Women's Health:

NIH Has Increased Its Efforts to Include Women in Research

HEHS-00-96: Published: May 2, 2000. Publicly Released: May 2, 2000.

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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.

GAO noted that: (1) NIH has made significant progress in implementing a strengthened policy on including women in clinical research; (2) NIH issued guidelines to implement the 1993 NIH Revitalization Act and conducted extensive training for scientists and reviewers; (3) the review process for extramural research now treats the inclusion of women and minorities as a matter of scientific merit, which affects a proposal's eligibility for funding, and it appears that NIH staff and researchers are working to ensure that, when appropriate, study findings will apply to both women and men; (4) NIH implemented a centralized inclusion tracking data system that is an important tool for monitoring the implementation of the inclusion policy; (5) NIH has made less progress in implementing the requirement that certain clinical trials be designed and carried out to permit valid analysis by sex, which could reveal whether interventions affect women and men differently; (6) more than 50 percent of the participants in clinical research studies that NIH funded in fiscal year (FY) 1997 were women, according to NIH; (7) minority women were well represented, especially black and Asian and Pacific Islander women, however, the proportion of Hispanic women enrolled was below their proportion in the general population; (8) ORWH has lead responsibility for ensuring that women and minorities are included in clinical research that NIH funds; (9) its budget grew from $9.4 million in FY 1993 to about $20 million in FY 2000; (10) ORWH uses its budget to leverage increased funding for research on women's health by the institutes and centers; (11) it has carried out extensive training and education on the inclusion policy for staff members, investigators, and institutional review boards; (12) however, ORWH has not conducted updated training on the data tracking system to ensure that its data are accurate and consistent; (13) NIH annually reports how much it spends on women's health, men's health, and conditions that affect both women and men; (14) however, the nature of scientific inquiry makes it impossible to predict how research will affect specific populations, especially with regard to the basic research that receives a substantial portion of NIH resources, and GAO found inconsistencies in the methods NIH staff use to produce its expenditure estimates; (15) according to NIH, spending on women's health conditions grew by 39 percent between fiscal years 1993 and 1999; and (16) NIH's total spending on diseases and conditions unique to or more prevalent in women grew more rapidly than NIH's overall spending from FY 1993 to FY 1999.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: National Institutes of Health

  2. Status: Closed - Implemented

    Comments: 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.

    Recommendation: 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.

    Agency Affected: Department of Health and Human Services: Public Health Service: National Institutes of Health


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