CHAPTER 12 – National Institutes of Health Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research

Publisher Summary National Institutes of Health (NIH) focused on scientific considerations in constructing its guidelines to meet the congressional mandate requiring the inclusion of women and minorities as subjects in clinical research. Implementation of the inclusion guidelines has supported the emerging field of sex-/gender-based medicine. Outreach efforts to communicate the requirements of this policy have been effective and have promoted continued dialog among investigators, potential volunteers, and their communities. The policy and procedures for implementing the requirements are effectively monitored and revised as science demands. Studies that do not meet the requirements are being properly identified, and administrative procedures allow for timely resolution of problems. Procedures have been developed to monitor and measure inclusion after research awards are made. Appropriate measures have also been instituted to ensure that the requirement to provide valid analysis of differences in intervention effect for NIH-defined phase III trials is being met and to encourage the publication of this information. The most cogent argument in favor of the NIH inclusion policy is the societal cost of continued gaps in scientific knowledge about important health problems that affect both women and men of diverse racial/ethnic groups. Sex and racial/ethnic differences must be appraised when generalizing results to entire populations.