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 Funded in Fiscal Year 2000 (Reported in FY 2000) and Fiscal Year 2001 (Reported in

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 women=s health movement. Following the issuance of the report of the Public Health Service Task Force on Women=s 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 July 1989, an NIH Memorandum on Inclusion stated that research solicitations should encourage inclusion of women and minorities and require a rationale if excluded, and that executive secretaries of scientific review groups should ensure that responsiveness to policy would be addressed and indicated in summary statements. In 1990, the Congressional Caucus for Women=s Issues requested the U.S. General Accounting Office (GAO) to conduct an investigation into the implementation of the guidelines for the inclusion of women by NIH. This report, in Congressional testimony, indicated that the implementation of the policy for the inclusion of women was slow, not well communicated, that gender analysis was not implemented, and that the impact of this policy could not be determined. The GAO testimony also indicated that there were differences in the implementation of the policy recommending the inclusion of minorities, and that not all Institutes and Centers (ICs) factored adherence to these policies into the scientific merit review.