I
107TH CONGRESS
2D SESSION
H. R. 4697
To amend the Public Health Service Act with respect to the protection
of human subjects in research.
IN THE HOUSE OF REPRESENTATIVES
MAY 9, 2002
Ms. DEGETTE (for herself and Mr. GREENWOOD) 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 ‘‘Human Research Sub-
ject Protections Act of 2002’’.
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
subpart D of part 50 of such title 21 (or
any successor regulations).
‘‘(C) In the case of human subject research
to which both of subparagraphs (A) and (B)
apply, the terms ‘common rule’ and ‘vulnerable-
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 Human Research Subject Pro-
tections Act of 2002, 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
research relating to emergency interventions;
the definition of ‘institution’; and requirements
for attestations by clinical investigators regard-
ing 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 subparagraphs
(B) and (C):
‘‘(i) The term ‘human subject re-
search’ means clinical research that is con-
ducted with the direct involvement of one
or more human subjects.
‘‘(ii) For purposes of the definition es-
tablished in clause (i), the term ‘research’
has the meaning that applies for purposes
of part 46 of title 45, Code of Federal
Regulations (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 research’
means clinical research that is a clinical inves-
tigation within the meaning of such part 50, ex-
cept as provided in subparagraph (C).
‘‘(C) The term ‘human subject research’
does not include the collection, analysis, or ab-
straction of data contained in records that were
made for purposes other than research or inves-
tigations conducted with human subjects, in-
cluding but not limited to business, health, fi-
nancial, research, marketing, survey, education,
or government records.
‘‘(D) The term ‘clinical research’ has the
meaning given such term in section 409(b).
‘‘(E) The term ‘human subject’ means a
living human being.
‘‘(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 monitoring com-
mittee’, with respect to human subject research
that is a clinical trial, means a group of individ-
uals with appropriate expertise that, on an on-
going basis during the conduct of such trial—
‘‘(i) reviews data that is generated
during the trial;
‘‘(ii) advises the sponsor regarding the
continuing safety of human subjects who
are or will be participating in the trial; and
‘‘(iii) advises such sponsor on the con-
tinued validity and scientific merit of the
trial.
‘‘(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
Instutional 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 Human Research
Subject Protections Act of 2002, 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) AGENCY-SPECIFIC ADDITIONAL PRO-
TECTIONS.—With respect to human subject re-
search that is conducted, supported, or other-
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 a living individual
as a subject in human subject research unless the
investigator 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) CONSENT FORM.—The consent of an indi-
vidual to be a human subject in human subject re-
search shall be documented by the principal investi-
gator for the research or another knowledgeable per-
son, and such documentation shall include an ac-
knowledgement by such individual that the indi-
vidual has with respect to the research been provided
a written explanation of the following:
‘‘(A) The purpose of the research.
‘‘(B) The potential risks and benefits of
being a subject in the research.
‘‘(C) As applicable to the research, the dif-
ference between research and therapeutic treat-
ment.
‘‘(D) The right to cease participation as a
subject at any time.
‘‘(E) The identity of the sponsors of the
research.
‘‘(F) Any conflict of interest that the in-
vestigators have in the research.
‘‘(G) As applicable to the research, the
medical tests and procedures that may be nec-
essary as part of the research, and the extent
to which the costs of such tests and procedures
will not be paid by the sponsor or other entities
involved in the research.
‘‘(H) Such additional information as the
Secretary may require.
‘‘(4) CERTAIN REQUIREMENTS REGARDING DIS-
CLOSURE
AND
UNDERSTANDING.—The Secretary
shall establish criteria regarding consent under para-
graph (1) that provide for the following:
‘‘(A) During the process of obtaining con-
sent, a prospective human subject is, through
the written explanation provided under para-
graph (2) and through written or oral answers
to questions from the prospective subject, pro-
vided full and complete information relevant to
the research involved.
‘‘(B) Such information is provided to the
prospective subject in the language and in a
manner that allows the subject to understand
the information and make an informed decision,
free of coercion, regarding participation as a
human subject.
