Human Research Protection and Promotion Act of 2000
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.
Referred to the Subcommittee on Health and Environment.