I 

111TH CONGRESS 

1ST SESSION H. R. 1715 

To amend the Public Health Service Act with respect to the protection 

of human subjects in research. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 25, 2009 

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. 

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 ‘‘Protection for Partici5 pants in Research Act of 2009’’. 


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

2 UNIFORM NATIONAL APPLICABILITY OF 

3 RULES. 

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

5 (42 U.S.C. 289 et seq.) is amended by inserting after sec6 tion 491 the following section: 

7 ‘‘SEC. 491A. PROTECTION OF HUMAN SUBJECTS IN RE8 SEARCH; UNIFORM NATIONAL APPLICA9 BILITY OF RULES. 

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

11 ‘‘(1) IN GENERAL.—Except as provided in para12 graph (2), all human subject research shall be con13 ducted in accordance with the Common Rule, and as 

14 applicable to the human subjects involved in such re15 search, with the vulnerable-populations rules. 

16 ‘‘(2) FDA RESEARCH.— 

17 ‘‘(A) APPLICABLE RULES.—All human 

18 subject research that is subject to the Federal 

19 Food, Drug, and Cosmetic Act or to section 

20 351 of this Act shall be conducted— 

21 ‘‘(i) in accordance with the provisions 

22 of parts 50 and 56 of title 21, Code of 

23 Federal Regulations (or any successor reg24 ulations); and 

25 ‘‘(ii) as applicable to the human sub26 jects involved in such research, in accordVerDate Nov 24 2008 03:15 Mar 26, 2009 Jkt 079200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1715.IH H1715

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1 ance with provisions applicable to vulner2 able populations under part 56 of such 

3 title 21 (or any successor regulations) and 

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

5 any successor regulations). 

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

7 subject research described in subparagraph 

8 (A)— 

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

10 section 491B to the Common Rule shall be 

11 treated as a reference to the provisions de12 scribed in subparagraph (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.—Paragraphs (1) and (2) 

18 apply to human subject research that— 

19 ‘‘(A) is conducted, supported, or otherwise 

20 subject to regulation under a provision of Fed21 eral law (other than this section), without re22 gard to whether the Federal agency that admin23 isters such law has taken administrative action 

24 to make the Common Rule applicable to the 

25 agency; or 


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1 ‘‘(B) is not described in subparagraph (A) 

2 and has activities that are in or that affect 

3 interstate commerce. 

4 ‘‘(4) HARMONIZATION.— 

5 ‘‘(A) REVIEW OF REGULATIONS.—Not 

6 later than 18 months after the date of the en7 actment of the Protection for Participants in 

8 Research Act of 2009, the Secretary shall com9 plete a review of the provisions of subpart A of 

10 part 46 of title 45, Code of Federal Regulations 

11 (referred to in this paragraph as ‘title 45 regu12 lations’), and the provisions of parts 50 and 56 

13 of title 21, Code of Federal Regulations (re14 ferred to in this paragraph as ‘title 21 regula15 tions’), in order to determine to what extent the 

16 differences in approach between the title 45 

17 regulations and the title 21 regulations can be 

18 harmonized toward the goal of having only such 

19 differences as are appropriate to reflect the 

20 legal or factual variations in human subject re21 search described in paragraph (2)(A) relative to 

22 other human subject research. The areas of dif23 ference reviewed shall include (but are not lim24 ited to) differences regarding the existence of a 

25 significant financial interest; provisions for reVerDate Nov 24 2008 03:15 Mar 26, 2009 Jkt 079200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1715.IH H1715

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1 search relating to emergency interventions; the 

2 definition of ‘institution’; and requirements for 

3 attestations by investigators regarding the pro4 tection of human subjects. 

5 ‘‘(B) RULEMAKING.— 

6 ‘‘(i) PURSUANT TO HARMONIZATION

7 REVIEW.—Not later than three years after 

8 completing the review under subparagraph 

9 (A), the Secretary shall publish in the Fed10 eral Register a proposed rule to modify the 

11 title 45 regulations, or the title 21 regula12 tions, or both, in accordance with the find13 ings of the review, unless the review finds 

14 that removing any of the differences in ap15 proach between the title 45 regulations and 

16 the title 21 regulations is not practicable. 

