I 

108TH CONGRESS 

1ST SESSION H. R. 3594

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

of human subjects in research. 

IN THE HOUSE OF REPRESENTATIVES 

NOVEMBER 21, 2003

Ms. DEGETTE introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL

To amend the Public Health Service Act with respect to 

the protection of human subjects in research.

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 2003’’. 
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1 SEC. 2. PROTECTION OF HUMAN SUBJECTS IN RESEARCH; 

2 UNIFORM NATIONAL APPLICABILITY OF COM3 MON RULE AND PROVISIONS PROTECTING 

4 VULNERABLE POPULATIONS. 

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

6 (42 U.S.C. 289 et seq.) is amended by inserting after sec7 tion 491 the following section: 

8 ‘‘PROTECTION OF HUMAN SUBJECTS; UNIFORM NATIONAL

9 APPLICABILITY OF COMMON RULE AND PROVISIONS

10 PROTECTING VULNERABLE POPULATIONS

11 ‘‘SEC. 491A. (a) PROTECTION OF HUMAN SUB12 JECTS.—

13 ‘‘(1) IN GENERAL.—All human subject research 

14 shall be conducted in accordance with the Common 

15 Rule, and as applicable to the human subjects in16 volved in such research, with the vulnerable-popu17 lations rules. 

18 ‘‘(2) APPLICABILITY.—Paragraph (1) applies to 

19 human subject research that—

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

21 subject to regulation under a provision of Fed22 eral law (other than this section), without re23 gard to whether the Federal agency that admin24 isters such law has taken administrative action 

25 to make the Common Rule applicable to the 

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

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

6 RULES.—For purposes of this section: 

7 ‘‘(A) Except as provided in subparagraph 

8 (B): 

9 ‘‘(i) The term ‘Common Rule’ means 

10 the provisions of subpart A of part 46 of 

11 title 45, Code of Federal Regulations (or 

12 any successor regulations), subject to sub13 paragraph (C). 

14 ‘‘(ii) The term ‘vulnerable-population 

15 rules’ means the provisions of subparts B 

16 through D of such part 46 (or any suc17 cessor regulations), subject to subpara18 graph (C). 

19 ‘‘(B) In the case of human subject re20 search that is subject to the Federal Food, 

21 Drug, and Cosmetic Act or to section 351 of 

22 this Act: 

23 ‘‘(i) The term ‘Common Rule’ means 

24 the provisions of parts 50 and 56 of title 
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1 21, Code of Federal Regulations (or any 

2 successor regulations). 

3 ‘‘(ii) The term ‘vulnerable-population 

4 rules’ has the meaning applicable under 

5 part 56 of such title 21 (or any successor 

6 regulations), and includes the provisions of 

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

8 any successor regulations). 

9 ‘‘(C) In the case of human subject research 

10 to which both subparagraphs (A) and (B) 

11 apply, the terms ‘Common Rule’ and ‘vulner12 able-population rules’ have the meaning given 

13 such terms in subparagraph (B). 

14 ‘‘(2) HARMONIZATION.—

15 ‘‘(A) REVIEW OF REGULATIONS.—Not 

16 later than 18 months after the date of the en17 actment of the Protection for Participants in 

18 Research Act of 2003, the Secretary shall com19 plete a review of the provisions of subpart A of 

20 part 46 of title 45, Code of Federal Regulations 

21 (referred to in this paragraph as ‘title 45 regu22 lations’), and the provisions of parts 50 and 56 

23 of title 21, Code of Federal Regulations (re24 ferred to in this paragraph as ‘title 21 regula25 tions’), in order to determine to what extent the 
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1 differences in approach between the title 45 

2 regulations and the title 21 regulations can be 

3 harmonized toward the goal of having only such 

4 differences as are appropriate to reflect the 

5 legal or factual variations in human subject re6 search described in paragraph (1)(B) relative to 

7 other human subject research. The areas of dif8 ference reviewed shall include (but are not lim9 ited to) differences regarding the existence of a 

10 significant financial interest; provisions for re11 search relating to emergency interventions; the 

12 definition of ‘institution’; and requirements for 

13 attestations by clinical investigators regarding 

14 the protection of human subjects. 

