional Review Board shall--
                    ``(A) have members with sufficient expertise or 
                experience to adequately review covered research at the 
                institution or institutions with respect to which the 
                Board is established or contractually associated;
                    ``(B) have programs or practices that adequately 
                educate members on principles and procedures of human 
                participant protection;
                    ``(C) adequately insulate decisions of the Board 
                from improper financial or other conflicts of interest;
                    ``(D) ensure that covered research that is reviewed 
                by such Board is conducted consistent with the ethical 
                principles described in section 491(a);
                    ``(E) adequately review the process of informed 
                consent and, for research involving greater than 
                minimal risk to a human participant or participants, 
                adequately monitor ongoing research;
                    ``(F) grant waivers only in accordance with section 
                492B(c); and
                    ``(G) conform to such other conditions as may be 
                specified by the Director.
            ``(3) Standards applicable to certain research.--In 
        establishing standards under paragraph (1), the Director may, 
        by regulation, establish certain additional standards required 
        to be met by--
                    ``(A) Boards that review covered research conducted 
                in countries not listed pursuant to subsection (m); or
                    ``(B) Cooperative Review Boards, as described in 
                subsection (l).
    ``(f) Accrediting Body.--
            ``(1) In general.--The Director may designate an outside 
        entity or entities (to be known as an `accrediting body') to 
        conduct an accreditation described in subsections (d) and (e), 
        if--
                    ``(A) the accrediting body meets standards 
                established by the Director through regulation; and
                    ``(B) the Director, based upon an annual 
                evaluation, determines that the performance of the 
                accrediting body is appropriate and acceptable.
            ``(2) Withdrawal of designation.--The Director may at any 
        time withdraw the designation of an entity or entities as an 
        accrediting body if the Director determines that the entity or 
        entities does not meet the standards established pursuant to 
        subsection (e).
    ``(g) Suspension and Revocation.--The Director may suspend or 
revoke the accreditation of an Institutional Review Board, or impose 
other restrictions on covered research conducted at the institution 
with respect to which such Board is established or with which the Board 
is contractually associated--
            ``(1) after the provision--
                    ``(A) of a notice of intent to apply such 
                suspension or revocation by the Director to the 
                chairperson of such Board and to the chief executive 
                officer of the institution with respect to which the 
                Board is established or with which the Board is 
contractually associated; and
                    ``(B) of an adequate opportunity for a hearing with 
                respect to the action described in the notice; or
            ``(2) immediately, or at such time as the Director may 
        determine appropriate, if, in the determination of the 
        Director, there is occurring, or there is likely to imminently 
        occur, significant and unreasonable harm to the health or 
        welfare of a human participant or human participants involved 
        in research reviewed by such Board.
    ``(h) Notification of Institutional Review Board.--
            ``(1) Investigators.--In submitting to an Institutional 
        Review Board a proposal to conduct covered research, the 
        investigator or investigators conducting such research shall 
        notify the Board--
                    ``(A) whether such proposal, or a proposal 
                substantially similar to such proposal, has been 
                submitted by such investigator or investigators 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 such investigators have been 
                disqualified or restricted by any Federal entity in 
                their ability to conduct covered research within the 
                preceding 10 years.
            ``(2) Sponsors.--
                    ``(A) In general.--Each sponsor of a proposal to 
