Outreach Notebook for the Inclusion, Recruitment and Retention of Women and Minority Subjects in Clinical Research. Principal Investigators' Notebook

摘要

In order to ensure that the policies for inclusion were firmly implemented by NIH, Congress enacted these policies into Public Law through a section in the NIH Revitalization Act of 1993 (PL 103-43), entitled Women and Minorities as Subjects in Clinical Research. In 1994, the NIH revised its inclusion policy to meet this mandate that women and minorities must be included in all of its clinical research studies. PL 103-43 essentially reinforced the existing NIH policies, but with four major differences. The new law requires that: (1) NIH ensure that women and minorities and their subpopulations be included in all human subject research; (2) women and minorities and their subpopulations be included in Phase III clinical trials in numbers adequate to allow for valid analyses of differences in intervention effect; (3) cost is not allowed as an acceptable reason for excluding these groups; and, (4) NIH initiate programs and support for outreach efforts to recruit and retain women and minorities and their subpopulations as volunteers in clinical studies.