National Institutes of Health:

Problems in Implementing Policy on Women in Study Populations

T-HRD-90-38: Published: Jun 18, 1990. Publicly Released: Jun 18, 1990.

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GAO discussed the National Institutes of Health's (NIH) progress in implementing its policy to encourage the inclusion of women in study populations. GAO found that: (1) the policy on women has not been well communicated or understood within NIH or the research community; (2) there were inconsistencies in how NIH has applied the policy in a key stage of the grant review process; (3) NIH policy on women applies only to extramural research, and the smaller intramural research program has no policy; and (4) although the original policy announcement encouraged researchers to analyze study results by gender, NIH officials have taken little action to implement this element of the policy.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: NIH staff and reviewers received training about the policy in fall 1990. Training will occur annually for new staff. The Acting Director, NIH, addressed the Institutes' advisory councils. A revised policy appeared in the NIH Guide to Grants and Contracts on August 24, 1990 and February 8, 1991, and will appear every 6 months. Grant application forms were revised and approved by OMB.

    Recommendation: To ensure effective implementation of its policy to encourage the inclusion of women in study populations, the Director, NIH, should inform NIH staff, grant reviewers, and the community of researchers NIH supports of the reasons for the policy and how it should be carried out.

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

  2. Status: Closed - Implemented

    Comments: NIH has implemented its system for tracking participation of women in study populations. Data will be readily accessible from NIH institutes.

    Recommendation: To ensure effective implementation of its policy to encourage the inclusion of women in study populations, the Director, NIH, should direct NIH institutes to maintain readily accessible data to allow assessment of the extent to which women are included in studies.

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

  3. Status: Closed - Implemented

    Comments: NIH completed the revision of PHS Form 398, which includes information about the policy. The revised form was approved by OMB and the booklet was published in January 1992.

    Recommendation: To ensure effective implementation of its policy to encourage the inclusion of women in study populations, the Director, NIH, should ensure that the planned revision of the grant application booklet adds a section explaining the policy and instructing applicants to respond to the requirement to include women in study populations, or to justify their exclusion.

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

  4. Status: Closed - Implemented

    Comments: Reviewers are now instructed to consider the gender make-up of the proposed study population when evaluating grant applications. Executive secretaries are responsible for ensuring that this issue is addressed, and deliberations on gender issues are documented in the summary statement.

    Recommendation: To ensure effective implementation of its policy to encourage the inclusion of women in study populations, the Director, NIH, should instruct members of review groups always to determine whether the gender of the study population is an issue of scientific merit affecting the priority score, and to document their decisions in the summary statements.

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

 

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