I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Research Participants 

5 Protection Modernization Act of 2011’’. 

mstockstill on DSK4VPTVN1PROD with BILLS

2 

•HR 2625 IH

1 SEC. 2. PROTECTION OF HUMAN SUBJECTS IN RESEARCH; 

2 APPLICABILITY OF RULES. 

3 Part H of title IV of the Public Health Service Act 

4 (42 U.S.C. 289 et seq.) is amended by inserting after sec5 tion 491 the following section: 

6 ‘‘SEC. 491A. PROTECTION OF HUMAN SUBJECTS IN RE7 SEARCH; APPLICABILITY OF RULES. 

8 ‘‘(a) PROTECTION OF HUMAN SUBJECTS.— 

9 ‘‘(1) IN GENERAL.—Except as provided in para10 graph (2), all human subject research described in 

11 paragraph (3)(A) shall be conducted in accordance 

12 with the HHS Human Subject Regulations, and as 

13 applicable to the human subjects involved in such re14 search, with the vulnerable-populations rules. 

15 ‘‘(2) FDA RESEARCH.— 

16 ‘‘(A) APPLICABLE RULES.—All human 

17 subject research that is subject to the Federal 

18 Food, Drug, and Cosmetic Act or to section 

19 351 of this Act shall be conducted— 

20 ‘‘(i) in accordance with the provisions 

21 of parts 50, 56, 312, and 812 of title 21, 

22 Code of Federal Regulations (or any suc23 cessor regulations); and 

24 ‘‘(ii) as applicable to the human sub25 jects involved in such research, in accord26 ance with provisions applicable to vulnermstockstill on DSK4VPTVN1PROD with BILLS

3 

•HR 2625 IH

1 able populations under part 56 of such 

2 title 21 (or any successor regulations) and 

3 subpart D of part 50 of such title 21 (or 

4 any successor regulations). 

5 ‘‘(B) REFERENCES.—In the case of human 

6 subject research described in subparagraph 

7 (A)— 

8 ‘‘(i) each reference in this section or 

9 section 491B to the HHS Human Subject 

10 Regulations shall be treated as a reference 

11 to the provisions described in subpara12 graph (A)(i); and 

13 ‘‘(ii) each reference in this section to 

14 the vulnerable population rules shall be 

15 treated as a reference to the provisions de16 scribed in subparagraph (A)(ii). 

17 ‘‘(3) APPLICABILITY.— 

18 ‘‘(A) IN GENERAL.—This section applies to 

19 human subject research that is— 

20 ‘‘(i) conducted or supported by the 

21 Department of Health and Human Serv22 ices; or 

23 ‘‘(ii) otherwise subject to regulation 

24 by the Department under a provision of 

25 Federal law (other than this section). 

mstockstill on DSK4VPTVN1PROD with BILLS

4 

•HR 2625 IH

1 ‘‘(B) OTHER FEDERAL DEPARTMENTS AND

2 AGENCIES.—The Secretary shall make available 

3 assistance to any Federal department or agency 

4 seeking— 

5 ‘‘(i) to improve the regulation or over6 sight of human subject research; or 

7 ‘‘(ii) to apply the HHS Human Sub8 ject Regulations or the vulnerable-popu9 lation rules to human subject research that 

10 is conducted, supported, or regulated by 

11 such department or agency. 

12 ‘‘(b) HHS HUMAN SUBJECT REGULATIONS; OTHER

13 DEFINITIONS.— 

14 ‘‘(1) HHS HUMAN SUBJECT REGULATIONS; 

15 VULNERABLE-POPULATION RULES.—For purposes of 

16 this section: 

17 ‘‘(A) Except as provided in subsection 

18 (a)(2)(B) (relating to FDA research), the term 

19 ‘HHS Human Subject Regulations’ means the 

20 provisions of subpart A of part 46 of title 45, 

21 Code of Federal Regulations (or any successor 

22 regulations). 

23 ‘‘(B) Except as provided in subsection 

24 (a)(2)(B) (relating to FDA research), the term 

25 ‘vulnerable-population rules’ means the provimstockstill on DSK4VPTVN1PROD with BILLS

5 

•HR 2625 IH

1 sions of subparts B through D of such part 46 

2 (or any successor regulations). 

