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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Protection for Partici-
pants in Research Act of 2009’’. 
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SEC. 2. PROTECTION OF HUMAN SUBJECTS IN RESEARCH; 
UNIFORM 
NATIONAL 
APPLICABILITY 
OF 
RULES. 
Part H of title IV of the Public Health Service Act 
(42 U.S.C. 289 et seq.) is amended by inserting after sec-
tion 491 the following section: 
‘‘SEC. 491A. PROTECTION OF HUMAN SUBJECTS IN RE-
SEARCH; 
UNIFORM 
NATIONAL 
APPLICA-
BILITY OF RULES. 
‘‘(a) PROTECTION OF HUMAN SUBJECTS.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), all human subject research shall be con-
ducted in accordance with the Common Rule, and as 
applicable to the human subjects involved in such re-
search, with the vulnerable-populations rules. 
‘‘(2) FDA RESEARCH.— 
‘‘(A) APPLICABLE
RULES.—All human 
subject research that is subject to the Federal 
Food, Drug, and Cosmetic Act or to section 
351 of this Act shall be conducted— 
‘‘(i) in accordance with the provisions 
of parts 50 and 56 of title 21, Code of 
Federal Regulations (or any successor reg-
ulations); and 
‘‘(ii) as applicable to the human sub-
jects involved in such research, in accord-
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ance with provisions applicable to vulner-
able populations under part 56 of such 
title 21 (or any successor regulations) and 
subpart D of part 50 of such title 21 (or 
any successor regulations). 
‘‘(B) REFERENCES.—In the case of human 
subject research described in subparagraph 
(A)— 
‘‘(i) each reference in this section or 
section 491B to the Common Rule shall be 
treated as a reference to the provisions de-
scribed in subparagraph (A)(i); and 
‘‘(ii) each reference in this section to 
the vulnerable population rules shall be 
treated as a reference to the provisions de-
scribed in subparagraph (A)(ii). 
‘‘(3) APPLICABILITY.—Paragraphs (1) and (2) 
apply to human subject research that— 
‘‘(A) is conducted, supported, or otherwise 
subject to regulation under a provision of Fed-
eral law (other than this section), without re-
gard to whether the Federal agency that admin-
isters such law has taken administrative action 
to make the Common Rule applicable to the 
agency; or 
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‘‘(B) is not described in subparagraph (A) 
and has activities that are in or that affect 
interstate commerce. 
‘‘(4) HARMONIZATION.— 
‘‘(A) REVIEW
OF
REGULATIONS.—Not 
later than 18 months after the date of the en-
actment of the Protection for Participants in 
Research Act of 2009, the Secretary shall com-
plete a review of the provisions of subpart A of 
part 46 of title 45, Code of Federal Regulations 
(referred to in this paragraph as ‘title 45 regu-
lations’), and the provisions of parts 50 and 56 
of title 21, Code of Federal Regulations (re-
ferred to in this paragraph as ‘title 21 regula-
tions’), in order to determine to what extent the 
differences in approach between the title 45 
regulations and the title 21 regulations can be 
harmonized toward the goal of having only such 
differences as are appropriate to reflect the 
legal or factual variations in human subject re-
search described in paragraph (2)(A) relative to 
other human subject research. The areas of dif-
ference reviewed shall include (but are not lim-
ited to) differences regarding the existence of a 
significant financial interest; provisions for re-
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search relating to emergency interventions; the 
definition of ‘institution’; and requirements for 
attestations by investigators regarding the pro-
tection of human subjects. 
‘‘(B) RULEMAKING.— 
‘‘(i) PURSUANT
TO
HARMONIZATION 
REVIEW.—Not later than three years after 
completing the review under subparagraph 
(A), the Secretary shall publish in the Fed-
eral Register a proposed rule to modify the 
title 45 regulations, or the title 21 regula-
tions, or both, in accordance with the find-
ings of the review, unless the review finds 
that removing any of the differences in ap-
proach between the title 45 regulations and 
the title 21 regulations is not practicable. 
