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Since 2001, the NIH has established the policy that "women and members of minority groups and their subpopulations" are required to be included on all NIH funded clinical research unless there is a clear justification. A more diverse sample of participants in clinical trials ensures that findings are more generalizable to the entire population. Amendments have been made to the initial policy. Review the links below for additional information on NIH and Diversity policies.

Initial policy on diversity in clinical trials
Requirement for Phase III Clinical Trials and submission of demographic data
FDA draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies