I
103D CONGRESS
1ST SESSION
H. R. 4
To amend the Public Health Service Act to revise and extend the programs
of the National Institutes of Health, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
JANUARY 5, 1993
Mr. WAXMAN (for himself, Mr. UPTON, Mrs. SCHROEDER, Ms. SNOWE, Mrs.
COLLINS of Illinois, Ms. DANNER, Ms. ENGLISH, Mrs. JOHNSON of Con-
necticut, Mrs. KENNELLY, Ms. LAMBERT, Mr. LEHMAN, Mrs. LOWEY of
New York, Mrs. LLOYD, Mr. MARKEY, Mrs. MINK, Mrs. MORELLA, Ms.
MOLINARI, Ms. NORTON, Mr. RICHARDSON, Ms. PELOSI, Mr. SANDERS,
Ms. SCHENK, Mr. SHARP, Ms. SLAUGHTER, Mr. STUDDS, Mr. SYNAR,
Mr. TOWNS, Mrs. UNSOELD, Ms. WATERS, Ms. WOOLSEY, and Mr.
WYDEN) introduced the following bill; which was referred to the Commit-
tee on Energy and Commerce
A BILL
To amend the Public Health Service Act to revise and extend
the programs of the National Institutes of Health, and
for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘National Institutes of Health Revitalization Act of
1993’’.
(b) TABLE OF CONTENTS.—The table of contents for
this Act is as follows:
Sec. 1. Short title; table of contents.
TITLE I—GENERAL PROVISIONS REGARDING TITLE IV OF
PUBLIC HEALTH SERVICE ACT
Subtitle A—Research Freedom
PART I—REVIEW OF PROPOSALS FOR BIOMEDICAL AND BEHAVIORAL
RESEARCH
Sec. 101. Establishment of certain provisions regarding research conducted or
supported by National Institutes of Health.
PART II—RESEARCH ON TRANSPLANTATION OF FETAL TISSUE
Sec. 111. Establishment of authorities.
Sec. 112. Purchase of human fetal tissue; solicitation or acceptance of tissue
as directed donation for use in transplantation.
Sec. 113. Nullification of moratorium.
Sec. 114. Report by General Accounting Office on adequacy of requirements.
PART III—MISCELLANEOUS REPEALS
Sec. 121. Repeals.
Subtitle B—Clinical Research Equity Regarding Women and Minorities
PART I—WOMEN AND MINORITIES AS SUBJECTS IN CLINICAL RESEARCH
Sec. 131. Requirement of inclusion in research.
Sec. 132. Peer review.
Sec. 133. Applicability to current projects.
PART II—OFFICE OF RESEARCH ON WOMEN’S HEALTH
Sec. 141. Establishment.
Subtitle C—Scientific Integrity
Sec. 151. Establishment of Office of Scientific Integrity.
Sec. 152. Commission on Scientific Integrity.
Sec. 153. Protection of whistleblowers.
Sec. 154. Requirement of regulations regarding protection against financial
conflicts of interest in certain projects of research.
Sec. 155. Effective dates.
TITLE II—NATIONAL INSTITUTES OF HEALTH IN GENERAL
Sec. 201. Health promotion research dissemination.
Sec. 202. Programs for increased support regarding certain States and re-
searchers.
Sec. 203. Children’s vaccine initiative.
Sec. 204. Plan for use of animals in research.
Sec. 205. Increased participation of women and disadvantaged individuals in
fields of biomedical and behavioral research.
Sec. 206. Requirements regarding surveys of sexual behavior.
Sec. 207. Discretionary fund of Director of National Institutes of Health.
Sec. 208. Miscellaneous provisions.
TITLE III—GENERAL PROVISIONS RESPECTING NATIONAL
RESEARCH INSTITUTES
Sec. 301. Appointment and authority of Directors of national research insti-
tutes.
Sec. 302. Program of research on osteoporosis, Paget’s disease, and related dis-
orders.
Sec. 303. Establishment of interagency program for trauma research.
TITLE IV—NATIONAL CANCER INSTITUTE
Sec. 401. Expansion and intensification of activities regarding breast cancer.
Sec. 402. Expansion and intensification of activities regarding prostate cancer.
Sec. 403. Authorization of appropriations.
TITLE V—NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Sec. 501. Education and training.
Sec. 502. Centers for the study of pediatric cardiovascular diseases.
Sec. 503. National Center on Sleep Disorders.
Sec. 504. Authorization of appropriations.
TITLE VI—NATIONAL INSTITUTE ON DIABETES AND DIGESTIVE
AND KIDNEY DISEASES
Sec. 601. Provisions regarding nutritional disorders.
TITLE VII—NATIONAL INSTITUTE ON ARTHRITIS AND
MUSCULOSKELETAL AND SKIN DISEASES
Sec. 701. Juvenile arthritis.
TITLE VIII—NATIONAL INSTITUTE ON AGING
Sec. 801. Alzheimer’s disease registry.
Sec. 802. Aging processes regarding women.
Sec. 803. Authorization of appropriations.
Sec. 804. Conforming amendment.
TITLE IX—NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS
DISEASES
Sec. 901. Tropical diseases.
Sec. 902. Chronic fatigue syndrome.
TITLE X—NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN
DEVELOPMENT
Subtitle A—Research Centers With Respect to Contraception and Research
Centers With Respect to Infertility
Sec. 1001. Grants and contracts for research centers.
Sec. 1002. Loan repayment program for research with respect to contraception
and infertility.
Subtitle B—Program Regarding Obstetrics and Gynecology
Sec. 1011. Establishment of program.
Subtitle C—Child Health Research Centers
Sec. 1021. Establishment of centers.
Subtitle D—Study Regarding Adolescent Health.
Sec. 1031. Prospective longitudinal study.
TITLE XI—NATIONAL EYE INSTITUTE
Sec. 1101. Clinical research on diabetes eye care.
TITLE XII—NATIONAL INSTITUTE OF NEUROLOGICAL
DISORDERS AND STROKE
Sec. 1201. Research on multiple sclerosis.
TITLE XIII—NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH
SCIENCES
Sec. 1301. Applied Toxicological Research and Testing Program.
TITLE XIV—NATIONAL LIBRARY OF MEDICINE
Subtitle A—General Provisions
Sec. 1401. Additional authorities.