‘‘(ii) SUBSEQUENT
RULEMAKING.— 
After the expiration of the three-year pe-
riod referred to in clause (i), or the publi-
cation of the proposed rule under clause 
(i), whichever occurs first, any rule pro-
mulgated by the Secretary that modifies 
the title 45 regulations or the title 21 reg-
ulations (including a modification that 
adds provisions), and results in there being 
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a difference between the title 45 regula-
tions and the title 21 regulations, shall be 
accompanied in the Federal Register by a 
statement of the reasons underlying the 
determination of the Secretary that, with 
respect to the goal described in subpara-
graph (A), the difference is appropriate to 
reflect the legal or factual variations in 
human subject research described in para-
graph (2)(A) relative to other human sub-
ject research. 
‘‘(b) COMMON RULE; OTHER DEFINITIONS.— 
‘‘(1) COMMON RULE; VULNERABLE-POPULATION 
RULES.—For purposes of this section: 
‘‘(A) The term ‘Common Rule’ means the 
provisions of subpart A of part 46 of title 45, 
Code of Federal Regulations (or any successor 
regulations). 
‘‘(B) 
The 
term 
‘vulnerable-population 
rules’ means the provisions of subparts B 
through D of such part 46 (or any successor 
regulations). 
‘‘(3) HUMAN
SUBJECT
RESEARCH.—For pur-
poses of this section: 
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‘‘(A) Except as provided in subparagraph 
(B), the term ‘human subject research’ means 
research, as defined in subpart A of part 46 of 
title 45, Code of Federal Regulations (or any 
successor regulations), that involves a human 
subject, as defined in such subpart A (or any 
successor regulations). 
‘‘(B) In the case of an investigation that is 
subject to the provisions of part 50 of title 21, 
Code of Federal Regulations (or successor regu-
lations), the term ‘human subject’ has the 
meaning given such term in such part 50, and 
the term ‘human subject research’ means a clin-
ical investigation as defined in such part 50. 
‘‘(4) OTHER
DEFINITIONS.—For purposes of 
this section: 
‘‘(A) The term ‘classified’, with respect to 
human subject research, refers to research that, 
within the meaning of section 552(b)(1)(A) of 
title 5, United States Code, is— 
‘‘(i) specifically authorized under cri-
teria established by an Executive order to 
be kept secret in the interest of national 
defense or foreign policy; and 
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‘‘(ii) is in fact properly classified pur-
suant to such Executive order. 
‘‘(B) The term ‘data safety and monitoring 
committee’, with respect to a human subject re-
search project, means a group of individuals 
with appropriate expertise that, on an ongoing 
basis during the conduct of such research 
project— 
‘‘(i) reviews data that are generated 
during the project; 
‘‘(ii) advises the investigator and 
sponsor regarding the continuing safety of 
human subjects who are or will be partici-
pating in the project; and 
‘‘(iii) advises such investigator and 
sponsor on the continued validity and sci-
entific merit of the project. 
‘‘(C) The term ‘Federal agency’ has the 
meaning given the term ‘Executive agency’ in 
section 105 of title 5, United States Code. 
‘‘(D) The terms ‘institution served by an 
Institutional Review Board’ and ‘institution 
served by the Board’ mean the public or private 
entity (university, health care provider, health 
plan, research organization, government agency, 
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independent institutional review board, or other 
entity) that establishes and is responsible for 
the operation of the Institutional Review Board. 
‘‘(E) 
The 
term 
‘Institutional 
Review 
Board’ has the meaning that applies under the 
Common Rule. 
‘‘(F) The term ‘lead Institutional Review 
Board’ means an Institutional Review Board 
that otherwise meets the requirements of the 
Common Rule and enters into a written agree-
ment with an institution, another Institutional 
Review Board, a sponsor, or a principal investi-
gator to approve and oversee human subject re-
search that is conducted at multiple locations. 
For purposes of this section, references to an 
Institutional Review Board include an Institu-
tional Review Board that serves a single institu-
tion as well as a lead Institutional Review 
Board. 
‘‘(G) The term ‘principal investigator’, 
with respect to human subject research, means 
the individual who, at the research location in-
volved, has the principal responsibility for the 
conduct of the research. 
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‘‘(H)(i) Except as provided in clause (ii), 
the term ‘sponsor’, with respect to human sub-
ject research, means the entity that provides 
the majority or plurality of the financial sup-
port for the conduct of the research. 
‘‘(ii) In the case of an investigation that is 
subject to the provisions of part 50 of title 21, 
Code of Federal Regulations (or successor regu-
lations), the term ‘sponsor’, with respect to 
human subject research, has the meaning that 
applies for purposes of such part 50. 
