When submitting an application for IRB review, the investigator should note whether all potential participants will be recruited without regard to gender, race, and/or ethnicity.
The inclusion of women and minority groups and their subpopulations in research is important, both to ensure that they receive an appropriate share of the benefits of research and that they do not bear a disproportionate burden. To the extent that participation in research offers direct benefits to the participants, under-representation of men, women or minority groups denies them the opportunity for benefit. Moreover, for purposes of generalizing research results, investigators must include the widest possible range of population groups. When scientifically appropriate, investigators should cite evidence or lack of evidence if a health situation or intervention in the proposed research may affect one gender or minorities and their subpopulations differently and describe how the proposed research addresses that evidence. Investigators should be prepared to describe the extent to which both genders and persons of various ethnic and racial backgrounds are or have been involved in similar research.