17 ‘‘(ii) SUBSEQUENT RULEMAKING.— 

18 After the expiration of the three-year pe19 riod referred to in clause (i), or the publi20 cation of the proposed rule under clause 

21 (i), whichever occurs first, any rule pro22 mulgated by the Secretary that modifies 

23 the title 45 regulations or the title 21 reg24 ulations (including a modification that 

25 adds provisions), and results in there being 


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1 a difference between the title 45 regula2 tions and the title 21 regulations, shall be 

3 accompanied in the Federal Register by a 

4 statement of the reasons underlying the 

5 determination of the Secretary that, with 

6 respect to the goal described in subpara7 graph (A), the difference is appropriate to 

8 reflect the legal or factual variations in 

9 human subject research described in para10 graph (2)(A) relative to other human sub11 ject research. 

12 ‘‘(b) COMMON RULE; OTHER DEFINITIONS.— 

13 ‘‘(1) COMMON RULE; VULNERABLE-POPULATION

14 RULES.—For purposes of this section: 

15 ‘‘(A) The term ‘Common Rule’ means the 

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

17 Code of Federal Regulations (or any successor 

18 regulations). 

19 ‘‘(B) The term ‘vulnerable-population 

20 rules’ means the provisions of subparts B 

21 through D of such part 46 (or any successor 

22 regulations). 

23 ‘‘(3) HUMAN SUBJECT RESEARCH.—For pur24 poses of this section: 


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1 ‘‘(A) Except as provided in subparagraph 

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

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

4 title 45, Code of Federal Regulations (or any 

5 successor regulations), that involves a human 

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

7 successor regulations). 

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

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

10 Code of Federal Regulations (or successor regu11 lations), the term ‘human subject’ has the 

12 meaning given such term in such part 50, and 

13 the term ‘human subject research’ means a clin14 ical investigation as defined in such part 50. 

15 ‘‘(4) OTHER DEFINITIONS.—For purposes of 

16 this section: 

17 ‘‘(A) The term ‘classified’, with respect to 

18 human subject research, refers to research that, 

19 within the meaning of section 552(b)(1)(A) of 

20 title 5, United States Code, is— 

21 ‘‘(i) specifically authorized under cri22 teria established by an Executive order to 

23 be kept secret in the interest of national 

24 defense or foreign policy; and 


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1 ‘‘(ii) is in fact properly classified pur2 suant to such Executive order. 

3 ‘‘(B) The term ‘data safety and monitoring 

4 committee’, with respect to a human subject re5 search project, means a group of individuals 

6 with appropriate expertise that, on an ongoing 

7 basis during the conduct of such research 

8 project— 

9 ‘‘(i) reviews data that are generated 

10 during the project; 

11 ‘‘(ii) advises the investigator and 

12 sponsor regarding the continuing safety of 

13 human subjects who are or will be partici14 pating in the project; and 

15 ‘‘(iii) advises such investigator and 

16 sponsor on the continued validity and sci17 entific merit of the project. 

18 ‘‘(C) The term ‘Federal agency’ has the 

19 meaning given the term ‘Executive agency’ in 

20 section 105 of title 5, United States Code. 

21 ‘‘(D) 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, 


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1 independent institutional review board, or other 

2 entity) that establishes and is responsible for 

3 the operation of the Institutional Review Board. 

4 ‘‘(E) The term ‘Institutional Review 

5 Board’ has the meaning that applies under the 

6 Common Rule. 

7 ‘‘(F) The term ‘lead Institutional Review 

8 Board’ means an Institutional Review Board 

9 that otherwise meets the requirements of the 

10 Common Rule and enters into a written agree11 ment with an institution, another Institutional 

12 Review Board, a sponsor, or a principal investi13 gator to approve and oversee human subject re14 search that is conducted at multiple locations. 

15 For purposes of this section, references to an 

16 Institutional Review Board include an Institu17 tional Review Board that serves a single institu18 tion as well as a lead Institutional Review 

19 Board. 

20 ‘‘(G) The term ‘principal investigator’, 

21 with respect to human subject research, means 

22 the individual who, at the research location in23 volved, has the principal responsibility for the 

24 conduct of the research. 


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1 ‘‘(H)(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 Common Rule (includ14 ing provisions regarding exemptions) and the vulner15 able-populations rules, as in effect on the day before 

16 the date of the enactment of the Protection for Par17 ticipants in Research Act of 2009, continue to be in 

18 effect on and after such date, subject to paragraph 

19 (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 Common Rule as 


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1 may be necessary to ensure that such provisions 

2 implement, and do not conflict with, this sec3 tion. 

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 Common Rule or the vulnerable-popu8 lations rules, except to the extent that any such 

9 modification is in conflict with this section. Any 

10 such modification shall be made by regulation. 

