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Highlights

Pursuant to a congressional request, GAO provided information on the National Institutes of Health's (NIH) efforts to include women in clinical research, focusing on: (1) the extent to which women are being included in clinical research that NIH funds; (2) the activities and accomplishments of the NIH Office of Research on Women's Health (ORWH) in promoting women's health research at NIH; and (3) how much funding NIH has allocated to research on health issues that affect women.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
National Institutes of Health 1. To strengthen the capacity of biomedical research to produce information on health applicable to all segments of the population, the Director, NIH, should ensure that the agency implements the requirement that phase III clinical trials be designed and carried out to allow for the valid analysis of differences between women and men as fully as it implements other elements of the inclusion policy. Specifically, NIH should appropriately communicate this requirement to applicants, that peer review groups explicitly determine whether each proposed phase III clinical trial is required to have such a study design, and that summary statements document the initial reviewers' decisions.
Closed - Implemented
NIH released revised guidelines on the inclusion of women and minorities in clinical research. These guidelines update and provide further guidance on planning, conducting, and reporting the analysis of sex/gender and/or race/ethnicity differences in the intervention effect in NIH Phase III clinical trials. NIH also developed a new term and condition of award statement for Phase III clinical trials that requires that a description of plans to conduct analyses, as appropriate, by sex/gender and/or racial/ethnic groups be included in clinical trial protocols; and the results of the subset analyses be reported to NIH in Progress Reports, Competitive Renewal applications (or contract renewals/extensions), and in the required Final Progress Report. NIH is developing guidelines and instructions for reviewers and scientific review administrators that will (1) clarify the need to review Phase III clinical trial proposals for both inclusion requirements and proposed analyses by sex/gender, and (2) provide guidance on proper documentation of the review. NIH also plans to provide training to program and review officials and grants and contracts management staff to ensure compliance with the policy requirements on the analysis of sex/gender and/or race/ethnicity differences in intervention effect.
National Institutes of Health 2. To improve the accuracy of NIH's tracking data on the inclusion of women and minorities, the Director, NIH, should ensure that NIH staff who transmit data to the tracking system receive ongoing training on the requirements and purpose of the system.
Closed - Implemented
In May 2002, NIH deployed a new electronic database for grant review, management, and administration, including a computerized system for standardizing and collecting inclusion data. NIH has conducted several training efforts to assist staff in using the new system. In January 2002, NIH conducted and archived a videocast training session on the updated policies and procedures on sex/gender and minority inclusion. The session was mandatory for all NIH program, grants management, and review staff involved in the administration of clinical research. A comprehensive training manual explaining the new policies and procedures was developed as a training resource and remains available electronically for all NIH staff. In May 2002, NIH provided a second session for the Center for Scientific Review that highlighted the issues and requirements for scientific review staff. Also in May 2002, NIH published an on-line users guide and offered 2-hour demonstrations of the system. To date, 10 such sessions have been conducted, with one archived for subsequent staff training. Since July 2002, an additional eight 3-hour, in-depth, hands-on training sessions have been provided. The training materials for this course will be available electronically in mid-September, and additional demonstration and hands-on training sessions will be offered in fall 2002, and winter 2003.

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