3 ‘‘(2) HUMAN SUBJECT RESEARCH.—For pur4 poses of this section: 

5 ‘‘(A) Except as provided in subparagraph 

6 (B), the term ‘human subject research’ means 

7 research, as defined in subpart A of part 46 of 

8 title 45, Code of Federal Regulations (or any 

9 successor regulations), that involves a human 

10 subject, as defined in such subpart A (or any 

11 successor regulations). 

12 ‘‘(B) In the case of an investigation that is 

13 subject to the provisions of part 50 of title 21, 

14 Code of Federal Regulations (or successor regu15 lations), the term ‘human subject’ has the 

16 meaning given such term in such part 50, and 

17 the term ‘human subject research’ means a clin18 ical investigation as defined in such part 50. 

19 ‘‘(3) OTHER DEFINITIONS.—For purposes of 

20 this section: 

21 ‘‘(A) The terms ‘institution served by an 

22 institutional review board’ and ‘institution 

23 served by the board’ mean the public or private 

24 entity (university, health care provider, health 

25 plan, research organization, government agency, 

mstockstill on DSK4VPTVN1PROD with BILLS

6 

•HR 2625 IH

1 independent institutional review board, or other 

2 entity) that establishes and is responsible for 

3 the operation of the institutional review board. 

4 ‘‘(B) The term ‘institutional review board’ 

5 has the meaning that applies to the term ‘insti6 tutional review board’ under the HHS Human 

7 Subject Regulations. 

8 ‘‘(C) The term ‘lead institutional review 

9 board’ means an institutional review board that 

10 otherwise meets the requirements of the HHS 

11 Human Subject Regulations and enters into a 

12 written agreement with an institution, another 

13 institutional review board, a sponsor, or a prin14 cipal investigator to approve and oversee human 

15 subject research that is conducted at multiple 

16 locations. For purposes of this section, ref17 erences to an institutional review board include 

18 an institutional review board that serves a sin19 gle institution as well as a lead institutional re20 view board. 

21 ‘‘(D) The term ‘principal investigator’, 

22 with respect to human subject research, means 

23 the individual who, at the research location in24 volved, has the principal responsibility for the 

25 conduct of the research. 

mstockstill on DSK4VPTVN1PROD with BILLS

7 

•HR 2625 IH

1 ‘‘(E)(i) Except as provided in clause (ii), 

2 the term ‘sponsor’, with respect to human sub3 ject research, means the entity that provides 

4 the majority or plurality of the financial sup5 port for the conduct of the research. 

6 ‘‘(ii) In the case of an investigation that is 

7 subject to the provisions of part 50 of title 21, 

8 Code of Federal Regulations (or successor regu9 lations), the term ‘sponsor’, with respect to 

10 human subject research, has the meaning that 

11 applies for purposes of such part 50. 

12 ‘‘(c) SCOPE OF AUTHORITY OF SECRETARY.— 

13 ‘‘(1) IN GENERAL.—The HHS Human Subject 

14 Regulations (including provisions regarding exemp15 tions) and the vulnerable-populations rules, as in ef16 fect on the day before the date of the enactment of 

17 the Research Participants Protection Modernization 

18 Act of 2011, continue to be in effect on and after 

19 such date, subject to paragraph (2). 

20 ‘‘(2) MODIFICATIONS.— 

21 ‘‘(A) COMPLIANCE WITH LAW.—Promptly 

22 after the date of the enactment of the Act re23 ferred to in paragraph (1), the Secretary shall 

24 promulgate regulations to make such modifica25 tions to the provisions of the HHS Human 

mstockstill on DSK4VPTVN1PROD with BILLS

8 

•HR 2625 IH

1 Subject Regulations as may be necessary to en2 sure that such provisions implement, and do not 

3 conflict with, this section. 

4 ‘‘(B) OTHER MODIFICATIONS.—This sec5 tion may not be construed as affecting the au6 thority of the Secretary to modify the provisions 

7 of the HHS Human Subject Regulations or the 

8 vulnerable-populations rules, except to the ex9 tent that any such modification is in conflict 

10 with this section. Any such modification shall 

11 be made by regulation. 

12 ‘‘(C) CONSIDERATION OF CERTAIN MAT13 TERS.— 

14 ‘‘(i) IN GENERAL.—The Secretary 

15 shall, with respect to the HHS Human 

16 Subject Regulations, consider the matters 

17 specified in clause (iii) and make a deter18 mination of whether any of the provisions 

19 of such Rule or any guidance associated 

20 with such Rule should be modified accord21 ingly. 

