I 
112TH CONGRESS 
1ST SESSION H. R. 2625 
To amend the Public Health Service Act with respect to human subject 
research to improve protections for human subjects and, where appro-
priate because of the type research involved, to reduce regulatory bur-
dens. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 22, 2011 
Ms. DEGETTE introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To amend the Public Health Service Act with respect to 
human subject research to improve protections for 
human subjects and, where appropriate because of the 
type research involved, to reduce regulatory burdens. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Research Participants 
Protection Modernization Act of 2011’’. 
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SEC. 2. PROTECTION OF HUMAN SUBJECTS IN RESEARCH; 
APPLICABILITY OF RULES. 
Part H of title IV of the Public Health Service Act 
(42 U.S.C. 289 et seq.) is amended by inserting after sec-
tion 491 the following section: 
‘‘SEC. 491A. PROTECTION OF HUMAN SUBJECTS IN RE-
SEARCH; APPLICABILITY OF RULES. 
‘‘(a) PROTECTION OF HUMAN SUBJECTS.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), all human subject research described in 
paragraph (3)(A) shall be conducted in accordance 
with the HHS Human Subject Regulations, and as 
applicable to the human subjects involved in such 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, 56, 312, and 812 of title 21, 
Code of Federal Regulations (or any suc-
cessor regulations); and 
‘‘(ii) as applicable to the human sub-
jects involved in such research, in accord-
ance with provisions applicable to vulner-
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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 HHS Human Subject 
Regulations shall be treated as a reference 
to the provisions described in subpara-
graph (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.— 
‘‘(A) IN GENERAL.—This section applies to 
human subject research that is— 
‘‘(i) conducted or supported by the 
Department of Health and Human Serv-
ices; or 
‘‘(ii) otherwise subject to regulation 
by the Department under a provision of 
Federal law (other than this section). 
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‘‘(B) OTHER FEDERAL DEPARTMENTS AND 
AGENCIES.—The Secretary shall make available 
assistance to any Federal department or agency 
seeking— 
‘‘(i) to improve the regulation or over-
sight of human subject research; or 
‘‘(ii) to apply the HHS Human Sub-
ject Regulations or the vulnerable-popu-
lation rules to human subject research that 
is conducted, supported, or regulated by 
such department or agency. 
‘‘(b) HHS HUMAN SUBJECT REGULATIONS; OTHER 
DEFINITIONS.— 
‘‘(1) HHS HUMAN
SUBJECT
REGULATIONS; 
VULNERABLE-POPULATION RULES.—For purposes of 
this section: 
‘‘(A) Except as provided in subsection 
(a)(2)(B) (relating to FDA research), the term 
‘HHS Human Subject Regulations’ means the 
provisions of subpart A of part 46 of title 45, 
Code of Federal Regulations (or any successor 
regulations). 
‘‘(B) Except as provided in subsection 
(a)(2)(B) (relating to FDA research), the term 
‘vulnerable-population rules’ means the provi-
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sions of subparts B through D of such part 46 
(or any successor regulations). 
‘‘(2) HUMAN
SUBJECT
RESEARCH.—For pur-
poses of this section: 
‘‘(A) Except as provided in subparagraph 
(B), the term ‘human subject research’ means 
research, as defined in subpart A of part 46 of 
title 45, Code of Federal Regulations (or any 
successor regulations), that involves a human 
subject, as defined in such subpart A (or any 
successor regulations). 
‘‘(B) In the case of an investigation that is 
subject to the provisions of part 50 of title 21, 
Code of Federal Regulations (or successor 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. 
‘‘(3) OTHER
DEFINITIONS.—For purposes of 
this section: 
‘‘(A) The terms ‘institution served by an 
institutional review board’ and ‘institution 
served by the board’ mean the public or private 
entity (university, health care provider, health 
plan, research organization, government agency, 
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independent institutional review board, or other 
entity) that establishes and is responsible for 
the operation of the institutional review board. 
‘‘(B) The term ‘institutional review board’ 
has the meaning that applies to the term ‘insti-
tutional review board’ under the HHS Human 
Subject Regulations. 
‘‘(C) The term ‘lead institutional review 
board’ means an institutional review board that 
otherwise meets the requirements of the HHS 
Human Subject Regulations and enters into a 
written agreement with an institution, another 
institutional review board, a sponsor, or a prin-
cipal investigator to approve and oversee human 
subject research that is conducted at multiple 
locations. For purposes of this section, ref-
erences to an institutional review board include 
an institutional review board that serves a sin-
gle institution as well as a lead institutional re-
view board. 
‘‘(D) 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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‘‘(E)(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 HHS Human Subject 
Regulations (including provisions regarding exemp-
tions) and the vulnerable-populations rules, as in ef-
fect on the day before the date of the enactment of 
the Research Participants Protection Modernization 
Act of 2011, continue to be in effect on and after 
such date, subject to paragraph (2). 