‘‘(c) SCOPE OF AUTHORITY OF SECRETARY.— 
‘‘(1) IN GENERAL.—The Common Rule (includ-
ing provisions regarding exemptions) and the vulner-
able-populations rules, as in effect on the day before 
the date of the enactment of the Protection for Par-
ticipants in Research Act of 2009, continue to be in 
effect on and after such date, subject to paragraph 
(2). 
‘‘(2) MODIFICATIONS.— 
‘‘(A) COMPLIANCE WITH LAW.—Promptly 
after the date of the enactment of the Act re-
ferred to in paragraph (1), the Secretary shall 
promulgate regulations to make such modifica-
tions to the provisions of the Common Rule as 
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may be necessary to ensure that such provisions 
implement, and do not conflict with, this sec-
tion. 
‘‘(B) OTHER
MODIFICATIONS.—This sec-
tion may not be construed as affecting the au-
thority of the Secretary to modify the provisions 
of the Common Rule or the vulnerable-popu-
lations rules, except to the extent that any such 
modification is in conflict with this section. Any 
such modification shall be made by regulation. 
‘‘(C) CONSIDERATION
OF
CERTAIN
MAT-
TERS.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall, with respect to the Common Rule, 
consider the matters specified in clause 
(iii) and make a determination of whether 
any of the provisions of such Rule should 
be modified accordingly. 
‘‘(ii) TIMING.—The Secretary shall 
publish the determination required by 
clause (i) and publish the determination in 
the Federal Register— 
‘‘(I) except as provided in sub-
clause (II), not later than 18 months 
after the date of the enactment of the 
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Protection for Participants in Re-
search Act of 2009; and 
‘‘(II) in the case of a determina-
tion on the matters specified in clause 
(iii)(VII), not later than 18 months 
after the submission of the report re-
quired by section 7 of the Protection 
for Participants in Research Act of 
2009. 
‘‘(iii) LIST OF MATTERS FOR CONSID-
ERATION.—The matters referred to in 
clause (i) with respect to the Common 
Rule are the following: 
‘‘(I) Whether the list of exemp-
tions from applicability of the Com-
mon Rule, as in effect on the day be-
fore the date of enactment referred to 
in clause (ii)(I), should be modified or 
new categories of exemptions estab-
lished. 
‘‘(II) Whether and under what 
circumstances research that studies 
human tissue or other types of clinical 
specimens should not be considered 
human subject research. 
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‘‘(III) Whether and under what 
circumstances research that studies 
data that do not involve any inter-
action or intervention with a living 
human should be considered human 
subject research. 
‘‘(IV) Whether the list of cat-
egories of research that are exempt 
from Investigational Review Board re-
view or are eligible for expedited re-
view under the Common Rule, as in 
effect on the day before the date of 
enactment referred to in clause (i), 
should be modified, and whether new 
categories of such exempt research or 
research eligible for expedited review 
should be established. 
‘‘(V) Whether modified proce-
dures should apply to human subject 
research that poses minimal risk to 
the subjects, including whether there 
are any types of such research for 
which some aspect of the requirement 
of informed consent or documentation 
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of informed consent should apply dif-
ferently. 
‘‘(VI) Whether Institutional Re-
view Boards include sufficient num-
bers of minority individuals (as de-
fined in section 485E(c)) as Board 
members when reviewing proposals 
designed to include human subjects 
who are minority individuals. 
‘‘(VII) Whether the requirements 
for the number of members of an In-
stitutional Review Board who are in-
dividuals whose primary expertise is 
in nonscientific areas, and the number 
of members of an Institutional Review 
Board who are individuals who are 
not affiliated with the institution 
served by the Board, should be in-
creased. 
‘‘(VIII) Such additional matters 
as the Secretary determines to be ap-
propriate. 
‘‘(D) AGENCY-SPECIFIC ADDITIONAL PRO-
TECTIONS.—With respect to human subject re-
search that is conducted, supported, or other-
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wise subject to regulation under a provision of 
Federal law (other than this section), the Sec-
retary may under subparagraph (A) permit the 
Federal agency involved to establish additional 
protections for the protection of human subjects 
if the Secretary determines that such additional 
protections are not in conflict with protections 
established under this section. 
