Can you design a clinical research study/respond to a contract solicitation that includes only one sex and/or one racial/ethnic group or subpopulation?
YES. If you propose a study of only one sex or racial/ethnic group (or subpopulation), you must have a scientific justification for limiting the diversity of your study population, such as high prevalence of the condition, unique disease characteristics, or gaps in knowledge in the selected population. In this case, you must justify why your study has a limited target population and provide in your application information or reference to any published reports about ongoing studies that address the appropriate diversity.
