United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office Health, Education, and Human Services Division author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 2000-05-02 monographic deposited born digital GA 1.13:HEHS-00-96 https://www.govinfo.gov/app/details/GAOREPORTS-HEHS-00-96 P0b002ee1803a0007 f:he00096 DGPO 2010-08-12 2011-03-24 GAOREPORTS-HEHS-00-96 machine generated eng fdlp REPORT GAOREPORTS-HEHS-00-96 HEHS-00-96 Research grants Health research programs Medical research Health statistics Women Minorities Letter Report HEHS 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.<p/>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. https://www.govinfo.gov/content/pkg/GAOREPORTS-HEHS-00-96/html/GAOREPORTS-HEHS-00-96.htm GAO/HEHS-00-96 https://www.govinfo.gov/app/details/GAOREPORTS-HEHS-00-96 Letter Report GAO/HEHS-00-96; Women's Health: NIH Has Increased Its Efforts to Include; Research grants Health research programs Medical research Health statistics Women Minorities Public Law 103-43