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Open Recommendations (17 total)

Biomedical Research: NIH Should Publicly Report More Information about the Licensing of Its Intellectual Property

GAO-21-52
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1 Open Recommendations
Agency Affected Recommendation Status
National Institutes of Health The Director of NIH should determine—in collaboration with outside stakeholders as appropriate—what licensing information is most useful to enable the public's and policymakers' understanding of licensing outcomes and impacts and, to the extent permitted by law, publicly report such information in an accessible and searchable format to the maximum extent possible. (Recommendation 2)
Open
HHS concurred with GAO's recommendation, and took several steps following the report's issuance. NIH published information about NIH-owned patents and active commercial licenses on its technology transfer website. Agency officials stated that NIH will deploy a new enterprise technology transfer system that will enable the agency to publish additional information and provide an improved user interface that allows searches of a new technology transfer database, which will include information on the effective dates of licenses. The NIH officials further stated that this system is in the final stages of development and testing, and that they expect it to be launched at the end of calendar year 2022.

Scientific Integrity: HHS Agencies Need to Develop Procedures and Train Staff on Reporting and Addressing Political Interference

GAO-22-104613
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1 Open Recommendations
Agency Affected Recommendation Status
National Institutes of Health The NIH Director should ensure that procedures for reporting and addressing potential political interference in scientific decision-making are developed and documented, including adding a definition of political interference, and that its scientific integrity trainings on these procedures are updated. (Recommendation 5)
Open
As of April 2024, HHS was updating its departmental scientific integrity policy and its operating divisions, including NIH, were also updating their individual scientific integrity policies. The updated policies will include specific provisions prohibiting political interference and will establish procedures for reporting and handling allegations of scientific integrity violations, including those involving alleged political interference. HHS plans to finalize its policy in 2024 and will make the policy publicly available on its website.

Research Reliability: Federal Actions Needed to Promote Stronger Research Practices

GAO-22-104411
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1 Open Recommendations
Agency Affected Recommendation Status
National Institutes of Health The Director of NIH should collect information on relevant indicators of rigor to assess the research projects the agency funds, and implement steps, as needed, to promote strong research practices in future work. (Recommendation 1)
Open
HHS agreed with this recommendation. In December 2022, HHS said it plans to issue a Notice encouraging grant applications to include elements of rigorous study design in NIH-supported publications describing vertebrate animal and cephalopod research. The agency believes this will increase consistency of reporting for this type of research. HHS is also exploring whether machine learning or natural language processing approaches could be used to identify elements of rigor in NIH-funded publications. HHS will provide a status update in July 2023.

Research Reliability: Federal Actions Needed to Promote Stronger Research Practices

GAO-22-104411
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1 Open Recommendations
Agency Affected Recommendation Status
National Institutes of Health The Director of NIH should take steps to collect information to determine whether current policies and requirements are adequate to achieve transparency by ensuring research results and data are findable, accessible, and usable, and implement programmatic or policy changes, if needed. (Recommendation 2)
Open – Partially Addressed
HHS agreed with this recommendation. On January 25, 2023, a new NIH data-sharing policy went into effect. Under this policy, researchers--through submission of a Data Management and Sharing Plan--are required to prospectively plan for how scientific data will be preserved and shared. HHS notes that the plan encourages data management and data sharing practices be consistent with the Findable, Accessible, Interoperable, and Reusable (FAIR) data principles. NIH will monitor grant recipients' compliance with the data management plan at regular intervals. In addition, NIH intends to assess the process and outcomes associated with the new policy, which will inform potential future policy changes. NIH has issued several pieces of guidance on implementation of the new data sharing policy, and has created and developed initiatives to promote FAIR data sharing.