11 ‘‘(C) CONSIDERATION OF CERTAIN MAT12 TERS.— 

13 ‘‘(i) IN GENERAL.—The Secretary 

14 shall, with respect to the Common Rule, 

15 consider the matters specified in clause 

16 (iii) and make a determination of whether 

17 any of the provisions of such Rule should 

18 be modified accordingly. 

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

20 publish the determination required by 

21 clause (i) and publish the determination in 

22 the Federal Register— 

23 ‘‘(I) except as provided in sub24 clause (II), not later than 18 months 

25 after the date of the enactment of the 


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1 Protection for Participants in Re2 search Act of 2009; and 

3 ‘‘(II) in the case of a determina4 tion on the matters specified in clause 

5 (iii)(VII), not later than 18 months 

6 after the submission of the report re7 quired by section 7 of the Protection 

8 for Participants in Research Act of 

9 2009. 

10 ‘‘(iii) LIST OF MATTERS FOR CONSID11 ERATION.—The matters referred to in 

12 clause (i) with respect to the Common 

13 Rule are the following: 

14 ‘‘(I) Whether the list of exemp15 tions from applicability of the Com16 mon Rule, as in effect on the day be17 fore the date of enactment referred to 

18 in clause (ii)(I), should be modified or 

19 new categories of exemptions estab20 lished. 

21 ‘‘(II) Whether and under what 

22 circumstances research that studies 

23 human tissue or other types of clinical 

24 specimens should not be considered 

25 human subject research. 


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1 ‘‘(III) Whether and under what 

2 circumstances research that studies 

3 data that do not involve any inter4 action or intervention with a living 

5 human should be considered human 

6 subject research. 

7 ‘‘(IV) Whether the list of cat8 egories of research that are exempt 

9 from Investigational Review Board re10 view or are eligible for expedited re11 view under the Common Rule, as in 

12 effect on the day before the date of 

13 enactment referred to in clause (i), 

14 should be modified, and whether new 

15 categories of such exempt research or 

16 research eligible for expedited review 

17 should be established. 

18 ‘‘(V) Whether modified proce19 dures should apply to human subject 

20 research that poses minimal risk to 

21 the subjects, including whether there 

22 are any types of such research for 

23 which some aspect of the requirement 

24 of informed consent or documentation 


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1 of informed consent should apply dif2 ferently. 

3 ‘‘(VI) Whether Institutional Re4 view Boards include sufficient num5 bers of minority individuals (as de6 fined in section 485E(c)) as Board 

7 members when reviewing proposals 

8 designed to include human subjects 

9 who are minority individuals. 

10 ‘‘(VII) Whether the requirements 

11 for the number of members of an In12 stitutional Review Board who are in13 dividuals whose primary expertise is 

14 in nonscientific areas, and the number 

15 of members of an Institutional Review 

16 Board who are individuals who are 

17 not affiliated with the institution 

18 served by the Board, should be in19 creased. 

20 ‘‘(VIII) Such additional matters 

21 as the Secretary determines to be ap22 propriate. 

23 ‘‘(D) AGENCY-SPECIFIC ADDITIONAL PRO24 TECTIONS.—With respect to human subject re25 search that is conducted, supported, or otherVerDate Nov 24 2008 03:15 Mar 26, 2009 Jkt 079200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H1715.IH H1715

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1 wise subject to regulation under a provision of 

2 Federal law (other than this section), the Sec3 retary may under subparagraph (A) permit the 

4 Federal agency involved to establish additional 

5 protections for the protection of human subjects 

6 if the Secretary determines that such additional 

7 protections are not in conflict with protections 

8 established under this section. 

9 ‘‘(d) RIGHT OF INFORMED CONSENT.— 

10 ‘‘(1) IN GENERAL.—For purposes of subsection 

11 (a), a principal investigator may not, except as pro12 vided in the Common Rule, involve an individual as 

13 a subject in human subject research unless the in14 vestigator or other knowledgeable person has ob15 tained the informed consent of the individual to be 

16 a subject. 

17 ‘‘(2) LEGALLY AUTHORIZED REPRESENTA18 TIVE.—References in this section to obtaining con19 sent from an individual shall be considered to be ref20 erences to obtaining consent from the legally author21 ized representative of the individual in any case in 

22 which the individual lacks legal competence to pro23 vide consent. 

