For Researchers and Administrative Staff:

Research oversight is a critical component of effective biosafety and biosecurity practices and the responsible conduct of research involving biological agents and toxins. As part of ongoing updates and assessments of existing policies, the United States Government (USG) released the May 2024 DURC/PEPP Policy and associated Implementation Guidance, which supersedes the previous Federal DURC Policies. The new DURC/PEPP Policy defines and outlines oversight requirements for two categories of research at USG-funded institutions — “Category 1 research” involving dual use research of concern (DURC), and “Category 2 research” involving pathogens with enhanced pandemic potential (PEPP).

The DURC/PEPP Policy expands oversight of DURC to a wider scope of agents including all Select Agents and Toxins, all Risk Group 4 and most Risk Group 3 agents listed in the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), and biological agents added during future updates to the DURC/PEPP Policy Implementation Guidance. There will be new oversight roles for researchers, applicants, recipients, and granting agencies. The DURC/PEPP Policy addresses the identification and mitigation of biosafety, biosecurity, and information risks associated with manipulation of certain pathogens that could cause significant harm to society, be it accidental or intentional. Updates reflect the evolving nature of scientific and technological risks. 

General Expectations for Institutions and Researchers

Institutions, through their researchers, must assess their research at the proposal stage and continuously throughout the research life cycle for whether the research falls under the scope of Category 1 and/or Category 2 research as described in the DURC/PEPP Policy and Implementation Guidance. To assist with this, UH is providing links to general information about DURC/PEPP, as well as a PI Self-Assessment Tool, in the myGrant proposal questionnaire. Detailed training on DURC/PEPP is also available and highly recommended for researchers via the Collaborative Institutional Training Initiative (CITI Program). Those who have potential Category 1 or 2 research will be required to take this training.

For potential Category 1 or Category 2 research projects, once the applicant receives notification from the granting agency to provide supporting materials, the researcher must work with their Institutional Review Entity (IRE) to determine whether it meets the definition of Category 1 or Category 2. Researchers must also work with their IRE to develop a risk-benefit assessment and risk mitigation plan, as applicable, that must be approved by the granting agency before work can begin or continue. 

Granting agencies will require institutional assessments of awards that are active at the time the policy goes into effect. The UH IBC and IRE will review new and ongoing research at UH to fulfill this institutional requirement of identifying potential DURC/PEPP projects. Researchers may receive a notification to complete a DURC/PEPP form in addition to his/her IBC registration form if the IBC deems that further review is needed to properly asses the project.

Please contact the UH IBC via email with any questions about this notice. Addition notices and clarification may be sent as they are received from federal agencies.