HOW THE NEW NIH GUIDELINES ON INCLUSION OF WOMEN AND MINORITIES APPLY- EFFICACY TRIALS, EFFECTIVENESS TRIALS, AND VALIDITY

The NIH (National Institutes of Health) Guidelines on the Inclusion of women and Minorities as Subjects in Clinical Research requires invest igators applying for NIH research funds to develop and, if funded, imp lement plans for the inclusion of women and minority populations in th eir research, when that research involves human participants. It is th e purpose of this article to help investigators understand (a)the scie ntific context and rationale behind the NIH Guidelines; (b) the NIH-de fined concepts and the specific content of the NIH Guidelines; and (c) how the intent of the NIH Guidelines is related to mental health serv ices research, the most applied area of mental health research. The ar ticle also discusses where investigators can find additional informati on as they work to implement the NIH Guidelines.