[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2625 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 2625

 To amend the Public Health Service Act with respect to human subject 
     research to improve protections for human subjects and, where 
appropriate because of the type research involved, to reduce regulatory 
                                burdens.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 22, 2011

 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 human subject 
     research to improve protections for human subjects and, where 
appropriate because of the type research involved, to reduce regulatory 
                                burdens.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Research Participants Protection 
Modernization Act of 2011''.

SEC. 2. PROTECTION OF HUMAN SUBJECTS IN RESEARCH; APPLICABILITY OF 
              RULES.

    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:

``SEC. 491A. PROTECTION OF HUMAN SUBJECTS IN RESEARCH; APPLICABILITY OF 
              RULES.

    ``(a) Protection of Human Subjects.--
            ``(1) In general.--Except as provided in paragraph (2), all 
        human subject research described in paragraph (3)(A) shall be 
        conducted in accordance with the HHS Human Subject Regulations, 
        and as applicable to the human subjects involved in such 
        research, with the vulnerable-populations rules.
            ``(2) FDA research.--
                    ``(A) Applicable rules.--All human subject research 
                that is subject to the Federal Food, Drug, and Cosmetic 
                Act or to section 351 of this Act shall be conducted--
                            ``(i) in accordance with the provisions of 
                        parts 50, 56, 312, and 812 of title 21, Code of 
                        Federal Regulations (or any successor 
                        regulations); and
                            ``(ii) as applicable to the human subjects 
                        involved in such research, in accordance with 
                        provisions applicable to vulnerable populations 
                        under part 56 of such title 21 (or any 
                        successor regulations) and subpart D of part 50 
                        of such title 21 (or any successor 
                        regulations).
                    ``(B) References.--In the case of human subject 
                research described in subparagraph (A)--
                            ``(i) each reference in this section or 
                        section 491B to the HHS Human Subject 
                        Regulations shall be treated as a reference to 
                        the provisions described in subparagraph 
                        (A)(i); and
                            ``(ii) each reference in this section to 
                        the vulnerable population rules shall be 
                        treated as a reference to the provisions 
                        described in subparagraph (A)(ii).
            ``(3) Applicability.--
                    ``(A) In general.--This section applies to human 
                subject research that is--
                            ``(i) conducted or supported by the 
                        Department of Health and Human Services; or
                            ``(ii) otherwise subject to regulation by 
                        the Department under a provision of Federal law 
                        (other than this section).
                    ``(B) Other federal departments and agencies.--The 
                Secretary shall make available assistance to any 
                Federal department or agency seeking--
                            ``(i) to improve the regulation or 
                        oversight of human subject research; or
                            ``(ii) to apply the HHS Human Subject 
                        Regulations or the vulnerable-population rules 
                        to human subject research that is conducted, 
                        supported, or regulated by such department or 
                        agency.
    ``(b) HHS Human Subject Regulations; Other Definitions.--
            ``(1) HHS human subject regulations; vulnerable-population 
        rules.--For purposes of this section:
                    ``(A) Except as provided in subsection (a)(2)(B) 
                (relating to FDA research), the term `HHS Human Subject 
                Regulations' means the provisions of subpart A of part 
                46 of title 45, Code of Federal Regulations (or any 
                successor regulations).
                    ``(B) Except as provided in subsection (a)(2)(B) 
                (relating to FDA research), the term `vulnerable-
                population rules' means the provisions of subparts B 
                through D of such part 46 (or any successor 
                regulations).
            ``(2) 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.
            ``(3) Other definitions.--For purposes of this section:
                    ``(A) The terms `institution served by an 
                institutional review board' and `institution served by 
                the board' mean the public or private entity 
                (university, health care provider, health plan, 
                research organization, government agency, independent 
                institutional review board, or other entity) that 
                establishes and is responsible for the operation of the 
                institutional review board.
                    ``(B) The term `institutional review board' has the 
                meaning that applies to the term `institutional review 
                board' under the HHS Human Subject Regulations.
                    ``(C) The term `lead institutional review board' 
                means an institutional review board that otherwise 
                meets the requirements of the HHS Human Subject 
                Regulations 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.
                    ``(D) 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.
                    ``(E)(i) Except as provided in clause (ii), the 
                term `sponsor', with respect to human subject research, 
                means the entity that provides the majority or 
                plurality of the financial support 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 HHS Human Subject Regulations 
        (including provisions regarding exemptions) and the vulnerable-
        populations rules, as in effect on the day before the date of 
        the enactment of the Research Participants Protection 
        Modernization Act of 2011, 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 HHS Human 
                Subject Regulations 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 HHS Human Subject 
                Regulations 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.--The Secretary shall, 
                        with respect to the HHS Human Subject 
                        Regulations, consider the matters specified in 
                        clause (iii) and make a determination of 
                        whether any of the provisions of such Rule or 
                        any guidance associated with such Rule should 
                        be modified accordingly.
                            ``(ii) Timing.--The Secretary shall publish 
                        the determination required by clause (i) in the 
                        Federal Register--
                                    ``(I) except as provided in 
                                subclause (II), not later than 3 years 
                                after the date of the enactment of the 
                                Research Participants Protection 
                                Modernization Act of 2011; and
                                    ``(II) in the case of a 
                                determination on the matters specified 
                                in clause (iii)(IX), not later than 18 
                                months after the submission of the 
                                report required by section 5 of the 
                                Research Participants Protection 
                                Modernization Act of 2011.
                            ``(iii) List of matters for 
                        consideration.--The matters referred to in 
                        clause (i) with respect to the HHS Human 
                        Subject Regulations are the following:
                                    ``(I) How requirements regarding 
                                the definition and management of 
                                potential financial conflict of 
                                interest, including both investigator 
                                and institutional conflicts of 
                                interest, should be strengthened and 
                                enforced to protect human subjects more 
                                effectively.
