[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3594 Introduced in House (IH)]







108th CONGRESS
  1st Session
                                H. R. 3594

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           November 21, 2003

 Ms. DeGette 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 ``Protection for Participants in 
Research Act of 2003''.

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 part 56 
                        of such title 21 (or any successor 
                        regulations), and includes the provisions of 
                        subpart D of part 50 of such title 21 (or any 
                        successor regulations).
                    ``(C) In the case of human subject research to 
                which both 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 
                Protection for Participants in Research Act of 2003, 
                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 subparagraph (B), the 
                term `human subject research' means research, as 
                defined in subpart A of part 46 of title 45, Code of 
                Federal Regulations (or any successor regulations), 
                that involves a human subject, as defined in such 
                subpart A (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' has the meaning given such term in 
                such part 50, and the term `human subject research' 
                means a clinical investigation as defined in such part 
                50.
            ``(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 safety and monitoring 
                committee', with respect to a human subject research 
                project, means a group of individuals with appropriate 
                expertise that, on an ongoing basis during the conduct 
                of such research project--
                            ``(i) reviews data that is generated during 
                        the project;
                            ``(ii) advises the sponsor regarding the 
                        continuing safety of human subjects who are or 
                        will be participating in the project; and
                            ``(iii) advises such sponsor on the 
                        continued validity and scientific merit of the 
                        project.
                    ``(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 
                Institutional 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 
        Protection for Participants in Research Act of 2003, 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) Consideration of certain matters.--
                            ``(i) In general.--Not later than 18 months 
                        after the date of the enactment of the 
                        Protection for Participants in Research Act of 
                        2003, the Secretary shall, with respect to the 
                        Common Rule--
                                    ``(I) consider the matters 
                                specified in clause (ii) and make a 
                                determination of whether any of the 
                                provisions of such Rule should be 
                                modified accordingly; and
                                    ``(II) publish the determination in 
                                the Federal Register.
                            ``(ii) List of matters for consideration.--
                        The matters referred to in clause (i) with 
                        respect to the Common Rule are the following:
                            ``(I) Whether the list of exemptions from 
                        applicability of the Common Rule, as in effect 
                        on the day before the date of enactment 
                        referred to in clause (i), should be modified 
                        or new categories of exemptions established.
                            ``(II) Whether there are circumstances in 
                        which research that studies human tissue or 
                        other types of clinical specimens should not be 
                        considered human subject research.
                            ``(III) Whether research that studies data 
                        that do not involve any interaction or 
                        intervention with a living human should be 
                        considered human subject research.
                            ``(IV) Whether the list of expedited 
                        procedures under the Common Rule, as in effect 
                        on the day before the date of enactment 
                        referred to in clause (i), should be modified 
                        or new categories of expedited procedures 
                        established.
                            ``(V) Whether modified procedures should 
                        apply to human subject research that poses 
                        minimal risk to the subjects, including whether 
                        there are any types of such research for which 
                        some aspect of the requirement of informed 
                        consent or documentation of informed consent 
                        should apply differently.
                            ``(VI) Whether Institutional Review Boards 
                        include sufficient numbers of minority 
                        individuals (as defined in section 485E(c)) as 
                        Board members when reviewing proposals designed 
                        to have a population of human subjects a 
                        majority of whom are minority individuals.
                            ``(VII) Such additional matters as the 
                        Secretary determines to be appropriate.
                    ``(D) 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 an 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) Certain requirements regarding disclosure and 
        understanding.--The Secretary shall establish criteria 
        regarding consent under paragraph (1) that--
                    ``(A) provide for the provision of full and 
                complete information relevant to the research to a 
                prospective human subject;
                    ``(B) require such information to be provided in 
                language understandable to such subject;
                    ``(C) require that only individuals knowledgeable 
                about the research provide such information to the 
                subject and answer questions from the subject; and
                    ``(D) require that information be provided to the 
                subject on how to contact the Office for Human Research 
                Protections to submit questions about the rights of 
                subjects or to report concerns regarding the research.
            ``(4) 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 significant conflict of interest, as 
                        defined by applicable Federal regulations.
                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) 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).
                    ``(C) 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.
                    ``(D) 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.
                    ``(E) In the case of a proposal for a high-risk 
                research project, the Board reviews the data safety and 
                monitoring plan (pursuant to subsection (f)) as a part 
                of the review by the Board of the proposal.
                    ``(F) With respect to the research involved, each 