‘‘(2) MODIFICATIONS.— 
‘‘(A) COMPLIANCE WITH LAW.—Promptly 
after the date of the enactment of the Act re-
ferred to in paragraph (1), the Secretary shall 
promulgate regulations to make such modifica-
tions to the provisions of the HHS Human 
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Subject Regulations as may be necessary to en-
sure that such provisions implement, and do not 
conflict with, this section. 
‘‘(B) OTHER
MODIFICATIONS.—This sec-
tion may not be construed as affecting the au-
thority of the Secretary to modify the provisions 
of the HHS Human Subject Regulations or the 
vulnerable-populations rules, except to the ex-
tent 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 HHS Human 
Subject Regulations, consider the matters 
specified in clause (iii) and make a deter-
mination of whether any of the provisions 
of such Rule or any guidance associated 
with such Rule should be modified accord-
ingly. 
‘‘(ii) TIMING.—The Secretary shall 
publish the determination required by 
clause (i) in the Federal Register— 
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‘‘(I) except as provided in sub-
clause (II), not later than 3 years 
after the date of the enactment of the 
Research 
Participants 
Protection 
Modernization Act of 2011; and 
‘‘(II) in the case of a determina-
tion on the matters specified in clause 
(iii)(IX), not later than 18 months 
after the submission of the report re-
quired by section 5 of the Research 
Participants Protection Modernization 
Act of 2011. 
‘‘(iii) LIST OF MATTERS FOR CONSID-
ERATION.—The matters referred to in 
clause (i) with respect to the HHS Human 
Subject Regulations are the following: 
‘‘(I) How requirements regarding 
the definition and management of po-
tential financial conflict of interest, 
including both investigator and insti-
tutional conflicts of interest, should be 
strengthened and enforced to protect 
human subjects more effectively. 
‘‘(II) Whether the list of exemp-
tions from applicability of the HHS 
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Human Subject Regulations, as in ef-
fect on the day before the date of en-
actment referred to in clause (ii)(I), 
should be expanded to include new 
categories. 
‘‘(III) Whether and under what 
circumstances research that studies 
human tissue or other types of clinical 
specimens should not be considered a 
clinical investigation. 
‘‘(IV) Whether the list of cat-
egories of research that are eligible 
for expedited review under the HHS 
Human Subject Regulations, as in ef-
fect on the day before the date of en-
actment referred to in clause (ii)(I), 
should be expanded to include new 
categories of research eligible for ex-
pedited review. 
‘‘(V) Whether institutional review 
boards include sufficient numbers of 
minority individuals as board mem-
bers when reviewing proposals de-
signed to include human subjects who 
are minority individuals. 
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‘‘(VI) Whether the requirements 
for the number of members of an in-
stitutional review board who are indi-
viduals whose primary expertise is in 
nonscientific areas, and the number of 
members of an institutional review 
board who are individuals who are not 
affiliated with the institution served 
by the board, should be increased. 
‘‘(VII) Whether institutional re-
view boards include sufficient num-
bers of individuals with appropriate 
scientific expertise. 
‘‘(VIII) How to enhance the pro-
tection of people with diminished deci-
sionmaking capacity with respect to 
their participation as subjects in 
human subject research. 
‘‘(IX) How the requirements for 
institutional review board review in 
multisite research should be modified 
to reduce regulatory burden while pro-
tecting human subjects, including use 
of a lead institutional review board. 
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‘‘(X) How the requirements for 
managing 
and 
reporting 
adverse 
events and unanticipated problems 
should be modified— 
‘‘(aa) to increase consistency 
between such requirements of the 
Office for Human Research Pro-
tections of the Department of 
Health and Human Services and 
the corresponding requirements 
of the Food and Drug Adminis-
tration; and 
‘‘(bb) to reduce regulatory 
burden appropriately while pro-
tecting human subjects. 
‘‘(XI) How the requirements for 
approval and oversight of human sub-
jects research that poses no more 
than minimal risk to participants (in-
cluding requirements of informed con-
sent, documentation of informed con-
sent, and continuing review) should be 
modified to reduce regulatory burden 
(including burden on institutions, in-
stitutional review boards, and inves-
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tigators) while protecting research 
participants, including clarification of 
the circumstances in which informed 
consent does not need to be writing. 
‘‘(XII) Whether research that 
would be defined as a ‘clinical inves-
tigation’ under part 50 of title 21, 
Code of Federal Regulations, should 
comply with the guideline published 
by the Food and Drug Administration 
and endorsed by the International 
Conference 
on 
Harmonisation 
of 
Technical Requirements for Registra-
tion of Pharmaceuticals for Human 
Use, entitled ‘Good Clinical Practice: 
Consolidated Guideline’, and how in-
vestigators can be educated effectively 
regarding compliance with this guide-
line. 