24 ‘‘(3) CERTAIN REQUIREMENTS REGARDING DIS25 CLOSURE AND UNDERSTANDING.—The Secretary 


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1 shall establish criteria regarding consent under para2 graph (1) that— 

3 ‘‘(A) provide for the provision of full and 

4 complete information relevant to the research to 

5 a prospective human subject; 

6 ‘‘(B) require such information to be pro7 vided in language understandable to such sub8 ject; 

9 ‘‘(C) require that only individuals knowl10 edgeable about the research provide such infor11 mation to the subject and answer questions 

12 from the subject; and 

13 ‘‘(D) require that information be provided 

14 to the subject on how to contact the Office for 

15 Human Research Protections to submit ques16 tions about the rights of subjects or to report 

17 concerns regarding the research. 

18 ‘‘(4) WRITTEN ATTESTATION BY INVESTI19 GATOR.—A principal investigator who involves a 

20 human subject in research shall, in accordance with 

21 the criteria of the Secretary, file with the Institu22 tional Review Board for the research a written attes23 tation that the investigator is familiar with require24 ments for the protection of human subjects, includVerDate Nov 24 2008 03:15 Mar 26, 2009 Jkt 079200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H1715.IH H1715

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1 ing the requirement of informed consent, and agrees 

2 to comply with such requirements. 

3 ‘‘(e) INSTITUTIONAL REVIEW BOARDS.— 

4 ‘‘(1) REQUIREMENTS FOR BOARDS.—Human 

5 subject research may not be conducted unless an In6 stitutional Review Board has, for purposes of the 

7 Common Rule (and the vulnerable-populations rules, 

8 as applicable), approved the proposal for such re9 search. With respect to the research involved, the 

10 approval by the Board of the proposal for the re11 search is not effective unless, in addition to condi12 tions established by the Secretary, the following con13 ditions are met: 

14 ‘‘(A) The institution served by the Board 

15 ensures that the Board has an orientation pro16 gram for new members and a continuing edu17 cation program for existing members of the 

18 Board, and with respect to ethical matters that 

19 relate to research, a continuing education pro20 gram for all members of the Board. 

21 ‘‘(B) The institution served by the Board 

22 has submitted to the Secretary a registration 

23 informing the Secretary of the existence of the 

24 Board, and the registration was in such form, 

25 was made in such manner, and contained such 


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1 information as the Secretary requested regard2 ing functions of the Board under this section. 

3 ‘‘(C) In the case of a proposal for a re4 search project requiring a data safety and mon5 itoring plan, the Board reviews the data safety 

6 and monitoring plan (pursuant to subsection 

7 (f)) as a part of the review by the Board of the 

8 proposal. 

9 ‘‘(D) With respect to the research involved, 

10 each member of the Board has disclosed any 

11 significant financial interest, as defined by ap12 plicable Federal regulations, to the institution 

13 served by the Board, and such institution has 

14 disclosed any such disclosures to the Board. 

15 ‘‘(E) A member of the Board does not par16 ticipate in the review by the Board of a pro17 posal for research if the member has a signifi18 cant financial interest, as defined by applicable 

19 Federal regulations, in the research. The provi20 sion by such member of information to other 

21 members of the Board does not constitute 

22 Board participation for purposes of this sub23 paragraph. 

24 ‘‘(F) The institution served by the Board 

25 annually submits to the Secretary a report that 


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1 compiles data on the number of new research 

2 proposals reviewed, the number of continuing 

3 research projects reviewed, the number of re4 viewed biomedical research proposals, the num5 ber of reviewed behavioral or social sciences re6 search proposals, the number of reviewed multi7 disciplinary research proposals, and any addi8 tional information determined appropriate by 

9 the Secretary. 

10 ‘‘(G) The institution served by the Board 

11 submits to the Secretary such reports regarding 

12 the Board as the Secretary determines to be ap13 propriate. 

14 ‘‘(2) NOTIFICATION OF INSTITUTIONAL REVIEW

15 BOARD AND SPONSORS BY INVESTIGATORS.— 

16 ‘‘(A) In submitting to an Institutional Re17 view Board a proposal for human subject re18 search, the investigators for the research shall 

19 notify the institution served by the Board— 

20 ‘‘(i) of any significant financial inter21 est, as defined by applicable Federal regu22 lations; 

23 ‘‘(ii) whether the investigators have 

24 been disqualified or restricted by any Fed25 eral, State, or local entity in their ability 


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1 to conduct human subject research, includ2 ing being ineligible to conduct human sub3 ject research with investigational new 

4 drugs, being ineligible for approval of new 

5 drug applications, or agreeing to some 

6 other form of restriction regarding re7 search; and 

8 ‘‘(iii) whether the proposal has been 

9 submitted to any other Institutional Re10 view Board and, as applicable, of any find11 ings made by such Board. 