15 ‘‘(B) RULEMAKING.— 

16 ‘‘(i) PURSUANT TO HARMONIZATION

17 REVIEW.—Not later than three years after 

18 completing the review under subparagraph 

19 (A), the Secretary shall publish in the Fed20 eral Register a proposed rule to modify the 

21 title 45 regulations, or the title 21 regula22 tions, or both, in accordance with the find23 ings of the review, unless the review finds

24 that removing any of the differences in ap-
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1 proach between the title 45 regulations and 

2 the title 21 regulations is not practicable. 

3 ‘‘(ii) SUBSEQUENT RULEMAKING.—

4 After the expiration of the three-year pe5 riod referred to in clause (i), or the publi6 cation of the proposed rule under clause 

7 (i), whichever occurs first, any rule pro8 mulgated by the Secretary that modifies 

9 the title 45 regulations or the title 21 reg10 ulations (including a modification that 

11 adds provisions), and results in there being 

12 a difference between the title 45 regula13 tions and the title 21 regulations, shall be 

14 accompanied in the Federal Register by a 

15 statement of the reasons underlying the 

16 determination of the Secretary that, with 

17 respect to the goal described in subpara18 graph (A), the difference is appropriate to 

19 reflect the legal or factual variations in 

20 human subject research described in para21 graph (1)(B) relative to other human sub22 ject research. 

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 is generated 

10 during the project; 

11 ‘‘(ii) advises the sponsor regarding the 

12 continuing safety of human subjects who 

13 are or will be participating in the project; 

14 and 

15 ‘‘(iii) advises such sponsor on the con16 tinued validity and scientific merit of the 

17 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 term ‘institution served by an 

22 Institutional Review Board’ means the public or 

23 private entity (university, health care provider, 

24 health plan, research organization, government 

25 agency, or other entity) that establishes and is 
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1 responsible for the operation of the Institutional 

2 Review Board. 

3 ‘‘(E) The term ‘Institutional Review 

4 Board’ has the meaning that applies under the 

5 Common Rule. 

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

7 Board’ means an Institutional Review Board 

8 that otherwise meets the requirements of the 

9 Common Rule and enters into a written agree10 ment with an institution, another Institutional 

11 Review Board, a sponsor, or a principal investi12 gator to approve and oversee human subject re13 search that is conducted at multiple locations. 

14 For purposes of this section, references to an 

15 Institutional Review Board include an Institu16 tional Review Board that serves a single institu17 tion as well as a lead Institutional Review 

18 Board. 

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

20 with respect to human subject research, means 

21 the individual who, at the research location in22 volved, has the principal responsibility for the 

23 conduct of the research. 

24 ‘‘(H)(i) Except as provided in clause (ii), 

25 the term ‘sponsor’, with respect to human sub-
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1 ject research, means the entity that has the 

2 principal financial responsibility for the conduct 

3 of the research. 

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

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

6 Code of Federal Regulations (or successor regu7 lations), the term ‘sponsor’, with respect to 

8 human subject research, has the meaning that 

9 applies for purposes of such part 50. 

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

11 ‘‘(1) IN GENERAL.—The Common Rule (includ12 ing provisions regarding exemptions) and the vulner13 able-populations rules, as in effect on the day before 

14 the date of the enactment of the Protection for Par15 ticipants in Research Act of 2003, continue to be in 

16 effect on and after such date, subject to paragraph 

17 (2). 

18 ‘‘(2) MODIFICATIONS.—

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

20 after the date of the enactment of the Act re21 ferred to in paragraph (1), the Secretary shall 

22 promulgate regulations to make such modifica23 tions to the provisions of the Common Rule as 

24 may be necessary to ensure that such provisions
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1 implement, and do not conflict with, this sec2 tion. 