‘‘(d) RIGHT OF INFORMED CONSENT.— 
‘‘(1) IN GENERAL.—For purposes of subsection 
(a), a principal investigator may not, except as pro-
vided in the Common Rule, involve an individual as 
a subject in human subject research unless the in-
vestigator or other knowledgeable person has ob-
tained the informed consent of the individual to be 
a subject. 
‘‘(2) 
LEGALLY
AUTHORIZED
REPRESENTA-
TIVE.—References in this section to obtaining con-
sent from an individual shall be considered to be ref-
erences to obtaining consent from the legally author-
ized representative of the individual in any case in 
which the individual lacks legal competence to pro-
vide consent. 
‘‘(3) CERTAIN REQUIREMENTS REGARDING DIS-
CLOSURE
AND
UNDERSTANDING.—The Secretary 
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shall establish criteria regarding consent under para-
graph (1) that— 
‘‘(A) provide for the provision of full and 
complete information relevant to the research to 
a prospective human subject; 
‘‘(B) require such information to be pro-
vided in language understandable to such sub-
ject; 
‘‘(C) require that only individuals knowl-
edgeable about the research provide such infor-
mation to the subject and answer questions 
from the subject; and 
‘‘(D) require that information be provided 
to the subject on how to contact the Office for 
Human Research Protections to submit ques-
tions about the rights of subjects or to report 
concerns regarding the research. 
‘‘(4) WRITTEN
ATTESTATION
BY
INVESTI-
GATOR.—A principal investigator who involves a 
human subject in research shall, in accordance with 
the criteria of the Secretary, file with the Institu-
tional Review Board for the research a written attes-
tation that the investigator is familiar with require-
ments for the protection of human subjects, includ-
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ing the requirement of informed consent, and agrees 
to comply with such requirements. 
‘‘(e) INSTITUTIONAL REVIEW BOARDS.— 
‘‘(1) REQUIREMENTS
FOR
BOARDS.—Human 
subject research may not be conducted unless an In-
stitutional Review Board has, for purposes of the 
Common Rule (and the vulnerable-populations rules, 
as applicable), approved the proposal for such re-
search. With respect to the research involved, the 
approval by the Board of the proposal for the re-
search is not effective unless, in addition to condi-
tions established by the Secretary, the following con-
ditions are met: 
‘‘(A) The institution served by the Board 
ensures that the Board has an orientation pro-
gram for new members and a continuing edu-
cation program for existing members of the 
Board, and with respect to ethical matters that 
relate to research, a continuing education pro-
gram for all members of the Board. 
‘‘(B) The institution served by the Board 
has submitted to the Secretary a registration 
informing the Secretary of the existence of the 
Board, and the registration was in such form, 
was made in such manner, and contained such 
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compiles data on the number of new research 
proposals reviewed, the number of continuing 
research projects reviewed, the number of re-
viewed biomedical research proposals, the num-
ber of reviewed behavioral or social sciences re-
search proposals, the number of reviewed multi-
disciplinary research proposals, and any addi-
tional information determined appropriate by 
the Secretary. 
‘‘(G) The institution served by the Board 
submits to the Secretary such reports regarding 
the Board as the Secretary determines to be ap-
propriate. 
‘‘(2) NOTIFICATION OF INSTITUTIONAL REVIEW 
BOARD AND SPONSORS BY INVESTIGATORS.— 
‘‘(A) In submitting to an Institutional Re-
view Board a proposal for human subject re-
search, the investigators for the research shall 
notify the institution served by the Board— 
‘‘(i) of any significant financial inter-
est, as defined by applicable Federal regu-
lations; 
‘‘(ii) whether the investigators have 
been disqualified or restricted by any Fed-
eral, State, or local entity in their ability 
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to conduct human subject research, includ-
ing being ineligible to conduct human sub-
ject research with investigational new 
drugs, being ineligible for approval of new 
drug applications, or agreeing to some 
other form of restriction regarding re-
search; and 
‘‘(iii) whether the proposal has been 
submitted to any other Institutional Re-
view Board and, as applicable, of any find-
ings made by such Board. 
‘‘(B) A notification required by subpara-
graph (A) shall be submitted to the institution 
served by the Board— 
‘‘(i) at the time of submitting the pro-
posal for human subject research to the 
Board; or 
‘‘(ii) in the case of circumstances aris-
ing after such submission, immediately. 
