NIH guidelines encourage investigators to actively recruit women and minorities into their trials in order to assure that adequate numbers are included in clinical research. These groups must be included in such a way that valid analyses of differences can be accomplished, especially in Phase III clinical trials. Outreach programs are recommended, and cost is not an acceptable reason to exclude underrepresented groups. Inclusion requirements to not apply if they are inappropriate with respect to the subjects' health or the purpose of the research, or other circumstances as designated by federal agencies. They do not apply if there is substantial evidence that there are no differences in the study variables or treatment effects.
Clinical research includes any biomedical or behavioral research in human subjects.
The HIC requires that clinical research protocols include adequate representation of women. Specifically, there should be approximately equal numbers of both sexes in populations at risk unless different proportions are appropriate because of known prevalence, incidence, morbidity, mortality rates, or expected intervention effect. Such exceptions should be described in the protocol as part of the justification for any apparent gender inequity. The rationale must be scientifically based. The HIC requires that clinical research protocols include adequate representation of minorities, including their sub-populations.