I
106TH CONGRESS
2D SESSION
H. R. 3569
To amend the Public Health Service Act to establish an independent office
to be known as the Office for Protection of Human Research Subjects,
and to assign to such Office responsibility for administering regulations
regarding the protection of human subjects in Federal research projects.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY 2, 2000
Mr. KUCINICH (for himself, Mr. TOWNS, Mr. LATOURETTE, Mr. WAXMAN,
and Mr. SANDERS) introduced the following bill; which was referred to
the Committee on Commerce
A BILL
To amend the Public Health Service Act to establish an
independent office to be known as the Office for Protec-
tion of Human Research Subjects, and to assign to such
Office responsibility for administering regulations regard-
ing the protection of human subjects in Federal research
projects.
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 Pro-
tection and Promotion Act of 2000’’.
SEC. 2. ESTABLISHMENT OF INDEPENDENT OFFICE FOR
PROTECTION OF HUMAN RESEARCH SUB-
JECTS.
The Public Health Service Act (42 U.S.C. 201 et
seq.) is amended by adding at the end the following:
‘‘TITLE XXVIII—PROTECTION OF HUMAN
RESEARCH SUBJECTS
‘‘SEC. 2801. OFFICE FOR PROTECTION OF HUMAN RE-
SEARCH SUBJECTS.
‘‘(a) IN GENERAL.—There is established as an inde-
pendent establishment in the executive branch an office
to be known as the Office for Protection of Human Re-
search Subjects (in this title referred to as the ‘Office’),
which shall be headed by a director appointed by the
President.
‘‘(b) PROTECTION OF SUBJECTS.—
‘‘(1) IN GENERAL.—The Director of the Office
shall by regulation establish criteria for the protec-
tion of human subjects in research conducted, sup-
ported, or otherwise subject to regulation by the
Federal Government (in this title referred to as
‘Federal research projects’), including provisions re-
garding the informed consent of individuals to serve
as such subjects.
‘‘(2) REGULATIONS.—
‘‘(A) IN GENERAL.—In the case of covered
Federal agencies under subsection (c)—
‘‘(i) regulations promulgated under
paragraph (1) by the Director of the Office
supersede all regulations for criteria de-
scribed in such paragraph that were in ef-
fect on the day before the date of the en-
actment of the Human Research Protec-
tion and Promotion Act of 2000, subject to
subparagraph (B); and
‘‘(ii) on and after such date of enact-
ment, the Director of the Office has exclu-
sive authority to issue regulations for cri-
teria described in paragraph (1).
‘‘(B) CERTAIN
REGULATIONS.—Effective
on the date of the enactment of the Human Re-
search Protection and Promotion Act of 2000,
all provisions of part 46 of title 45, Code of
Federal Regulations, are deemed to have been
promulgated under paragraph (1) by the Direc-
tor of the Office. Subject to subsection (c), such
provisions continue to be in effect, and such
provisions may be modified by the Director of
the Office by regulation.
‘‘(c) APPLICABILITY OF REGULATIONS.—
‘‘(1) COVERED FEDERAL AGENCIES.—Except as
provided in paragraphs (2) through (4), regulations
under subsection (b) apply—
‘‘(A) to each Federal agency that, as of
October 1, 1999, was subject to the policy
under subpart A of part 46 of title 45, Code of
Federal Regulations (including Federal agencies
that, pursuant to section 101(a) of such part,
were subject to such policy by reason of having
taken appropriate administrative action); and
‘‘(B) to each Federal agency that takes ap-
propriate administrative action after October 1,
1999, to provide that regulations under sub-
section (b) apply to the agency.
‘‘(2) EXEMPTIONS.—The Director of the Office
may by regulation exempt any Federal research
project from the applicability of regulations under
subsection (b). Exemptions under the preceding sen-
tence may be established for a specified project or
for categories of projects, including a category pro-
viding that all Federal research projects of an agen-
cy are exempt.
‘‘(3) OTHER
EXEMPTIONS.—The exemptions
described in section 46.101(b) of title 45, Code of
Federal Regulations, as of the date of the enactment
of the Human Research Protection and Promotion
Act of 2000 continue to be in effect unless modified
by the Director of the Office.
‘‘(4) CERTAIN REGULATIONS.—In the case of a
covered Federal agency that, as of the date of the
enactment of the Human Research Protection and
Promotion Act of 2000, was not subject to the provi-
sions of subparts B through D of part 46 of title 45,
Code of Federal Regulations, the applicability of
such provisions to Federal research projects of the
agency pursuant to paragraph (1) is subject to the
condition that such provisions apply only to Federal
research projects of the agency that are approved on
or after such date of enactment.
‘‘(d) CONSULTATIONS.—In making any modifications
to regulations under subsection (b), the Director of the
Office shall consult with the other members of the Inter-
agency Committee under section 2803.
‘‘SEC. 2802. INSTITUTIONAL REVIEW BOARDS; ETHICS GUID-
ANCE PROGRAM.
‘‘(a) IN GENERAL.—In carrying out section 2801(b),
the Director of the Office shall comply with the following:
‘‘(1) The Director shall require that each entity
that applies to carry out a Federal research project
under a grant, contract, or cooperative agreement
from a covered Federal agency submit in or with its
application for such grant, contract, or cooperative
agreement assurances satisfactory to the Director
that the entity has established a board, to be known
as an Institutional Review Board, to review such
projects at or supported by the entity in order to
protect the rights of the human subjects in such
projects.
‘‘(2) The Director shall establish a program
under which requests for clarification and guidance
with respect to ethical issues raised in connection
with Federal research projects are responded to
promptly and appropriately.
‘‘(3) The Director shall establish a process for
the prompt and appropriate response to information
provided to any Federal agency regarding violations
of the rights of human subjects in Federal research
project. The process shall include procedures for re-
ceiving reports regarding possible violations and for
taking appropriate action with respect to such viola-
tions.
‘‘(b) CERTAIN INSTITUTIONAL REVIEW BOARDS.—
Any board that, on the day before the date of the enact-
ment of the Human Research Protection and Promotion
Act of 2000, was considered to be an Institutional Review
Board under section 491(a) of this Act (as in effect on
such day) shall be considered to be an Institutional Review
Board that meets the requirements of subsection (a) of
this section unless notified otherwise by the Director of
the Office.
‘‘SEC. 2803. INTERAGENCY COORDINATING COMMITTEE.
‘‘(a) IN GENERAL.—The Director of the Office shall
establish a committee to be known as the Interagency Co-
ordinating Committee on Protection of Human Research
Subjects (in this title referred to as the ‘Interagency Com-
mittee’).
‘‘(b) DUTIES.—The Interagency Committee shall de-
velop recommendations on carrying out this title, including
recommendations on coordinating the administration of
regulations under section 2801(b) at the various Federal
agencies with responsibilities regarding Federal research
projects.
‘‘(c) COMPOSITION; CHAIR.—The Interagency Com-
mittee shall be composed of the Director of the Office and
the heads of covered Federal agencies (or the designees
of the Director of the Office and the agency heads). The
Director of the Office (or the designee of the Director)
shall serve as the chair of the Interagency Committee.
‘‘(d) REVIEW OF REGULATIONS; REPORT TO CON-
GRESS.—