3 ‘‘(B) OTHER MODIFICATIONS.—This sec4 tion may not be construed as affecting the au5 thority of the Secretary to modify the provisions 

6 of the Common Rule or the vulnerable-popu7 lations rules, except to the extent that any such 

8 modification is in conflict with this section. Any 

9 such modification shall be made by regulation. 

10 ‘‘(C) CONSIDERATION OF CERTAIN MAT11 TERS.—

12 ‘‘(i) IN GENERAL.—Not later than 18 

13 months after the date of the enactment of 

14 the Protection for Participants in Research 

15 Act of 2003, the Secretary shall, with re16 spect to the Common Rule—

17 ‘‘(I) consider the matters speci18 fied in clause (ii) and make a deter19 mination of whether any of the provi20 sions of such Rule should be modified 

21 accordingly; and 

22 ‘‘(II) publish the determination 

23 in the Federal Register. 

24 ‘‘(ii) LIST OF MATTERS FOR CONSID25 ERATION.—The matters referred to in 
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1 clause (i) with respect to the Common 

2 Rule are the following: 

3 ‘‘(I) Whether the list of exemptions 

4 from applicability of the Common Rule, as 

5 in effect on the day before the date of en6 actment referred to in clause (i), should be 

7 modified or new categories of exemptions 

8 established. 

9 ‘‘(II) Whether there are circumstances 

10 in which research that studies human tis11 sue or other types of clinical specimens 

12 should not be considered human subject re13 search. 

14 ‘‘(III) Whether research that studies 

15 data that do not involve any interaction or 

16 intervention with a living human should be 

17 considered human subject research. 

18 ‘‘(IV) Whether the list of expedited 

19 procedures under the Common Rule, as in 

20 effect on the day before the date of enact21 ment referred to in clause (i), should be 

22 modified or new categories of expedited 

23 procedures established. 

24 ‘‘(V) Whether modified procedures 

25 should apply to human subject research 
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1 that poses minimal risk to the subjects, in2 cluding whether there are any types of 

3 such research for which some aspect of the 

4 requirement of informed consent or docu5 mentation of informed consent should 

6 apply differently. 

7 ‘‘(VI) Whether Institutional Review 

8 Boards include sufficient numbers of mi9 nority individuals (as defined in section 

10 485E(c)) as Board members when review11 ing proposals designed to have a popu12 lation of human subjects a majority of 

13 whom are minority individuals. 

14 ‘‘(VII) Such additional matters as the 

15 Secretary determines to be appropriate. 

16 ‘‘(D) AGENCY-SPECIFIC ADDITIONAL PRO17 TECTIONS.—With respect to human subject re18 search that is conducted, supported, or other19 wise subject to regulation under a provision of 

20 Federal law (other than this section), the Sec21 retary may under subparagraph (A) permit the 

22 Federal agency involved to establish additional 

23 protections for the protection of human subjects 

24 if the Secretary determines that such additional 
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1 protections are not in conflict with protections 

2 established under this section. 

3 ‘‘(d) RIGHT OF INFORMED CONSENT.—

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

5 (a), a principal investigator, may not, except as pro6 vided in the Common Rule, involve an individual as 

7 a subject in human subject research unless the in8 vestigator or other knowledgeable person has ob9 tained the informed consent of the individual to be 

10 a subject. 

11 ‘‘(2) LEGALLY AUTHORIZED REPRESENTA12 TIVE.—References in this section to obtaining con13 sent from an individual shall be considered to be ref14 erences to obtaining consent from the legally author15 ized representative of the individual in any case in 

16 which the individual lacks legal competence to pro17 vide consent. 

18 ‘‘(3) CERTAIN REQUIREMENTS REGARDING DIS19 CLOSURE AND UNDERSTANDING.—The Secretary 

20 shall establish criteria regarding consent under para21 graph (1) that—

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

23 complete information relevant to the research to 

24 a prospective human subject; 
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1 ‘‘(B) require such information to be pro2 vided in language understandable to such sub3 ject; 

4 ‘‘(C) require that only individuals knowl5 edgeable about the research provide such infor6 mation to the subject and answer questions 

7 from the subject; and 

8 ‘‘(D) require that information be provided 

9 to the subject on how to contact the Office for 

10 Human Research Protections to submit ques11 tions about the rights of subjects or to report 

12 concerns regarding the research. 