12 ‘‘(B) A notification required by subpara13 graph (A) shall be submitted to the institution 

14 served by the Board— 

15 ‘‘(i) at the time of submitting the pro16 posal for human subject research to the 

17 Board; or 

18 ‘‘(ii) in the case of circumstances aris19 ing after such submission, immediately. 

20 ‘‘(3) INSTITUTION REVIEW OF CONFLICTS OF

21 INTEREST.—The institution served by an Institu22 tional Review Board shall review such significant fi23 nancial interests as are submitted under paragraph 

24 (2) to determine whether such interests create or 

25 may reasonably appear to create conflicts of interest, 


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1 and then shall seek to manage, reduce, or eliminate 

2 such conflicts of interest. 

3 ‘‘(4) PROJECTS INVOLVING MULTIPLE LOCA4 TIONS.—For purposes of meeting the Common Rule 

5 requirements for review and supervision of research 

6 by an Institutional Review Board, such activities 

7 may be performed by an Institutional Review Board 

8 or a lead Institutional Review Board, at the option 

9 of the institution where the research is conducted. 

10 ‘‘(5) VOLUNTARY ACCREDITATION.—The Sec11 retary may in accordance with this paragraph facili12 tate the accreditation of institutions and Institu13 tional Review Boards by recognizing a private ac14 crediting entity or entities. For purposes of the pre15 ceding sentence: 

16 ‘‘(A) The Secretary may recognize an ac17 crediting entity if— 

18 ‘‘(i) such entity submits to the Sec19 retary the standards and procedures that 

20 the entity requires institutions and Institu21 tional Review Boards to meet in order to 

22 be accredited by the entity; 

23 ‘‘(ii) the Secretary determines that 

24 such standards and procedures include 

25 standards and procedures ensuring that 


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1 the policies and procedures of institutions 

2 and Institutional Review Boards accredited 

3 by the entity are in compliance with Fed4 eral regulations governing human subject 

5 research; and 

6 ‘‘(iii) the entity annually submits to 

7 the Secretary a report describing any 

8 changes in the standards and procedures 

9 described in clause (ii). 

10 ‘‘(B) The Secretary may not require that 

11 any institution, Institutional Review Board, or 

12 program for the protection of human subjects 

13 in research, or any component thereof, be ac14 credited. 

15 ‘‘(C) Nothing in this section may be con16 strued as authorizing the Secretary— 

17 ‘‘(i) to establish or approve accredita18 tion standards or procedures for institu19 tions, Institutional Review Boards, or pro20 grams for the protection of human subjects 

21 in research, or any component thereof; or 

22 ‘‘(ii) to recognize any standards or 

23 procedures for institutions or Institutional 

24 Review Boards other than the standards 


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1 and procedures described in subparagraph 

2 (A)(ii). 

3 ‘‘(6) COST RECOVERY.—Institutions may re4 cover costs associated with compliance for human 

5 subject protections under this part from government 

6 sponsors of research as direct costs. 

7 ‘‘(f) DATA SAFETY AND MONITORING PLANS.— 

8 ‘‘(1) IN GENERAL.—If a human subject re9 search project meets the criteria developed under 

10 paragraph (2), such project shall be conducted in ac11 cordance with a data safety and monitoring plan. 

12 ‘‘(2) CRITERIA.—The Secretary shall develop 

13 criteria for determining whether a human subject re14 search project must be conducted in accordance with 

15 a data safety and monitoring plan. 

16 ‘‘(3) CONTENTS.—A data safety and moni17 toring plan under this subsection shall include the 

18 following: 

19 ‘‘(A) A requirement that the sponsor of the 

20 human subject research project use a data safe21 ty and monitoring committee in affiliation with 

22 the project. 

23 ‘‘(B) Minimum requirements for the re24 porting by the principal investigator of informa25 tion on such data safety and monitoring plan to 


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1 the Institutional Review Board for the project 

2 and to the institution served by the Board. 

3 ‘‘(C) A requirement that the data safety 

4 and monitoring committee described in sub5 paragraph (A) provide reports on the findings 

6 of the committee regarding the project to such 

7 investigator, Board, and institution. 

8 ‘‘(D)(i) A requirement that the principal 

9 investigator report to the Institutional Review 

10 Board for the project and the sponsor of the 

11 project— 

12 ‘‘(I) in the case of any unantici13 pated problem in the project involving 

14 risks to human subjects or other indi15 viduals, immediately; and 

16 ‘‘(II) in the case of any adverse 

17 event in the project, in a timely man18 ner appropriate to the severity of the 

19 event and whether the event is unex20 pected. 

