[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4697 Introduced in House (IH)]







107th CONGRESS
  2d Session
                                H. R. 4697

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 9, 2002

 Ms. DeGette (for herself and Mr. Greenwood) introduced the following 
    bill; which was referred to the Committee on Energy and 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 2002''.

SEC. 2. 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) Protection of Human Subjects.--
            ``(1) In general.--All human subject research shall be 
        conducted in accordance with the common rule, and as applicable 
        to the human subjects involved in such research, with the 
        vulnerable-populations rules.
            ``(2) Applicability.--Paragraph (1) applies to human 
        subject research that--
                    ``(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.
    ``(b) Common Rule; Other Definitions.--
            ``(1) Common rule; vulnerable-population rules.--For 
        purposes of this section:
                    ``(A) Except as provided in subparagraph (B):
                            ``(i) The term `common rule' means the 
                        provisions of subpart A of part 46 of title 45, 
                        Code of Federal Regulations (or any successor 
                        regulations), subject to subparagraph (C).
                            ``(ii) The term `vulnerable-population 
                        rules' means the provisions of subparts B 
                        through D of such part 46 (or any successor 
                        regulations), subject to subparagraph (C).
                    ``(B) In the case of human subject research that is 
                subject to the Federal Food, Drug, and Cosmetic Act or 
                to section 351 of this Act:
                            ``(i) The term `common rule' means the 
                        provisions of parts 50 and 56 of title 21, Code 
                        of Federal Regulations (or any successor 
                        regulations).
                            ``(ii) The term `vulnerable-population 
                        rules' has the meaning applicable under subpart 
                        D of part 50 of such title 21 (or any successor 
                        regulations).
                    ``(C) In the case of human subject research to 
                which both of subparagraphs (A) and (B) apply, the 
                terms `common rule' and `vulnerable-population rules' 
                have the meaning given such terms in subparagraph (B).
            ``(2) Harmonization.--
                    ``(A) Review of regulations.--Not later than 18 
                months after the date of the enactment of the Human 
                Research Subject Protections Act of 2002, the Secretary 
                shall complete a review of the provisions of subpart A 
                of part 46 of title 45, Code of Federal Regulations 
                (referred to in this paragraph as `title 45 
                regulations'), and the provisions of parts 50 and 56 of 
                title 21, Code of Federal Regulations (referred to in 
                this paragraph as `title 21 regulations'), in order to 
                determine to what extent the  differences in approach 
between the title 45 regulations and the title 21 regulations can be 
harmonized toward the goal of having only such differences as are 
appropriate to reflect the legal or factual variations in human subject 
research described in paragraph (1)(B) relative to other human subject 
research. The areas of difference reviewed shall include (but are not 
limited to) differences regarding the existence of a significant 
financial interest; provisions for research relating to emergency 
interventions; the definition of `institution'; and requirements for 
attestations by clinical investigators regarding the protection of 
human subjects.
                    ``(B) Rulemaking.--
                            ``(i) Pursuant to harmonization review.--
                        Not later than three years after completing the 
                        review under subparagraph (A), the Secretary 
                        shall publish in the Federal Register a 
                        proposed rule to modify the title 45 
                        regulations, or the title 21 regulations, or 
                        both, in accordance with the findings of the 
                        review, unless the review finds that removing 
                        any of the differences in approach between the 
                        title 45 regulations and the title 21 
                        regulations is not practicable.
                            ``(ii) Subsequent rulemaking.--After the 
                        expiration of the three-year period referred to 
                        in clause (i), or the publication of the 
                        proposed rule under clause (i), whichever 
                        occurs first, any rule promulgated by the 
                        Secretary that modifies the title 45 
                        regulations or the title 21 regulations 
                        (including a modification that adds 
                        provisions), and results in there being a 
                        difference between the title 45 regulations and 
                        the title 21 regulations, shall be accompanied 
                        in the Federal Register by a statement of the 
                        reasons underlying the determination of the 
                        Secretary that, with respect to the goal 
                        described in subparagraph (A), the difference 
                        is appropriate to reflect the legal or factual 
                        variations in human subject research described 
                        in paragraph (1)(B) relative to other human 
                        subject research.
            ``(3) Human subject research.--For purposes of this 