‘‘(XIII) Such additional matters 
as the Secretary determines to be ap-
propriate. 
‘‘(d) INSTITUTIONAL REVIEW BOARDS.— 
‘‘(1) NOTIFICATION OF INSTITUTIONAL REVIEW 
BOARD AND SPONSORS BY INVESTIGATORS.— 
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‘‘(A) REQUIREMENT.—In submitting to an 
institutional review board a proposal for human 
subject research, the investigators for the re-
search 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 
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 review 
board and, as applicable, of any findings 
made by such board. 
‘‘(B) TIMING.—A notification required by 
subparagraph (A) shall be submitted to the in-
stitution served by the board— 
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‘‘(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. 
‘‘(2) INSTITUTIONAL REVIEW OF CONFLICTS OF 
INTEREST.—The institution served by an institu-
tional review board shall— 
‘‘(A) review such significant financial in-
terests as are submitted to the institution under 
paragraph (1) to determine whether such inter-
ests create or may reasonably appear to create 
conflicts of interest; and 
‘‘(B) seek to eliminate or manage such 
conflicts of interest. 
‘‘(3) COST
RECOVERY.—Institutions may re-
cover costs associated with compliance for human 
subject protections under this part from government 
sponsors of research as direct costs. 
‘‘(e) INSTITUTIONAL PROGRAMS OF EDUCATION.— 
For fiscal year 2012 and subsequent fiscal years, the 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 
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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 program 
to educate investigators and board members on the protec-
tion of human subjects in research. 
‘‘(f) APPLICABILITY OF REQUIREMENTS.—The re-
quirements of this section apply on and after the date of 
the enactment of the Research Participants Protection 
Modernization Act of 2011.’’. 
SEC. 3. OFFICE FOR HUMAN RESEARCH PROTECTIONS. 
(a) IN GENERAL.—Part H of title IV of the Public 
Health Service Act (42 U.S.C. 289 et seq.), as amended 
by section 2 of this Act, is amended by inserting after 
section 491A the following section: 
‘‘SEC. 491B. OFFICE FOR HUMAN RESEARCH PROTECTIONS. 
‘‘(a) IN GENERAL.—There is established within the 
office of the Secretary an office to be known as the Office 
for Human Research Protections (in this section referred 
to as the ‘Office’). The Office shall be headed by a 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— 
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‘‘(1) shall provide for the protection of human 
subjects in research by carrying out activities in ac-
cordance with section 491A; 
‘‘(2) shall establish criteria regarding assur-
ances of compliance with the requirements of section 
491A; 
‘‘(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; 
‘‘(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— 
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‘‘(A) consult with the entity regarding im-
provements in human subject protections in 
such research; and 
‘‘(B) provide advice on compliance with 
section 491A, including with respect to differing 
interpretations 
among 
institutional 
review 
boards of a provision of such section; 
‘‘(6) may make grants to entities that conduct 
or support human subject research for the purpose 
of assisting the entities in carrying out programs to 
recruit and train minority individuals to serve as 
members of institutional review boards; 
‘‘(7) shall consult with experts in biomedical, 
behavioral, and social sciences research in carrying 
out the duties of the Director; and 
‘‘(8) shall carry out such additional authorities 
of the Secretary regarding the protection of human 
subjects in research as the Secretary determines to 
be appropriate. 
‘‘(c) MODEL EDUCATION PROGRAMS.—The Director 
of the Office may make grants for the development of 
model education programs that may be used by institu-
tions served by institutional review boards to promote best 
practices in institutional management of human subject 
research. 
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‘‘(d) FUNDING.— 
‘‘(1) AUTHORIZATION
OF
APPROPRIATIONS.— 
For the purpose of carrying out this section, there 
are authorized to be appropriated $20,000,000 for 
fiscal year 2012, and such sums as may be nec-
essary for fiscal year 2013 and each subsequent fis-
cal year. 
‘‘(2) MODEL EDUCATION PROGRAMS.—For the 
purpose of carrying out subsection (c), there are au-
thorized to be appropriated such sums as may be 
necessary for fiscal year 2012 and each subsequent 
fiscal year. 
‘‘(3) RULE
OF
CONSTRUCTION.—Nothing in 
this section or section 491A may be construed as a 
change in the budget authority or authorization of 
appropriations for the Food and Drug Administra-
tion.’’. 
(b) FUNCTIONS, PERSONNEL, ASSETS, AND LIABIL-
ITIES.—All functions, personnel, assets, and liabilities of 
the Office for Human Research Protection of the Depart-
ment of Health and Human Services, as in existence on 
the day before the date of the enactment of this Act, shall 
be transferred to the Office for Human Research Protec-
tions established by section 491B of the Public Health 
Service Act, as added by subsection (a). 
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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: ‘‘, sharing of information 
between the Director of NIH and the Director of 
such Office,’’. 
Æ 
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