Outreach Notebook for the NIH Guidelines on Inclusion of Women and Minorities asSubjects in Clinical Research

摘要

The Director of NIH, in consultation with the Director of the Office of Researchon Women's Health and the Director of the Office of Research on Minority Health, shall conduct or support outreach programs for the recruitment of women and members of minority groups as subjects in projects of clinical research. The goal of this legislation is to increase the opportunities for obtaining critically important information with which to enhance health and treat disease among all Americans-and to detect and account for significant differences between genders or racial and ethnic groups where they exist. As part of its campaign to integrate these new guidelines into the biomedical and behavioral research infrastructure, the NIH has developed this notebook, a primer, outlining key issues in the recruitment and retention of individuals into studies. The suggestions presented in this notebook are not requirements that must be incorporated into research applications/proposals. They are presented to provide guidance to investigators and their research teams as they consider the scientific question(s), study design, and methods to facilitate appropriate enrollment of study participants.