What is required by the 1993 NIH Revitalization Act?
• NIH ensure women and minorities and their subpopulations are included in clinical research; • for clinical trials, women and minorities and their subpopulations are included as subjects. In Phase III clinical trials, they must be included in numbers adequate to allow for valid analyses of differences in intervention effect (See this section; Questions 2 and 3 for further details on analysis plans); • NIH establish guidelines for circumstances under which such inclusion is inappropriate; • cost is not allowed as an acceptable reason for excluding these groups; and, • NIH initiate programs and support for outreach efforts to recruit and retain women and minorities and their subpopulations as participants in clinical studies. Guidelines developed in response to this law were published in the Federal Register in March 1994, and in the NIH Guide for Grants and Contracts in August 2000 and October 2001. NIH will not fund any grant, cooperative agreement or contract or support any intramura
