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.
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 2003’’.
SEC. 2. PROTECTION OF HUMAN SUBJECTS IN RESEARCH; 
UNIFORM NATIONAL APPLICABILITY OF COM-
MON RULE AND PROVISIONS PROTECTING 
VULNERABLE POPULATIONS. 
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: 
‘‘PROTECTION OF HUMAN SUBJECTS; UNIFORM NATIONAL 
APPLICABILITY OF COMMON RULE AND PROVISIONS 
PROTECTING VULNERABLE POPULATIONS 
‘‘SEC. 491A. (a) PROTECTION
OF HUMAN SUB-
JECTS.—
‘‘(1) IN GENERAL.—All human subject research 
shall be conducted in accordance with the Common 
Rule, and as applicable to the human subjects in-
volved in such research, with the vulnerable-popu-
lations rules. 
‘‘(2) APPLICABILITY.—Paragraph (1) applies 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
‘‘(B) is not described in subparagraph (A) 
and has activities that are in or that affect 
interstate commerce. 
‘‘(b) COMMON RULE; OTHER DEFINITIONS.—
‘‘(1) COMMON RULE; VULNERABLE-POPULATION 
RULES.—For purposes of this section: 
‘‘(A) Except as provided in subparagraph 
(B): 
‘‘(i) The term ‘Common Rule’ means 
the provisions of subpart A of part 46 of 
title 45, Code of Federal Regulations (or 
any successor regulations), subject to sub-
paragraph (C). 
‘‘(ii) The term ‘vulnerable-population 
rules’ means the provisions of subparts B 
through D of such part 46 (or any suc-
cessor regulations), subject to subpara-
graph (C). 
‘‘(B) 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: 
‘‘(i) The term ‘Common Rule’ means 
the provisions of parts 50 and 56 of title
21, Code of Federal Regulations (or any 
successor regulations). 
‘‘(ii) The term ‘vulnerable-population 
rules’ has the meaning applicable under 
part 56 of such title 21 (or any successor 
regulations), and includes the provisions of 
subpart D of part 50 of such title 21 (or 
any successor regulations). 
‘‘(C) In the case of human subject research 
to which both subparagraphs (A) and (B) 
apply, the terms ‘Common Rule’ and ‘vulner-
able-population rules’ have the meaning given 
such terms in subparagraph (B). 
‘‘(2) 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 2003, 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 (1)(B) 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-
search relating to emergency interventions; the 
definition of ‘institution’; and requirements for 
attestations by clinical investigators regarding 
the protection 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 
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 (1)(B) relative to other human sub-
ject research. 
‘‘(3) 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. 
‘‘(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
‘‘(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 is generated 
during the project; 
‘‘(ii) advises the sponsor regarding the 
continuing safety of human subjects who 
are or will be participating in the project; 
and 
‘‘(iii) advises such sponsor on the con-
tinued validity and scientific 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 term ‘institution served by an 
Institutional Review Board’ means the public or 
private entity (university, health care provider, 
health plan, research organization, government 
agency, 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. 
‘‘(H)(i) Except as provided in clause (ii), 
the term ‘sponsor’, with respect to human sub-
ject research, means the entity that has the 
principal financial responsibility 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 2003, 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 
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.—Not later than 18 
months after the date of the enactment of 
the Protection for Participants in Research 
Act of 2003, the Secretary shall, with re-
spect to the Common Rule—
‘‘(I) consider the matters speci-
fied in clause (ii) and make a deter-
mination of whether any of the provi-
sions of such Rule should be modified 
accordingly; and 
‘‘(II) publish the determination 
in the Federal Register. 
‘‘(ii) 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 exemptions 
from applicability of the Common Rule, as 
in effect on the day before the date of en-
actment referred to in clause (i), should be 
modified or new categories of exemptions 
established. 
‘‘(II) Whether there are circumstances 
in which research that studies human tis-
sue or other types of clinical specimens 
should not be considered human subject re-
search. 
‘‘(III) Whether research that studies 
data that do not involve any interaction or 
intervention with a living human should be 
considered human subject research. 
‘‘(IV) Whether the list of expedited 
procedures under the Common Rule, as in 
effect on the day before the date of enact-
ment referred to in clause (i), should be 
modified or new categories of expedited 
procedures established. 
‘‘(V) Whether modified procedures 
should apply to human subject research
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; 
‘‘(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