        section:
                    ``(A) Except as provided in subparagraphs (B) and 
                (C):
                            ``(i) The term `human subject research' 
                        means clinical research that is conducted with 
                        the direct involvement of one or more human 
                        subjects.
                            ``(ii) For purposes of the definition 
                        established in clause (i), the term `research' 
                        has the meaning that applies for purposes of 
                        part 46 of title 45, Code of Federal 
                        Regulations (or any successor regulations).
                    ``(B) In the case of an investigation that is 
                subject to the provisions of part 50 of title 21, Code 
                of Federal Regulations (or successor regulations), the 
                term `human subject research' means clinical research 
                that is a clinical investigation within the meaning of 
                such part 50, except as provided in subparagraph (C).
                    ``(C) The term `human subject research' does not 
                include the collection, analysis, or abstraction of 
                data contained in records that were made for purposes 
                other than research or investigations conducted with 
                human subjects, including but not limited to business, 
                health, financial, research, marketing, survey, 
                education, or government records.
                    ``(D) The term `clinical research' has the meaning 
                given such term in section 409(b).
                    ``(E) The term `human subject' means a living human 
                being.
            ``(4) Other definitions.--For purposes of this section:
                    ``(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 term `data monitoring committee', with 
                respect to human subject research that is a clinical 
                trial, means a group of individuals with appropriate 
                expertise that, on an ongoing basis during the conduct 
                of such trial--
                            ``(i) reviews data that is generated during 
                        the trial;
                            ``(ii) advises the sponsor regarding the 
                        continuing safety of human subjects who are or 
                        will be participating in the trial; and
                            ``(iii) advises such sponsor on the 
                        continued validity and scientific merit of the 
                        trial.
                    ``(C) The term `Federal agency' has the meaning 
                given the term `Executive agency' in section 105 of 
                title 5, United States Code.
                    ``(D) The term `institution served by an 
                Institutional Review Board' means the public or private 
                entity (university, health care provider, health plan, 
                research organization, government agency, or other 
                entity) that establishes and is responsible for the 
                operation of the Institutional Review Board.
                    ``(E) The term `Institutional Review Board' has the 
                meaning that applies under the common rule.
                    ``(F) The term `lead Institutional Review Board' 
                means an Institutional Review Board that otherwise 
                meets the requirements of the common rule and enters 
                into a written agreement with an institution, another 
                Institutional Review Board, a sponsor, or a principal 
                investigator to approve and oversee human subject 
                research that is conducted at multiple locations. For 
                purposes of this section, references to an Instutional 
                Review Board include an Institutional Review Board that 
                serves a single institution as well as a lead 
                Institutional Review Board.
                    ``(G) The term `principal investigator', with 
                respect to human subject research, means the individual 
                who, at the research location involved, has the 
                principal responsibility for the conduct of the 
                research.
                    ``(H)(i) Except as provided in clause (ii), the 
                term `sponsor', with respect to human subject research, 
                means the entity that has the principal financial 
                responsibility for the conduct of the research.
                    ``(ii) In the case of an investigation that is 
                subject to the provisions of part 50 of title 21, Code 
                of Federal Regulations (or successor regulations), the 
                term `sponsor', with respect to human subject research, 
                has the meaning that applies for purposes of such part 
                50.
    ``(c) Scope of Authority of Secretary.--
            ``(1) In general.--The common rule (including provisions 
        regarding exemptions) 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 2002, continue to be 
        in effect on and after such date, subject to paragraph (2).
            ``(2) Modifications.--
                    ``(A) Compliance with law.--Promptly after the date 
                of the enactment of the Act referred to in paragraph 
                (1), the Secretary shall promulgate regulations to make 
                such modifications to the provisions of the common rule 
                as may be necessary to ensure that such provisions 
                implement, and do not conflict with, this section.
                    ``(B) Other modifications.--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.
                    ``(C) 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.
    ``(d) Right of Informed Consent.--
            ``(1) In general.--For purposes of subsection (a), a 
