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)(C) 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-
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-
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 
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.—If the Director de-
termines that an Institutional Review Board is 
not in compliance with the Common 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 effective for purposes of 
section 491A(e)(1), unless such projects 
were approved by another Institutional Re-
view Board; or 
‘‘(ii) may provide that all approvals of 
research by the Board are not effective for 
purposes of such section, in any case in 
which the Director determines that the 
noncompliance creates a significant threat 
to the rights and welfare of human sub-
jects in projects approved by the Board. 
‘‘(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 
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 2004, and such sums as may be nec-
essary for fiscal year 2005 and each subsequent fis-
cal year. 
‘‘(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 2004 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’’. 
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.
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