‘‘(3) INSTITUTION REVIEW OF CONFLICTS OF 
INTEREST.—The institution served by an Institu-
tional Review Board shall review such significant fi-
nancial interests as are submitted under paragraph 
(2) to determine whether such interests create or 
may reasonably appear to create conflicts of interest, 
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and then shall seek to manage, reduce, or eliminate 
such conflicts of interest. 
‘‘(4) PROJECTS
INVOLVING
MULTIPLE
LOCA-
TIONS.—For purposes of meeting the Common Rule 
requirements for review and supervision of research 
by an Institutional Review Board, such activities 
may be performed by an Institutional Review Board 
or a lead Institutional Review Board, at the option 
of the institution where the research is conducted. 
‘‘(5) VOLUNTARY
ACCREDITATION.—The Sec-
retary may in accordance with this paragraph facili-
tate the accreditation of institutions and Institu-
tional Review Boards by recognizing a private ac-
crediting entity or entities. For purposes of the pre-
ceding sentence: 
‘‘(A) The Secretary may recognize an ac-
crediting entity if— 
‘‘(i) such entity submits to the Sec-
retary the standards and procedures that 
the entity requires institutions and Institu-
tional Review Boards to meet in order to 
be accredited by the entity; 
‘‘(ii) the Secretary determines that 
such standards and procedures include 
standards and procedures ensuring that 
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the policies and procedures of institutions 
and Institutional Review Boards accredited 
by the entity are in compliance with Fed-
eral regulations governing human subject 
research; and 
‘‘(iii) the entity annually submits to 
the Secretary a report describing any 
changes in the standards and procedures 
described in clause (ii). 
‘‘(B) The Secretary may not require that 
any institution, Institutional Review Board, or 
program for the protection of human subjects 
in research, or any component thereof, be ac-
credited. 
‘‘(C) Nothing in this section may be con-
strued as authorizing the Secretary— 
‘‘(i) to establish or approve accredita-
tion standards or procedures for institu-
tions, Institutional Review Boards, or pro-
grams for the protection of human subjects 
in research, or any component thereof; or 
‘‘(ii) to recognize any standards or 
procedures for institutions or Institutional 
Review Boards other than the standards 
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and procedures described in subparagraph 
(A)(ii). 
‘‘(6) COST
RECOVERY.—Institutions may re-
cover costs associated with compliance for human 
subject protections under this part from government 
sponsors of research as direct costs. 
‘‘(f) DATA SAFETY AND MONITORING PLANS.— 
‘‘(1) IN
GENERAL.—If a human subject re-
search project meets the criteria developed under 
paragraph (2), such project shall be conducted in ac-
cordance with a data safety and monitoring plan. 
‘‘(2) CRITERIA.—The Secretary shall develop 
criteria for determining whether a human subject re-
search project must be conducted in accordance with 
a data safety and monitoring plan. 
‘‘(3) CONTENTS.—A data safety and moni-
toring plan under this subsection shall include the 
following: 
‘‘(A) A requirement that the sponsor of the 
human subject research project use a data safe-
ty and monitoring committee in affiliation with 
the project. 
‘‘(B) Minimum requirements for the re-
porting by the principal investigator of informa-
tion on such data safety and monitoring plan to 
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the Institutional Review Board for the project 
and to the institution served by the Board. 
‘‘(C) A requirement that the data safety 
and monitoring committee described in sub-
paragraph (A) provide reports on the findings 
of the committee regarding the project to such 
investigator, Board, and institution. 
‘‘(D)(i) A requirement that the principal 
investigator report to the Institutional Review 
Board for the project and the sponsor of the 
project— 
‘‘(I) in the case of any unantici-
pated problem in the project involving 
risks to human subjects or other indi-
viduals, immediately; and 
‘‘(II) in the case of any adverse 
event in the project, in a timely man-
ner appropriate to the severity of the 
event and whether the event is unex-
pected. 
‘‘(ii) An unanticipated problem or adverse 
event referred to in subclause (I) or (II) of 
clause (i), respectively, shall be reported by the 
principal investigator, in addition to the reports 
required by clause (i), as directed by the Sec-
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retary by regulation. Such regulations shall en-
sure comprehensive and coordinated reporting 
to all relevant parties. 
