[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4697 Introduced in House (IH)]
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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Human Research Subject Protections
Act of 2002''.
SEC. 2. PROTECTION OF HUMAN SUBJECTS IN RESEARCH; UNIFORM NATIONAL
APPLICABILITY OF COMMON 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 section 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 Subjects.--
``(1) In general.--All human subject research shall be
conducted in accordance with the common rule, and as applicable
to the human subjects involved in such research, with the
vulnerable-populations rules.
``(2) Applicability.--Paragraph (1) applies to human
subject research that--
``(A) is conducted, supported, or otherwise subject
to regulation under a provision of Federal law (other
than this section), without regard to whether the
Federal agency that administers 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 subparagraph (C).
``(ii) The term `vulnerable-population
rules' means the provisions of subparts B
through D of such part 46 (or any successor
regulations), subject to subparagraph (C).
``(B) In the case of human subject research 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 enactment of the Human
Research Subject Protections Act of 2002, the Secretary
shall complete 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
regulations'), and the provisions of parts 50 and 56 of
title 21, Code of Federal Regulations (referred to in
this paragraph as `title 21 regulations'), 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
research described in paragraph (1)(B) relative to other human subject
research. The areas of difference reviewed shall include (but are not
limited 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 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 Federal Register a
proposed rule to modify the title 45
regulations, or the title 21 regulations, or
both, in accordance with the findings of the
review, unless the review finds that removing
any of the differences in approach between the
title 45 regulations and the title 21
regulations is not practicable.
``(ii) Subsequent rulemaking.--After the
expiration of the three-year period referred to
in clause (i), or the publication of the
proposed rule under clause (i), whichever
occurs first, any rule promulgated by the
Secretary that modifies the title 45
regulations or the title 21 regulations
(including a modification that adds
provisions), and results in there being a
difference between the title 45 regulations 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 subparagraph (A), the difference
is appropriate to reflect the legal or factual
variations in human subject research described
in paragraph (1)(B) relative to other human
subject research.
``(3) Human subject research.--For purposes of this
section:
``(A) Except as provided in subparagraphs (B) and
(C):
``(i) The term `human subject research'
means clinical research that is conducted with
the direct involvement of one or more human
subjects.
``(ii) For purposes of the definition
established 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 regulations), the
term `human subject research' means clinical research
that is a clinical investigation within the meaning of
such part 50, except as provided in subparagraph (C).
``(C) The term `human subject research' does not
include the collection, analysis, or abstraction of
data contained in records that were made for purposes
other than research or investigations conducted with
human subjects, including but not limited to business,
health, financial, 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
criteria 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
pursuant to such Executive order.
``(B) The term `data monitoring committee', with
respect to human subject research that is a clinical
trial, means a group of individuals with appropriate
expertise that, on an ongoing 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
continued 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 agreement with an institution, another
Institutional Review Board, a sponsor, or a principal
investigator to approve and oversee human subject
research that is conducted at multiple locations. For
purposes of this section, references to an Instutional
Review Board include an Institutional Review Board that
serves a single institution 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 involved, 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 subject 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 regulations), 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 (including provisions
regarding exemptions) and the vulnerable-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 referred to in paragraph
(1), the Secretary shall promulgate regulations to make
such modifications to the provisions of the common rule
as may be necessary to ensure that such provisions
implement, and do not conflict with, this section.
``(B) Other modifications.--This section may not be
construed as affecting the authority of the Secretary
to modify the provisions of the common rule or the
vulnerable-populations 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 protections.--With
respect to human subject research that is conducted,
supported, or otherwise subject to regulation under a
provision of Federal law (other than this section), the
Secretary 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 provided in the
common rule, involve a living individual as a subject in human
subject research unless the investigator or other knowledgeable
person has obtained the informed consent of the individual to
be a subject.
``(2) Legally authorized representative.--References in
this section to obtaining consent from an individual shall be
considered to be references to obtaining consent from the
legally authorized representative of the individual in any case
in which the individual lacks legal competence to provide
consent.