Sec. 1402. Authorization of appropriations.
Subtitle B—Financial Assistance
Sec. 1411. Establishment of program of grants for development of education
technologies.
Subtitle C—National Information Center on Health Services Research and
Health Care Technology
Sec. 1421. Establishment of Center.
Sec. 1422. Conforming provisions.
TITLE XV—OTHER AGENCIES OF NATIONAL INSTITUTES OF
HEALTH
Subtitle A—Division of Research Resources
Sec. 1501. Redesignation of Division as National Center for Research Re-
sources.
Sec. 1502. Biomedical and behavioral research facilities.
Sec. 1503. Construction program for national primate research center.
Subtitle B—National Center for Nursing Research
Sec. 1511. Redesignation of National Center for Nursing Research as National
Institute of Nursing Research.
Sec. 1512. Study on adequacy of number of nurses.
Subtitle C—National Center for Human Genome Research
Sec. 1521. Purpose of Center.
TITLE XVI—AWARDS AND TRAINING
Subtitle A—National Research Service Awards
Sec. 1601. Requirement regarding women and individuals from disadvantaged
backgrounds.
Subtitle B—Acquired Immune Deficiency Syndrome
Sec. 1611. Loan repayment program.
Subtitle C—Loan Repayment for Research Generally
Sec. 1621. Establishment of program.
Subtitle D—Scholarship and Loan Repayment Programs Regarding
Professional Skills Needed by National Institutes of Health
Sec. 1631. Establishment of programs.
Sec. 1632. Funding.
Subtitle E—Funding for Awards and Training Generally
Sec. 1641. Authorization of appropriations.
TITLE XVII—NATIONAL FOUNDATION FOR BIOMEDICAL
RESEARCH
Sec. 1701. Date certain for appointment of Board members.
Sec. 1702. Miscellaneous provisions.
TITLE XVIII—RESEARCH WITH RESPECT TO ACQUIRED IMMUNE
DEFICIENCY SYNDROME
Sec. 1801. Revision and extension of various programs.
TITLE XIX—STUDIES
Sec. 1901. Acquired immune deficiency syndrome.
Sec. 1902. Malnutrition in the elderly.
Sec. 1903. Research activities on chronic fatigue syndrome.
Sec. 1904. Report on medical uses of biological agents in development of de-
fenses against biological warfare.
Sec. 1905. Personnel study of recruitment, retention and turnover.
Sec. 1906. Procurement.
TITLE XX—MISCELLANEOUS PROVISIONS
Sec. 2001. Designation of Senior Biomedical Research Service in honor of
Silvio Conte, and limitation on number of members.
Sec. 2002. Technical corrections.
Sec. 2003. Biennial report on carcinogens.
Sec. 2004. Master plan for physical infrastructure for research.
Sec. 2005. Transfer of provisions of title xxvii.
Sec. 2006. Certain authorization of appropriations.
TITLE XXI—EFFECTIVE DATES
Sec. 2101. Effective dates.
TITLE I—GENERAL PROVISIONS
REGARDING TITLE IV OF PUB-
LIC HEALTH SERVICE ACT
Subtitle A—Research Freedom
PART I—REVIEW OF PROPOSALS FOR
BIOMEDICAL AND BEHAVIORAL RESEARCH
SEC. 101. ESTABLISHMENT OF CERTAIN PROVISIONS RE-
GARDING RESEARCH CONDUCTED OR SUP-
PORTED 
BY 
NATIONAL 
INSTITUTES 
OF
HEALTH.
Part G of title IV of the Public Health Service Act
(42 U.S.C. 289 et seq.) is amended by inserting after sec-
tion 492 the following new section:
‘‘CERTAIN PROVISIONS REGARDING REVIEW AND
APPROVAL OF PROPOSALS FOR RESEARCH
‘‘SEC. 492A. (a) REVIEW AS PRECONDITION TO RE-
SEARCH.—
‘‘(1) PROTECTION OF HUMAN RESEARCH SUB-
JECTS.—
‘‘(A) In the case of any application submit-
ted to the Secretary for financial assistance to
conduct research, the Secretary may not ap-
prove or fund any application that is subject to
review under section 491(a) by an Institutional
Review Board unless the application has under-
gone review in accordance with such section and
has been recommended for approval by a major-
ity of the members of the Board conducting
such review.
‘‘(B) In the case of research that is subject
to review under procedures established by the
Secretary for the protection of human subjects
in clinical research conducted by the National
Institutes of Health, the Secretary may not au-
thorize the conduct of the research unless the
research has, pursuant to such procedures, been
recommended for approval.
‘‘(2) PEER REVIEW.—In the case of any appli-
cation submitted to the Secretary for financial as-
sistance to conduct research, the Secretary may not
approve or fund any application that is subject to
technical and scientific peer review under section
492(a) unless the application has undergone peer re-
view in accordance with such section and has been
recommended for approval by a majority of the
members of the entity conducting such review.
‘‘(b) ETHICAL REVIEW OF RESEARCH.—
‘‘(1) PROCEDURES
REGARDING
WITHHOLDING
OF FUNDS.—If research has been recommended for
approval for purposes of subsection (a), the Sec-
retary may not withhold funding for the research on
ethical grounds unless—
‘‘(A) the Secretary convenes an advisory
board in accordance with paragraph (4) to
study the ethical implications of the research;
and
‘‘(B) the majority of the advisory board
recommends that, on ethical grounds, the Sec-
retary withhold funds for the research.
‘‘(2) APPLICABILITY.—The limitation estab-
lished in paragraph (1) regarding the authority to
withhold funds on ethical grounds shall apply with-
out regard to whether the withholding of funds is
characterized as a disapproval, a moratorium, a pro-
hibition, or other description.
‘‘(3) PRELIMINARY MATTERS REGARDING USE
OF PROCEDURES.—
‘‘(A) If the Secretary makes a determina-
tion that an advisory board should be convened
for purposes of paragraph (1), the Secretary
shall, through a statement published in the
Federal Register, announce the intention of the
Secretary to convene such a board.
‘‘(B) A statement issued under subpara-
graph (A) shall include a request that inter-
ested individuals submit to the Secretary rec-
ommendations specifying the particular individ-
uals who should be appointed to the advisory
board involved. The Secretary shall consider
such recommendations in making appointments
to the board.