                member of the Board has disclosed any significant 
                financial interests, as defined by applicable Federal 
                regulations, to the institution served by the Board, 
                and such institution has disclosed any such disclosures 
                to the Board.
                    ``(G) A member of the Board does not participate in 
                the review by the Board of a proposal for research if 
                the member has a significant conflict of interest, as 
                defined by applicable Federal regulations, 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.
                    ``(H) 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 reviewed biomedical research proposals, the 
                number of reviewed behaviorial or social sciences 
                research proposals, and any additional information 
                determined appropriate by the Secretary.
                    ``(I) 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 institution served by the Board--
                    ``(A) of any significant financial conflicts of 
                interest, as defined by applicable Federal regulations;
                    ``(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 significant financial conflicts of interest as are 
        submitted under paragraph (2) to determine whether such 
        interests create or may reasonably appear to create conflicts 
        of interest, and then shall seek to manage, reduce, or 
        eliminate such conflicts of interest.
            ``(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 
        institutions and Institutional Review Boards by recognizing a 
        private accrediting entity or entities. For purposes of the 
        preceding sentence:
                    ``(A) The Secretary may recognize an accrediting 
                entity if--
                            ``(i) such entity submits to the Secretary 
                        the standards and procedures that the entity 
                        requires institutions and Institutional Review 
                        Boards to meet in order to be accredited by the 
                        entity;
                            ``(ii) the Secretary determines that such 
                        standards and procedures include standards and 
                        procedures ensuring that the policies and 
                        procedures of institutions and Institutional 
                        Review Boards accredited by the entity are in 
                        compliance with Federal regulations governing 
                        human subject research; and
                            ``(iii) the entity annually submits to the 
                        Secretary a report describing any changes in 
                        the standards and procedures described in 
                        clause (ii).
                    ``(B) The Secretary may not require that any 
                institution, Institutional Review Board, or program for 
                the protection of human subjects in research, or any 
                component thereof, be accredited.
                    ``(C) Nothing in this section may be construed as 
                authorizing the Secretary--
                            ``(i) to establish or approve accreditation 
                        standards or procedures for institutions, 
                        Institutional Review Boards, or programs for 
                        the protection of human subjects in research, 
                        or any component thereof; or
                            ``(ii) to recognize any standards or 
                        procedures for institutions or Institutional 
                        Review Boards other than the standards and 
                        procedures described in subparagraph (A)(ii).
            ``(6) Cost recovery.--Institutions may recover costs 
        associated with compliance for human subject protections under 
        this part from government sponsors of research as direct costs.
    ``(f) Improved Monitoring of High-Risk Research.--With respect to 
high-risk human subject research projects:
            ``(1) The Secretary shall establish criteria for 
        identifying proposals for such projects that require a data 
        safety and monitoring plan. The criteria shall include--
                    ``(A) a provision that the Secretary may require 
                the sponsor of the project to utilize a data safety and 
                monitoring committee in affiliation with the research 
                project;
                    ``(B) minimum requirements for the reporting by the 
                principal investigator of information on such plan to 
                the Institutional Review Board for the research project 
                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 
                research project to such investigator, Board, and 
                institution.
            ``(2) The Secretary shall require that an adverse event in 
        the research project be reported by the principal investigator 
        to the Institutional Review Board for the research project, and 
        to the sponsor of the research project, in a timely manner 
        appropriate to the severity of the event and whether the event 
        is unexpected. Such events shall in addition be reported by the 
        principal investigator as directed by the Secretary. Such 
        regulations shall ensure comprehensive and coordinated 
        reporting to all relevant parties.
    ``(g) Institutional Programs of Education.--For fiscal year 2004 
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 Institutional 
        Review Board, the Secretary shall determine whether an entity 
        (including an individual, as applicable under the request) has 
        violated any requirement under this section, and shall disclose 
        to such 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 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 Protection 
for Participants in Research Act of 2003.''.

SEC. 3. OFFICE FOR 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 for 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 for 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 (d) 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 direct 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 subjects in human subject 
        research;
            ``(4) may, in collaboration with the Director of NIH, the 
        Commissioner of Food and Drugs, or the head of any other 
        Federal department or agency, 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--
                    ``(A) consult with the entity regarding 
                improvements in human subject protections in such 
                research; and
                    ``(B) provide advice on compliance with the Common 
                Rule, including with respect to differing 
                interpretations among Institutional Review Boards of a 
                provision of such Rule;
            ``(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)(C) and to develop best practices 
in institutional management of human subject research.
    ``(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 described in 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 2004, and such sums as 
        may be necessary for fiscal year 2005 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 2004 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 for 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. 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. 6. 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>