Human Research Protection and Promotion Act of 2000

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.

Summary: 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 . 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.