21 ‘‘(ii) An unanticipated problem or adverse 

22 event referred to in subclause (I) or (II) of 

23 clause (i), respectively, shall be reported by the 

24 principal investigator, in addition to the reports 

25 required by clause (i), as directed by the SecVerDate Nov 24 2008 03:15 Mar 26, 2009 Jkt 079200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\H1715.IH H1715

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1 retary by regulation. Such regulations shall en2 sure comprehensive and coordinated reporting 

3 to all relevant parties. 

4 ‘‘(g) INSTITUTIONAL PROGRAMS OF EDUCATION.— 

5 For fiscal year 2010 and subsequent fiscal years, the Sec6 retary may not make an award of a grant, cooperative 

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

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

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

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

11 with a public entity or a private academic institution, un12 less the public entity or private academic institution (as 

13 the case may be) maintains or contracts for a comprehen14 sive and ongoing program to educate investigators and 

15 Board members on the protection of human subjects in 

16 research. 

17 ‘‘(h) CERTAIN CLASSIFIED HUMAN SUBJECT RE18 SEARCH.—Notwithstanding any other provision of law, 

19 Federal funds may not be expended for the conduct of 

20 classified human subject research if— 

21 ‘‘(1) the Institutional Review Board reviewing 

22 the proposal for the research pursuant to this sec23 tion has under the Common Rule waived the re24 quirement to obtain the informed consent of the 

25 human subjects in the research; or 


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1 ‘‘(2) the research is exempt from the require2 ment under the Common Rule that the proposal for 

3 the research be reviewed by such a Board. 

4 ‘‘(i) DISCLOSURE OF VIOLATIONS.— 

5 ‘‘(1) DISCLOSURES.—Upon the request of an 

6 Institutional Review Board, the Secretary shall de7 termine whether an entity (including an individual, 

8 as applicable under the request) has violated any re9 quirement under this section, and shall disclose to 

10 such Board the findings of the Secretary. 

11 ‘‘(2) NOTICE TO SUBJECT OF DISCLOSURE.—If 

12 pursuant to a request under paragraph (1) the Sec13 retary discloses that an entity has violated a require14 ment under this section, the Secretary shall in writ15 ing notify the entity of the disclosure, including the 

16 identity of the Institutional Review Board to which 

17 the disclosure was made. 

18 ‘‘(j) APPLICABILITY OF REQUIREMENTS.—The re19 quirements of this section apply on and after the date of 

20 the enactment of the Protection for Participants in Re21 search Act of 2009.’’. 

22 SEC. 3. OFFICE FOR HUMAN RESEARCH PROTECTIONS. 

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

24 (42 U.S.C. 289 et seq.), as amended by section 2 of this 


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1 Act, is amended by inserting after section 491A the fol2 lowing section: 

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

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

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

6 for Human Research Protections (in this section referred 

7 to as the ‘Office’). The Office shall be headed by a direc8 tor, who shall be appointed by the Secretary. The Sec9 retary shall carry out this section acting through the Di10 rector of the Office. 

11 ‘‘(b) CERTAIN DUTIES.—The Director of the Of12 fice— 

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

14 subjects in research by carrying out activities in ac15 cordance with subsection (d) regarding compliance 

16 with the Common Rule, as defined in and modified 

17 pursuant to section 491A; 

18 ‘‘(2) shall establish criteria regarding assur19 ances of compliance with the requirements of the 

20 Common Rule; 

21 ‘‘(3) shall direct activities within the Depart22 ment of Health and Human Services, and coordinate 

23 the activities of the Department with other Federal 

24 departments and agencies, with respect to the pro25 tection of subjects in human subject research; 


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

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

3 head of any other Federal department or agency, 

4 carry out educational and quality improvement pro5 grams for human subject protections for principal 

6 investigators, members of Institutional Review 

7 Boards, and other appropriate persons, including the 

8 generation of resource materials relating to the re9 sponsibilities of the research community for the pro10 tection of human subjects in research; 

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

12 conducts or supports human subject research— 

13 ‘‘(A) consult with the entity regarding im14 provements in human subject protections in 

15 such research; and 

16 ‘‘(B) provide advice on compliance with the 

17 Common Rule, including with respect to dif18 fering interpretations among Institutional Re19 view Boards of a provision of such Rule; 

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

21 or support human subject research for the purpose 

22 of assisting the entities in carrying out programs to 

23 recruit and train minority individuals (as defined in 

24 section 485E(c)) to serve as members of Institu25 tional Review Boards; 


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

2 behavioral, and social sciences research in carrying 

3 out the duties of the Director; and 

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

5 of the Secretary regarding the protection of human 

6 subjects in research as the Secretary determines to 

7 be appropriate. 