                conduct covered research shall notify the Institutional 
                Review Board reviewing such research whether such 
                sponsor has been disqualified or restricted by any 
                Federal entity in their ability to conduct covered 
                research within the preceding 10 years.
                    ``(B) Rule of construction.--For purposes of 
                subparagraph (A), a Federal department or agency shall 
                not be considered a sponsor of a proposal to conduct 
                covered research.
            ``(3) Institutions.--Each institution or institutions at 
        which a project of covered research is proposed to be conducted 
        shall notify the Institutional Review Board reviewing such 
        research whether such institution has been disqualified or 
        restricted by any Federal entity in their ability to conduct 
        covered research within the preceding 10 years.
    ``(i) Activities.--
            ``(1) Data.--The Director shall collect and maintain data 
        on the number of projects of covered research involving greater 
        than a minimal risk, the number of human participants enrolled 
        in such research, the number of waivers granted under section 
        492B(c), and such other information as may, as determined by 
        the Director, be necessary to assess the protection of human 
        participants.
            ``(2) Report.--The Director shall annually submit reports 
        to the appropriate committees of Congress on the data collected 
        under paragraph (1).
    ``(j) Cost Recovery.--Institutions may recover costs associated 
with compliance with human participant protections from sponsors of 
such research that are Federal agencies as direct costs.
    ``(k) Demonstration Grants.--
            ``(1) In general.--The Secretary may award demonstration 
        grants, on a competitive basis, to eligible entities to permit 
        such entities to improve, enhance, or refine the functioning of 
        Institutional Review Boards, consistent with the common rule, 
        this section, section 492A, and applicable State and local 
        laws.
            ``(2) Activities.--Activities to be supported under grants 
        under paragraph (1) may include--
                    ``(A) developing, enhancing, or establishing 
                administrative procedures that facilitate cooperative 
                Institutional Review Board review of applications to 
                conduct research on human participants;
                    ``(B) improving coordination and collaboration 
                among Institutional Review Boards in the review of 
                research conducted at more than one institution or 
                site; and
                    ``(C) other activities that improve the functions 
                of Institutional Review Boards, as determined 
                appropriate by the Secretary.
            ``(3) Eligible entities.--Entities eligible to receive 
        grants under paragraph (1) shall include hospitals, academic 
        institutions, and other public or private not for profit 
        entities.
            ``(4) Authorization of appropriations.--For carrying out 
        the activities described in this subsection, there are 
        authorized to be appropriated $15,000,000 for fiscal year 2003, 
        and such sums as may be necessary for each of fiscal years 2004 
        and 2005.
    ``(l) Voluntary Cooperative Review for Multi-Site Research.--
            ``(1) Election of cooperative review.--An Institutional 
        Review Board established at or in contractual association with 
        an institution at which multi-site research is proposed to be 
        conducted may, with the consent of the sponsor of such 
        research, voluntarily authorize a Cooperative Review Board to 
        review a proposal to conduct such multi-site research.
            ``(2) Limitations.--An Institutional Review Board entering 
        into a cooperative agreement that is authorized under paragraph 
        (1) shall--
                    ``(A) retain final authority to approve or reject a 
                proposal to conduct covered research at the institution 
                at which such Board is established, or with which such 
                Board is contractually associated;
                    ``(B) not amend, or cause to be amended, a proposal 
                to conduct multi-site research that has been approved 
                by a Cooperative Review Board established under 
                paragraph (6) unless such amendments are required to 
                comply with State or local law; and