‘‘(C) The Secretary may not make appoint-
ments to an advisory board under paragraph
(1) until the expiration of the 30-day period be-
ginning on the date on which the statement re-
quired in subparagraph (A) is made with re-
spect to the board.
‘‘(4) ETHICS ADVISORY BOARDS.—
‘‘(A) Any advisory board convened for pur-
poses of paragraph (1) shall be known as an
ethics advisory board (hereafter in this para-
graph referred to as an ‘ethics board’).
‘‘(B)(i) An ethics board shall advise, con-
sult with, and make recommendations to the
Secretary regarding the ethics of the project of
biomedical or behavioral research with respect
to which the board has been convened.
‘‘(ii) Not later than 180 days after the
date on which the statement required in para-
graph (3)(A) is made with respect to an ethics
board, the board shall submit to the Secretary,
and to the Committee on Energy and Com-
merce of the House of Representatives and the
Committee on Labor and Human Resources of
the Senate, a report describing the findings of
the board regarding the project of research in-
volved and making a recommendation under
clause (i) of whether the Secretary should or
should not withhold funds for the project. The
report shall include the information considered
in making the findings.
‘‘(C) An ethics board shall be composed of
no fewer than 14, and no more than 20, indi-
viduals who are not officers or employees of the
United States. The Secretary shall make ap-
pointments to the board from among individ-
uals with special qualifications and competence
to provide advice and recommendations regard-
ing ethical matters in biomedical and behavioral
research. Of the members of the board—
‘‘(i) no fewer than 1 shall be an attor-
ney;
‘‘(ii) no fewer than 1 shall be an
ethicist;
‘‘(iii) no fewer than 1 shall be a prac-
ticing physician;
‘‘(iv) no fewer than 1 shall be a theo-
logian; and
‘‘(v) no fewer than one-third, and no
more than one-half, shall be scientists with
substantial accomplishments in biomedical
or behavioral research.
‘‘(D) The term of service as a member of
an ethics board shall be for the life of the
board. If such a member does not serve the full
term of such service, the individual appointed to
fill the resulting vacancy shall be appointed for
the remainder of the term of the predecessor of
the individual.
‘‘(E) A member of an ethics board shall be
subject to removal from the board by the Sec-
retary for neglect of duty or malfeasance or for
other good cause shown.
‘‘(F) The Secretary shall designate an indi-
vidual from among the members of an ethics
board to serve as the chair of the board.
‘‘(G) In carrying out subparagraph (B)(i)
with respect to a project of research, an ethics
board shall conduct inquiries and hold public
hearings.
‘‘(H) With respect to information relevant
to the duties described in subparagraph (B)(i),
an ethics board shall have access to all such in-
formation possessed by the Department of
Health and Human Services, or available to the
Secretary from other agencies.
‘‘(I) Members of an ethics board shall re-
ceive compensation for each day engaged in car-
rying out the duties of the board, including
time engaged in traveling for purposes of such
duties. Such compensation may not be provided
in an amount in excess of the maximum rate of
basic pay payable for GS–18 of the General
Schedule.
‘‘(J) The Secretary, acting through the Di-
rector of the National Institutes of Health,
shall provide to each ethics board such staff
and other assistance as may be necessary to
carry out the duties of the board.
‘‘(K) An ethics board shall terminate 30
days after the date on which the report required
in subparagraph (B)(ii) is submitted to the Sec-
retary and the congressional committees speci-
fied in such subparagraph.’’.
PART II—RESEARCH ON TRANSPLANTATION OF
FETAL TISSUE
SEC. 111. ESTABLISHMENT OF AUTHORITIES.
Part G of title IV of the Public Health Service Act
(42 U.S.C. 289 et seq.) is amended by inserting after sec-
tion 498 the following new section:
‘‘RESEARCH ON TRANSPLANTATION OF FETAL TISSUE
‘‘SEC. 498A. (a) ESTABLISHMENT OF PROGRAM.—
‘‘(1) IN GENERAL.—The Secretary may conduct
or support research on the transplantation of human
fetal tissue for therapeutic purposes.
‘‘(2) SOURCE OF TISSUE.—Human fetal tissue
may be used in research carried out under para-
graph (1) regardless of whether the tissue is ob-
tained pursuant to a spontaneous or induced abor-
tion or pursuant to a stillbirth.
‘‘(b) INFORMED CONSENT OF DONOR.—
‘‘(1) IN
GENERAL.—In research carried out
under subsection (a), human fetal tissue may be
used only if the woman providing the tissue makes
a statement, made in writing and signed by the
woman, declaring that—
‘‘(A) the woman donates the fetal tissue
for use in research described in subsection (a);
‘‘(B) the donation is made without any re-
striction regarding the identity of individuals
who may be the recipients of transplantations
of the tissue; and
‘‘(C) the woman has not been informed of
the identity of any such individuals.
‘‘(2) ADDITIONAL
STATEMENT.—In research
carried out under subsection (a), human fetal tissue
may be used only if the attending physician with re-
spect to obtaining the tissue from the woman in-
volved makes a statement, made in writing and
signed by the physician, declaring that—
‘‘(A) in the case of tissue obtained pursu-
ant to an induced abortion—
‘‘(i) the consent of the woman for the
abortion was obtained prior to requesting
or obtaining consent for the tissue to be
used in such research; and
‘‘(ii) no alteration of the timing,
method, or procedures used to terminate
the pregnancy was made solely for the pur-
poses of obtaining the tissue;
‘‘(B) the tissue has been donated by the
woman in accordance with paragraph (1); and
‘‘(C) full disclosure has been provided to
the woman with regard to—
‘‘(i) such physician’s interest, if any,
in the research to be conducted with the
tissue; and
‘‘(ii) any known medical risks to the
woman or risks to her privacy that might
be associated with the donation of the tis-
sue and that are in addition to risks of
such type that are associated with the
woman’s medical care.