``(3) Consent form.--The consent of an individual to be a
human subject in human subject research shall be documented by
the principal investigator for the research or another
knowledgeable person, and such documentation shall include an
acknowledgement by such individual that the individual 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 difference
between research and therapeutic treatment.
``(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
investigators have in the research.
``(G) As applicable to the research, the medical
tests and procedures that may be necessary 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 disclosure and
understanding.--The Secretary shall establish criteria
regarding consent under paragraph (1) that provide for the
following:
``(A) During the process of obtaining consent, a
prospective human subject is, through the written
explanation provided under paragraph (2) and through
written or oral answers to questions from the
prospective subject, provided 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 knowledgeable about
the research, and can reasonably be expected to be able
to answer questions from the subject regarding the
research, is authorized to provide such information to
the subject.
``(D) The written statement under paragraph (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 subject, together with
information on how to contact the Office of Human
Research Protections to submit questions about
subjects' rights or to report concerns regarding the
research.
``(5) Written attestation by investigator.--A principal
investigator who involves a human subject in research shall, in
accordance with the criteria of the Secretary, file with the
Institutional Review Board for the research a written
attestation that the investigator is familiar with requirements
for the protection of human subjects, including 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 Institutional Review Board has, for
purposes of the common rule (and the vulnerable-populations
rules, as applicable), approved the proposal for such research.
With respect to the research involved, the approval by the
Board of the proposal for the research is not effective unless,
in addition to conditions established by the Secretary, the
following conditions 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 expertise is in
scientific areas.
``(ii) Not fewer than two members or 20
percent of all members (whichever is greater)
are individuals whose primary expertise is in
nonscientific areas.
``(iii) Not fewer than two members or 20
percent of all members (whichever is greater)
are individuals who are not affiliated 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
nonproprietary interest).
The appointment of a member of the Board to meet the
requirement of clause (iii) also qualifies 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 research 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 appointment 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 research 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 appointment
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 research, 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 categories 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 members present at the meeting include the members
required under such subparagraph.
``(E) The institution served by the Board ensures
that the Board has an orientation program for new
members and a continuing education program for existing
members of the Board, and with respect to ethical
matters that relate to research, a continuing education
program 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 regarding 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 committee (operated
pursuant to subsection (f)) as a part of the review by
the Board of the proposal.
``(H) With respect to the research involved, each
member of the Board has disclosed to the institution
served by the Board, and such institution 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 research;
and
``(iii) direct financial relationships or
arrangements with private sponsors of the
research, excluding ownership of any
independently-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 participate in
the review by the Board of a proposal 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
purposes 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 appropriate
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 appropriate.
``(2) Notification of institutional review board by
investigators.--In submitting to an Institutional Review Board
a proposal for human subject 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 conflict of
interest;
``(B) whether the investigators have been
disqualified or restricted by any Federal entity in
their ability to conduct human subject research,
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 submitted by
the principal investigator to any other Institutional
Review Board.
``(3) Institution review of conflicts of interest.--The
institution served by an Institutional Review Board shall
review such conflicts of interest or interests that create the
appearance of a conflict of interest as are submitted under
paragraph (2) and shall seek to reduce or eliminate and shall
oversee such conflicts of interest, with respect to the
research.
``(4) Projects involving multiple locations.--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 Secretary may in
accordance with this paragraph facilitate 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 accrediting
entity if the accrediting entity submits to the
Secretary the accrediting standards of the entity, the
Secretary determines that the standards further the
purposes of this section, and the accrediting entity
annually submits to the Secretary a report describing
any changes in the accrediting standards or procedures
of the entity.
``(B) The Secretary shall biannually evaluate the
performance of the accrediting entity.
``(C) The Secretary may withdraw recognition of the
accrediting entity if the Secretary determines that the
requirements of subparagraph (A) are not met.
``(D) The Secretary may not require that any
Institutional Review Board be accredited.
``(6) Cost recovery.--Institutions may recover costs
associated with compliance for human subject protections under
this Act from government sponsors of research as direct costs.