                    ``(C) conduct such activities as are required to 
                monitor and ensure the safety of covered research that 
                is reviewed by such Board  and conducted at the 
institution at which such Board is established or with which such Board 
is contractually associated.
            ``(3) Research deemed to meet requirements.--Multi-site 
        research shall be deemed to meet the requirement for review 
        established under subsection (b)(1) if such research is 
        recommended for approval by a majority of the members of a 
        Cooperative Review Board.
            ``(4) Definition.--In this section, the term `Cooperative 
        Review Board' means an Institutional Review Board that reviews 
        covered research that is conducted at more than one institution 
        and that conforms to such conditions as the Director may by 
        regulation specify in accordance with subsection (e)(3).
            ``(5) Additional boards established by secretary.--The 
        Secretary shall establish one or more Cooperative Review Boards 
        in accordance with this subsection and with such regulations as 
        may be promulgated by the Director under subsection (e)(3).
    ``(m) Federally Sponsored or Regulated Research Conduct Overseas.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of the Research Revitalization Act of 2002, and every 
        5 years thereafter, the Director, in consultation with the 
        Secretary of State, shall determine and publish a list of those 
        foreign countries in which protections for human research 
        participants are substantially equivalent to those of the 
        United States.
            ``(2) Requirement for review.--
                    ``(A) Countries on the list.--Effective beginning 
                on the date that is 3 years after the date of enactment 
                of the Research Revitalization Act of 2002, no 
                investigator shall conduct research described in 
                section 492B(h)(2)(A) or 492B(h)(2)(B) in a country 
                listed by the Director pursuant to paragraph (1) unless 
                a proposal to conduct such research shall have been 
                submitted to and approved by an ethics review board 
                authorized to review such research in the country in 
                which it is to be conducted.
                    ``(B) Countries not on the list.--Effective 
                beginning on the date that is 3 years after the date of 
                enactment of the Research Revitalization Act of 2002, 
                no investigator shall conduct research described in 
                section 492B(h)(2)(A) or 492B(h)(2)(B) involving 
                greater than minimal risk in a country not listed by 
                the Director pursuant to paragraph (1) unless a 
                proposal to conduct such research shall have been 
                submitted to and approved by--
                            ``(i) an ethics review committee authorized 
                        to review such research in the country in which 
                        it is to be conducted, if such a committee 
                        exists; and
                            ``(ii) an Institutional Review Board that--
                                    ``(I) has been accredited to review 
                                covered research, pursuant to 
                                subsection (d); and
                                    ``(II) conforms to such other 
                                conditions as the Director may 
                                establish by regulation under 
                                subsection (b)(3)(A).
    ``(n) Data and Safety Monitoring Board.--
            ``(1) In general.--The Director may by regulation require 
        the establishment of a Data and Safety Monitoring Board (or an 
        equivalent committee) to provide enhanced oversight for areas 
        of research that, in the determination of the Director--
                    ``(A) involve novel techniques, methods, or 
                materials;
                    ``(B) pose special concerns to the health or 
                welfare of human participants enrolled in such 
                research; and
                    ``(C) involve greater than minimal risk to human 
                participants enrolled in such research.
            ``(2) Limitations.--The limitations on participation 
        applicable to a member of an Institutional Review Board under 
        section 492B(b)(2) shall apply to members of a Data Safety and 
        Monitoring Board (or equivalent committee) established under 
        paragraph (1).''.