‘‘(c) INFORMED CONSENT
OF RESEARCHER
AND
DONEE.—In research carried out under subsection (a),
human fetal tissue may be used only if the individual with
the principal responsibility for conducting the research in-
volved makes a statement, made in writing and signed by
the individual, declaring that the individual—
‘‘(1) is aware that—
‘‘(A) the tissue is human fetal tissue;
‘‘(B) the tissue may have been obtained
pursuant to a spontaneous or induced abortion
or subsequent to a stillbirth; and
‘‘(C) the tissue was donated for research
purposes;
‘‘(2) has provided such information to other in-
dividuals with responsibilities regarding the research;
‘‘(3) will require, prior to obtaining the consent
of an individual to be a recipient of a transplan-
tation of the tissue, written acknowledgment of re-
ceipt of such information by such recipient; and
‘‘(4) has had no part in any decisions as to the
timing, method, or procedures used to terminate the
pregnancy made solely for the purposes of the re-
search.
‘‘(d) AVAILABILITY OF STATEMENTS FOR AUDIT.—
‘‘(1) IN
GENERAL.—In research carried out
under subsection (a), human fetal tissue may be
used only if the head of the agency or other entity
conducting the research involved certifies to the Sec-
retary that the statements required under sub-
sections (a)(3), (b)(2), and (c) will be available for
audit by the Secretary.
‘‘(2) CONFIDENTIALITY OF AUDIT.—Any audit
conducted by the Secretary pursuant to paragraph
(1) shall be conducted in a confidential manner to
protect the privacy rights of the individuals and enti-
ties involved in such research, including such indi-
viduals and entities involved in the donation, trans-
fer, receipt, or transplantation of human fetal tissue.
With respect to any material or information obtained
pursuant to such audit, the Secretary shall—
‘‘(A) use such material or information only
for the purposes of verifying compliance with
the requirements of this section;
‘‘(B) not disclose or publish such material
or information, except where required by Fed-
eral law, in which case such material or infor-
mation shall be coded in a manner such that
the identities of such individuals and entities
are protected; and
‘‘(C) not maintain such material or infor-
mation after completion of such audit, except
where necessary for the purposes of such audit.
‘‘(e) APPLICABILITY OF STATE AND LOCAL LAW.—
‘‘(1) RESEARCH
CONDUCTED
BY
RECIPIENTS
OF
ASSISTANCE.—The Secretary may not provide
support for research under subsection (a) to conduct
the research in accordance with applicable State and
local law.
‘‘(2) RESEARCH CONDUCTED BY SECRETARY.—
The Secretary may conduct research under sub-
section (a) only in accordance with applicable State
and local law.
‘‘(f) DEFINITION.—For purposes of this section, the
term ‘human fetal tissue’ means tissue or cells obtained
from a dead human embryo or fetus after a spontaneous
or induced abortion, or after a stillbirth.’’.
SEC. 112. PURCHASE OF HUMAN FETAL TISSUE; SOLICITA-
TION OR ACCEPTANCE OF TISSUE AS DI-
RECTED DONATION FOR USE IN TRANSPLAN-
TATION.
Part G of title IV of the Public Health Service Act,
as amended by section 111 of this Act, is amended by in-
serting after section 498A the following new section:
‘‘PROHIBITIONS REGARDING HUMAN FETAL TISSUE
‘‘SEC. 498B. (a) PURCHASE OF TISSUE.—It shall be
unlawful for any person to knowingly acquire, receive, or
otherwise transfer any human fetal tissue for valuable con-
sideration if the transfer affects interstate commerce.
‘‘(b) SOLICITATION OR ACCEPTANCE OF TISSUE AS
DIRECTED DONATION FOR USE IN TRANSPLANTATION.—
It shall be unlawful for any person to solicit or knowingly
acquire, receive, or accept a donation of human fetal tissue
for the purpose of transplantation of such tissue into an-
other person if the donation affects interstate commerce,
the tissue will be or is obtained pursuant to an induced
abortion, and—
‘‘(1) the donation will be or is made pursuant
to a promise to the donating individual that the do-
nated tissue will be transplanted into a recipient
specified by such individual;
‘‘(2) the donated tissue will be transplanted
into a relative of the donating individual; or
‘‘(3) the person who solicits or knowingly ac-
quires, receives, or accepts the donation has provided
valuable consideration for the costs associated with
such abortion.
‘‘(c) CRIMINAL PENALTIES FOR VIOLATIONS.—
‘‘(1) IN
GENERAL.—Any person who violates
subsection (a) or (b) shall be fined in accordance
with title 18, United States Code, subject to para-
graph (2), or imprisoned for not more than 10
years, or both.
‘‘(2) PENALTIES APPLICABLE TO PERSONS RE-
CEIVING CONSIDERATION.—With respect to the im-
position of a fine under paragraph (1), if the person
involved violates subsection (a) or (b)(3), a fine shall
be imposed in an amount not less than twice the
amount of the valuable consideration received.
‘‘(d) DEFINITIONS.—For purposes of this section:
‘‘(1) The term ‘human fetal tissue’ has the
meaning given such term in section 498A(f).
‘‘(2) The term ‘interstate commerce’ has the
meaning given such term in section 201(b) of the
Federal Food, Drug, and Cosmetic Act.
‘‘(3) The term ‘valuable consideration’ does not
include reasonable payments associated with the
transportation, implantation, processing, preserva-
tion, quality control, or storage of human fetal
tissue.’’.
SEC. 113. NULLIFICATION OF MORATORIUM.
(a) IN GENERAL.—Except as provided in subsection
(c), no official of the executive branch may impose a policy
that the Department of Health and Human Services is
prohibited from conducting or supporting any research on
the transplantation of human fetal tissue for therapeutic
purposes. Such research shall be carried out in accordance
with section 498A of the Public Health Service Act (as
added by section 111 of this Act), without regard to any
such policy that may have been in effect prior to the date
of the enactment of this Act.
(b) PROHIBITION AGAINST WITHHOLDING OF FUNDS
IN CASES OF TECHNICAL AND SCIENTIFIC MERIT.—
(1) IN GENERAL.—In the case of any proposal
for research on the transplantation of human fetal
tissue for therapeutic purposes, the Secretary of
Health and Human Services may not withhold funds
for the research if—
(A) the research has been approved for
purposes of section 492A(a) of the Public
Health Service Act (as added by section 101 of
this Act);
(B) the research will be carried out in ac-
cordance with section 498A of such Act (as
added by section 111 of this Act); and
(C) there are reasonable assurances that
the research will not utilize any human fetal tis-
sue that has been obtained in violation of sec-
tion 498B(a) of such Act (as added by section
112 of this Act).