13 ‘‘(4) WRITTEN ATTESTATION BY INVESTI14 GATOR.—A principal investigator who involves a 

15 human subject in research shall, in accordance with 

16 the criteria of the Secretary, file with the Institu17 tional Review Board for the research a written attes18 tation that the investigator is familiar with require19 ments for the protection of human subjects, includ20 ing the requirement of informed consent, and agrees 

21 to comply with such requirements. 

22 ‘‘(e) INSTITUTIONAL REVIEW BOARDS.—

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

24 subject research may not be conducted unless an In25 stitutional Review Board has, for purposes of the
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1 Common Rule (and the vulnerable-populations rules, 

2 as applicable), approved the proposal for such re3 search. With respect to the research involved, the 

4 approval by the Board of the proposal for the re5 search is not effective unless, in addition to condi6 tions established by the Secretary, the following con7 ditions are met: 

8 ‘‘(A) Of the membership of such Board: 

9 ‘‘(i) Not fewer than two members or 

10 25 percent of all members, whichever is 

11 greater, are individuals whose primary ex12 pertise is in scientific areas. 

13 ‘‘(ii) Not fewer than two members or 

14 20 percent of all members (whichever is 

15 greater) are individuals whose primary ex16 pertise is in nonscientific areas. 

17 ‘‘(iii) Not fewer than two members or 

18 20 percent of all members (whichever is 

19 greater) are individuals who are not affili20 ated with the institution served by the 

21 Board (other than by serving on the 

22 Board), who are not immediate family 

23 members of any individual who is affiliated 

24 with the institution, and who do not have 
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1 a significant conflict of interest, as defined 

2 by applicable Federal regulations. 

3 The appointment of a member of the Board to 

4 meet the requirement of clause (iii) also quali5 fies toward meeting the requirement of clause 

6 (ii) if the primary expertise of such member is 

7 in a nonscientific area. 

8 ‘‘(B) In reviewing a proposal for research, 

9 the Board does not consider a quorum to have 

10 been established for a meeting unless the mem11 bers present at the meeting include one or more 

12 members from each of the three categories de13 scribed in subparagraph (A). 

14 ‘‘(C) 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 ‘‘(D) 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 ‘‘(E) In the case of a proposal for a high4 risk research project, the Board reviews the 

5 data safety and monitoring plan (pursuant to 

6 subsection (f)) as a part of the review by the 

7 Board of the proposal. 

8 ‘‘(F) With respect to the research involved, 

9 each member of the Board has disclosed any 

10 significant financial interests, as defined by ap11 plicable Federal regulations, to the institution 

12 served by the Board, and such institution has 

13 disclosed any such disclosures to the Board. 

14 ‘‘(G) A member of the Board does not par15 ticipate in the review by the Board of a pro16 posal for research if the member has a signifi17 cant conflict of interest, as defined by applica18 ble Federal regulations, in the research. The 

19 provision by such member of information to 

20 other members of the Board does not constitute 

21 Board participation for purposes of this sub22 paragraph. 

23 ‘‘(H) The institution served by the Board 

24 annually submits to the Secretary a report that 

25 compiles data on the number of new research 
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1 proposals reviewed, the number of continuing 

2 research projects reviewed, the number of re3 viewed biomedical research proposals, the num4 ber of reviewed behaviorial or social sciences re5 search proposals, and any additional informa6 tion determined appropriate by the Secretary. 

7 ‘‘(I) The institution served by the Board 

8 submits to the Secretary such reports regarding 

9 the Board as the Secretary determines to be ap10 propriate. 