‘‘(g) INSTITUTIONAL PROGRAMS OF EDUCATION.— 
For fiscal year 2010 and subsequent fiscal years, the Sec-
retary may not make an award of a grant, cooperative 
agreement, or contract under this Act to a public entity 
or a private academic institution, or make an award of 
a grant, cooperative agreement, or contract under this Act 
for the conduct of research at or through or in affiliation 
with a public entity or a private academic institution, un-
less the public entity or private academic institution (as 
the case may be) maintains or contracts for a comprehen-
sive and ongoing program to educate investigators and 
Board members on the protection of human subjects in 
research. 
‘‘(h) CERTAIN CLASSIFIED HUMAN SUBJECT RE-
SEARCH.—Notwithstanding any other provision of law, 
Federal funds may not be expended for the conduct of 
classified human subject research if— 
‘‘(1) the Institutional Review Board reviewing 
the proposal for the research pursuant to this sec-
tion has under the Common Rule waived the re-
quirement to obtain the informed consent of the 
human subjects in the research; or 
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‘‘(2) the research is exempt from the require-
ment under the Common Rule that the proposal for 
the research be reviewed by such a Board. 
‘‘(i) DISCLOSURE OF VIOLATIONS.— 
‘‘(1) DISCLOSURES.—Upon the request of an 
Institutional Review Board, the Secretary shall de-
termine whether an entity (including an individual, 
as applicable under the request) has violated any re-
quirement under this section, and shall disclose to 
such Board the findings of the Secretary. 
‘‘(2) NOTICE TO SUBJECT OF DISCLOSURE.—If 
pursuant to a request under paragraph (1) the Sec-
retary discloses that an entity has violated a require-
ment under this section, the Secretary shall in writ-
ing notify the entity of the disclosure, including the 
identity of the Institutional Review Board to which 
the disclosure was made. 
‘‘(j) APPLICABILITY OF REQUIREMENTS.—The re-
quirements of this section apply on and after the date of 
the enactment of the Protection for Participants in Re-
search Act of 2009.’’. 
SEC. 3. OFFICE FOR HUMAN RESEARCH PROTECTIONS. 
Part H of title IV of the Public Health Service Act 
(42 U.S.C. 289 et seq.), as amended by section 2 of this 
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Act, is amended by inserting after section 491A the fol-
lowing section: 
‘‘SEC. 491B. OFFICE FOR HUMAN RESEARCH PROTECTIONS. 
‘‘(a) IN GENERAL.—There is established within the 
office of the Secretary an office to be known as the Office 
for Human Research Protections (in this section referred 
to as the ‘Office’). The Office shall be headed by a direc-
tor, who shall be appointed by the Secretary. The Sec-
retary shall carry out this section acting through the Di-
rector of the Office. 
‘‘(b) CERTAIN DUTIES.—The Director of the Of-
fice— 
‘‘(1) shall provide for the protection of human 
subjects in research by carrying out activities in ac-
cordance with subsection (d) regarding compliance 
with the Common Rule, as defined in and modified 
pursuant to section 491A; 
‘‘(2) shall establish criteria regarding assur-
ances of compliance with the requirements of the 
Common Rule; 
‘‘(3) shall direct activities within the Depart-
ment of Health and Human Services, and coordinate 
the activities of the Department with other Federal 
departments and agencies, with respect to the pro-
tection of subjects in human subject research; 
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‘‘(4) may, in collaboration with the Director of 
NIH, the Commissioner of Food and Drugs, or the 
head of any other Federal department or agency, 
carry out educational and quality improvement pro-
grams for human subject protections for principal 
investigators, members of Institutional Review 
Boards, and other appropriate persons, including the 
generation of resource materials relating to the re-
sponsibilities of the research community for the pro-
tection of human subjects in research; 
‘‘(5) shall, upon the request of an entity that 
conducts or supports human subject research— 
‘‘(A) consult with the entity regarding im-
provements in human subject protections in 
such research; and 
‘‘(B) provide advice on compliance with the 
Common Rule, including with respect to dif-
fering interpretations among Institutional Re-
view Boards of a provision of such Rule; 
‘‘(6) may make grants to entities that conduct 
or support human subject research for the purpose 
of assisting the entities in carrying out programs to 
recruit and train minority individuals (as defined in 
section 485E(c)) to serve as members of Institu-
tional Review Boards; 
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‘‘(7) shall consult with experts in biomedical, 
behavioral, and social sciences research in carrying 
out the duties of the Director; and 
‘‘(8) shall carry out such additional authorities 
of the Secretary regarding the protection of human 
subjects in research as the Secretary determines to 
be appropriate. 