        principal investigator, may not, except as provided in the 
        common rule, involve a living individual as a subject in human 
        subject research unless the investigator or other knowledgeable 
        person has obtained the informed consent of the individual to 
        be a subject.
            ``(2) Legally authorized representative.--References in 
        this section to obtaining consent from an individual shall be 
        considered to be references to obtaining consent from the 
        legally authorized representative of the individual in any case 
        in which the individual lacks legal competence to provide 
        consent.
            ``(3) Consent form.--The consent of an individual to be a 
        human subject in human subject research shall be documented by 
        the principal investigator for the research or another 
        knowledgeable person, and such documentation shall include an 
        acknowledgement by such individual that the individual has with 
        respect to the research been provided a written explanation of 
        the following:
                    ``(A) The purpose of the research.
                    ``(B) The potential risks and benefits of being a 
                subject in the research.
                    ``(C) As applicable to the research, the difference 
                between research and therapeutic treatment.
                    ``(D) The right to cease participation as a subject 
                at any time.
                    ``(E) The identity of the sponsors of the research.
                    ``(F) Any conflict of interest that the 
                investigators have in the research.
                    ``(G) As applicable to the research, the medical 
                tests and procedures that may be necessary as part of 
                the research, and the extent to which the costs of such 
                tests and procedures will not be paid by the sponsor or 
                other entities involved in the research.
                    ``(H) Such additional information as the Secretary 
                may require.
            ``(4) Certain requirements regarding disclosure and 
        understanding.--The Secretary shall establish criteria 
        regarding consent under paragraph (1) that provide for the 
        following:
                    ``(A) During the process of obtaining consent, a 
                prospective human subject is, through the written 
                explanation provided under paragraph (2) and through 
                written or oral answers to questions from the 
                prospective subject, provided full and complete 
                information relevant to the research involved.
                    ``(B) Such information is provided to the 
                prospective subject in the language and in a manner 
                that allows the subject to understand the information 
                and make an informed decision, free of coercion, 
                regarding participation as a human subject.
                    ``(C) Only an individual who is knowledgeable about 
                the research, and can reasonably be expected to be able 
                to answer questions from the subject regarding the 
                research, is authorized to provide such information to 
                the subject.
                    ``(D) The written statement under paragraph (2) 
                provides the information required in such paragraph in 
                a clear and conspicuous manner.
                    ``(E) A copy of the documentation of the consent of 
                the subject is provided to the subject, together with 
                information on how to contact the Office of Human 
                Research Protections to submit questions about 
                subjects' rights or to report concerns regarding the 
                research.
            ``(5) Written attestation by investigator.--A principal 
        investigator who involves a human subject in research shall, in 
        accordance with the criteria of the Secretary, file with the 
        Institutional Review Board for the research a written 
        attestation that the investigator is familiar with requirements 
        for the protection of human subjects, including the requirement 
        of informed consent, and agrees to comply with such 
        requirements.
    ``(e) Institutional Review Boards.--
            ``(1) Requirements for boards.--Human subject research may 
        not be conducted unless an Institutional Review Board has, for 
        purposes of the common rule (and the vulnerable-populations 
        rules, as applicable), approved the proposal for such research. 
        With respect to the research involved, 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 two members or 25 
                        percent of all members, whichever is greater, 
                        are individuals whose primary expertise is in 
                        scientific areas.
                            ``(ii) Not fewer than two members or 20 
                        percent of all members (whichever is greater) 
                        are individuals whose primary expertise is in 
                        nonscientific areas.
                            ``(iii) Not fewer than two members or 20 
                        percent of all members (whichever is greater) 
                        are individuals who are not affiliated with the 
                        institution served by the Board (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).
                The appointment of a member of the Board to meet the 
                requirement of clause (iii) also qualifies toward 
                meeting the requirement of clause (ii) if the primary 
                expertise of such member is in a nonscientific area.
                    ``(B) When reviewing a proposal for research that 
                is designed to include as a subject an individual who 