(2) STANDING APPROVAL REGARDING ETHICAL
STATUS.—In the case of any proposal for research
on the transplantation of human fetal tissue for
therapeutic purposes, the issuance in December
1988 of the Report of the Human Fetal Tissue
Transplantation Research Panel shall be deemed to
be a report—
(A) issued by an ethics advisory board pur-
suant to section 492A(b)(4)(B)(ii) of the Public
Health Service Act (as added by section 101 of
this Act); and
(B) finding, on a basis that is neither arbi-
trary nor capricious, that there are no ethical
grounds for withholding funds for the research.
(c) AUTHORITY FOR WITHHOLDING FUNDS FROM
RESEARCH.—In the case of any research on the transplan-
tation of human fetal tissue for therapeutic purposes, the
Secretary of Health and Human Services may withhold
funds for the research if any of the conditions specified
in any of subparagraphs (A) through (C) of subsection
(b)(1) are not met with respect to the research.
(d) DEFINITION.—For purposes of this section, the
term ‘‘human fetal tissue’’ has the meaning given such
term in section 498A(f) of the Public Health Service Act
(as added by section 111 of this Act).
SEC. 114. REPORT BY GENERAL ACCOUNTING OFFICE ON
ADEQUACY OF REQUIREMENTS.
(a) IN GENERAL.—With respect to research on the
transplantation of human fetal tissue for therapeutic pur-
poses, the Comptroller General of the United States shall
conduct an audit for the purpose of determining—
(1) whether and to what extent such research
conducted or supported by the Secretary of Health
and Human Services has been conducted in accord-
ance with section 498A of the Public Health Service
Act (as added by section 111 of this Act); and
(2) whether and to what extent there have been
violations of section 498B of such Act (as added by
section 112 of this Act).
(b) REPORT.—Not later than May 19, 1995, the
Comptroller General of the United States shall complete
the audit required in subsection (a) and submit to the
Committee on Energy and Commerce of the House of
Representatives, and to the Committee on Labor and
Human Resources of the Senate, a report describing the
findings made pursuant to the audit.
PART III—MISCELLANEOUS REPEALS
SEC. 121. REPEALS.
(a) CERTAIN BIOMEDICAL ETHICS BOARD.—Title III
of the Public Health Service Act (42 U.S.C. 241 et seq.)
is amended by striking part J.
(b) OTHER REPEALS.—Part G of title IV of the Pub-
lic Health Service Act (42 U.S.C. 289 et seq.) is amend-
ed—
(1) in section 498, by striking subsection (c);
and
(2) by striking section 499; and
(3) by redesignating section 499A as section
499.
(c) NULLIFICATION OF CERTAIN REGULATION.—The
provisions of section 204(d) of part 46 of title 45 of the
Code of Federal Regulations (45 CFR 46.204(d)) shall
not have any legal effect.
Subtitle B—Clinical Research Eq-
uity Regarding Women and Mi-
norities
PART I—WOMEN AND MINORITIES AS SUBJECTS
IN CLINICAL RESEARCH
SEC. 131. REQUIREMENT OF INCLUSION IN RESEARCH.
Part G of title IV of the Public Health Service Act,
as amended by section 101 of this Act, is amended by in-
serting after section 492A the following new section:
‘‘INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH
‘‘SEC. 492B. (a) In conducting or supporting clinical
research for purposes of this title, the Director of NIH
shall, subject to subsection (b), ensure that—
‘‘(1) women are included as subjects in each
project of such research; and
‘‘(2) members of minority groups are included
as subjects in such research.
‘‘(b) The requirement established in subsection (a)
regarding women and members of minority groups shall
not apply to a project of clinical research if the inclusion,
as subjects in the project, of women and members of mi-
nority groups, respectively—
‘‘(1) is inappropriate with respect to the health
of the subjects;
‘‘(2) is inappropriate with respect to the pur-
pose of the research; or
‘‘(3) is inappropriate under such other cir-
cumstances as the Director of NIH may designate.
‘‘(c) In the case of any project of clinical research
in which women or members of minority groups will under
subsection (a) be included as subjects in the research, the
Director of NIH shall ensure that the project is designed
and carried out in a manner sufficient to provide for a
valid analysis of whether the variables being tested in the
research affect women or members of minority groups, as
the case may be, differently than other subjects in the
research.
‘‘(d)(1) The Director of NIH, in consultation with the
Director of the Office of Research on Women’s Health,
shall establish guidelines regarding—
‘‘(A) the circumstances under which the inclu-
sion of women and minorities in projects of clinical
research is inappropriate for purposes of subsection
(b);
‘‘(B) the manner in which such projects are re-
quired to be designed and carried out for purposes
of subsection (c), including a specification of the cir-
cumstances in which the requirement of such sub-
section does not apply on the basis of impracticabil-
ity; and
‘‘(C) the conduct of outreach programs for the
recruitment of women and members of minority
groups as subjects in such research.
‘‘(2) With respect to the circumstances under which
the inclusion of women or members of minority groups (as
the case may be) as subjects in clinical research is inap-
propriate for purposes of subsection (b), the guidelines es-
tablished under paragraph (1)(A)—
‘‘(A) shall provide that the costs of such inclu-
sion in a project of clinical research is not a permis-
sible consideration in determining whether such in-
clusion is inappropriate unless the data of com-
parable quality regarding women or members of mi-
nority groups, respectively, that would be obtained in
such project in the event that such inclusion were re-
quired will be obtained through other means; and
‘‘(B) may provide that such inclusion in a
project of clinical research is not required if there is
substantial scientific data demonstrating that there
is no significant difference between—
‘‘(i) the effects that the variables to be
studied in the project have on women or mem-
bers of minority groups, respectively; and
‘‘(ii) the effects that the variables have on
the individuals who would serve as subjects in
the project in the event that such inclusion were
not required.
‘‘(3) The guidelines required in paragraph (1) shall
be established and published in the Federal Register not
later than 120 days after the date of the enactment of
the National Institutes of Health Revitalization Act of
1993.