‘‘(c) MODEL EDUCATION PROGRAM.—The Director 
of the Office may make grants for the development of a 
model education program to be used by institutions served 
by Institutional Review Boards to satisfy the requirements 
under section 491A(e)(1)(A) and to develop best practices 
in institutional management of human subject research. 
‘‘(d) COMPLIANCE AND ENFORCEMENT.— 
‘‘(1) AUDITS OF INVESTIGATORS AND INSTITU-
TIONS.—The Director of the Office may conduct au-
dits of entities that conduct or support human sub-
ject research in order to determine whether such en-
tities are complying with the Common Rule. 
‘‘(2) CORRECTIVE ACTION PLAN.—If the Direc-
tor of the Office determines that an entity referred 
to in paragraph (1) is not in compliance with the 
Common Rule, the Director of the Office, after pro-
viding to an appropriate representative of the entity 
an oral or written summary of the reasons under-
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lying such determination, may require the entity to 
develop and to implement a plan for corrective ac-
tion to bring the entity into compliance. 
‘‘(3) RESTRICTIONS.—If the Director of the Of-
fice determines that an entity referred to in para-
graph (1) is not in compliance with the Common 
Rule, the Director may impose restrictions on the 
extent to which the entity may conduct or support 
human subject research. The restrictions may in-
clude any of the following: 
‘‘(A) Suspending research protocols. 
‘‘(B) Prohibiting the inclusion of additional 
human subjects in particular research projects. 
‘‘(C) Suspending or terminating particular 
research projects, unless doing so would endan-
ger the human subjects participating in such 
projects. 
‘‘(D) Suspending the provision of Federal 
funds for particular research projects conducted 
or supported by or through the entity, or for 
particular research protocols of the entity. 
‘‘(E) Suspending the provision of Federal 
funds for all research projects conducted or 
supported by or through the entity, in any case 
in which the Secretary determines that the non-
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compliance creates a significant threat to the 
rights and welfare of human subjects in such 
projects. 
‘‘(F) In the case of individuals who are or 
were investigators in the research involved, 
after notice and an opportunity for a hearing— 
‘‘(i) suspending or debarring the indi-
viduals from receiving Federal funds for 
conducting human subject research; or 
‘‘(ii) suspending or debarring the indi-
viduals from serving as principal investiga-
tors in human subject research. 
‘‘(4) INSTITUTIONAL REVIEW BOARDS.— 
‘‘(A) AUDITS.—In carrying out paragraph 
(1), the Director of the Office may conduct au-
dits of Institutional Review Boards in order to 
determine whether such Boards are complying 
with the Common Rule (including conditions 
described in section 491A(e)). 
‘‘(B) CORRECTIVE ACTION PLAN.—If the 
Director of the Office determines that an Insti-
tutional Review Board is not in compliance with 
the Common Rule, the Director of the Office, 
after providing to an appropriate representative 
of such Board, or of the institution served by 
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the Board, an oral or written summary of the 
reasons underlying such determination, may re-
quire the Board to develop and to implement a 
plan for corrective action to bring the Board 
into compliance. 
‘‘(C) RESTRICTIONS.— 
‘‘(i) IN GENERAL.—If the Director de-
termines that an Institutional Review 
Board is not in compliance with the Com-
mon Rule, the Director may— 
‘‘(I) in the case of the research 
projects with respect to which the 
Board was or is not in compliance, 
provide that the approvals of the 
Board for such projects are not effec-
tive 
for 
purposes 
of 
section 
491A(e)(1), unless such projects were 
approved by another Institutional Re-
view Board; or 
‘‘(II) provide that all approvals of 
research by the Board are not effec-
tive for purposes of such section, in 
any case in which the Director deter-
mines that the noncompliance creates 
a significant threat to the rights and 
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welfare of human subjects in projects 
approved by the Board. 