22 ‘‘(ii) TIMING.—The Secretary shall 

23 publish the determination required by 

24 clause (i) in the Federal Register— 

mstockstill on DSK4VPTVN1PROD with BILLS

9 

•HR 2625 IH

1 ‘‘(I) except as provided in sub2 clause (II), not later than 3 years 

3 after the date of the enactment of the 

4 Research Participants Protection 

5 Modernization Act of 2011; and 

6 ‘‘(II) in the case of a determina7 tion on the matters specified in clause 

8 (iii)(IX), not later than 18 months 

9 after the submission of the report re10 quired by section 5 of the Research 

11 Participants Protection Modernization 

12 Act of 2011. 

13 ‘‘(iii) LIST OF MATTERS FOR CONSID14 ERATION.—The matters referred to in 

15 clause (i) with respect to the HHS Human 

16 Subject Regulations are the following: 

17 ‘‘(I) How requirements regarding 

18 the definition and management of po19 tential financial conflict of interest, 

20 including both investigator and insti21 tutional conflicts of interest, should be 

22 strengthened and enforced to protect 

23 human subjects more effectively. 

24 ‘‘(II) Whether the list of exemp25 tions from applicability of the HHS 

mstockstill on DSK4VPTVN1PROD with BILLS

10 

•HR 2625 IH

1 Human Subject Regulations, as in ef2 fect on the day before the date of en3 actment referred to in clause (ii)(I), 

4 should be expanded to include new 

5 categories. 

6 ‘‘(III) Whether and under what 

7 circumstances research that studies 

8 human tissue or other types of clinical 

9 specimens should not be considered a 

10 clinical investigation. 

11 ‘‘(IV) Whether the list of cat12 egories of research that are eligible 

13 for expedited review under the HHS 

14 Human Subject Regulations, as in ef15 fect on the day before the date of en16 actment referred to in clause (ii)(I), 

17 should be expanded to include new 

18 categories of research eligible for ex19 pedited review. 

20 ‘‘(V) Whether institutional review 

21 boards include sufficient numbers of 

22 minority individuals as board mem23 bers when reviewing proposals de24 signed to include human subjects who 

25 are minority individuals. 

mstockstill on DSK4VPTVN1PROD with BILLS

11 

•HR 2625 IH

1 ‘‘(VI) Whether the requirements 

2 for the number of members of an in3 stitutional review board who are indi4 viduals whose primary expertise is in 

5 nonscientific areas, and the number of 

6 members of an institutional review 

7 board who are individuals who are not 

8 affiliated with the institution served 

9 by the board, should be increased. 

10 ‘‘(VII) Whether institutional re11 view boards include sufficient num12 bers of individuals with appropriate 

13 scientific expertise. 

14 ‘‘(VIII) How to enhance the pro15 tection of people with diminished deci16 sionmaking capacity with respect to 

17 their participation as subjects in 

18 human subject research. 

19 ‘‘(IX) How the requirements for 

20 institutional review board review in 

21 multisite research should be modified 

22 to reduce regulatory burden while pro23 tecting human subjects, including use 

24 of a lead institutional review board. 

mstockstill on DSK4VPTVN1PROD with BILLS

12 

•HR 2625 IH

1 ‘‘(X) How the requirements for 

2 managing and reporting adverse 

3 events and unanticipated problems 

4 should be modified— 

5 ‘‘(aa) to increase consistency 

6 between such requirements of the 

7 Office for Human Research Pro8 tections of the Department of 

9 Health and Human Services and 

10 the corresponding requirements 

11 of the Food and Drug Adminis12 tration; and 

13 ‘‘(bb) to reduce regulatory 

14 burden appropriately while pro15 tecting human subjects. 

16 ‘‘(XI) How the requirements for 

17 approval and oversight of human sub18 jects research that poses no more 

19 than minimal risk to participants (in20 cluding requirements of informed con21 sent, documentation of informed con22 sent, and continuing review) should be 

23 modified to reduce regulatory burden 

24 (including burden on institutions, in25 stitutional review boards, and invesmstockstill on DSK4VPTVN1PROD with BILLS

13 

•HR 2625 IH

1 tigators) while protecting research 

2 participants, including clarification of 

3 the circumstances in which informed 

4 consent does not need to be writing. 