SEC. 202. CLERICAL AMENDMENT; RULE OF CONSTRUCTION; SEVERABILITY.

    (a) Clerical Amendment.--Section 492A(a) of the Public Health 
Service Act (42 U.S.C. 289a-1(a)(1)) is amended by striking paragraph 
(1).
    (b) Rule of Construction Concerning Preemption.--Nothing in this 
Act, or an amendment made by this Act, shall be construed to preempt 
any provision of State law that provides protections to human research 
subjects that are equal to or greater than the protections provided for 
in this Act or amendments.
    (c) Severability.--If any provision of this Act, an amendment made 
by this Act, or the application of such provision or amendment to any 
person or circumstance is held to be unconstitutional, the remainder of 
this Act, the amendments made by this Act, and the application of the 
provisions of such to any person or circumstance shall not be affected 
thereby.

           TITLE III--IMPROVING THE TRAINING OF INVESTIGATORS

SEC. 301. IMPROVING THE TRAINING OF INVESTIGATORS.

    Part H of title IV of the Public Health Service Act (42 U.S.C. 289 
et seq.) is amended by inserting after section 491A (as added by 
section 201) the following:

``SEC. 491B. IMPROVING THE TRAINING OF INVESTIGATORS.

    ``(a) Payment for Recruitment of Participants.--
            ``(1) Regulations.--While recognizing that payment of human 
        participants may at times be necessary and appropriate, not 
        later than 1 year after the date of enactment of this section, 
        the Director, in consultation with the Advisory Committee 
        established under section 491A(d) and such Federal officials as 
        may be necessary, shall promulgate regulations regarding 
        payments for the recruitment or participation of human 
        participants in covered research.
            ``(2) Requirements of regulations.--Regulations established 
        under paragraph (1) shall specify the amount of payments or 
        conditions under which such payments may be made that shall be 
        considered by an Institutional Review Board to be incompatible 
        with the principles of section 491(a).
    ``(b) Disclosure in Publication.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this section, the Secretary shall by regulation 
        require that each applicant for a grant, contract or 
        cooperative agreement which is administered by the Secretary 
        include in its application or contract proposal assurances 
        satisfactory to the Secretary that such applicant shall, upon 
        publication in a peer-reviewed medium of the results of or a 
        description of the research that is the subject of such 
        application--
                    ``(A) disclose to the editors or publishers of such 
                publication whether such applicant holds a significant 
                investment interest in any financially interested 
                entity that is, in whole or in part, the sponsor of 
                such research; and
                    ``(B) disclose to the editors or publishers of such 
                publication whether such applicant has received 
                significant income from any financially interested 
                entity that is in whole or in part the sponsor of such 
                research.
            ``(2) Recommendation of congress.--It is the recommendation 
        of Congress that editors and publishers of peer-reviewed 
        publications in which the results of research conducted by 
        recipients of awards from the Secretary are published should 
        include a description of the information described in 
        subparagraph (A) and (B) of paragraph (1) with respect to such 
        research when such results are published.
            ``(3) Actions of the secretary.--Consistent with existing 
        legal authority, the Secretary shall take action to promote the 
        implementation of the recommendation described in paragraph 
        (2).
    ``(c) Placebos.--
            ``(1) Regulations.--Not later than 1 year after the date of 
        enactment of the Research Revitalization Act of 2002, the 
        Director shall promulgate regulations regarding the appropriate 
        use of placebos or nontreatment in covered research.
            ``(2) Requirements.--In promulgating regulations under 
        paragraph (1), the Director shall require that a placebo or 
        nontreatment may not be used in such research if--
                    ``(A) another treatment that is available to the 
                investigator and has been shown to be effective could 
                reasonably be provided to a human participant or 
                participants in such research; and
                    ``(B) there is risk of significant harm to a human 
                participant or participants in such research in the 
                absence of treatment or following administration of a 
                placebo.
    ``(d) Authorization of Appropriations.--For the purposes of 
carrying out this section, there are authorized to be appropriated such 
sums as may be necessary for fiscal year 2003 and for each subsequent 
fiscal year.''.

               TITLE IV--FINANCIAL CONFLICTS OF INTEREST

SEC. 401. FINANCIAL CONFLICTS OF INTEREST.

    Part H of title IV of the Public Health Service Act (42 U.S.C. 289 
et seq.) is amended--
            (1) by redesignating section 492B as section 492D; and
            (2) by inserting after section 492A, the following:

``SEC. 492B. FINANCIAL CONFLICTS OF INTEREST.

    ``(a) Disclosure of Potential Financial Conflicts of Interests.--
            ``(1) Investigators.--
                    ``(A) In general.--An investigator submitting to an 
                Institutional Review Board an application to conduct 
                covered research shall disclose to such Board--
                            ``(i) all significant income received by 
                        such investigator from a financially interested 
                        entity that is, in whole or in part, the 
                        sponsor of such research; and
                            ``(ii) all significant investment interests 
                        owned or controlled by such investigator, in a 
                        financially interested entity that is, in whole 
                        or in part, the sponsor of such research.
                    ``(B) Optional role of conflict of interest 
                committee.--An Institutional Review Board may deem an 
                investigator to have complied with the requirements of 
                subparagraph (A) if such investigator shall have 
                submitted the information described in such 
                subparagraph to a conflict of interest committee that 
                is established at the institution with respect to which 
                the Institutional Review Board is established or 
                associated, so long as the conflict of interest 
                committee provides a summary of such information to 
                such Institutional Review Board, including a 
                determination based on such information as to whether a 
                significant income or a significant investment interest 
                exists.
            ``(2) Board members.--
                    ``(A) In general.--A member of an Institutional 
                Review Board shall disclose to such Board--
                            ``(i) all significant income received by 
                        such member from a financially interested 
                        entity that is, in whole or in part, the 
                        sponsor of any covered research reviewed by 
                        such Board; and
                            ``(ii) all significant investment interests 
                        owned or controlled by such member, in a 
                        financially interested entity that is, in whole 
                        or in part, the sponsor of any covered research 
                        reviewed by such Board.
                    ``(B) Optional role of conflict of interest 
                committee.--An Institutional Review Board may deem a 
                board member to have complied with the requirements of 
                subparagraph (A) if such member shall have submitted 
                the information described in such subparagraph to a 
                conflict of interest committee that is established at 
the institution with respect to which the Institutional Review Board is 
established or associated, so long as the conflict of interest 
committee provides a summary of such information to such Institutional 
Review Board, including a determination based on such information as to 
whether a significant income or a significant investment interest 
exists.
            ``(3) Updated information.--If the information described in 
        paragraphs (1) or (2) with respect to an investigator or Board 
        member substantially changes subsequent to the date on which 
        such information is submitted to the Institutional Review Board 
        as described in either such paragraph, or to a conflict of 
        interest committee, such investigator or Board member shall 
        provide such Institutional Review Board or conflict of interest 
        committee, as appropriate, with a statement describing such 
        changes as soon as practicable following the date of such 
        change.
    ``(b) Protection Against Financial Conflicts of Interest.--
            ``(1) Investigators.--Unless an Institutional Review Board 
        determines that the compelling circumstances described in 
        subsection (c) exist, such Institutional Review Board shall not 
        approve, and an investigator shall not conduct, covered 
        research involving greater than minimal risk if, based on 
        information provided under subsection (a)(1)(A) or based on a 
        summary of such information provided by a conflict of interest 
        committee under subsection (a)(1)(B), or based on other 
        reasonable criteria, such Institutional Review Board determines 
        that an investigator directly participating in such research--
                    ``(A) owns or controls a significant investment 
                interest in a financially interested entity that is in 
                whole or in part, the sponsor of such research; or
                    ``(B) receives significant income from a 
                financially interested entity that is, in whole or in 
                part, the sponsor of such research.
            ``(2) Board members.--A member of an Institutional Review 
        Board shall not participate in the review of covered research 
        involving greater than minimal risk if, based on information 
        provided under subsection (a)(2)(A) or based on a summary of 
        such information provided by a conflict of interest committee 
        under subsection (a)(2)(B), or based on other reasonable 
        criteria, such Institutional Review Board determines that the 
        Board member--
                    ``(A) owns or controls a significant investment 
                interest in a financially interested entity that is in 
                whole or in part, the sponsor of such research; or
                    ``(B) receives significant income from a 
                financially interested entity that is, in whole or in 
                part, the sponsor of such research.