                is a member of a vulnerable population, the Board 
                includes at least one member who is an expert in the 
                issues involving such population; allows such member to 
                fully participate in the Board review process; and 
                provides such member with the same voting rights as 
                other members of the Board. The appointment of a member 
                of the Board to meet the requirement of this 
                subparagraph may also qualify toward meeting the 
                requirement of clause (ii) of subparagraph (A), or 
                clause (iii) of such subparagraph, if such member 
                satisfies the criteria described in the clause 
                involved.
                    ``(C) When reviewing a proposal for research that 
                is designed to include as subjects a significant number 
                of minority individuals (as defined in section 
                485E(c)), the Board includes minority members; allows 
                such members to fully participate in the Board review 
                process; and provides such members with the same voting 
                rights as other members of the Board. The appointment 
                of a member of the Board to meet the requirement of 
                this subparagraph may also qualify toward meeting the 
                requirement of clause (ii) of subparagraph (A), or 
                clause (iii) of such subparagraph, if such member 
                satisfies the criteria described in the clause 
                involved.
                    ``(D)(i) In reviewing a proposal for 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 from each of 
                the three categories described in subparagraph (A).
                    ``(ii) In any case in which the Board will under 
                subparagraph (C) review a proposal for research that is 
                designed to include as subjects a significant number of 
                minority individuals, the Board does not consider a 
                quorum to have been established for a meeting unless 
                the members present at the meeting include the members 
                required under such subparagraph.
                    ``(E) The institution served by the Board ensures 
                that the Board has an orientation program for new 
                members and a continuing education program for existing 
                members of the Board, and with respect to ethical 
                matters that relate to research, a continuing education 
                program for all members of the Board.
                    ``(F) The institution served by the Board has 
                submitted to the Secretary a registration informing the 
                Secretary of the existence of the Board, and the 
                registration was in such form, was made in such manner, 
                and contained such information as the Secretary 
                requested regarding functions of the Board under this 
                section.
                    ``(G) In the case of a proposal for a high risk 
                trial, the Board reviews the data safety and monitoring 
                plan of the data monitoring committee (operated 
                pursuant to subsection (f)) as a part of the review by 
                the Board of the proposal.
                    ``(H) With respect to the research involved, each 
                member of the Board has disclosed to the institution 
                served by the Board, and such institution has disclosed 
                to the Board, any actual conflicts of interest, or 
                interests that create the appearance of a conflict of 
                interest, with respect to such research, including (but 
                not limited to)--
                            ``(i) involvement as investigators in the 
                        research;
                            ``(ii) ownership interests in the research; 
                        and
                            ``(iii) direct financial relationships or 
                        arrangements with private sponsors of the 
                        research, excluding ownership of any 
                        independently-managed investment plan (such as 
                        mutual funds) that may own a financial interest 
                        in such a sponsor.
                    ``(I) A member of the Board does not participate in 
                the review by the Board of a proposal for research if 
                the member has a conflict of interest (including a 
                nonproprietary interest) in the research. The provision 
                by such member of information to other members of the 
                Board does not constitute Board participation for 
                purposes of this subparagraph.
                    ``(J) The institution served by the Board annually 
                submits to the Secretary a report that compiles 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 any additional information determined appropriate 
                by the Secretary.
                    ``(K) The institution served by the Board submits 
                to the Secretary such reports regarding the Board as 
                the Secretary determines to be appropriate.
            ``(2) Notification of institutional review board by 
        investigators.--In submitting to an Institutional Review Board 
        a proposal for human subject research, the investigators for 
        the research shall notify the Board, and the institution served 
        by the Board--
                    ``(A) of any actual conflicts of interest, or 
                interests that create the appearance of a conflict of 
                interest;
                    ``(B) whether the investigators have been 
                disqualified or restricted by any Federal entity in 
                their ability to conduct human subject research, 