‘‘(C) Only an individual who is knowledge-
able about the research, and can reasonably be
expected to be able to answer questions from
the subject regarding the research, is author-
ized to provide such information to the subject.
‘‘(D) The written statement under para-
graph (2) provides the information required in
such paragraph in a clear and conspicuous
manner.
‘‘(E) A copy of the documentation of the
consent of the subject is provided to the sub-
ject, together with information on how to con-
tact the Office of Human Research Protections
to submit questions about subjects’ rights or to
report concerns regarding the research.
‘‘(5) 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-
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) Of the membership of such Board:
‘‘(i) Not fewer than two members or
25 percent of all members, whichever is
greater, are individuals whose primary ex-
pertise is in scientific areas.
‘‘(ii) Not fewer than two members or
20 percent of all members (whichever is
greater) are individuals whose primary ex-
pertise is in nonscientific areas.
‘‘(iii) Not fewer than two members or
20 percent of all members (whichever is
greater) are individuals who are not affili-
ated with the institution served by the
Board (other than by serving on the
Board), who are not immediate family
members of any individual who is affiliated
with the institution, and who do not have
a conflict of interest (including nonpropri-
etary interest).
The appointment of a member of the Board to
meet the requirement of clause (iii) also quali-
fies toward meeting the requirement of clause
(ii) if the primary expertise of such member is
in a nonscientific area.
‘‘(B) When reviewing a proposal for re-
search that is designed to include as a subject
an individual who is a member of a vulnerable
population, the Board includes at least one
member who is an expert in the issues involving
such population; allows such member to fully
participate in the Board review process; and
provides such member with the same voting
rights as other members of the Board. The ap-
pointment of a member of the Board to meet
the requirement of this subparagraph may also
qualify toward meeting the requirement of
clause (ii) of subparagraph (A), or clause (iii)
of such subparagraph, if such member satisfies
the criteria described in the clause involved.
‘‘(C) When reviewing a proposal for re-
search that is designed to include as subjects a
significant number of minority individuals (as
defined in section 485E(c)), the Board includes
minority members; allows such members to fully
participate in the Board review process; and
provides such members with the same voting
rights as other members of the Board. The ap-
pointment of a member of the Board to meet
the requirement of this subparagraph may also
qualify toward meeting the requirement of
clause (ii) of subparagraph (A), or clause (iii)
of such subparagraph, if such member satisfies
the criteria described in the clause involved.
‘‘(D)(i) In reviewing a proposal for re-
search, the Board does not consider a quorum
to have been established for a meeting unless
the members present at the meeting include one
or more members from each of the three cat-
egories described in subparagraph (A).
‘‘(ii) In any case in which the Board will
under subparagraph (C) review a proposal for
research that is designed to include as subjects
a significant number of minority individuals,
the Board does not consider a quorum to have
been established for a meeting unless the mem-
bers present at the meeting include the mem-
bers required under such subparagraph.
‘‘(E) 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.
‘‘(F) 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
information as the Secretary requested regard-
ing functions of the Board under this section.
‘‘(G) In the case of a proposal for a high
risk trial, the Board reviews the data safety and
monitoring plan of the data monitoring com-
mittee (operated pursuant to subsection (f)) as
a part of the review by the Board of the pro-
posal.
‘‘(H) With respect to the research involved,
each member of the Board has disclosed to the
institution served by the Board, and such insti-
tution has disclosed to the Board, any actual
conflicts of interest, or interests that create the
appearance of a conflict of interest, with respect
to such research, including (but not limited
to)—
‘‘(i) involvement as investigators in
the research;
‘‘(ii) ownership interests in the re-
search; and
‘‘(iii) direct financial relationships or
arrangements with private sponsors of the
research, excluding ownership of any inde-
pendently-managed investment plan (such
as mutual funds) that may own a financial
interest in such a sponsor.
‘‘(I) A member of the Board does not par-
ticipate in the review by the Board of a pro-
posal for research if the member has a conflict
of interest (including a nonproprietary interest)
in the research. The provision by such member
of information to other members of the Board
does not constitute Board participation for pur-
poses of this subparagraph.
