Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight
On January 9, 2017, the White House Office of Science and Technology Policy (OSTP) released Recommended Policy Guidance for Departmental Development of Review Mechanisms for Potential Pandemic Pathogen Care and Oversight. The Guidance recommends consistent and appropriate Federal agency review and reporting processes for the oversight of Federally funded research that is anticipated to create, transfer, or use enhanced potential pandemic pathogens (PPP). The guidance recommends that Federal agencies adopt an appropriate review process if they wish to consider conducting or funding studies that may be anticipated to enhance PPP. Adoption of these recommendations will satisfy the requirements for lifting the current research funding pause on certain life sciences research that could generate enhanced PPP.
The OSTP recommended policy guidance provides a mechanism for the establishment of agency review processes that take into account the scientific and public health benefits, the biosafety and biosecurity risks, and the appropriate risk mitigation measures pertinent to the proposed research. The Department of Health and Human Services (HHS) projects that have had funding paused will be reviewed using a new process in accordance with the recommended guidance. Any projects that are determined suitable to proceed will do so with appropriate risk mitigation measures in place.
In conjunction with the recommended policy guidance, OSTP issued a statement that:
- Explains that the recommended policy guidance implements the National Science Advisory Board for Biosecurity’s (NSABB’s) call for a multi-disciplinary, pre-funding review mechanism for certain research proposals;
- Describes the guidance’s recommendation that Federal departments and agencies establish an appropriate review process if they plan to fund studies anticipated to create, transfer, or use enhanced PPP;
- Points out that these review processes should assess risks and benefits of such projects and develop risk mitigation plans commensurate with the projects’ risks; and
- Notes that the NSABB will examine the HHS review process after it has been applied to paused projects.
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Deliberative Process and Funding Pause on Certain Types of Gain-of-Function Research
On October 16, 2014, the White House announced that the U.S. Government will launch a deliberative process in order to assess the risks and benefits of certain gain-of-function (GOF) experiments. The NIH Director also published a Statement on Funding Pause on Certain Types of Gain-of-Function Research on October 17, 2014. During this deliberative process, U.S. government departments and agencies will pause the release of federal funding for GOF studies that enhances the pathogenicity or transmissibility among mammals by respiratory droplets of influenza, MERS, or SARS.
The pause will allow the U.S. Government, in partnership with the life sciences community and stakeholders, to conduct a comprehensive assessment of gain-of-function research with the explicit goal of developing a new federal policy framework to guide future investments in this area of research. To learn more, see the Frequently Asked Questions on the U.S. Government Gain-of-Function Deliberative Process and Research Funding Pause on Selected Gain-of-Function Research Involving Influenza, MERS, and SARS Viruses.
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