What is sufficient and appropriate representation of women and minorities?
Ideally, women and minorities in the study population are in the same proportions as in the U.S. population having the disease entity being studied. If prevalence is unknown, the NHLBI standard for evaluation of the proposed study population is the composition of the population of the United States which, according to the 2010 census, is 51% women and 30% minorities. However, there are acceptable justifications for a study population that does not meet these criteria. (See answers to questions 4-6 below and Section II [subsection on exclusions] in the NIH Guidelines). • Question: Does the policy permit a study population that contains only one gender or minority group or subpopulation? Answer: If a study of only one gender or minority group or subpopulation is proposed, there must be a scientific justification for limiting the diversity of the study population, such as high prevalence of the condition, unique disease characteristics, or gaps in knowledge in the select population. The r