‘‘(4) For fiscal year 1994 and subsequent fiscal years,
the Director of NIH may not approve any proposal of clin-
ical research to be conducted or supported by any agency
of the National Institutes of Health unless the proposal
specifies the manner in which the research will comply
with subsection (a).
‘‘(e) The advisory council of each national research
institute shall annually submit to the Director of NIH and
the Director of the institute involved a report describing
the manner in which the agency has complied with sub-
section (a).’’.
SEC. 132. PEER REVIEW.
Section 492 of the Public Health Service Act (42
U.S.C. 289a) is amended by adding at the end the follow-
ing new subsection:
‘‘(c)(1) In technical and scientific peer review under
this section of proposals for clinical research, the consider-
ation of any such proposal (including the initial consider-
ation) shall, except as provided in paragraph (2), include
an evaluation of the technical and scientific merit of the
proposal regarding compliance with section 492B(a).
‘‘(2) Paragraph (1) shall not apply to any proposal
for clinical research that, pursuant to subsection (b) of
section 492B, is not subject to the requirement of sub-
section (a) of such section regarding the inclusion of
women and members of minority groups as subjects in
clinical research.’’.
SEC. 133. APPLICABILITY TO CURRENT PROJECTS.
Section 492B of the Public Health Service Act, as
added by section 131 of this Act, shall not apply with re-
spect to projects of clinical research for which initial fund-
ing was provided prior to the date of the enactment of
this Act. With respect to the inclusion of women and mi-
norities as subjects in clinical research conducted or sup-
ported by the National Institutes of Health, any policies
of the Secretary of Health and Human Services regarding
such inclusion that are in effect on the day before the date
of the enactment of this Act shall continue to apply to
the projects referred to in the preceding sentence.
PART II—OFFICE OF RESEARCH ON WOMEN’S
HEALTH
SEC. 141. ESTABLISHMENT.
(a) IN GENERAL.—Title IV of the Public Health
Service Act, as amended by section 2 of Public Law 101–
613, is amended—
(1) by redesignating section 486 as section
485A;
(2) by redesignating parts F through H as
parts G through I, respectively; and
(3) by inserting after part E the following new
part:
‘‘PART F—RESEARCH ON WOMEN’S HEALTH
‘‘SEC. 486. OFFICE OF RESEARCH ON WOMEN’S HEALTH.
‘‘(a) ESTABLISHMENT.—There is established within
the Office of the Director of NIH an office to be known
as the Office of Research on Women’s Health (in this part
referred to as the ‘Office’). The Office shall be headed by
a director, who shall be appointed by the Director of NIH.
‘‘(b) PURPOSE.—The Director of the Office shall—
‘‘(1) identify projects of research on women’s
health that should be conducted or supported by the
national research institutes;
‘‘(2) identify multidisciplinary research relating
to research on women’s health that should be so con-
ducted or supported;
‘‘(3) carry out paragraphs (1) and (2) with re-
spect to the aging process in women, with priority
given to menopause;
‘‘(4) promote coordination and collaboration
among entities conducting research identified under
any of paragraphs (1) through (3);
‘‘(5) encourage the conduct of such research by
entities receiving funds from the national research
institutes;
‘‘(6) recommend an agenda for conducting and
supporting such research;
‘‘(7) promote the sufficient allocation of the re-
sources of the national research institutes for con-
ducting and supporting such research;
‘‘(8) assist in the administration of section
492B with respect to the inclusion of women as sub-
jects in clinical research; and
‘‘(9) prepare the report required in section
486B.
‘‘(c) COORDINATING COMMITTEE.—
‘‘(1) In carrying out subsection (b), the Direc-
tor of the Office shall establish a committee to be
known as the Coordinating Committee on Research
on Women’s Health (hereafter in this subsection re-
ferred to as the ‘Coordinating Committee’).
‘‘(2) The Coordinating Committee shall be com-
posed of the Directors of the national research insti-
tutes (or the designees of the Directors).
‘‘(3) The Director of the Office shall serve as
the chair of the Coordinating Committee.
‘‘(4) With respect to research on women’s
health, the Coordinating Committee shall assist the
Director of the Office in—
‘‘(A) identifying the need for such re-
search, and making an estimate each fiscal year
of the funds needed to adequately support the
research;
‘‘(B) identifying needs regarding the co-
ordination of research activities, including in-
tramural and extramural multidisciplinary ac-
tivities;
‘‘(C) supporting the development of meth-
odologies to determine the circumstances in
which obtaining data specific to women (includ-
ing data relating to the age of women and the
membership of women in ethnic or racial
groups) is an appropriate function of clinical
trials of treatments and therapies;
‘‘(D) supporting the development and ex-
pansion of clinical trials of treatments and
therapies for which obtaining such data has
been determined to be an appropriate function;
and
‘‘(E) encouraging the national research in-
stitutes to conduct and support such research,
including such clinical trials.
‘‘(d) ADVISORY COMMITTEE.—
‘‘(1) In carrying out subsection (b), the Direc-
tor of the Office shall establish an advisory commit-
tee to be known as the Advisory Committee on Re-
search on Women’s Health (hereafter in this sub-
section referred to as the ‘Advisory Committee’).
‘‘(2) The Advisory Committee shall be com-
posed of no fewer than 12, and not more than 18
individuals, who are not officers or employees of the
Federal Government. The Director of the Office
shall make appointments to the Advisory Committee
from among physicians, practitioners, scientists, and
other health professionals, whose clinical practice,
research specialization, or professional expertise in-
cludes a significant focus on research on women’s
health. A majority of the members of the Advisory
Committee shall be women.
‘‘(3) The Director of the Office shall serve as
the chair of the Advisory Committee.
‘‘(4) The Advisory Committee shall—
‘‘(A) advise the Director of the Office on
appropriate research activities to be undertaken
by the national research institutes with respect
to—
‘‘(i) research on women’s health;
‘‘(ii) research on gender differences in
clinical drug trials, including responses to
pharmacological drugs;
‘‘(iii) research on gender differences
in disease etiology, course, and treatment;
‘‘(iv) research on obstetrical and gyne-
cological health conditions, diseases, and
treatments; and
‘‘(v) research on women’s health con-
ditions which require a multidisciplinary
approach;
‘‘(B) report to the Director of the Office
on such research;
‘‘(C) provide recommendations to such Di-
rector regarding activities of the Office (includ-
ing recommendations on the development of the
methodologies described in subsection (c)(4)(C)
and recommendations on priorities in carrying
out research described in subparagraph (A));
and
‘‘(D) assist in monitoring compliance with
section 492B regarding the inclusion of women
in clinical research.