8 ‘‘(c) MODEL EDUCATION PROGRAM.—The Director 

9 of the Office may make grants for the development of a 

10 model education program to be used by institutions served 

11 by Institutional Review Boards to satisfy the requirements 

12 under section 491A(e)(1)(A) and to develop best practices 

13 in institutional management of human subject research. 

14 ‘‘(d) COMPLIANCE AND ENFORCEMENT.— 

15 ‘‘(1) AUDITS OF INVESTIGATORS AND INSTITU16 TIONS.—The Director of the Office may conduct au17 dits of entities that conduct or support human sub18 ject research in order to determine whether such en19 tities are complying with the Common Rule. 

20 ‘‘(2) CORRECTIVE ACTION PLAN.—If the Direc21 tor of the Office determines that an entity referred 

22 to in paragraph (1) is not in compliance with the 

23 Common Rule, the Director of the Office, after pro24 viding to an appropriate representative of the entity 

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1 lying such determination, may require the entity to 

2 develop and to implement a plan for corrective ac3 tion to bring the entity into compliance. 

4 ‘‘(3) RESTRICTIONS.—If the Director of the Of5 fice determines that an entity referred to in para6 graph (1) is not in compliance with the Common 

7 Rule, the Director may impose restrictions on the 

8 extent to which the entity may conduct or support 

9 human subject research. The restrictions may in10 clude any of the following: 

11 ‘‘(A) Suspending research protocols. 

12 ‘‘(B) Prohibiting the inclusion of additional 

13 human subjects in particular research projects. 

14 ‘‘(C) Suspending or terminating particular 

15 research projects, unless doing so would endan16 ger the human subjects participating in such 

17 projects. 

18 ‘‘(D) Suspending the provision of Federal 

19 funds for particular research projects conducted 

20 or supported by or through the entity, or for 

21 particular research protocols of the entity. 

22 ‘‘(E) Suspending the provision of Federal 

23 funds for all research projects conducted or 

24 supported by or through the entity, in any case 

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1 compliance creates a significant threat to the 

2 rights and welfare of human subjects in such 

3 projects. 

4 ‘‘(F) In the case of individuals who are or 

5 were investigators in the research involved, 

6 after notice and an opportunity for a hearing— 

7 ‘‘(i) suspending or debarring the indi8 viduals from receiving Federal funds for 

9 conducting human subject research; or 

10 ‘‘(ii) suspending or debarring the indi11 viduals from serving as principal investiga12 tors in human subject research. 

13 ‘‘(4) INSTITUTIONAL REVIEW BOARDS.— 

14 ‘‘(A) AUDITS.—In carrying out paragraph 

15 (1), the Director of the Office may conduct au16 dits of Institutional Review Boards in order to 

17 determine whether such Boards are complying 

18 with the Common Rule (including conditions 

19 described in section 491A(e)). 

20 ‘‘(B) CORRECTIVE ACTION PLAN.—If the 

21 Director of the Office determines that an Insti22 tutional Review Board is not in compliance with 

23 the Common Rule, the Director of the Office, 

24 after providing to an appropriate representative 

25 of such Board, or of the institution served by 


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1 the Board, an oral or written summary of the 

2 reasons underlying such determination, may re3 quire the Board to develop and to implement a 

4 plan for corrective action to bring the Board 

5 into compliance. 

6 ‘‘(C) RESTRICTIONS.— 

7 ‘‘(i) IN GENERAL.—If the Director de8 termines that an Institutional Review 

9 Board is not in compliance with the Com10 mon Rule, the Director may— 

11 ‘‘(I) in the case of the research 

12 projects with respect to which the 

13 Board was or is not in compliance, 

14 provide that the approvals of the 

15 Board for such projects are not effec16 tive for purposes of section 

17 491A(e)(1), unless such projects were 

18 approved by another Institutional Re19 view Board; or 

20 ‘‘(II) provide that all approvals of 

21 research by the Board are not effec22 tive for purposes of such section, in 

23 any case in which the Director deter24 mines that the noncompliance creates 

25 a significant threat to the rights and 


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1 welfare of human subjects in projects 

2 approved by the Board. 

3 ‘‘(ii) RESULTING RISKS.—In deter4 mining that an approval is not effective 

5 under subclause (I) or (II) of clause (i), 

6 the Director shall take into consideration 

7 human subject safety risks that may result 

8 from such a determination, including the 

9 immediate withdrawal of a study treat10 ment, and shall require that appropriate 

11 measures be taken to eliminate such risks. 