                including being ineligible to conduct human subject 
                research with investigational new drugs, being 
                ineligible for approval of new drug applications, or 
                agreeing to some other form of restriction regarding 
                research; and
                    ``(C) whether the proposal has been submitted by 
                the principal investigator to any other Institutional 
                Review Board.
            ``(3) Institution review of conflicts of interest.--The 
        institution served by an Institutional Review Board shall 
        review such conflicts of interest or interests that create the 
        appearance of a conflict of interest as are submitted under 
        paragraph (2) and shall seek to reduce or eliminate and shall 
        oversee such conflicts of interest, with respect to the 
        research.
            ``(4) Projects involving multiple locations.--For purposes 
        of meeting the common rule requirements for review and 
        supervision of research by an Institutional Review Board, such 
        activities may be performed by an Institutional Review Board or 
        a lead Institutional Review Board, at the option of the 
        institution where the research is conducted.
            ``(5) Voluntary accreditation.--The Secretary may in 
        accordance with this paragraph facilitate the accreditation of 
        Institutional Review Boards and institutions by a private 
        accrediting entity or entities. For purposes of the preceding 
        sentence:
                    ``(A) The Secretary may recognize an accrediting 
                entity if the accrediting entity submits to the 
                Secretary the accrediting standards of the entity, the 
                Secretary determines that the standards further the 
                purposes of this section, and the accrediting entity 
                annually submits to the Secretary a report describing 
                any changes in the accrediting standards or procedures 
                of the entity.
                    ``(B) The Secretary shall biannually evaluate the 
                performance of the accrediting entity.
                    ``(C) The Secretary may withdraw recognition of the 
                accrediting entity if the Secretary determines that the 
                requirements of subparagraph (A) are not met.
                    ``(D) The Secretary may not require that any 
                Institutional Review Board be accredited.
            ``(6) Cost recovery.--Institutions may recover costs 
        associated with compliance for human subject protections under 
        this Act from government sponsors of research as direct costs.
    ``(f) Improved Monitoring of High Risk Clinical Trials.--With 
respect to human subjects in high risk clinical trials:
            ``(1) The Secretary shall establish criteria for 
        identifying high risk clinical trials requiring a data  safety 
and monitoring plan for each such trial. The criteria shall include--
                    ``(A) a provision that the Secretary may require 
                the sponsor of the trial to utilize a data monitoring 
                committee in affiliation with the trial;
                    ``(B) minimum requirements for the reporting by the 
                principal investigator of information on such plan to 
                the Institutional Review Board for the trial and to the 
                institution served by the Board; and
                    ``(C) the requirement that such committee provide 
                reports on the findings of the committee regarding the 
                trial to such investigator, Board, and institution.
            ``(2) The Secretary shall require that adverse events in 
        such a trial be reported by the principal investigator for the 
        trial in a timely manner appropriate to whether the event is 
        unexpected and its severity to the Institutional Review Board 
        for the trial, and to the sponsor of the trial. Such events 
        shall in addition be reported by the principal investigator to 
        the Director of the Office of Human Research Protections, or 
        the Commissioner of Food and Drugs, whichever administers the 
        common rule as applied to the trial. Such regulations shall 
        ensure comprehensive and coordinated reporting to all relevant 
        parties.
    ``(g) Institutional Programs of Education.--For fiscal year 2003 
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) maintains or contracts for a 
comprehensive and ongoing program to educate investigators and Board 
members on the protection of human subjects in research.
    ``(h) Certain Classified Human Subject Research.--Notwithstanding 
any other provision of law, Federal funds may not be expended for the 
conduct of classified human subject research if--
            ``(1) 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
            ``(2) the research is exempt from the requirement under the 
        common rule that the proposal for the research be reviewed by 
        such a Board.
    ``(i) Disclosure of Violations.--
            ``(1) Disclosures.-- Upon the request of an entity that 
        conducts or supports research, or upon the request of an 
        Institutional Review Board, the Secretary shall determine 
        whether another entity (including an individual, as applicable 
        under the request) has violated any requirement under this 
        section, and shall disclose to such entity or Board the 
        findings of the Secretary.
            ``(2) Notice to subject of disclosure.--If pursuant to a 
        request under paragraph (1) the Secretary discloses that an 
        entity has violated a requirement under this section, the 
        Secretary shall in writing notify the entity of the disclosure, 
        including the identity of the entity or Institutional Review 
        Board to which the disclosure was made.
    ``(j) 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 2002.''.