    ``(c) Compelling Circumstances.--
            ``(1) In general.--An Institutional Review Board may waive 
        the requirements of subsection (b)(1) with respect to an 
        investigator proposing to conduct covered research, and an 
        investigator may conduct such research, if such Institutional 
        Review Board determines that there exist compelling 
        circumstances as described in paragraph (2) that justify such a 
        waiver.
            ``(2) Determinations.--With respect to an investigator, a 
        waiver may be granted under paragraph (1) only if the 
        Institutional Review Board finds that--
                    ``(A) the investigator who is the subject of the 
                waiver is uniquely qualified to conduct such research;
                    ``(B) such research could not safely or practicably 
                be conducted in the absence of such waiver;
                    ``(C) the significance of such research is 
                sufficient to justify such waiver; and
                    ``(D) no human participant in such research is 
                reasonably likely to suffer significant or unreasonable 
                harm as a result to the granting of such waiver.
    ``(d) Declaration of Financial Interests to Research 
Participants.--If an Institutional Review Board grants a waiver under 
subsection (c) with respect to an investigator conducting a project of 
covered research, such Institutional Review Board shall require that 
all human participants who are considering enrolling in such research 
be provided, as part of the informed consent process, with information, 
in such form as may be deemed appropriate by such Institutional Review 
Board, that clearly indicates that an investigator directly involved in 
the conduct of such research--
            ``(1) owns or controls a significant investment interest in 
        a financially interested entity that is in whole or in part, 
        the sponsor of such research; or
            ``(2) receives significant income from a financially 
        interested entity that is, in whole or in part, the sponsor of 
        such research.
    ``(e) Additional Safeguards.--If an Institutional Review Board 
grants a waiver under subsection (c) with respect to an investigator 
conducting a project of covered research, such Institutional Review 
Board shall require that the investigator or investigators conducting 
such research institute additional measures to safeguard the health and 
welfare of human participants enrolled in such research. Such measures 
may include--
            ``(1) audits of the informed consent process;
            ``(2) requirements that a disinterested observer monitor 
        the informed consent process;
            ``(3) the establishment of a data safety monitoring board;
            ``(4) requirements that an investigator place certain 
        financial interests in escrow prior to the conduct of such 
        research; or
            ``(5) such other measures as may be determined by such 
        Institutional Review Board to be reasonable and necessary.
    ``(f) Rule of Construction.--Subsections (a) and (b) shall not be 
construed to limit the authority of an Institutional Review Board to 
require--
            ``(1) disclosure of income or investment interests other 
        than those described in such subsection;
            ``(2) disclosure of income or investment interests to human 
        participants involved in covered research; or
            ``(3) adherence to such other procedures as may be 
        necessary to comply with section 491.
    ``(g) Institutional Conflicts of Interest.--Not later than 2 years 
after the date of enactment of the Research Revitalization Act of 2002, 
the Director, in collaboration with the advisory committee described in 
section 491(e), and with scientific, medical, and academic professional 
organizations, shall promulgate regulations to limit improper conflicts 
of interest that may affect research involving human participants that 
may arise as a result of investments made by educational or other not-
for-profit institutions at which covered research is conducted in a 
financially interested entity that is, in whole or in part, the sponsor 
of such research.
    ``(h) Definitions.--In this section, and sections 491, 491A, 491B, 
492B, and 492C:
            ``(1) Financially interested entity.--The term `financially 
        interested entity' means any entity with financial interests 
        that would reasonably appear to be affected by the conduct or 
        outcome of a project of covered research. Such term shall not 
        include any Federal agency.
            ``(2) Covered research.--The term `covered research' means 
        research that is conducted using one or more human 
        participants, and that--
                    ``(A) is--
                            ``(i) conducted or supported by a Federal 
                        agency; and
                            ``(ii) not described in subsection 101(b) 
                        of part 46 of title 45, Code of Federal 
                        Regulations (as in effect on the day before the 
                        date of enactment of the Research 
                        Revitalization Act of 2001);
                    ``(B) is not described in subparagraph (A), and 
                that--
                            ``(i) is otherwise subject to regulation 
                        under a provision of Federal law (other than 
                        this section), including research that forms 
                        part of an investigational new drug under 
                        section 505 of the Food, Drug, and Cosmetics 
                        Act, a class III device under section 515 of 
                        such Act, or a biological product under section 
                        351 of the Public Health Service Act; and