11 ‘‘(2) NOTIFICATION OF INSTITUTIONAL REVIEW

12 BOARD BY INVESTIGATORS.—In submitting to an In13 stitutional Review Board a proposal for human sub14 ject research, the investigators for the research shall 

15 notify the institution served by the Board—

16 ‘‘(A) of any significant financial conflicts 

17 of interest, as defined by applicable Federal 

18 regulations; 

19 ‘‘(B) whether the investigators have been 

20 disqualified or restricted by any Federal entity 

21 in their ability to conduct human subject re22 search, including being ineligible to conduct 

23 human subject research with investigational 

24 new drugs, being ineligible for approval of new
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1 drug applications, or agreeing to some other 

2 form of restriction regarding research; and 

3 ‘‘(C) whether the proposal has been sub4 mitted by the principal investigator to any other 

5 Institutional Review Board. 

6 ‘‘(3) INSTITUTION REVIEW OF CONFLICTS OF

7 INTEREST.—The institution served by an Institu8 tional Review Board shall review such significant fi9 nancial conflicts of interest as are submitted under 

10 paragraph (2) to determine whether such interests 

11 create or may reasonably appear to create conflicts 

12 of interest, and then shall seek to manage, reduce, 

13 or eliminate such conflicts of interest. 

14 ‘‘(4) PROJECTS INVOLVING MULTIPLE LOCA15 TIONS.—For purposes of meeting the Common Rule 

16 requirements for review and supervision of research 

17 by an Institutional Review Board, such activities 

18 may be performed by an Institutional Review Board 

19 or a lead Institutional Review Board, at the option 

20 of the institution where the research is conducted. 

21 ‘‘(5) VOLUNTARY ACCREDITATION.—The Sec22 retary may in accordance with this paragraph facili23 tate the accreditation of institutions and Institu24 tional Review Boards by recognizing a private ac-
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1 crediting entity or entities. For purposes of the pre2 ceding sentence: 

3 ‘‘(A) The Secretary may recognize an ac4 crediting entity if—

5 ‘‘(i) such entity submits to the Sec6 retary the standards and procedures that 

7 the entity requires institutions and Institu8 tional Review Boards to meet in order to 

9 be accredited by the entity; 

10 ‘‘(ii) the Secretary determines that 

11 such standards and procedures include 

12 standards and procedures ensuring that 

13 the policies and procedures of institutions 

14 and Institutional Review Boards accredited 

15 by the entity are in compliance with Fed16 eral regulations governing human subject 

17 research; and 

18 ‘‘(iii) the entity annually submits to 

19 the Secretary a report describing any 

20 changes in the standards and procedures 

21 described in clause (ii). 

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

23 any institution, Institutional Review Board, or 

24 program for the protection of human subjects 
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1 in research, or any component thereof, be ac2 credited. 

3 ‘‘(C) Nothing in this section may be con4 strued as authorizing the Secretary—

5 ‘‘(i) to establish or approve accredita6 tion standards or procedures for institu7 tions, Institutional Review Boards, or pro8 grams for the protection of human subjects 

9 in research, or any component thereof; or 

10 ‘‘(ii) to recognize any standards or 

11 procedures for institutions or Institutional 

12 Review Boards other than the standards 

13 and procedures described in subparagraph 

14 (A)(ii). 

15 ‘‘(6) COST RECOVERY.—Institutions may re16 cover costs associated with compliance for human 

17 subject protections under this part from government 

18 sponsors of research as direct costs. 

19 ‘‘(f) IMPROVED MONITORING OF HIGH-RISK RE20 SEARCH.—With respect to high-risk human subject re21 search projects: 

22 ‘‘(1) The Secretary shall establish criteria for 

23 identifying proposals for such projects that require 

24 a data safety and monitoring plan. The criteria shall 

25 include—
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1 ‘‘(A) a provision that the Secretary may 

2 require the sponsor of the project to utilize a 

3 data safety and monitoring committee in affili4 ation with the research project; 

5 ‘‘(B) minimum requirements for the re6 porting by the principal investigator of informa7 tion on such plan to the Institutional Review 

8 Board for the research project and to the insti9 tution served by the Board; and 

10 ‘‘(C) the requirement that such committee 

11 provide reports on the findings of the com12 mittee regarding the research project to such 

13 investigator, Board, and institution. 

