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Q: SECTION 1. SHORT TITLE.

This Act may be cited as the ''Human Research Protection and
Promotion Act of 2000''.

SEC. 2. ESTABLISHMENT OF INDEPENDENT OFFICE FOR PROTECTION OF HUMAN
RESEARCH SUBJECTS.

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 RESEARCH SUBJECTS.

''(a) In General.--There is established as an independent
establishment in the executive branch an office to be known as the
Office for Protection of Human Research 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 protection of human
subjects in research conducted, supported, or otherwise subject
to regulation by the Federal Government (in this title referred
to as 'Federal research projects'), including provisions
regarding 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
described in such paragraph that were in effect
on the day before the date of the enactment of
the Human Research Protection and Promotion Act
of 2000, subject to subparagraph (B); and
''(ii) on and after such date of enactment,
the Director of the Office has exclusive
authority to issue regulations for criteria
described in paragraph (1).
''(B) Certain regulations.--Effective on the date
of the enactment of the Human Research 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
Director 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 appropriate
administrative action after October 1, 1999, to provide
that regulations under subsection (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 sentence may be established for a specified
project or for categories of projects, including a category
providing that all Federal research projects of an agency 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 provisions 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 Interagency Committee under section 2803.

''SEC. 2802. INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE 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 receiving reports regarding possible violations and for
taking appropriate action with respect to such violations.
''(b) Certain Institutional Review Boards.--Any board that, on the
day before the date of the enactment 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 Coordinating Committee on
Protection of Human Research Subjects (in this title referred to as the
'Interagency Committee').
''(b) Duties.--The Interagency Committee shall develop
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 Committee 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 Congress.--
''(1) In general.--Not later than one year after the date
of the enactment of the Human Research Protection and Promotion
Act of 2000, the Interagency Committee--
''(A) shall complete a review of regulations under
section 2801(b), including a review of--
''(i) regulations deemed to have been
promulgated by the Director of the Office
pursuant to section 2801(b)(2)(B); and
''(ii) the exemptions referred to in
section 2801(c)(3);
''(B) shall make such recommendations regarding the
regulations as the Interagency Committee determines to
be appropriate; and
''(C) shall submit to the congressional committees
specified in paragraph (2) a report describing the
activities carried out under subparagraph (A) and any
recommendations regarding such regulations.
''(2) Congressional committees.--The congressional
committees referred to in paragraph (1)(C) are the Committee on
Commerce and the Committee on Government Reform in the House of
Representatives, and the Committee on Health, Education, Labor, and
Pensions in the Senate.

''SEC. 2804. CERTAIN ADMINISTRATIVE AUTHORITIES.

''In carrying out this title, the Director of the Office--
''(1) may appoint and fix the compensation of officers and
employees for the Office in accordance with chapter 51 of title
5, United States Code, and subchapter III of chapter 53 of such
title;
''(2) may acquire, without regard to the Act of March 3,
1877 (40 U.S.C. 34), by lease or otherwise through the
Administrator of General Services, buildings or portions of
buildings in the District of Columbia or communities located
adjacent to the District of Columbia for use for a period not
to exceed 10 years;
''(3) may enter into contracts, subject to the availability
of amounts made available in appropriations Act, including
contracts for financial and administrative services (such as
budget and accounting, financial reporting, personnel, and
procurement) with the General Services Administration, or such
other Federal agencies as the Director of the Office determines
to be appropriate;
''(4) may use, with their consent, the services, equipment,
personnel, information, and facilities of other Federal, State,
or local public agencies, with or without reimbursement;
''(5) may in accordance with section 3109 of title 5,
United States Code, obtain the assistance and advice of experts
and consultants; and
''(6) may accept voluntary and uncompensated services.

''SEC. 2805. DEFINITIONS.

For purposes of this title:
''(1) The term 'agency' has the meaning given the term
'Executive agency' in section 105 of title 5, United States
Code.
''(2) The term 'by regulation' refers to rulemaking in
accordance with the procedures described in section 553 of
title 5, United States Code, for substantive rules (including
notice and comment procedures).
''(3) The term 'covered Federal agency' means a Federal
agency described in section 2801(c)(1).
''(4) The term 'Federal research projects' has the meaning
indicated for such term in section 2801(b)(1).
''(5) The term 'Interagency Committee' has the meaning
indicated for such term in section 2803(a).
''(6) The term 'Office' has the meaning indicated for such
term in section 2801(a).''.

SEC. 3. CONFORMING PROVISIONS.

(a) Repeal.--Section 491 of the Public Health Service Act (42
U.S.C. 289) is repealed.
(b) Rule of Construction.--With respect to a covered Federal agency
as defined in title XXVIII of the Public Health Service Act, as added
by the amendment made by section 2--
(1) such amendment does not terminate any office or other
administrative unit in such an agency that before the date of
the enactment of this Act was established with respect to the
protection of human subjects in research conducted, supported,
or otherwise subject to regulation by the Federal Government;
and
(2) on and after the date of the enactment of this Act such
an office or unit has only such duties as may be assigned by
the Director of the Office for Protection of Human Research
Subjects under such title XXVIII, after consultation with the
head of the agency within which the office or unit is
established, and the Director may terminate the office or unit,
after consultation with such agency head.
A:
Requires the Office Director to establish criteria by regulation for the protection of human subjects in research conducted, supported, or otherwise subject to regulation by the Federal Government (Federal research projects). Provides that in the case of covered agencies: (1) such regulations supersede all regulations for such criteria that were in effect before this Act's enactment date; and (2) the Director has exclusive authority to issue such regulations after such date. Deems current regulations to have been promulgated by the Director and authorizes their continuation or modification by the Director.
Applies such regulations to each Federal agency that: (1) as of October 1, 1999, was subject to the basic policy under current regulations for protection of human research subjects; and (2) takes appropriate administrative action after such date to provide that regulations under this Act apply to the agency. Authorizes the Director to exempt any Federal research project from such regulations. Continues exemptions under current regulations unless modified by the Director. Applies the following provisions under existing regulations to Federal research projects of an agency that currently is not subject to such provisions only to projects that are approved after this Act's enactment date: (1) additional protections pertaining to research, development, and related activities involving fetuses, pregnant women, and human in vitro fertilization; (2) additional protections pertaining to biomedical and behavioral research involving prisoners as subjects; and (3) additional protections pertaining to children as research subjects.
Sets forth provisions similar to those under existing law that require entities applying to carry out Federal research projects to establish institutional review boards, but replaces the authority of the Secretary of Health and Human Services with that of the Director. Continues the existence of current institutional review boards that meet this Act's requirements.
Requires the Director to establish an Interagency Coordinating Committee on Protection of Human Research Subjects to develop recommendations on carrying out this Act, review regulations, and report to specified congressional committees.
Provides that, after this Act's enactment, any office or unit within an agency that was established for the protection of human research subjects in Federal research has only such duties as may be assigned by the Director and authorizes the Director to terminate such office or unit.