SEC. 3. OFFICE OF HUMAN RESEARCH PROTECTIONS.

    Part H of title IV of the Public Health Service Act (42 U.S.C. 289 
et seq.), as amended by section 2 of this Act, is amended by inserting 
after section 491A the following section:

                 ``office of human research protections

    ``Sec.  491B. (a) In General.--There is established within the 
Office of the Secretary an office to be known as the Office of Human 
Research Protections (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) Certain Duties.-- The Director of the Office--
            ``(1) shall provide for the protection of human subjects in 
        research by carrying out activities in accordance with 
        subsection (c) regarding compliance with the common rule, as 
        defined in and modified pursuant to section 491A;
            ``(2) shall establish criteria regarding assurances of 
        compliance with the requirements of the common rule;
            ``(3) shall coordinate activities within the Department of 
        Health and Human Services, and coordinate the activities of the 
        Department with other Federal departments and agencies, with 
respect to the protection of human subjects in human subject research;
            ``(4) may, in collaboration with the Director of NIH and 
        the Commissioner of Food and Drugs, carry out educational and 
        quality improvement programs for human subject protections for 
        principal investigators, members of Institutional Review 
        Boards, and other appropriate persons, including the generation 
        of resource materials relating to the responsibilities of the 
        research community for the protection of human subjects in 
        research;
            ``(5) shall, upon the request of an entity that conducts or 
        supports human subject research, consult with the entity 
        regarding improvements in human subject protections in such 
        research;
            ``(6) may make grants to entities that conduct or support 
        human subject research for the purpose of assisting the 
        entities in carrying out programs to recruit and train minority 
        individuals (as defined in section 485E(c)) to serve as members 
        of Institutional Review Boards;
            ``(7) shall consult with experts in biomedical, behavioral, 
        and social sciences research in carrying out the duties of the 
        Director; and
            ``(8) shall carry out such additional authorities of the 
        Secretary regarding the protection of human subjects in 
        research as the Secretary determines to be appropriate.
    ``(c) Model Education Program.--The Director of the Office may make 
grants for the development of a model education program to be used by 
institutions served by Institutional Review Boards to satisfy the 
requirements under section 491A(e)(1)(E) and to develop best practices 
in institutional management of clinical trials.
    ``(d) Compliance and Enforcement.--
            ``(1) Audits of investigators and institutions.--The 
        Director of the Office may conduct audits of entities that 
        conduct or support human subject research in order to determine 
        whether such entities are complying with the common rule.
            ``(2) Corrective action plan.--If the Director of the 
        Office determines that an entity referred to in paragraph (1) 
        is not in compliance with the common rule, the Director of the 
        Office, after providing to an appropriate representative of the 
        entity an oral or written summary of the reasons underlying 
        such determination, may require the entity to develop and to 
        implement a plan for corrective action to bring the entity into 
        compliance.
            ``(3) Restrictions.--If the Director of the Office 
        determines that an entity referred to in paragraph (1) is not 
        in compliance with the common rule, the Director may impose 
        restrictions on the extent to which the entity may conduct or 
        support human subject research. The restrictions may include 
        any of the following:
                    ``(A) Suspending research protocols.
                    ``(B) Prohibiting the inclusion of additional human 
                subjects in particular research projects.
                    ``(C) Suspending or terminating particular research 
                projects, unless doing so would endanger the human 
                subjects participating in such projects.
                    ``(D) Suspending the provision of Federal funds for 
                particular research projects conducted or supported by 
                or through the entity, or for particular research 
                protocols of the entity.
                    ``(E) Suspending the provision of Federal funds for 
                all research projects conducted or supported by or 
                through the entity, in any case in which the Secretary 
                determines that the noncompliance creates a significant 
                threat to the rights and welfare of human subjects in 
                such projects.
                    ``(F) In the case of individuals who are or were 
                investigators in the research involved, after notice 
                and an opportunity for a hearing--
                            ``(i) suspending or debarring the 
                        individuals from receiving Federal funds for 
                        conducting human subject research; or
                            ``(ii) suspending or debarring the 
                        individuals from serving as principal 
                        investigators in human subject research.
            ``(4) Institutional review boards.--