                                    ``(II) Whether the list of 
                                exemptions from applicability of the 
                                HHS Human Subject Regulations, as in 
                                effect on the day before the date of 
                                enactment referred to in clause 
                                (ii)(I), should be expanded to include 
                                new categories.
                                    ``(III) Whether and under what 
                                circumstances research that studies 
                                human tissue or other types of clinical 
                                specimens should not be considered a 
                                clinical investigation.
                                    ``(IV) Whether the list of 
                                categories of research that are 
                                eligible for expedited review under the 
                                HHS Human Subject Regulations, as in 
                                effect on the day before the date of 
                                enactment referred to in clause 
                                (ii)(I), should be expanded to include 
                                new categories of research eligible for 
                                expedited review.
                                    ``(V) Whether institutional review 
                                boards include sufficient numbers of 
                                minority individuals as board members 
                                when reviewing proposals designed to 
                                include human subjects who are minority 
                                individuals.
                                    ``(VI) Whether the requirements for 
                                the number of members of an 
                                institutional review board who are 
                                individuals whose primary expertise is 
                                in nonscientific areas, and the number 
                                of members of an institutional review 
                                board who are individuals who are not 
                                affiliated with the institution served 
                                by the board, should be increased.
                                    ``(VII) Whether institutional 
                                review boards include sufficient 
                                numbers of individuals with appropriate 
                                scientific expertise.
                                    ``(VIII) How to enhance the 
                                protection of people with diminished 
                                decisionmaking capacity with respect to 
                                their participation as subjects in 
                                human subject research.
                                    ``(IX) How the requirements for 
                                institutional review board review in 
                                multisite research should be modified 
                                to reduce regulatory burden while 
                                protecting human subjects, including 
                                use of a lead institutional review 
                                board.
                                    ``(X) How the requirements for 
                                managing and reporting adverse events 
                                and unanticipated problems should be 
                                modified--
                                            ``(aa) to increase 
                                        consistency between such 
                                        requirements of the Office for 
                                        Human Research Protections of 
                                        the Department of Health and 
                                        Human Services and the 
                                        corresponding requirements of 
                                        the Food and Drug 
                                        Administration; and
                                            ``(bb) to reduce regulatory 
                                        burden appropriately while 
                                        protecting human subjects.
                                    ``(XI) How the requirements for 
                                approval and oversight of human 
                                subjects research that poses no more 
                                than minimal risk to participants 
                                (including requirements of informed 
                                consent, documentation of informed 
                                consent, and continuing review) should 
                                be modified to reduce regulatory burden 
                                (including burden on institutions, 
                                institutional review boards, and 
                                investigators) while protecting 
                                research participants, including 
                                clarification of the circumstances in 
                                which informed consent does not need to 
                                be writing.
                                    ``(XII) Whether research that would 
                                be defined as a `clinical 
                                investigation' under part 50 of title 
                                21, Code of Federal Regulations, should 
                                comply with the guideline published by 
                                the Food and Drug Administration and 
                                endorsed by the International 
                                Conference on Harmonisation of 
                                Technical Requirements for Registration 
                                of Pharmaceuticals for Human Use, 
                                entitled `Good Clinical Practice: 
                                Consolidated Guideline', and how 
                                investigators can be educated 
                                effectively regarding compliance with 
                                this guideline.
                                    ``(XIII) Such additional matters as 
                                the Secretary determines to be 
                                appropriate.
    ``(d) Institutional Review Boards.--
            ``(1) Notification of institutional review board and 
        sponsors by investigators.--
                    ``(A) Requirement.--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--
                            ``(i) of any significant financial 
                        interest, as defined by applicable Federal 
                        regulations;
                            ``(ii) whether the investigators have been 
                        disqualified or restricted by any Federal, 
                        State, or local 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
                            ``(iii) whether the proposal has been 
                        submitted to any other institutional review 
                        board and, as applicable, of any findings made 
                        by such board.
                    ``(B) Timing.--A notification required by 
                subparagraph (A) shall be submitted to the institution 
                served by the board--
                            ``(i) at the time of submitting the 
                        proposal for human subject research to the 
                        board; or
                            ``(ii) in the case of circumstances arising 
                        after such submission, immediately.
            ``(2) Institutional review of conflicts of interest.--The 
        institution served by an institutional review board shall--
                    ``(A) review such significant financial interests 
                as are submitted to the institution under paragraph (1) 
                to determine whether such interests create or may 
                reasonably appear to create conflicts of interest; and
                    ``(B) seek to eliminate or manage such conflicts of 
                interest.
            ``(3) Cost recovery.--Institutions may recover costs 
        associated with compliance for human subject protections under 
        this part from government sponsors of research as direct costs.
    ``(e) Institutional Programs of Education.--For fiscal year 2012 
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 
program to educate investigators and board members on the protection of 
human subjects in research.
    ``(f) Applicability of Requirements.--The requirements of this 
section apply on and after the date of the enactment of the Research 
Participants Protection Modernization Act of 2011.''.

