Monitoring Adherence to the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research. Comprehensive Report: Tracking of Human Subjects Research as Reported in Fiscal Year 2009 and Fiscal Year 2010

摘要

The establishment and implementation of policies for the inclusion of women and minorities in clinical research funded by the National Institutes of Health (NIH) has its origins in the womens health movement. Following the issuance of the report of the Public Health Service Task Force on Womens Health in 1985, the NIH established a policy in 1986 for the inclusion of women in clinical research. This policy, which urged the inclusion of women, was first published in the NIH Guide to Grants and Contracts in 1987. Later that year, minority and other scientists at the NIH recognized the need to address the inclusion of minority populations. Therefore, in a later 1987 version of the NIH guide, a policy encouraging the inclusion of minorities in clinical studies was first published. In order to ensure that the policies for inclusion were firmly implemented by NIH, the Congress made what had previously been policy 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, NIH revised its inclusion policy to be in compliance with the statutory language. The Revitalization Act essentially reinforced the existing NIH policies, but with four major differences: that NIH ensure that women and minorities and their subpopulations be included in all clinical research; that 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; that cost is not allowed as an acceptable reason for excluding these groups; and, that NIH initiate programs and support for outreach efforts to recruit and retain women and minorities and their subpopulations as participants in clinical studies.