14 ‘‘(2) The Secretary shall require that an ad15 verse event in the research project be reported by 

16 the principal investigator to the Institutional Review 

17 Board for the research project, and to the sponsor 

18 of the research project, in a timely manner appro19 priate to the severity of the event and whether the 

20 event is unexpected. Such events shall in addition be 

21 reported by the principal investigator as directed by 

22 the Secretary. Such regulations shall ensure com23 prehensive and coordinated reporting to all relevant 

24 parties. 
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1 ‘‘(g) INSTITUTIONAL PROGRAMS OF EDUCATION.—

2 For fiscal year 2004 and subsequent fiscal years, the Sec3 retary may not make an award of a grant, cooperative 

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

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

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

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

8 with a public entity or a private academic institution, un9 less the public entity or private academic institution (as 

10 the case may be) maintains or contracts for a comprehen11 sive and ongoing program to educate investigators and 

12 Board members on the protection of human subjects in 

13 research. 

14 ‘‘(h) CERTAIN CLASSIFIED HUMAN SUBJECT RE15 SEARCH.—Notwithstanding any other provision of law, 

16 Federal funds may not be expended for the conduct of 

17 classified human subject research if—

18 ‘‘(1) the Institutional Review Board reviewing 

19 the proposal for the research pursuant to this sec20 tion has under the Common Rule waived the re21 quirement to obtain the informed consent of the 

22 human subjects in the research; or 

23 ‘‘(2) the research is exempt from the require24 ment under the Common Rule that the proposal for 

25 the research be reviewed by such a Board.
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1 ‘‘(i) DISCLOSURE OF VIOLATIONS.—

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

3 Institutional Review Board, the Secretary shall de4 termine whether an entity (including an individual, 

5 as applicable under the request) has violated any re6 quirement under this section, and shall disclose to 

7 such Board the findings of the Secretary. 

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

9 pursuant to a request under paragraph (1) the Sec10 retary discloses that an entity has violated a require11 ment under this section, the Secretary shall in writ12 ing notify the entity of the disclosure, including the 

13 identity of the Institutional Review Board to which 

14 the disclosure was made. 

15 ‘‘(j) APPLICABILITY OF REQUIREMENTS.—The re16 quirements of this section apply on and after the date of 

17 the enactment of the Protection for Participants in Re18 search Act of 2003.’’. 

19 SEC. 3. OFFICE FOR HUMAN RESEARCH PROTECTIONS. 

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

21 (42 U.S.C. 289 et seq.), as amended by section 2 of this 

22 Act, is amended by inserting after section 491A the fol23 lowing section: 

24 ‘‘OFFICE FOR HUMAN RESEARCH PROTECTIONS

25 ‘‘SEC. 491B. (a) IN GENERAL.—There is established 

26 within the office of the Secretary an office to be known 
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1 as the Office for Human Research Protections (in this sec2 tion referred to as the ‘Office’). The Office shall be headed 

3 by a director, who shall be appointed by the Secretary. 

4 The Secretary shall carry out this section acting through 

5 the Director of the Office. 

6 ‘‘(b) CERTAIN DUTIES.—The Director of the Of7 fice—

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

9 subjects in research by carrying out activities in ac10 cordance with subsection (d) regarding compliance 

11 with the Common Rule, as defined in and modified 

12 pursuant to section 491A; 

13 ‘‘(2) shall establish criteria regarding assur14 ances of compliance with the requirements of the 

15 Common Rule; 

16 ‘‘(3) shall direct activities within the Depart17 ment of Health and Human Services, and coordinate 

18 the activities of the Department with other Federal 

19 departments and agencies, with respect to the pro20 tection of subjects in human subject research; 

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

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

23 head of any other Federal department or agency, 

24 carry out educational and quality improvement pro25 grams for human subject protections for principal 
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1 investigators, members of Institutional Review 