5 ‘‘(XII) Whether research that 

6 would be defined as a ‘clinical inves7 tigation’ under part 50 of title 21, 

8 Code of Federal Regulations, should 

9 comply with the guideline published 

10 by the Food and Drug Administration 

11 and endorsed by the International 

12 Conference on Harmonisation of 

13 Technical Requirements for Registra14 tion of Pharmaceuticals for Human 

15 Use, entitled ‘Good Clinical Practice: 

16 Consolidated Guideline’, and how in17 vestigators can be educated effectively 

18 regarding compliance with this guide19 line. 

20 ‘‘(XIII) Such additional matters 

21 as the Secretary determines to be ap22 propriate. 

23 ‘‘(d) INSTITUTIONAL REVIEW BOARDS.— 

24 ‘‘(1) NOTIFICATION OF INSTITUTIONAL REVIEW

25 BOARD AND SPONSORS BY INVESTIGATORS.— 

mstockstill on DSK4VPTVN1PROD with BILLS

14 

•HR 2625 IH

1 ‘‘(A) REQUIREMENT.—In submitting to an 

2 institutional review board a proposal for human 

3 subject research, the investigators for the re4 search shall notify the institution served by the 

5 board— 

6 ‘‘(i) of any significant financial inter7 est, as defined by applicable Federal regu8 lations; 

9 ‘‘(ii) whether the investigators have 

10 been disqualified or restricted by any Fed11 eral, State, or local entity in their ability 

12 to conduct human subject research, includ13 ing being ineligible to conduct human sub14 ject research with investigational new 

15 drugs, being ineligible for approval of new 

16 drug applications, or agreeing to some 

17 other form of restriction regarding re18 search; and 

19 ‘‘(iii) whether the proposal has been 

20 submitted to any other institutional review 

21 board and, as applicable, of any findings 

22 made by such board. 

23 ‘‘(B) TIMING.—A notification required by 

24 subparagraph (A) shall be submitted to the in25 stitution served by the board— 

mstockstill on DSK4VPTVN1PROD with BILLS

15 

•HR 2625 IH

1 ‘‘(i) at the time of submitting the pro2 posal for human subject research to the 

3 board; or 

4 ‘‘(ii) in the case of circumstances aris5 ing after such submission, immediately. 

6 ‘‘(2) INSTITUTIONAL REVIEW OF CONFLICTS OF

7 INTEREST.—The institution served by an institu8 tional review board shall— 

9 ‘‘(A) review such significant financial in10 terests as are submitted to the institution under 

11 paragraph (1) to determine whether such inter12 ests create or may reasonably appear to create 

13 conflicts of interest; and 

14 ‘‘(B) seek to eliminate or manage such 

15 conflicts of interest. 

16 ‘‘(3) COST RECOVERY.—Institutions may re17 cover costs associated with compliance for human 

18 subject protections under this part from government 

19 sponsors of research as direct costs. 

20 ‘‘(e) INSTITUTIONAL PROGRAMS OF EDUCATION.— 

21 For fiscal year 2012 and subsequent fiscal years, the Sec22 retary may not make an award of a grant, cooperative 

23 agreement, or contract under this Act to a public entity 

24 or a private academic institution, or make an award of 

25 a grant, cooperative agreement, or contract under this Act 

mstockstill on DSK4VPTVN1PROD with BILLS

16 

•HR 2625 IH

1 for the conduct of research at or through or in affiliation 

2 with a public entity or a private academic institution, un3 less the public entity or private academic institution (as 

4 the case may be) maintains or contracts for a program 

5 to educate investigators and board members on the protec6 tion of human subjects in research. 

7 ‘‘(f) APPLICABILITY OF REQUIREMENTS.—The re8 quirements of this section apply on and after the date of 

9 the enactment of the Research Participants Protection 

10 Modernization Act of 2011.’’. 

11 SEC. 3. OFFICE FOR HUMAN RESEARCH PROTECTIONS. 

12 (a) IN GENERAL.—Part H of title IV of the Public 

13 Health Service Act (42 U.S.C. 289 et seq.), as amended 

14 by section 2 of this Act, is amended by inserting after 

15 section 491A the following section: 

16 ‘‘SEC. 491B. OFFICE FOR HUMAN RESEARCH PROTECTIONS. 

17 ‘‘(a) IN GENERAL.—There is established within the 

18 office of the Secretary an office to be known as the Office 

19 for Human Research Protections (in this section referred 

20 to as the ‘Office’). The Office shall be headed by a direc21 tor, who shall be appointed by the Secretary. The Sec22 retary shall carry out this section acting through the Di23 rector of the Office. 

