Women's Health: NIH Has Increased Its Efforts to Include Women in Research: HEHS-00-96.

The National Institutes of Health (NIH) has made significant progress toward the goal of including women and minorities in research. For the policy to have its intended effect, however, NIH needs to expand its focus beyond simple inclusion and to ensure that, when it is scientifically appropriate, researchers conducting clinical trials enroll populations and analyze study data in ways that enable them to learn whether interventions affect women and men differently. NIH staff, peer reviewers, and advisory council members should carry out this dimension of the inclusion policy as conscientiously as they attend to its other components. For example, when NIH initiates a phase III clinical trial through a request for application or proposal, unless NIH officials have determined that this particular trial is exempt from the requirement, the request should inform the applicants that they should design the trial to allow for a valid analysis of differences between women and men. As reviewers examine each application to receive funding for a phase III clinical trial, they need to explicitly consider whether the study should be structured to allow for analysis by sex. Also, NIH's tracking system is an important tool for monitoring the implementation of the inclusion policy, and the system is beginning to capture more information, such as enrollment targets, that will help assess the policy's success. NIH's recent steps to improve the system and move toward increased electronic reporting should help improve the accuracy and the timeliness of the data and improve the system's ability to measure progress. However, follow-up training on the requirements and the purpose of the tracking system is needed. Finally, NIH's data on spending on women's health must be interpreted with care. Determining which expenditures affect women's health is so complex and imprecise that it is easy to overstate or understate the extent of NIH's efforts. The nature of scientific inquiry makes it impossible to predict all the effects of research, and this is especially true for the basic research that makes up a large part of NIH's portfolio. [ABSTRACT FROM AUTHOR]

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