SEC. 3. OFFICE FOR HUMAN RESEARCH PROTECTIONS.

    (a) In General.--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:

``SEC. 491B. OFFICE FOR HUMAN RESEARCH PROTECTIONS.

    ``(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 section 
        491A;
            ``(2) shall establish criteria regarding assurances of 
        compliance with the requirements of section 491A;
            ``(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 section 
                491A, including with respect to differing 
                interpretations among institutional review boards of a 
                provision of such section;
            ``(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 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 Programs.--The Director of the Office may 
make grants for the development of model education programs that may be 
used by institutions served by institutional review boards to promote 
best practices in institutional management of human subject research.
    ``(d) 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 2012, and such sums as 
        may be necessary for fiscal year 2013 and each subsequent 
        fiscal year.
            ``(2) Model education programs.--For the purpose of 
        carrying out subsection (c), there are authorized to be 
        appropriated such sums as may be necessary for fiscal year 2012 
        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.''.
    (b) Functions, Personnel, Assets, and Liabilities.--All functions, 
personnel, assets, and liabilities of the Office for Human Research 
Protection of the Department of Health and Human Services, as in 
existence on the day before the date of the enactment of this Act, 
shall be transferred to the Office for Human Research Protections 
established by section 491B of the Public Health Service Act, as added 
by subsection (a).

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: ``, sharing of information between the Director 
        of NIH and the Director of such Office,''.
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