                            ``(ii) is not described in subsection 
                        101(b) of part 46 of title 45, Code of Federal 
                        Regulations (as in effect on the day before the 
                        date of enactment of the Research 
                        Revitalization Act of 2001); or
                    ``(C) is not described in subparagraph (A) or (B), 
                and that--
                            ``(i) has activities that are in or that 
                        affect interstate commerce;
                            ``(ii) is not described in subsection 
                        101(b) of part 46 of title 45, Code of Federal 
                        Regulations (as in effect on the day before the 
                        date of enactment of the Research 
                        Revitalization Act of 2002); and
                            ``(iii) is conducted within the United 
                        States, its territories or possessions.
            ``(3) Common rule.--The term `common rule' means the policy 
        for the protection of human research subjects as contained in 
        part 46 of title 45, Code of Federal Regulations (including all 
        subparts thereto).
            ``(4) Director.--The term `Director' means the Director of 
        the Office of Human Participant Protections (as established by 
        section 491(b).
            ``(5) Federal agency.--The term `Federal agency' has the 
        meaning given the term `Executive agency' in section 105 of 
        title 5, United States Code.
            ``(6) Human participant.--The term `human participant' has 
        the meaning given the term `human subject' under section 102(f) 
        of part 46 of title 45, Code of Federal Regulations, as in 
        effect on the day before the date of enactment of the Research 
        Revitalization Act of 2002.
            ``(7) Informed consent.--The term `informed consent' means 
        the process of requesting the voluntary agreement of an 
        individual, based on adequate knowledge and understanding of 
        relevant material available at the time of such agreement, to 
        participate in covered research.
            ``(8) Minimal risk.--The term `minimal risk' means the 
        probability and magnitude of physical or psychological harm 
        that is normally encountered in daily life, or in routine 
        medical, dental, or psychological examinations.
            ``(9) Research.--The term `research' means a systematic 
        investigation designed to develop or contribute to 
        generalizable knowledge.
            ``(10) Secretary.--The term `the Secretary' means the 
        Secretary of Health and Human Services.
            ``(11) Significant income.--
                    ``(A) In general.--The term `significant income' 
                means the receipt by an individual, or the right or 
                expectation, based on contractual arrangement, to 
                receive, any income from a financially interested 
                entity (or from an agent or other representative 
                thereof), whether in the form of a fee, salary, 
                allowance, forbearance, forgiveness, interest in real 
                or personal property, dividend, royalty derived from 
                the licensing of technology, rent, capital gain, real 
                or personal property, or any other form of 
                compensation, or any combination thereof, so long as 
                such income received from any one financially 
                interested entity, when aggregated for an individual 
                and that individual's spouse and dependent children 
                over the next 12 months, is expected to exceed $10,000, 
                or the dollar amount determined by the Director under 
                paragraph (12)(C).
                    ``(B) Limitation.--Such term shall not include any 
                income received from a financially interested entity 
                that is the principal employer of such individual.
            ``(12) Significant investment interest.--
                    ``(A) In general.--The term `significant investment 
                interest' means any stock, stock option, or similar 
                ownership interest by an individual in any financially 
                interested entity, the value of which, when aggregated 
                for an individual and that individual's spouse and 
                dependent children--
                            ``(i) exceeds $10,000 or the dollar amount 
                        determined by the Director under subparagraph 
                        (C), as determined through reference to public 
                        prices or other reasonable measures of fair 
                        market value; or
                            ``(ii) represents more than a 5 percent 
                        ownership interest in any single financially 
                        interested entity.
                    ``(B) Limitation.--Such term shall not include--
                            ``(i) any interest in a financially 
                        interested entity that arises solely by reason 
                        of an investment by a mutual, pension, or other 
                        institutional investment fund over which the 
                        individual involved does not exercise control; 
                        and
                            ``(ii) any interest in a financially 
                        interested entity that is the principal 
                        employer of such individual.
            ``(13) Adjustment of amounts.--The Director shall increase 
        the amounts described in paragraphs (11) and (12)(A)(i) for 
        each fiscal year to reflect the percentage increase, if any, in 
        the Consumer Price Index for all urban consumers for the 
        previous fiscal year.''.