Animal Use in Research: NIH Should Strengthen Oversight of Projects It Funds at Foreign Facilities

GAO-23-105736
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1 Open Recommendations
Agency Affected Recommendation Status
National Institutes of Health The Director of NIH should take steps—such as conducting site visits to foreign facilities that perform NIH-funded animal research or requiring third-party verification—to provide reasonable assurance that award recipients' annual self-reported project information is reliable and adequate to ensure the humane care and use of laboratory animals. (Recommendation 1)
Open
HHS concurred with this recommendation. As of September 2023, HHS noted that NIH's Office of Laboratory Research (OLAW) plans to initiate virtual site visits including a review of award recipients' annual Research Performance Progress Reports for a subset of foreign facilities that perform NIH-funded animal research beginning in Spring 2024. In addition, HHS stated that beginning in Spring 2024, the NIH OLAW will additionally confirm third-party documentation from national, regional, state, and/or local oversight entities as well as documentation of assessment by independent bodies, as available. We will continue to monitor NIH's progress on implementing this recommendation.

National Institutes of Health: Better Data Will Improve Understanding of Federal Contributions to Drug Development

GAO-23-105656
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1 Open Recommendations
Agency Affected Recommendation Status
National Institutes of Health The Director of NIH should update the Grants Policy Statement and NIH training materials to provide clear guidance that the government interest statement in a patent arising from NIH-funded research should name National Institutes of Health as the federal agency and correctly identify NIH awards using, at the minimum, the institute code and serial number. (Recommendation 1)
Open
HHS agreed with the recommendation. In its comments included in the report, HHS stated that NIH (1) would make appropriate edits to the NIH Grants Policy Statement, Section 8.2.4 Inventions and Patents (Exhibit 8), to provide clear guidance to NIH federal funding recipients that they should name in the government interest statements "National Institutes of Health" as the federal agency and correctly identify NIH awards using, at the minimum, the institute code and serial number; and (2) expected updates to be included in the next scheduled revision of the NIH Grants Policy Statement in October 2023. HHS also stated that NIH would update training materials to provide similar guidance at the next available opportunity. In its October 2023 letter responding to our report, HHS stated that NIH had updated training materials, and that it planned to release its updated policy in January 2024. We will reassess the status of this recommendation when HHS provides information on steps taken to implement it.

National Institutes of Health: Better Data Will Improve Understanding of Federal Contributions to Drug Development

GAO-23-105656
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1 Open Recommendations
Agency Affected Recommendation Status
National Institutes of Health The Director of NIH should develop a procedure describing how researchers can access NIH microdata for the purposes of studying and evaluating NIH's contributions to developing new drugs and treatments. (Recommendation 2)
Open
HHS agreed with the recommendation. In its October 2023 response to our report, HHS stated that NIH is in the process of developing a transparent process to provide external researchers with access to NIH microdata and will inform GAO about the status of this effort in October 2024. According to HHS, the effort includes gathering information from relevant NIH institutes, centers, and programs as well as from comparable federal programs to identify best practices for sharing microdata. We will reassess the status of this recommendation when HHS provides information on steps taken to implement it.

Data Science: NIH Needs to Implement Key Workforce Planning Activities

GAO-23-105594
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1 Open Recommendations
Agency Affected Recommendation Status
National Institutes of Health The NIH Director should ensure that NIH establishes a comprehensive data science workforce planning process that addresses the shortfalls noted in this report. (Recommendation 1)
Open
In December 2023, NIH stated that its working group of senior mission support personnel and data science subject matter experts was addressing this recommendation. The agency stated it would provide a status of the group's efforts in June 2024.

Data Science: NIH Needs to Implement Key Workforce Planning Activities

GAO-23-105594
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2 Open Recommendations
Agency Affected Recommendation Status
National Institutes of Health The NIH Director should ensure that NIH develops staffing requirements for the data science workforce. (Recommendation 2)
Open
In December 2023, NIH stated that its working group of senior mission support personnel and data science subject matter experts was addressing this recommendation. The agency stated it would provide a status of the group's efforts in June 2024.
National Institutes of Health The NIH Director should ensure that NIH reassesses its data science competency and staffing needs periodically. (Recommendation 3)
Open
In December 2023, NIH stated that its working group of senior mission support personnel and data science subject matter experts was addressing this recommendation. The agency stated it would provide a status of the group's efforts in June 2024.
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