In order to improve gender and ethnic diversity in health intervention research, the NIH Revitalization Act of 1993, Public Law 103-43, requires recruitment of women and minorities and their subpopulations in all clinical research studies, especially clinical trials.  Guidelines include:

• Ensure that women and members of minorities and their subpopulations be included in all human subject research



• For phase 3 clinical trials, ensure that women and minorities and their subpopulations be included so that valid analyses of differences in intervention effects can be accomplished



• Not allow cost as an acceptable reason for excluding these groups



• Initiate programs and support for outreach effects to recruit these groups into clinical studies

This section presents the typical challenges for the research team in its effort to recruit and retain women and minorities in clinical trials, and strategies to overcome these challenges.

Use the "Challenges" link to proceed.