‘‘(J) The institution served by the Board
annually submits to the Secretary a report that
compiles data on the number of new research
proposals reviewed, the number of continuing
research projects reviewed, the number of
human subjects involved in approved research,
and any additional information determined ap-
propriate by the Secretary.
‘‘(K) 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 BY INVESTIGATORS.—In submitting to an In-
stitutional Review Board a proposal for human sub-
ject research, the investigators for the research shall
notify the Board, and the institution served by the
Board—
‘‘(A) of any actual conflicts of interest, or
interests that create the appearance of a con-
flict of interest;
‘‘(B) whether the investigators have been
disqualified or restricted by any Federal entity
in their ability to conduct human subject re-
search, including being ineligible to conduct
human subject research with investigational
new drugs, being ineligible for approval of new
drug applications, or agreeing to some other
form of restriction regarding research; and
‘‘(C) whether the proposal has been sub-
mitted by the principal investigator to any other
Institutional Review Board.
‘‘(3) INSTITUTION REVIEW OF CONFLICTS OF
INTEREST.—The institution served by an Institu-
tional Review Board shall review such conflicts of in-
terest or interests that create the appearance of a
conflict of interest as are submitted under para-
graph (2) and shall seek to reduce or eliminate and
shall oversee such conflicts of interest, with respect
to the research.
‘‘(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 Institutional Review Boards
and institutions by a private accrediting entity or
entities. For purposes of the preceding sentence:
‘‘(A) The Secretary may recognize an ac-
crediting entity if the accrediting entity submits
the trial. Such regulations shall ensure comprehen-
sive and coordinated reporting to all relevant parties.
‘‘(g) INSTITUTIONAL PROGRAMS OF EDUCATION.—
For fiscal year 2003 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 require-
ment to obtain the informed consent of the human
subjects in the research; or
‘‘(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
entity that conducts or supports research, or upon
the request of an Institutional Review Board, the
Secretary shall determine whether another entity
(including an individual, as applicable under the re-
quest) has violated any requirement under this sec-
tion, and shall disclose to such entity or 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 entity or 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 Human Research Subject Protec-
tions Act of 2002.’’.
SEC. 3. OFFICE OF 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
Act, is amended by inserting after section 491A the fol-
lowing section:
‘‘OFFICE OF HUMAN RESEARCH PROTECTIONS
‘‘SEC. 491B. (a) IN GENERAL.—There is established
within the Office of the Secretary an office to be known
as the Office of Human Research Protections (in this sec-
tion referred to as the ‘Office’). The Office shall be headed
by a director, who shall be appointed by the Secretary.
The Secretary shall carry out this section acting through
the Director of the Office.
‘‘(b) CERTAIN
DUTIES.— The Director of the
Office—
‘‘(1) shall provide for the protection of human
subjects in research by carrying out activities in ac-
cordance with subsection (c) 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 coordinate activities within the De-
partment of Health and Human Services, and co-
ordinate the activities of the Department with other
Federal departments and agencies, with respect to
the protection of human subjects in human subject
research;
‘‘(4) may, in collaboration with the Director of
NIH and the Commissioner of Food and Drugs,
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, con-
sult with the entity regarding improvements in
human subject protections in such research;
‘‘(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
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)(E) and to develop best practices
in institutional management of clinical trials.
‘‘(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 ex-
tent 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 de-
scribed 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 under section 491A(b)(4)(F) (relating to
multiple Institutional Review Boards), the Di-
rector of the Office shall, in carrying out au-
thorities 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 2003, and such sums as may be nec-
essary for fiscal year 2004 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 2003 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 of 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. NATIONAL RESEARCH PROTECTIONS ADVISORY
COMMITTEE.
The Secretary of Health and Human Services shall
ensure the continuing operation of the National Research
Protections Advisory Committee in accordance with the
provisions for the operation of such Committee that were
established by the Secretary on June 6, 2000, and were
amended by the Secretary on January 19, 2001.
SEC. 6. 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. 7. 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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