2 Boards, and other appropriate persons, including the 

3 generation of resource materials relating to the re4 sponsibilities of the research community for the pro5 tection of human subjects in research; 

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

7 conducts or supports human subject research—

8 ‘‘(A) consult with the entity regarding im9 provements in human subject protections in 

10 such research; and 

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

12 Common Rule, including with respect to dif13 fering interpretations among Institutional Re14 view Boards of a provision of such Rule; 

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

16 or support human subject research for the purpose 

17 of assisting the entities in carrying out programs to 

18 recruit and train minority individuals (as defined in 

19 section 485E(c)) to serve as members of Institu20 tional Review Boards; 

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

22 behavioral, and social sciences research in carrying 

23 out the duties of the Director; and 

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

25 of the Secretary regarding the protection of human 
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1 subjects in research as the Secretary determines to 

2 be appropriate. 

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

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

5 model education program to be used by institutions served 

6 by Institutional Review Boards to satisfy the requirements 

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

8 in institutional management of human subject research. 

9 ‘‘(d) COMPLIANCE AND ENFORCEMENT.—

10 ‘‘(1) AUDITS OF INVESTIGATORS AND INSTITU11 TIONS.—The Director of the Office may conduct au12 dits of entities that conduct or support human sub13 ject research in order to determine whether such en14 tities are complying with the Common Rule. 

15 ‘‘(2) CORRECTIVE ACTION PLAN.—If the Direc16 tor of the Office determines that an entity referred 

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

18 Common Rule, the Director of the Office, after pro19 viding to an appropriate representative of the entity 

20 an oral or written summary of the reasons under21 lying such determination, may require the entity to 

22 develop and to implement a plan for corrective ac23 tion to bring the entity into compliance. 

24 ‘‘(3) RESTRICTIONS.—If the Director of the Of25 fice determines that an entity referred to in para-
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1 graph (1) is not in compliance with the Common 

2 Rule, the Director may impose restrictions on the 

3 extent to which the entity may conduct or support 

4 human subject research. The restrictions may in5 clude any of the following: 

6 ‘‘(A) Suspending research protocols. 

7 ‘‘(B) Prohibiting the inclusion of additional 

8 human subjects in particular research projects. 

9 ‘‘(C) Suspending or terminating particular 

10 research projects, unless doing so would endan11 ger the human subjects participating in such 

12 projects. 

13 ‘‘(D) Suspending the provision of Federal 

14 funds for particular research projects conducted 

15 or supported by or through the entity, or for 

16 particular research protocols of the entity. 

17 ‘‘(E) Suspending the provision of Federal 

18 funds for all research projects conducted or 

19 supported by or through the entity, in any case 

20 in which the Secretary determines that the non21 compliance creates a significant threat to the 

22 rights and welfare of human subjects in such 

23 projects.
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1 ‘‘(F) In the case of individuals who are or 

2 were investigators in the research involved, 

3 after notice and an opportunity for a hearing—

4 ‘‘(i) suspending or debarring the indi5 viduals from receiving Federal funds for 

6 conducting human subject research; or 

7 ‘‘(ii) suspending or debarring the indi8 viduals from serving as principal investiga9 tors in human subject research. 

10 ‘‘(4) INSTITUTIONAL REVIEW BOARDS.—

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

12 (1), the Director of the Office may conduct au13 dits of Institutional Review Boards in order to 

14 determine whether such Boards are complying 

15 with the Common Rule (including conditions 

16 described in section 491A(e)). 

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

18 Director of the Office determines that an Insti19 tutional Review Board is not in compliance with 

20 the Common Rule, the Director of the Office, 

21 after providing to an appropriate representative 

22 of such Board, or of the institution served by 

23 the Board, an oral or written summary of the 

24 reasons underlying such determination, may re25 quire the Board to develop and to implement a 
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1 plan for corrective action to bring the Board 

2 into compliance. 

