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Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PePP)
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Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential |
Biosafety Manual |
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Effective: 05/06/25 |
Version 2.0 |
On May 5, 2025, President Donald J. Trump signed an executive order (EO) titled "Improving the Safety and Security of Biological Research," aimed at enhancing oversight and reducing risks associated with certain life-sciences research. The EO suspends ongoing high-risk, gain-of-function research until a comprehensive policy framework is established to ensure safety and compliance with U.S. standards. It also requires the NIH Office of Science and Technology Policy to establish a policy framework that balances the advancement of scientific research with the necessity of safeguarding public health and national security.
- DEFINITIONS:
Dangerous gain-of-function research- means scientific research on an infectious agent or toxin with the potential to cause disease by enhancing its pathogenicity or increasing its transmissibility. Covered research activities are those that could result in significant societal consequences and that seek or achieve one or more of the following outcomes:
(a) enhancing the harmful consequences of the agent or toxin;
(b) disrupting beneficial immunological response or the effectiveness of an immunization against the agent or toxin;
(c) conferring to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitating their ability to evade detection methodologies;
(d) increasing the stability, transmissibility, or the ability to disseminate the agent or toxin;
(e) altering the host range or tropism of the agent or toxin;
(f) enhancing the susceptibility of a human host population to the agent or toxin; or
(g) generating or reconstituting an eradicated or extinct agent or toxin.
2.SCOPE:
The Policy applies to all research, regardless of funding source on any of WVU’s campuses.
3.RESPONSIBILITIES:
The Institutional Biosafety Officer (BSO) and the Institutional Biosafety Committee (IBC) is charged with ensuring the University is in compliance with the Policy.
4. PROCEDURE:
4.1. The EO pauses dangerous gain-of-function research that could or will make a naturally occurring pathogen or toxin more dangerous to American citizens.
4.2. The BSO will evaluate approved IBC protocols to determine if any active research needs halted and present the findings to the IBC and the Institutional Official.
4.3. The IBC will evaluate proposed IBC protocols as they are submitted to the committee.
4.4. Contact Biosafety@wvuhsc.onmicrosoft.com if you have any questions regarding the policy.
5. REFERENCES:
“Fact Sheet: President Donald J. Trump Achieves Improved Safety and Security of Biological Research”
“Improving the Safety and Security of Biological Research.”
Version History:
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Revision Control Table |
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Version |
Changes |
Revised by |
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1.0 |
Initial version |
Matt Stinoski |
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2.0 |
Revised due to 05/05/25 Executive Order |
Matt Stinoski |