Biosafety News – Office of Research Compliance /research-compliance Guidance and Resources for Research Compliance at the University of Maine Tue, 03 Mar 2026 23:56:32 +0000 en-US hourly 1 https://wordpress.org/?v=6.8.5 Biosafety: New NIH “Dangerous Gain-of-Function” Research Requirements for Notification, Suspension, or Termination – June 2025 /research-compliance/2025/06/24/biosafety-new-nih-dangerous-gain-of-function-research-requirements-for-notification-suspension-or-termination/ Tue, 24 Jun 2025 14:42:42 +0000 /research-compliance/?p=8047 On June 18, 2025, the National Institutes of Health (NIH) issued notice .

Within this notice, NIH provided the following definition of “dangerous gain-of-function research”:

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.”

According to the notice, which is effective immediately, NIH will:

Terminate funding and other support for projects, including unfunded collaborations/projects, meeting the definition of dangerous gain-of-function research conducted by foreign entities in countries of concern or foreign countries where there is not adequate oversight; and

Suspend all other funding and other support for projects, including unfunded collaborations/projects, meeting the definition of dangerous gain-of-function research at least until implementation of the new policy described in Section 4(a) of the Executive Order.”

Additionally:

“NIH is also requiring all awardees to review ongoing research activities to identify NIH funding and other support for projects, including unfunded collaborations/projects, meeting the definition of dangerous gain-of-function research that has not been identified as such by NIH and immediately notify the funding NIH Institute, Center, or Office. Review must be complete by June 30, 2025.

This notice is in response to the May 5, 2025 , which was followed by NIH’s first notice on this topic on May 7, 2025, .

Additionally, on June 20, 2025, the USDA issued a  with similar requirements to identify USDA-funded projects, inclusive of all source(s) or type(s) of funding, including in-kind support, that is believed to meet or has the potential to meet the dangerous gain-of-function definition. Other funders may release similar requirements in the coming days, please be sure to monitor your sponsor’s requirements and keep the IBC updated about your research activity and plans.

The Office of Research Compliance will continue to monitor for future updates and work to implement them as they are released. Further information will be shared as it is made available. In the meantime, please contact the IBC office with any questions regarding these updates, biosafety, or the IBC.

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Biosafety: New NIH Transparency Guidance – April 2025 /research-compliance/2025/04/29/biosafety-new-nih-transparency-guidance-april-2025/ Tue, 29 Apr 2025 18:59:58 +0000 /research-compliance/?p=7829 On March 28, 2025, the National Institutes of Health (NIH) issued implementation update .

This updated guidance will require institutions to publicly post approved minutes from all Institutional Biosafety Committee (IBC) meetings held on or after June 1, 2025. These minutes will be posted on the institution’s website after they have been formally approved and all appropriate and allowable redactions have been made.

Also as of June 1, 2025, the NIH Office of Science Policy (OSP) will be publicly posting rosters of all active IBCs including the names of all members.

The Office of Research Compliance is aware of these updates and is in the process of reviewing and implementing them. Further information will be shared in the coming months. In the meantime, please contact us with any questions regarding biosafety or the IBC.

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Revisions to Biosafety Policy and Protocol Form – Nov. 2024 /research-compliance/2024/11/14/revisions-to-biosafety-policy-and-protocol-form-nov-2024/ Thu, 14 Nov 2024 18:23:58 +0000 /research-compliance/?p=7235 91 Institutional Biosafety Committee (IBC) has issued minor revisions to the Policies and Procedures for Research Involving Recombinant or Synthetic Nucleic Acid Molecules or Infectious Agents (Word).

These revisions reflect the recent updates to the National Institutes of Health (NIH) Guidelines (issued April 2024) and the revised (issued May 2024).

As a result, there have also been minor updates to the IBC Protocol Form (Word). Please ensure you are always using the most current version of the forms by accessing them directly on the IBC Forms webpage.

If you have any questions regarding biosafety or these revisions, please contact the IBC.

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Biosafety NIH Revisions – Effective Sept. 30, 2024 /research-compliance/2024/04/30/biosafety-nih-revisions-effective-sept-30-2024/ Tue, 30 Apr 2024 19:30:40 +0000 /research-compliance/?p=5708 The National Institutes of Health (NIH) has issued revisions to the as of April 2024 – these revisions will become effective on September 30, 2024. The revisions include:

  1. New requirements for conducting research involving Gene Drive Modified Organisms (GDMOs)
  2. Replacing the term “helper viruses” with the broader term “helper systems”
  3. Amending the Risk Group (RG) categorization of West Nile Virus (WNV) and Saint Louis Encephalitis Virus (SLEV) to RG2

More details about these revisions are available in the .

The NIH Guidelines are used by the university’s Institutional Biosafety Committee (IBC) to review the use of biological materials and biohazards in research. More information about any changes to 91’s biosafety forms and/or policy resulting from these NIH revisions will be announced prior to the effective date. 

If you have any questions regarding biosafety or the NIH revisions, please contact the IBC.

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Updates to IBC Policy and Form Submission Process – March 2023 /research-compliance/2023/03/20/updates-to-ibc-policy-and-form-submission-process-march-2023/ Mon, 20 Mar 2023 15:00:33 +0000 /research-compliance/?p=4599

The following message was sent via email to all University of Maine employees on March 20, 2023 by the Office of the Vice President for Research and Dean of the Graduate School.

The Office of Research Compliance has worked with the Biosafety Officer, Dr. Andy Holmes, and the Institutional Biosafety Committee (IBC) to review and update the Policies and Procedures for Research Involving Recombinant or Synthetic Nucleic Acid Molecules or Infections Agents (PDF).

Two key changes to note:

  • New Registration Form: In order to ensure all biosafety spaces are inspected and that the IBC has a record of all biosafety work being conducted on campus, all labs (research and/or educational) using biological materials of any kind will fill out a basic Registration (containing information like PI, lab locations, BSL, summary of activity). Protocols will still be submitted to the IBC for individual projects for any non-exempt rDNA work and/or any non-exempt work that is BSL2 or higher; these protocols will be valid for 3 years.
  • Expanded definition of ‘PI’: The revised Policy adopts a broader definition of PI to include PIs, lab managers, research supervisors, instructors, or any individuals responsible for the biosafety work to be conducted.

The revised policy, updated Protocol Form and new Registration form are all available on the Biosafety section of the ORC website; direct links are below:

While the research community is encouraged to begin utilizing the new IBC Registration Form, this is a soft rollout during this spring and summer. IBC Registration will be required effective with the start of the Fall 2023 semester.

Please contact Dr. Holmes (andrew.p.holmes@maine.edu) or the Office of Research Compliance (umric@maine.edu) with any questions you may have regarding these changes.

Stay up to date with Biosafety and all other research compliance news by !

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