‘‘(5)(A) The Advisory Committee shall prepare
a biennial report describing the activities of the
Committee, including findings made by the Commit-
tee regarding—
‘‘(i) compliance with section 492B;
‘‘(ii) the extent of expenditures made for
research on women’s health by the agencies of
the National Institutes of Health; and
‘‘(iii) the level of funding needed for such
research.
‘‘(B) The report required in subparagraph (A)
shall be submitted to the Director of NIH for inclu-
sion in the report required in section 403.
‘‘(e) REPRESENTATION
OF WOMEN AMONG RE-
SEARCHERS.—The Secretary, acting through the Assist-
ant Secretary for Personnel and in collaboration with the
Director of the Office, shall determine the extent to which
women are represented among senior physicians and sci-
entists of the national research institutes and among phy-
sicians and scientists conducting research with funds pro-
vided by such institutes, and as appropriate, carry out ac-
tivities to increase the extent of such representation.
‘‘(f) DEFINITIONS.—For purposes of this part:
‘‘(1) The term ‘women’s health conditions’, with
respect to women of all age, ethnic, and racial
groups, means all diseases, disorders, and conditions
(including with respect to mental health)—
‘‘(A) unique to, more serious, or more
prevalent in women;
‘‘(B) for which the factors of medical risk
or types of medical intervention are different
for women, or for which it is unknown whether
such factors or types are different for women;
or
‘‘(C) with respect to which there has been
insufficient clinical research involving women as
subjects or insufficient clinical data on women.
‘‘(2) The term ‘research on women’s health’
means research on women’s health conditions, in-
cluding research on preventing such conditions.
‘‘SEC. 486A. NATIONAL DATA SYSTEM AND CLEARINGHOUSE
ON RESEARCH ON WOMEN’S HEALTH.
‘‘(a) DATA SYSTEM.—
‘‘(1) The Director of NIH, in consultation with
the Director of the Office, shall establish a data sys-
tem for the collection, storage, analysis, retrieval,
and dissemination of information regarding research
on women’s health that is conducted or supported by
the national research institutes. Information from
the data system shall be available through informa-
tion systems available to health care professionals
and providers, researchers, and members of the
public.
‘‘(2) The data system established under para-
graph (1) shall include a registry of clinical trials of
experimental treatments that have been developed
for research on women’s health. Such registry shall
include information on subject eligibility criteria,
sex, age, ethnicity or race, and the location of the
trial site or sites. Principal investigators of such
clinical trials shall provide this information to the
registry within 30 days after it is available. Once a
trial has been completed, the principal investigator
shall provide the registry with information pertain-
ing to the results, including potential toxicities or
adverse effects associated with the experimental
treatment or treatments evaluated.
‘‘(b) CLEARINGHOUSE.—The Director of NIH, in
consultation with the Director of the Office and with the
National Library of Medicine, shall establish, maintain,
and operate a program to provide information on research
and prevention activities of the national research institutes
that relate to research on women’s health.
‘‘SEC. 486B. BIENNIAL REPORT.
‘‘(a) IN GENERAL.—With respect to research on
women’s health, the Director of the Office shall, not later
than February 1, 1994, and biennially thereafter, prepare
a report—
‘‘(1) describing and evaluating the progress
made during the preceding 2 fiscal years in research
and treatment conducted or supported by the Na-
tional Institutes of Health;
‘‘(2) describing and analyzing the professional
status of women physicians and scientists of such
Institutes, including the identification of problems
and barriers regarding advancements;
‘‘(3) summarizing and analyzing expenditures
made by the agencies of such Institutes (and by
such Office) during the preceding 2 fiscal years; and
‘‘(4) making such recommendations for legisla-
tive and administrative initiatives as the Director of
the Office determines to be appropriate.
‘‘(b) INCLUSION IN BIENNIAL REPORT OF DIRECTOR
OF NIH.—The Director of the Office shall submit each
report prepared under subsection (a) to the Director of
NIH for inclusion in the report submitted to the President
and the Congress under section 403.’’.
(b) REQUIREMENT OF SUFFICIENT ALLOCATION OF
RESOURCES OF INSTITUTES.—Section 402(b) of the Pub-
lic Health Service Act (42 U.S.C. 282(b)) is amended—
(1) in paragraph (10), by striking ‘‘and’’ after
the semicolon at the end;
(2) in paragraph (11), by striking the period at
the end and inserting ‘‘; and’’; and
(3) by inserting after paragraph (11) the fol-
lowing new paragraph:
‘‘(12) after consultation with the Director of
the Office of Research on Women’s Health, shall en-
sure that resources of the National Institutes of
Health are sufficiently allocated for projects of re-
search on women’s health that are identified under
section 486(b).’’.
Subtitle C—Scientific Integrity
SEC. 151. ESTABLISHMENT OF OFFICE OF SCIENTIFIC IN-
TEGRITY.
(a) IN GENERAL.—Section 493 of the Public Health
Service Act (42 U.S.C. 289b) is amended to read as fol-
lows:
‘‘OFFICE OF SCIENTIFIC INTEGRITY
‘‘SEC. 493. (a) ESTABLISHMENT.—
‘‘(1) IN
GENERAL.—Not later than 90 days
after the date of enactment of this section, the Sec-
retary shall establish an office to be known as the
Office of Scientific Integrity (hereafter referred to in
this section as the ‘Office’), which shall be estab-
lished as an independent entity in the Department
of Health and Human Services.
‘‘(2) DIRECTOR.—The Office shall be headed by
a Director, who shall be appointed by the Secretary,
be experienced and specially trained in the conduct
of research, and have experience in the conduct of
investigations of scientific misconduct. The Sec-
retary shall carry out this section acting through the
Director of the Office. The Director shall report to
the Secretary.