24 ‘‘(b) CERTAIN DUTIES.—The Director of the Of25 fice— 

mstockstill on DSK4VPTVN1PROD with BILLS

17 

•HR 2625 IH

1 ‘‘(1) shall provide for the protection of human 

2 subjects in research by carrying out activities in ac3 cordance with section 491A; 

4 ‘‘(2) shall establish criteria regarding assur5 ances of compliance with the requirements of section 

6 491A; 

7 ‘‘(3) shall direct activities within the Depart8 ment of Health and Human Services, and coordinate 

9 the activities of the Department with other Federal 

10 departments and agencies, with respect to the pro11 tection of subjects in human subject research; 

12 ‘‘(4) may, in collaboration with the Director of 

13 NIH, the Commissioner of Food and Drugs, or the 

14 head of any other Federal department or agency, 

15 carry out educational and quality improvement pro16 grams for human subject protections for principal 

17 investigators, members of institutional review 

18 boards, and other appropriate persons, including the 

19 generation of resource materials relating to the re20 sponsibilities of the research community for the pro21 tection of human subjects in research; 

22 ‘‘(5) shall, upon the request of an entity that 

23 conducts or supports human subject research— 

mstockstill on DSK4VPTVN1PROD with BILLS

18 

•HR 2625 IH

1 ‘‘(A) consult with the entity regarding im2 provements in human subject protections in 

3 such research; and 

4 ‘‘(B) provide advice on compliance with 

5 section 491A, including with respect to differing 

6 interpretations among institutional review 

7 boards of a provision of such section; 

8 ‘‘(6) may make grants to entities that conduct 

9 or support human subject research for the purpose 

10 of assisting the entities in carrying out programs to 

11 recruit and train minority individuals to serve as 

12 members of institutional review boards; 

13 ‘‘(7) shall consult with experts in biomedical, 

14 behavioral, and social sciences research in carrying 

15 out the duties of the Director; and 

16 ‘‘(8) shall carry out such additional authorities 

17 of the Secretary regarding the protection of human 

18 subjects in research as the Secretary determines to 

19 be appropriate. 

20 ‘‘(c) MODEL EDUCATION PROGRAMS.—The Director 

21 of the Office may make grants for the development of 

22 model education programs that may be used by institu23 tions served by institutional review boards to promote best 

24 practices in institutional management of human subject 

25 research. 

mstockstill on DSK4VPTVN1PROD with BILLS

19 

•HR 2625 IH

1 ‘‘(d) FUNDING.— 

2 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.— 

3 For the purpose of carrying out this section, there 

4 are authorized to be appropriated $20,000,000 for 

5 fiscal year 2012, and such sums as may be nec6 essary for fiscal year 2013 and each subsequent fis7 cal year. 

8 ‘‘(2) MODEL EDUCATION PROGRAMS.—For the 

9 purpose of carrying out subsection (c), there are au10 thorized to be appropriated such sums as may be 

11 necessary for fiscal year 2012 and each subsequent 

12 fiscal year. 

13 ‘‘(3) RULE OF CONSTRUCTION.—Nothing in 

14 this section or section 491A may be construed as a 

15 change in the budget authority or authorization of 

16 appropriations for the Food and Drug Administra17 tion.’’. 

18 (b) FUNCTIONS, PERSONNEL, ASSETS, AND LIABIL19 ITIES.—All functions, personnel, assets, and liabilities of 

20 the Office for Human Research Protection of the Depart21 ment of Health and Human Services, as in existence on 

22 the day before the date of the enactment of this Act, shall 

23 be transferred to the Office for Human Research Protec24 tions established by section 491B of the Public Health 

25 Service Act, as added by subsection (a). 

mstockstill on DSK4VPTVN1PROD with BILLS

20 

•HR 2625 IH

1 SEC. 4. AMENDMENTS REGARDING PROCESS FOR RE2 SPONDING TO REPORTS OF VIOLATIONS. 

3 Section 491(b)(2) of the Public Health Service Act 

4 (42 U.S.C. 289(b)(2)) is amended— 

5 (1) in the first sentence, by inserting ‘‘or the 

6 Director of the Office for Human Research Protec7 tions’’ after ‘‘the Director of NIH’’; and 

8 (2) in the second sentence, by inserting after 

9 ‘‘this Act’’ the following: ‘‘, sharing of information 

10 between the Director of NIH and the Director of 

11 such Office,’’. 

Æ 

mstockstill on DSK4VPTVN1PROD with BILLS