``(f) Improved Monitoring of High Risk Clinical Trials.--With
respect to human subjects in high risk clinical trials:
``(1) The Secretary shall establish criteria for
identifying high risk clinical trials requiring a data safety
and monitoring plan for each such trial. The criteria shall include--
``(A) a provision that the Secretary may require
the sponsor of the trial to utilize a data monitoring
committee in affiliation with the trial;
``(B) minimum requirements for the reporting by the
principal investigator of information on such plan to
the Institutional Review Board for the trial and to the
institution served by the Board; and
``(C) the requirement that such committee provide
reports on the findings of the committee regarding the
trial to such investigator, Board, and institution.
``(2) The Secretary shall require that adverse events in
such a trial be reported by the principal investigator for the
trial in a timely manner appropriate to whether the event is
unexpected and its severity to the Institutional Review Board
for the trial, and to the sponsor of the trial. Such events
shall in addition be reported by the principal investigator to
the Director of the Office of Human Research Protections, or
the Commissioner of Food and Drugs, whichever administers the
common rule as applied to the trial. Such regulations shall
ensure comprehensive and coordinated reporting to all relevant
parties.
``(g) Institutional Programs of Education.--For fiscal year 2003
and subsequent fiscal years, the Secretary 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, unless the public entity or private
academic institution (as the case may be) maintains or contracts for a
comprehensive and ongoing program to educate investigators and Board
members on the protection of human subjects in research.
``(h) Certain Classified Human Subject Research.--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 section has under the common
rule waived the requirement to obtain the informed consent of
the human subjects in the research; or
``(2) the research is exempt from the requirement 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 request) has violated any requirement under this
section, 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 Secretary discloses that an
entity has violated a requirement under this section, the
Secretary shall in writing 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 requirements of this
section apply on and after the date of the enactment of the Human
Research Subject Protections 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 following 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 section 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 accordance with
subsection (c) regarding compliance with the common rule, as
defined in and modified pursuant to section 491A;
``(2) shall establish criteria regarding assurances of
compliance with the requirements of the common rule;
``(3) shall coordinate activities within the Department of
Health and Human Services, and coordinate 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 programs 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 responsibilities of the
research community for the protection of human subjects in
research;
``(5) shall, upon the request of an entity that conducts or
supports human subject research, consult 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 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 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 institutions.--The
Director of the Office may conduct audits of entities that
conduct or support human subject research in order to determine
whether such entities are complying with the common rule.
``(2) Corrective action plan.--If the Director 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 providing to an appropriate representative of the
entity an oral or written summary of the reasons underlying
such determination, may require the entity to develop and to
implement a plan for corrective action to bring the entity into
compliance.
``(3) Restrictions.--If the Director of the Office
determines that an entity referred to in paragraph (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 include
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 endanger 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 noncompliance 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
individuals from receiving Federal funds for
conducting human subject research; or
``(ii) suspending or debarring the
individuals from serving as principal
investigators in human subject research.
``(4) Institutional review boards.--
``(A) Audits.--In carrying out paragraph (1), the
Director of the Office may conduct audits 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 Institutional 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 require the Board to develop and to implement a
plan for corrective action to bring the Board into compliance.
``(C) Restrictions.--If the Director determines
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
Review 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 subjects in projects approved
by the Board.
``(D) Projects involving multiple locations.--In
the case of a project of human subject research for
which there is an agreement under section 491A(b)(4)(F)
(relating 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 operation 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 administration.--In
the case of human subject research 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 Review Board, unless the
Commissioner of Food and Drugs concurs in the exercise of the
authority involved.
``(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 necessary for fiscal year 2004 and each subsequent
fiscal year.
``(2) Model education program.--For the purpose of carrying
out subsection (c), there are authorized 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 Administration.''.
SEC. 4. AMENDMENTS REGARDING PROCESS FOR RESPONDING 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 Protections'' after ``the
Director of NIH''; and
(2) in the second sentence, by inserting after ``this Act''
the following: ``, the sharing of information 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 enactment 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
capacity 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 construed 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,
supported, or otherwise subject to regulation under Federal law.
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