‘‘(b) EXISTENCE OF ADMINISTRATIVE PROCESSES AS
CONDITION OF FUNDING FOR RESEARCH.—The Secretary
shall by regulation require that each entity that applies
for a grant, contract, or cooperative agreement under this
Act for any project or program that involves the conduct
of biomedical or behavioral research submit in or with its
application for such grant, contract, or cooperative agree-
ment assurances satisfactory to the Secretary that such
entity—
‘‘(1) has established (in accordance with regula-
tions which the Secretary shall prescribe) an admin-
istrative process to review reports of scientific mis-
conduct in connection with biomedical and behav-
ioral research conducted at or sponsored by such en-
tity; and
‘‘(2) will report to the Director any investiga-
tion of alleged scientific misconduct in connection
with projects for which funds have been made avail-
able under this Act that appears substantial.
‘‘(c) PROCESS FOR RESPONSE OF DIRECTOR.—The
Secretary shall establish by regulation a process to be fol-
lowed by the Director for the prompt and appropriate—
‘‘(1) response to information provided to the
Director respecting scientific misconduct in connec-
tion with projects for which funds have been made
available under this Act;
‘‘(2) receipt of reports by the Director of such
information from recipients of funds under this Act;
‘‘(3) conduct of investigations, when appro-
priate; and
‘‘(4) taking of other actions, including appro-
priate remedies, with respect to such misconduct.
‘‘(d) MONITORING
BY DIRECTOR.—The Secretary
shall by regulation establish procedures for the Director
to monitor administrative processes and investigations
that have been established or carried out under this sec-
tion.
‘‘(e) EFFECT ON PRESENT INVESTIGATIONS.—Noth-
ing in this section shall affect investigations which have
been or will be commenced prior to the promulgation of
final regulations under this section.’’.
(b) ESTABLISHMENT OF DEFINITION OF SCIENTIFIC
MISCONDUCT.—Not later than 90 days after the date on
which the report required under section 152(d) is submit-
ted to the Secretary of Health and Human Services, such
Secretary shall by regulation establish a definition for the
term ‘‘scientific misconduct’’ for purposes of section 493
of the Public Health Service Act, as amended by sub-
section (a) of this section.
SEC. 152. COMMISSION ON SCIENTIFIC INTEGRITY.
(a) IN GENERAL.—The Secretary of Health and
Human Services shall establish a commission to be known
as the Commission on Scientific Integrity (in this section
referred to as the ‘‘Commission’’).
(b) DUTIES.—The Commission shall develop rec-
ommendations for the Secretary of Health and Human
Services on the administration of section 493 of the Public
Health Service Act (as amended and added by section 151
of this Act).
(c) COMPOSITION.—The Commission shall be com-
posed of 12 members to be appointed by the Secretary
of Health and Human Services from among individuals
who are not officers or employees of the United States.
Of the members appointed to the Commission—
(1) three shall be scientists with substantial ac-
complishments in biomedical or behavioral research;
(2) three shall be individuals with experience in
investigating allegations of misconduct with respect
to scientific research;
(3) three shall be representatives of institutions
of higher education at which biomedical or behav-
ioral research is conducted; and
(4) three shall be individuals who are not de-
scribed in paragraphs (1), (2), or (3), at least one
of whom shall be an attorney and at least one of
whom shall be an ethicist.
(d) REPORT.—Not later than 120 days after the date
of enactment of this section, the Commission shall prepare
and submit to the Secretary of Health and Human Serv-
ices, the Committee on Energy and Commerce of the
House of Representatives, and the Committee on Labor
and Human Resources of the Senate, a report containing
the recommendations developed under subsection (b).
SEC. 153. PROTECTION OF WHISTLEBLOWERS.
Section 493 of the Public Health Service Act, as
amended by section 151 of this Act, is amended by adding
at the end the following new subsection:
‘‘(f) PROTECTION OF WHISTLEBLOWERS.—
‘‘(1) IN GENERAL.—In the case of any entity
required to establish administrative processes under
subsection (b), the Secretary shall by regulation es-
tablish standards for preventing, and for responding
to the occurrence of retaliation by such entity, its of-
ficials or agents, against an employee in the terms
and conditions of employment in response to the em-
ployee having in good faith—
‘‘(A) made an allegation that the entity, its
officials or agents, has engaged in or failed to
adequately respond to an allegation of scientific
misconduct; or
‘‘(B) cooperated with an investigation of
such an allegation.
‘‘(2) MONITORING BY SECRETARY.—The Sec-
retary shall establish by regulation procedures for
the Director to monitor the implementation of the
standards established by an entity under paragraph
(1) for the purpose of determining whether the pro-
cedures have been established, and are being uti-
lized, in accordance with the standards established
under such paragraph.
‘‘(3) NONCOMPLIANCE.—The Secretary shall by
regulation establish remedies for noncompliance by
an entity, its officials or agents, which has engaged
in retaliation in violation of the standards estab-
lished under paragraph (1). Such remedies may in-
clude termination of funding provided by the Sec-
retary for such project or recovery of funding being
provided by the Secretary for such project, or other
actions as appropriate.
‘‘(4) FINAL
RULE
FOR
REGULATIONS.—The
Secretary shall issue a final rule for the regulations
required in paragraph (1) not later than 180 days
‘‘(3) shall, as appropriate, provide for collabora-
tion among such agencies in carrying out such ac-
tivities.
‘‘(d) CERTAIN ACTIVITIES OF PROGRAM.—The Pro-
gram shall include—
‘‘(1) studies with respect to all phases of trau-
ma care, including prehospital, resuscitation, sur-
gical intervention, critical care, infection control,
wound healing, nutritional care and support, and
medical rehabilitation care;
‘‘(2) basic and clinical research regarding the
response of the body to trauma and the acute treat-
ment and medical rehabilitation of individuals who
are the victims of trauma; and
‘‘(3) basic and clinical research regarding trau-
ma care for pediatric and geriatric patients.
‘‘(e) MECHANISMS OF SUPPORT.—In carrying out the
Program, the Director, acting through the Directors of the
agencies referred to in subsection (c)(1), may make grants
to public and nonprofit entities, including designated trau-
ma centers.
‘‘(f) RESOURCES.—The Director shall assure the
availability of appropriate resources to carry out the Pro-
gram, including the plan established under subsection (b)
(including the activities described in subsection (d)).