     TITLE V--VIOLATIONS OF ETHICAL STANDARDS FOR PROTECTING HUMAN 
                              PARTICIPANTS

SEC. 501. VIOLATIONS OF ETHICAL STANDARDS FOR PROTECTING HUMAN 
              PARTICIPANTS.

    Part H of title IV of the Public Health Service Act (42 U.S.C. 289 
et seq.) is amended by inserting after section 492B (as added by 
section 401) the following:

``SEC. 492C. ENFORCEMENT.

    ``(a) Injunctions.--
            ``(1) In general.--If the Secretary has reason to believe, 
        upon the recommendation of the Director or upon any other 
        reasonable basis, that the continuation of any activity by an 
        investigator, a sponsor, or an Institutional Review Board would 
        cause significant and unreasonable harm to the health or 
        welfare of a human participant enrolled in covered research, 
        the Secretary may bring an action in the district court of the 
        United States for the district in which such covered research 
        is being conducted or in which an Institutional Review Board 
        that reviews such research is located to enjoin the 
        continuation of such research.
            ``(2) Temporary order.--Upon a proper showing in an action 
        under paragraph (1), a temporary injunction or restraining 
        order against the continuation of the research involved, 
        pending the issuance of a final order under this subsection, 
        shall be granted without bond by the district court.
    ``(b) Judicial Review.--
            ``(1) In general.--Any investigator, sponsor, or 
        Institutional Review Board that is the subject of an injunction 
        under subsection (a) may, at any time during the 60-day period 
        beginning on the date on which the injunction becomes final, 
        file a petition with the appropriate United States Court of 
        Appeals for judicial review of such injunction.
            ``(2) Action.--As soon as practicable after receipt of a 
        petition under paragraph (1), the clerk of the court shall 
        transmit a copy of the petition to the Secretary or other 
officer designated by the Secretary for that purpose. As soon as 
practicable after receipt such copy, the Secretary shall transmit a 
copy of the petition to the Secretary or other officer designated by 
the Secretary for that purpose. As soon as practicable after receipt of 
such copy, the Secretary shall file in the court the record on which 
the action of the Secretary is based, as provided for in section 2112 
of title 28, United States Code.
            ``(3) Additional evidence.--If a petitioner under paragraph 
        (1) applies to the court for leave to produce additional 
        evidence, and demonstrates to the satisfaction of the court 
        that such additional evidence is material and that there were 
        reasonable grounds for the failure to produce such evidence in 
        the proceeding before the Secretary, the court may order such 
        additional evidence (and evidence in rebuttal of such 
        additional evidence) to be taken before the Secretary, and to 
        be produced upon the hearing in such manner and upon such terms 
        and conditions as the court may deem proper. The Secretary may 
        modify the findings of the Secretary as to the facts, or make 
        new findings, by reason of the additional evidence so taken, 
        and the Secretary shall file such modified or new findings, and 
        the recommendations of the Secretary, if any, for the 
        modification or setting aside of the original action of the 
        Secretary, with the return of such additional evidence.
            ``(4) Judgment of court.--Upon the filing of a petition 
        under paragraph (1), the court shall have jurisdiction to 
        affirm the action that is the subject of the petition, or to 
        set such action aside in whole or in part, temporarily or 
        permanently. The findings of the Secretary as to the facts, if 
        supported by substantial evidence, shall be conclusive.
            ``(5) Finality of judgment.--The judgment of the court 
        affirming or setting aside, in whole or in part, an action of 
        the Secretary that is the subject of a petition under paragraph 
        (1) shall be final, subject to review by the Supreme Court of 
        the United States upon certiorari or certification as provided 
        for in section 1254 of title 28, United States Code.
    ``(c) Plans for Correction of Violations.--If the Secretary 
determines that an investigator or sponsor conducting covered research, 
or an Institutional Review Board reviewing covered research, has 
substantially violated the provisions of sections 491, 491A, or 491B, 
or regulations promulgated under such sections, the Secretary may 
require directed plans of correction in lieu of commencing an action 
under subsection (a).
    ``(d) Whistleblower Protection.--It shall be unlawful for any 
individual to knowingly terminate the employment of, or otherwise 
discipline, an employee because such employee has reported a violation 
of any requirement of section 491, 491A, 491B, 492B, or 492C, or any 
regulation promulgated under such sections, to the Secretary or the 
Attorney General (or to any individual acting on behalf of the 
Secretary or the Attorney General).
    ``(e) Sanctions for Substantial and Intentional Violations.--
Whoever substantially and intentionally violates any requirement of 
subsection (d) or section 491, 491A, 491B, 492B, or 492C, or any 
regulation promulgated under such subsection or sections, shall be 
subject to a civil penalty in an amount that is appropriate for the 
violation involved, but not to exceed $250,000.''.
                                 <all>