Recommendation: The Director of NIH should establish and implement a policy requiring all FACA committees under NIH's jurisdiction to post meeting minutes online. (Recommendation 6)

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

Comments: When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendation: The Director of the National Institutes of Health should fully develop and implement a mechanism to ensure researcher compliance with the public access plan and associated requirements. (Recommendation 25)

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

Comments: The National Institutes of Health concurred with this recommendation but stated that the agency already had mechanisms in place to ensure compliance with public access plan and associated requirements for publications and data. As discussed in the report, we believe our recommendation, as worded, appropriately reflected the extent to which the agency had implemented researcher compliance mechanisms at the time of issuance of our report. When we confirm what actions the agency has taken in response to the recommendation, we will provide updated information.

Recommendation: As the Subcommittee on Open Science moves forward, the National Institutes of Health co-chair, in coordination with other co-chairs and participating agencies, should take steps to fully implement leading practices that enhance and sustain collaboration. (Recommendation 35)

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

Comments: NIH concurred with GAO's November 2019 recommendation. NIH stated that the subcommittee and its working groups are actively coordinating and building consensus on issues and processes to implement leading practices that enhance and sustain collaboration across federal agencies. In March 2020, the Office of Science and Technology Policy provided information on steps the subcommittee has taken to address issues associated with public access to federally funded research results, including certain areas GAO identified as presenting challenges to public access plan implementation in the November 2019 report. GAO will collect and evaluate additional information to determine the extent to which these steps incorporate leading practices for interagency collaboration GAO has identified. By taking steps to fully implement the relevant leading practices we have identified, the subcommittee and its member agencies could better marshal their collective efforts to address common public access plan implementation challenges that agency officials and stakeholders identified.

Recommendation: As NIH-DFAS begins formalizing its internal guidance, the Director of NIH-DFAS should establish a mechanism for tracking key milestones in the indirect cost rate-setting process, such as when indirect cost rate proposals are due.

Agency: Department of Health and Human Services: Public Health Service: National Institutes of Health: Office of Management: Office of Acquisition and Logistics Management: Office of Acquisition Management and Policy: Division of Financial Advisory Services
Status: Open

Comments: HHS concurred with this recommendations. In response, HHS stated that National Institute of Health's Division of Financial Advisory Services (DFAS) will establish a mechanism for tracking key milestones in the indirect cost rate-setting process. NIH-DFAS has initiatives underway that include moving from paper to electronic submissions of indirect cost proposals and developing a replacement to its Commercial Rate Agreement Distribution Services website. DFAS is looking into the feasibility of incorporating key milestones into these two major initiatives. NIH-DFAS is currently working with a contractor to develop a web based system that will establish a tracking system to account for when indirect cost proposal are due from organizations. The original initiative to enable the electronic submission of indirect cost proposals was modified to incorporate this new requirement. NIH-DFAS anticipates the planned date for implementation of this system to be October 1, 2017. As of February 4, 2020, this recommendation is still open because DFAS does not have the "proposal due date" and "extension due date" data fields activated in eFLow. DFAS is looking into adding those enhancements and hope to have these updates implemented by June 30, 2020. On July 8th, 2020, NIH-DFAS notified us that they plan to update us with the status of this recommendation by October 2020. We will continue to monitor the status of this recommendation.

Recommendation: To ensure effective implementation of the Inclusion Policy in a manner consistent with the Revitalization Act's provisions regarding the design of certain clinical trials, the NIH Director should report on this summary data and the results of this analysis in NIH's regular biennial report to Congress on the inclusion of women in research.

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

Comments: In August 2020, NIH reported that summary data as described in our Recommendation 4--that is, data and analysis on awardees' plans to conduct valid analysis by sex/gender--will be included in the 2019-2020 version of this publication, which the agency expects will be published in October 2021. We will continue to monitor NIH's actions on this matter.

Recommendation: To help address the uncertainty NIH faces, related to the potential impact of increasing indirect costs on its funding of future research, the Director of NIH should assess the impact of growth in indirect costs on its research mission, including, as necessary, planning for how to deal with potential future increases in indirect costs that could limit the amount of funding available for total research, including the direct costs of research projects.

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

Comments: As of July 7, 2015, NIH provided some information indicating that it had taken action to address our recommendation by tracking the size of indirect costs as a proportion of NIH's overall budget as part of the agency's annual budget planning process and risk assessment program. However, we determined that the actions did not fully address the recommendation because they focus on the agency's overall budget and do not assess the potential ongoing impact of indirect costs for universities on its mission. As of September 2018, NIH officials have not informed us of any additional actions taken to implement this recommendation. We will update the status of this recommendation when we receive additional information.