‘‘(ii) RESULTING
RISKS.—In deter-
mining that an approval is not effective 
under subclause (I) or (II) of clause (i), 
the Director shall take into consideration 
human subject safety risks that may result 
from such a determination, including the 
immediate withdrawal of a study treat-
ment, and shall require that appropriate 
measures be taken to eliminate such risks. 
‘‘(D) PROJECTS INVOLVING MULTIPLE LO-
CATIONS.—In the case of a project of human 
subject research for which there is an agree-
ment described in section 491A(b)(4)(F) (relat-
ing to multiple Institutional Review Boards), 
the Director of the Office shall, in carrying out 
authorities under this subsection with respect to 
an Institutional Review Board, ensure that no 
action is taken that adversely affects the oper-
ation of a project of human subject research at 
any project location for which such Institutional 
Review Board had no responsibilities. 
‘‘(5) NOTIFICATION OF FEDERAL AND STATE 
REGULATORY AGENCIES.—In any case in which the 
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Director of the Office takes an action described in 
paragraph (3)(E) or (4)(C)(ii) against an entity that 
conducts or supports human subject research, or 
against an Institutional Review Board, respectively, 
the Director shall notify relevant Federal and State 
regulatory agencies, and as applicable, the sponsors 
of the research, of the deficiencies in the operation 
of the entity or Board. 
‘‘(6) COORDINATION WITH FOOD AND DRUG AD-
MINISTRATION.—In the case of human subject re-
search that is subject to the Federal Food, Drug, 
and Cosmetic Act or to section 351 of this Act, no 
authority under this subsection may be carried out 
with respect to an entity that conducts or supports 
such research, or with respect to an Institutional Re-
view Board, unless the Commissioner of Food and 
Drugs concurs in the exercise of the authority in-
volved. 
‘‘(e) FUNDING.— 
‘‘(1) AUTHORIZATION
OF
APPROPRIATIONS.— 
For the purpose of carrying out this section, there 
are authorized to be appropriated $20,000,000 for 
fiscal year 2010, and such sums as may be nec-
essary for fiscal year 2011 and each subsequent fis-
cal year. 
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‘‘(2) MODEL EDUCATION PROGRAM.—For the 
purpose of carrying out subsection (c), there are au-
thorized to be appropriated such sums as may be 
necessary for fiscal year 2010 and each subsequent 
fiscal year. 
‘‘(3) RULE
OF
CONSTRUCTION.—Nothing in 
this section or section 491A may be construed as a 
change in the budget authority or authorization of 
appropriations for the Food and Drug Administra-
tion.’’. 
SEC. 4. AMENDMENTS REGARDING PROCESS FOR RE-
SPONDING TO REPORTS OF VIOLATIONS. 
Section 491(b)(2) of the Public Health Service Act 
(42 U.S.C. 289(b)(2)) is amended— 
(1) in the first sentence, by inserting ‘‘or the 
Director of the Office for Human Research Protec-
tions’’ after ‘‘the Director of NIH’’; and 
(2) in the second sentence, by inserting after 
‘‘this Act’’ the following: ‘‘, the sharing of informa-
tion between the Director of NIH and the Director 
of such Office, and’’. 
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SEC. 5. ENHANCED HUMAN SUBJECT PROTECTIONS FOR 
PEOPLE WITH DIMINISHED DECISIONMAKING 
CAPACITY. 
Not later than three years after the date of the enact-
ment of this Act, the Secretary of Health and Human 
Services shall, for purposes of section 491A of the Public 
Health Service Act, promulgate regulations to enhance the 
protection of people with diminished decisionmaking ca-
pacity with respect to their participation as subjects in 
human subject research. 
SEC. 6. RULE OF CONSTRUCTION REGARDING INDIVIDUAL 
AGENCY OFFICES. 
The amendments made by this Act may not be con-
strued as terminating any office or other administrative 
unit in a Federal agency that, on the day before the date 
of the enactment of this Act, had duties relating to the 
protection of human subjects in research conducted, sup-
ported, or otherwise subject to regulation under Federal 
law. 
SEC. 7. STUDY ON INCREASING THE NUMBER OF CERTAIN 
IRB MEMBERS. 
(a) STUDY.—Not later than 36 months after the date 
of the enactment of this Act, the Secretary of Health and 
Human Services shall— 
(1) complete a study on whether the require-
ments for the number of members of an Institu-
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