                    ``(A) Audits.--In carrying out paragraph (1), the 
                Director of the Office may conduct audits of 
                Institutional Review Boards in order to determine 
                whether such Boards are complying with the common rule 
                (including conditions described in section 491A(e)).
                    ``(B) Corrective action plan.--If the Director of 
                the Office determines that an Institutional Review 
                Board is not in compliance with the common rule, the 
                Director of the Office, after providing to an 
                appropriate representative of such Board, or of the 
                institution served by the Board, an oral or written 
                summary of the reasons underlying such determination, 
                may require the Board to develop and to implement a  
plan for corrective action to bring the Board into compliance.
                    ``(C) Restrictions.--If the Director determines 
                that an Institutional Review Board is not in compliance 
                with the common rule, the Director may--
                            ``(i) in the case of the research projects 
                        with respect to which the Board was or is not 
                        in compliance, provide that the approvals of 
                        the Board for such projects are not effective 
                        for purposes of section 491A(e)(1), unless such 
                        projects were approved by another Institutional 
                        Review Board; or
                            ``(ii) may provide that all approvals of 
                        research by the Board are not effective for 
                        purposes of such section, in any case in which 
                        the Director determines that the noncompliance 
                        creates a significant threat to the rights and 
                        welfare of human subjects in projects approved 
                        by the Board.
                    ``(D) Projects involving multiple locations.--In 
                the case of a project of human subject research for 
                which there is an agreement under section 491A(b)(4)(F) 
                (relating to multiple Institutional Review Boards), the 
                Director of the Office shall, in carrying out 
                authorities under this subsection with respect to an 
                Institutional Review Board, ensure that no action is 
                taken that adversely affects the operation of a project 
                of human subject research at any project location for 
                which such Institutional Review Board had no 
                responsibilities.
            ``(5) Notification of federal and state regulatory 
        agencies.--In any case in which the Director of the Office 
        takes an action described in paragraph (3)(E) or (4)(C)(ii) 
        against an entity that conducts or supports human subject 
        research, or against an Institutional Review Board, 
        respectively, the Director shall notify relevant Federal and 
        State regulatory agencies, and as applicable, the sponsors of 
        the research, of the deficiencies in the operation of the 
        entity or Board.
            ``(6) Coordination with food and drug administration.--In 
        the case of human subject research that is subject to the 
        Federal Food, Drug, and Cosmetic Act or to section 351 of this 
        Act, no authority under this subsection may be carried out with 
        respect to an entity that conducts or supports such research, 
        or with respect to an Institutional Review Board, unless the 
        Commissioner of Food and Drugs concurs in the exercise of the 
        authority involved.
    ``(e) Funding.--
            ``(1) Authorization of appropriations.--For the purpose 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 fiscal year 2004 and each subsequent 
        fiscal year.
            ``(2) Model education program.--For the purpose of carrying 
        out subsection (c), there are authorized to be appropriated 
        such sums as may be necessary for fiscal year 2003 and each 
        subsequent fiscal year.
            ``(3) Rule of construction.--Nothing in this section or 
        section 491A may be construed as a change in the budget 
        authority or authorization of appropriations for the Food and 
        Drug Administration.''.

SEC. 4. AMENDMENTS REGARDING PROCESS FOR RESPONDING TO REPORTS OF 
              VIOLATIONS.

    Section 491(b)(2) of the Public Health Service Act (42 U.S.C. 
289(b)(2)) is amended--
            (1) in the first sentence, by inserting ``or the Director 
        of the Office of Human Research Protections'' after ``the 
        Director of NIH''; and
            (2) in the second sentence, by inserting after ``this Act'' 
        the following: ``, the sharing of information between the 
        Director of NIH and the Director of such Office, and''.

SEC. 5. NATIONAL RESEARCH PROTECTIONS ADVISORY COMMITTEE.

    The Secretary of Health and Human Services shall ensure the 
continuing operation of the National Research Protections Advisory 
Committee in accordance with the provisions for the operation of such 
Committee that were established by the Secretary on June 6, 2000, and 
were amended by the Secretary on January 19, 2001.

SEC. 6. ENHANCED HUMAN SUBJECT PROTECTIONS FOR PEOPLE WITH DIMINISHED 
              DECISIONMAKING CAPACITY.

    Not later than three years 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 human 
subject research.

SEC. 7. 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.
                                 <all>