NIH Revitalization Act of 1993
The NIH Revitalization Act of 1993, Public Law 103-43, was enacted on June 10, 1993, by the 103rd U.S. Congress. This act significantly expanded and revised the programs of the National Institutes of Health (NIH) with a key aim to ensure the inclusion of women and minorities in clinical research.
Key Provisions
Inclusion of Women and Minorities
- Mandated inclusion of women and minorities in NIH-funded clinical research to ensure research is applicable to all demographic groups.
- Guidelines for inclusion were to be developed within 180 days of the Act's enactment.
Research Integrity and Ethics
- Establishment of the Office of Research Integrity within the Department of Health and Human Services.
- Provisions for protecting whistleblowers and managing conflicts of interest.
Establishment of Offices
- Creation of the Office of Research on Minority Health.
- Creation of the Office of Behavioral and Social Sciences Research at NIH.
Impact and Implementation
Clinical Trial Enrollment
- Despite mandates, challenges in achieving proportional representation in clinical trials persist.
- Disproportionate participation rates of minorities in cancer research noted.
Policy Enforcement
- NIH required to ensure research proposals include plans for demographic inclusion.
- Inconsistent compliance in reporting and analysis by demographic groups.
Long-term Effects
- Influenced future health policy and research practices, including the 2016 Sex as a Biological Variable Act.
Legacy and Future Directions
- The 30th anniversary in 2023 highlighted both successes and areas for improvement in health equity research.