Fast Facts

Federal research funding is key for advancing science and innovation. But federal funding comes with administrative requirements—e.g., documentation and reporting—that allow for oversight. Are those requirements getting in the way of research? The Office of Management and Budget could find out.

A 2016 law requires the OMB to establish a board to provide information on the effects of regulations related to federal research requirements and make recommendations on aligning and streamlining requirements.

It hasn't done so and authority for the board ends on Sept. 30, 2021. Congress should consider extending the board's authorization.

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Highlights

What GAO Found

As of January 2021, the Office of Management and Budget (OMB) had not established the Research Policy Board as required by the 21st Century Cures Act. The act requires OMB to establish the Board within 1 year of the December 13, 2016 enactment of the act. The Board is to provide information on the effects of regulations related to federal research requirements. OMB stated that it had not established the Board because of issues with the Department of Health and Human Services’ (HHS) and other federal agencies’ full participation in the Board’s potential activities to develop or implement a modified approach to indirect cost policies.

According to OMB, “the Board would necessarily delve into issues related to compliance burden and indirect cost reimbursement to entities that receive federal funding for research.” Specifically, OMB pointed to a statutory provision appearing in annual appropriations bills that it believes prohibits HHS and other agencies from taking action on issues that could implicate certain indirect cost provisions. According to OMB, this provision could, if continued in future bills, “complicate or even possibly prohibit HHS from participating in major elements of the Board’s process.”

OMB stated that, without representation of a major research agency such as the National Institutes of Health (NIH), which is part of HHS, “OMB would not be equipped to meet the statutory goals of the Board.” However, HHS stated in October 2020 that the indirect cost provision would not prohibit NIH’s participation on the Board and that the department was not aware of any other appropriations law provision that would prohibit such participation. GAO has no basis to disagree with HHS’s position.

The 21st Century Cures Act does not specifically direct the Board to examine issues related to indirect costs, and we identified other issues that may fall within the scope of the Board’s activities. For example, the act specifies five activities that the Board may conduct, including creating a forum for the discussion of research policy or regulatory gaps, and identifying regulatory process improvements and policy changes. The Board could consider examining these or other issues related to streamlining and harmonizing regulations and reducing administrative burden in federally funded research in accordance with the 21st Century Cures Act.

By not having established the Board, OMB is missing opportunities for the Board to provide information on the effects of regulations related to requirements for federally funded research, and to make recommendations to harmonize and streamline such requirements. Further, OMB has limited time to establish the Board and the Board may have insufficient time to complete its work before the Board is set to terminate on September 30, 2021.

Why GAO Did This Study

The 21st Century Cures Act requires OMB to establish an advisory committee, to be known as the Research Policy Board, that is responsible for making recommendations on modifying and harmonizing regulation of federally funded research to reduce administrative burden. The Board is to consist of both federal and non-federal members and include not more than 10 members from federal agencies, including officials from OMB, the Office of Science and Technology Policy (OSTP), HHS, the National Science Foundation, and other departments and agencies that support or regulate scientific research, as determined by the OMB Director.

The 21st Century Cures Act includes a provision for GAO to conduct an independent evaluation of the Board’s activities. This report examines the steps OMB has taken to establish the Board as required by the 21st Century Cures Act. GAO reviewed written responses and other information from OMB, HHS, and OSTP; the 21st Century Cures Act and other laws related to the Board and its establishment; relevant reports on issues related to administrative burden; and related documents such as memoranda and agency guidance. GAO submitted a draft report containing the results of its evaluation to Congress on December 10, 2020.

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Recommendations

Congress should consider extending the period of authorization for the Research Policy Board, giving OMB additional time to establish the Research Policy Board and complete its statutory mission under the 21st Century Cures Act. GAO recommends that OMB establish the Research Policy Board as mandated by the 21st Century Cures Act and report to Congress on the Board’s activities. OMB did not agree or disagree with this recommendation. We maintain that the evidence in this report shows the need for our recommendation.

Matter for Congressional Consideration

Matter Status Comments
Congress should consider extending the period of authorization for the Research Policy Board, giving OMB additional time to establish the Research Policy Board and complete its statutory mission under the 21st Century Cures Act. (Matter for Consideration 1)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Recommendations for Executive Action

Agency Affected Recommendation Status
Office of Management and Budget 1. The Director of OMB should establish the Research Policy Board as mandated by the 21st Century Cures Act and report to Congress on the Board's activities. (Recommendation 1)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

Full Report

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