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Research Reviewed Under the HHS P3CO Framework

S3: Science Safety Security

Since the adoption of the HHS P3CO Framework, the P3CO Review Group has reviewed four projects. All were evaluated through the National Institutes of Health (NIH) peer review process and found to be scientifically meritorious prior to referral for HHS P3CO review.

Two of the projects underwent peer review in 2013, were found to be scientifically meritorious, and were funded via mechanisms that allow for the addition of specialized terms and conditions of funding and management of risk. Both of these projects were subsequently determined to be subject to the funding pause on certain gain-of-function (GoF) experiments, announced in October 2014, resulting in the funds being redirected within the awards to support other non-GoF research. In 2018, the funding agency referred those two projects, with corresponding risk-benefit analyses and risk mitigation plans, to HHS for review under the HHS P3CO Framework. The HHS P3CO Review Group determined that, for these two projects, the research was acceptable for HHS funding with recommended changes to increase the potential benefits while decreasing risks; suggested changes were included as terms and conditions of the awards. Further, it was determined that there were no feasible, equally efficacious alternative methods to address the same question in a manner that poses less risk than the proposed approaches. In 2019, the National Institute of Allergy and Infectious Diseases (NIAID) approved the release of funds to support these projects. NIAID support for both of these projects has since ended.

Two additional projects, with corresponding risk-benefit analyses and risk mitigation plans, were referred to HHS for review under the HHS P3CO Framework in 2019 and 2024. The HHS P3CO Review Group determined that the ePPP components of these projects were not acceptable for HHS funding as proposed. NIAID did not fund the ePPP portions of these proposed projects. NIAID recommended the removal of ePPP research from the project referred in 2019, while no part of the project referred in 2024 was funded.

Information about the NIH-funded research projects is available on NIH RePORTER, an electronic tool that allows users to search a repository of NIH-funded research projects and access publications and patents resulting from NIH funding, and other publicly available sites. Information about reviewed projects can be found at: