Abstract
Inclusion of women and members of racial and ethnic minority groups in NIH-supported clinical research is dictated by ethical and scientific reasons. The historical exclusion of women and minority groups from clinical trials became recognized as unjust. The advances in research methods, knowledge and the growth of the women’s health and other advocacy movements made it evident that exclusion of any subgroup is inappropriate. NIH-funded clinical research must have an inclusion plan, and for Phase III trials a plan to analyze data for sex/gender and racial/ethnic differences. Inclusion policies, which have the force of law, have resulted in changes in clinical research practices and in the advancement of knowledge about health and diseases of women, and in sex, racial and ethnic differences in risk factors, symptoms, diagnostic methods, and treatment.
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