Update: Impact of EO on DURC-PEPP Policy Implementation
In our Winter newsletter, we provided information on a new government policy on Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (2024 DURC-PEPP policy). This U.S. government policy was scheduled to go into effect on May 6, 2025. However, an Executive Order signed by the President on May 5, 2025 titled “Improving the Safety and Security of Biological Research” has superseded the implementation of the 2024 DURC-PEPP policy. The Executive Order expressed concern that the 2024 policy provides insufficient oversight and enforcement of “dangerous gain-of-function research.”
The University of California system has advised campuses to follow the UC DURC-PEPP policy for any funding agencies that have not rescinded their implementation of the 2024 DURC-PEPP policy and to ensure that all dangerous gain-of-function research is paused. While we anticipate that impacts to UCSB researchers should be minimal, as we are not aware of any such research being conducted on campus, it is important for PIs to proactively identify potential dangerous gain-of-function research. Please notify Barry Rowan (rowan@research.ucsb.edu) if you anticipate proposing or conducting research that meets the definition listed below.
The Executive Order requires:
- Immediate termination of federal funding for gain-of-function research in countries of concern.
- Immediate suspension of federal funding for domestic gain-of-function research until the DURC-PEPP policy is revised or replaced.
- Revision or replacement of the 2024 DURC-PEPP policy within 120 days.
- Development of a requirement to track non-federally funded gain-of-function research taking place in the U.S within 180 days.
- Requirement for additional reporting to the U.S. government, including making information publicly available.
- Increase in penalties for noncompliance, including loss of federal funding.
The Executive Order defines “dangerous gain-of-function research as:
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.
As federal sponsors release guidance on this issue, we will post updates on our DURC-PEPP web page.
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Remember to Update Conflict of Interest Disclosures
As summer approaches, please remember to update your conflict of interest (COI) disclosures to include new activities, such as consulting, which you may participate in over the summer months, and were not previously reported. Investigators and Key Personnel on government funded awards are required to report certain outside financial interests. Disclosures are submitted through ORCOI.
For awards sponsored by PHS (e.g., NIH), or by sponsors who have COI policies that align with PHS requirements (e.g., DoE), disclosure is required if compensation (per entity) exceeds $5,000 for the prior 12 months and the activity is related to your institutional responsibilities (directly related to the credentials expertise, licenses, achievements, publications and patents upon which your UC Santa Barbara appointment was and is currently based).
For awards sponsored by NSF or NASA, or by sponsors who have COI policies that align with NSF or NASA requirements, disclosure is required if compensation exceeds $10,000 for the prior 12 months and the activity would reasonably appear to be affected by your funded or proposed research and educational activities.
Please update your COI disclosure within 30 days after the start of a new outside relationship, the end of a previously reported relationship, or a change in relationship (for example, a change in reportable role with the outside entity or change in value of the relationship).
If you have any questions about Conflict of Interest reporting requirements, please contact Nicole Foley in the Conflict of Interest Office at coi@research.ucsb.edu.
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Conflict of Commitment and Outside Activity Policy
Conflict of Interest reporting is separate, and in addition to, Conflict of Commitment reporting, which is governed by APM - 025 and is managed by Academic Personnel through the OATS system.
The University's Conflict of Commitment Policy requires senate faculty to report consulting but does not require prior approval unless a student is involved in the activity.
For any questions regarding UC OATS reporting requirements, please contact Helly Kwee in Academic Personnel at helly.kwee@ucsb.edu.
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Updated DOD Decision Matrix
The Department of Defense (DoD) released an updated Decision Matrix to Inform Fundamental Research Proposal Mitigation Decisions. These updates will be effective for all proposals submitted on or after May 9, 2025. PIs and key personnel applying for or receiving DoD funding should be familiar with this matrix and may reach out to exportcontrol@research.ucsb.edu if they have any questions. The matrix indicates which foreign affiliations, collaborations, and funding may require mitigation measures and which are prohibited by recipients of DoD funding.
The updated matrix added the following prohibition , as specified in Section 238 of the FY 2025 NDAA:
“Collaborations for the specific purpose of fundamental research between institutions of higher education and academic institutions that are included in the most recently updated list developed pursuant to section 1286 of the NDAA for FY 2019, as amended, or employees of such institutions.”
This means the DoD will not fund projects that involve a collaboration with one of those institutions. Please see the list of restricted foreign research institutions (last column) for an up to date list of these institutions.
The updated matrix also updates some of the dates that would trigger mitigation measures and removes the distinction between “associations” and “affiliations.” Lastly, the updated matrix clarifies that co-authorships with listed institutions should not be the basis for the denial of an award but may result in mitigation measures being requested on a project-by-project basis.
The current matrix can always be found here: https://basicresearch.defense.gov/Programs/Academic-Research-Security/
If you have any questions about how to interpret DoD’s decision matrix, please contact Monica Woltmon at exportcontrol@research.ucsb.edu.
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Consenting Participants for Future Contact
When planning out a protocol, investigators may consider whether they are interested in re-contacting participants following the conclusion of the project (e.g., for additional research opportunities). When this issue arises, it is helpful to consider how best to request participant permission for future contact.
While incorporating a future contact option directly within the main informed consent document is generally acceptable — provided it is clearly stated as optional —there are also circumstances where a separate, standalone form is either preferred or required. Some federal agencies such as the NIH and DoD recommend or mandate the use of a separate form to collect recontact information, especially when subsequent studies may be different in scope, risk, or sponsorship. This practice helps delineate the initial study from future research endeavors, supports precise documentation of consent for recontact, and reinforces the autonomy of participants. The use of a separate form may also streamline compliance with data protection and privacy requirements, especially when storing identifiable information for future outreach.
Investigators should review applicable sponsor policies and consult with Human Subjects staff during study development to determine the most appropriate strategy for obtaining future contact permissions. Where possible, aligning consent practices with agency expectations upfront can help avoid delays during IRB review or study monitoring.
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Updated: Human Subjects "When Do I Modify an Approved Protocol"
Any modification to your research (exempt, expedited, or full board) requires HSC review and approval prior to implementation. Modifications that do not pose any new or additional risks to participants are typically handled via expedited review procedures. Modifications that are substantive in nature and increase risk to the subjects are reviewed by the full board at a convened HSC meeting.
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Reminder: Responsible Conduct of Research Training
As a reminder, all researchers supported by NSF are required to complete the Responsible Conduct of Research training online via CITIProgram. Researchers required to complete this training are notified by the Office of Research. Instructions, along with more information regarding this training requirement can be found on the Responsible Conduct of Research web page.
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Upcoming Events
Interested in hosting a human subjects webinar for your department, class, or research team? We can present on a variety of topics from recruitment to informed consent. Contact us at hsc@research.ucsb.edu to schedule a webinar today!
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