3 ‘‘(C) RESTRICTIONS.—If the Director de4 termines that an Institutional Review Board is 

5 not in compliance with the Common Rule, the 

6 Director may—

7 ‘‘(i) in the case of the research 

8 projects with respect to which the Board 

9 was or is not in compliance, provide that 

10 the approvals of the Board for such 

11 projects are not effective for purposes of 

12 section 491A(e)(1), unless such projects 

13 were approved by another Institutional Re14 view Board; or 

15 ‘‘(ii) may provide that all approvals of 

16 research by the Board are not effective for 

17 purposes of such section, in any case in 

18 which the Director determines that the 

19 noncompliance creates a significant threat 

20 to the rights and welfare of human sub21 jects in projects approved by the Board. 

22 ‘‘(D) PROJECTS INVOLVING MULTIPLE LO23 CATIONS.—In the case of a project of human 

24 subject research for which there is an agree25 ment described in section 491A(b)(4)(F) (relat-
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•HR 3594 IH 

1 ing to multiple Institutional Review Boards), 

2 the Director of the Office shall, in carrying out 

3 authorities under this subsection with respect to 

4 an Institutional Review Board, ensure that no 

5 action is taken that adversely affects the oper6 ation of a project of human subject research at 

7 any project location for which such Institutional 

8 Review Board had no responsibilities. 

9 ‘‘(5) NOTIFICATION OF FEDERAL AND STATE

10 REGULATORY AGENCIES.—In any case in which the 

11 Director of the Office takes an action described in 

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

13 conducts or supports human subject research, or 

14 against an Institutional Review Board, respectively, 

15 the Director shall notify relevant Federal and State 

16 regulatory agencies, and as applicable, the sponsors 

17 of the research, of the deficiencies in the operation 

18 of the entity or Board. 

19 ‘‘(6) COORDINATION WITH FOOD AND DRUG AD20 MINISTRATION.—In the case of human subject re21 search that is subject to the Federal Food, Drug, 

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

23 authority under this subsection may be carried out 

24 with respect to an entity that conducts or supports 

25 such research, or with respect to an Institutional Re-
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1 view Board, unless the Commissioner of Food and 

2 Drugs concurs in the exercise of the authority in3 volved. 

4 ‘‘(e) FUNDING.—

5 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—

6 For the purpose of carrying out this section, there 

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

8 fiscal year 2004, and such sums as may be nec9 essary for fiscal year 2005 and each subsequent fis10 cal year. 

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

12 purpose of carrying out subsection (c), there are au13 thorized to be appropriated such sums as may be 

14 necessary for fiscal year 2004 and each subsequent 

15 fiscal year. 

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

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

18 change in the budget authority or authorization of 

19 appropriations for the Food and Drug Administra20 tion.’’. 

21 SEC. 4. AMENDMENTS REGARDING PROCESS FOR RE22 SPONDING TO REPORTS OF VIOLATIONS. 

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

24 (42 U.S.C. 289(b)(2)) is amended—
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1 (1) in the first sentence, by inserting ‘‘or the 

2 Director of the Office for Human Research Protec3 tions’’ after ‘‘the Director of NIH’’; and 

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

5 ‘‘this Act’’ the following: ‘‘, the sharing of informa6 tion between the Director of NIH and the Director 

7 of such Office, and’’. 

8 SEC. 5. ENHANCED HUMAN SUBJECT PROTECTIONS FOR 

9 PEOPLE WITH DIMINISHED DECISIONMAKING 

10 CAPACITY. 

11 Not later than three years after the date of the enact12 ment of this Act, the Secretary of Health and Human 

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

14 Health Service Act, promulgate regulations to enhance the 

15 protection of people with diminished decisionmaking ca16 pacity with respect to their participation as subjects in 

17 human subject research. 

18 SEC. 6. RULE OF CONSTRUCTION REGARDING INDIVIDUAL 

19 AGENCY OFFICES. 

20 The amendments made by this Act may not be con21 strued as terminating any office or other administrative 

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

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

24 protection of human subjects in research conducted, sup-
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1 ported, or otherwise subject to regulation under Federal 

2 law.

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