12 ‘‘(D) PROJECTS INVOLVING MULTIPLE LO13 CATIONS.—In the case of a project of human 

14 subject research for which there is an agree15 ment described in section 491A(b)(4)(F) (relat16 ing to multiple Institutional Review Boards), 

17 the Director of the Office shall, in carrying out 

18 authorities under this subsection with respect to 

19 an Institutional Review Board, ensure that no 

20 action is taken that adversely affects the oper21 ation of a project of human subject research at 

22 any project location for which such Institutional 

23 Review Board had no responsibilities. 

24 ‘‘(5) NOTIFICATION OF FEDERAL AND STATE

25 REGULATORY AGENCIES.—In any case in which the 


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1 Director of the Office takes an action described in 

2 paragraph (3)(E) or (4)(C)(ii) against an entity that 

3 conducts or supports human subject research, or 

4 against an Institutional Review Board, respectively, 

5 the Director shall notify relevant Federal and State 

6 regulatory agencies, and as applicable, the sponsors 

7 of the research, of the deficiencies in the operation 

8 of the entity or Board. 

9 ‘‘(6) COORDINATION WITH FOOD AND DRUG AD10 MINISTRATION.—In the case of human subject re11 search that is subject to the Federal Food, Drug, 

12 and Cosmetic Act or to section 351 of this Act, no 

13 authority under this subsection may be carried out 

14 with respect to an entity that conducts or supports 

15 such research, or with respect to an Institutional Re16 view Board, unless the Commissioner of Food and 

17 Drugs concurs in the exercise of the authority in18 volved. 

19 ‘‘(e) FUNDING.— 

20 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.— 

21 For the purpose of carrying out this section, there 

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

23 fiscal year 2010, and such sums as may be nec24 essary for fiscal year 2011 and each subsequent fis25 cal year. 


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1 ‘‘(2) MODEL EDUCATION PROGRAM.—For the 

2 purpose of carrying out subsection (c), there are au3 thorized to be appropriated such sums as may be 

4 necessary for fiscal year 2010 and each subsequent 

5 fiscal year. 

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

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

8 change in the budget authority or authorization of 

9 appropriations for the Food and Drug Administra10 tion.’’. 

11 SEC. 4. AMENDMENTS REGARDING PROCESS FOR RE12 SPONDING TO REPORTS OF VIOLATIONS. 

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

14 (42 U.S.C. 289(b)(2)) is amended— 

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

16 Director of the Office for Human Research Protec17 tions’’ after ‘‘the Director of NIH’’; and 

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

19 ‘‘this Act’’ the following: ‘‘, the sharing of informa20 tion between the Director of NIH and the Director 

21 of such Office, and’’. 


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1 SEC. 5. ENHANCED HUMAN SUBJECT PROTECTIONS FOR 

2 PEOPLE WITH DIMINISHED DECISIONMAKING 

3 CAPACITY. 

4 Not later than three years after the date of the enact5 ment of this Act, the Secretary of Health and Human 

6 Services shall, for purposes of section 491A of the Public 

7 Health Service Act, promulgate regulations to enhance the 

8 protection of people with diminished decisionmaking ca9 pacity with respect to their participation as subjects in 

10 human subject research. 

11 SEC. 6. RULE OF CONSTRUCTION REGARDING INDIVIDUAL 

12 AGENCY OFFICES. 

13 The amendments made by this Act may not be con14 strued as terminating any office or other administrative 

15 unit in a Federal agency that, on the day before the date 

16 of the enactment of this Act, had duties relating to the 

17 protection of human subjects in research conducted, sup18 ported, or otherwise subject to regulation under Federal 

19 law. 

20 SEC. 7. STUDY ON INCREASING THE NUMBER OF CERTAIN 

21 IRB MEMBERS. 

22 (a) STUDY.—Not later than 36 months after the date 

23 of the enactment of this Act, the Secretary of Health and 

24 Human Services shall— 

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1 tional Review Board who are individuals whose pri2 mary expertise is in nonscientific areas, and the 

3 number of members of an Institutional Review 

4 Board who are individuals who are not affiliated 

5 with the institution served by the Board, should be 

6 increased; and 

7 (2) submit a report to the Congress on the re8 sults of such study. 

9 (b) DEFINITIONS.—In this section, the terms ‘‘insti10 tution served by the Board’’ and ‘‘Institutional Review 

11 Board’’ have the meanings given to such terms in section 

12 491A(b)(4) of the Public Health Service Act, as added by 

13 section 2 of this Act. 

Æ 


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