A bill to amend the Public Health Service Act to require that, as appropriate, women and members of minority groups be included as subjects in clinical research conducted under the Act.
Clinical Trials Fairness Act - Amends provisions of the Public Health Service Act relating to the national research institutes and provisions relating to the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) to direct the Secretary of Health and Human Services to ensure, in conducting or supporting clinical research, that women and minority groups are included as research subjects, unless inappropriate. Requires that any project be designed and carried out so as to provide for a valid analysis of whether the research variables affect women or minorities differently than other subjects.
Directs the Secretary to establish within the advisory council of each agency of an institute and ADAMHA a Clinical Research Equity Subcommittee to review all clinical research of that agency to determine whether the research is being conducted in accordance with requirements of this Act. Provides for suspension or revocation of the authority for any project the Secretary determines is not being conducted in accordance with those requirements. Defines "minority groups" to mean racial and ethnic minority groups.
Requires that the technical and scientific peer review process in the institutes and ADAMHA include an evaluation of the inclusion of women and minority groups as research subjects.
Introduced in Senate
Read twice and referred to the Committee on Labor and Human Resources.
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