Memorandum of Understanding - Shared Oversight of VHA BSL-3 Research - Biosafety Level 3 Laboratory Space

Sep 1, 2026

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Memorandum of Understanding (MOU) outlines the terms under which an Affiliate permits VA research requiring Biosafety Level 3 (BSL-3) containment to be conducted in its BSL-3 laboratory space. It establishes shared responsibilities for laboratory safety and security oversight, including roles of respective institutional biosafety committees and compliance with NIH Guidelines and BSL-3 requirements. The agreement excludes select agent use in VA research off-site and requires written approvals, comprehensive proposal review, and timely incident reporting within five business days.

LanguageEnglish

CategoryLetters

FormatDOCX

Pages7

Reading Time3 min

AccessFree to download

Shared Oversight Agreement Framework

Scope and Regulatory Boundaries

Shared Responsibilities and Approvals

General Stipulations and Review Requirements

Security Measures and Incident Reporting

Memorandum of Understanding between the (VAMC) and (Affiliate) concerning Shared Oversight of VHA BSL-3 Research conducted in (Affiliate) BSL-3 Laboratory Space Effective Date: Upon the date of the last signature by authorized agents to this Memorandum of Understanding This Memorandum of Understanding (“MOU”) is entered by the (VAMC) and (AFFILIATE) and sets forth the terms and conditions in accordance with which (AFFILIATE) will permit the conduct of VA research requiring Biosafety Level 3 (BSL-3) containment in (AFFILIATE) BSL-3 laboratory space. This MOU does not address the use of Select agents, defined as biological material including the Centers for Disease Control (“CDC”) list of select agents and toxins, APHIS biological agents, and products of such biological material, i.e. toxins. ( HYPERLINK "http://www.selectagents.gov" www.selectagents.gov). Use of such defined hazardous agents in VA research is restricted to VA owned or leased space. Oversight of laboratory safety and security at (AFFILIATE) and (VAMC) are the responsibility of the (Affiliate office or committee) and the (VAMC office or committee) respectively. Similarly, the Institutional Biosafety Committee (IBC) of the (Affiliate) and the (VAMC), which are registered with the National Institutes of Health Office of Science Policy (NIH-OSP), are responsible for the approval and the oversight of all research performed at their respective institutions that is governed by the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). Both (AFFILIATE) and (VAMC) will maintain their respective NIH-OSP IBC registrations and will notify the other party, within five business days, of any change or lapse in registration. All VA research governed by the NIH Guidelines must be approved by the (VAMC) IBC, the VA Subcommittee on Research Safety, and the VA Research and Development Committee (R&DC), and the VA Associate Chief of Staff for Research (ACOS/R). VA research includes research that is conducted under the auspices of (VAMC), by (VAMC) investigators during their VA tour of duty, and that uses (VAMC) funding or resources, irrespective of location. The parties also acknowledge that, for VA research conducted in (AFFILIATE) laboratory space, (Affiliate office or committee) will ensure compliance with all applicable Federal, state, and local laws that pertain to research safety and security, including Office of Research and Development (ORD) policies. Through this MOU, (Affiliate office or committee) agrees to provide post-approval oversight (including managing any safety or security incidents) for VAMC research requiring BSL-3 containment that is conducted in laboratories or facilities located and maintained at (AFFILIATE), on the (VAMC)’s behalf. (Affiliate office or committee) agrees to meet or exceed the CDC and National Institutes of Health (NIH) Guidelines for BSL-3 research, as incorporated within the (Affiliate office or committee) Manual. This agreement does not abrogate the VAMC’s responsibility for oversight of all VA research, but defines and delegates specific aspects of research oversight to the (AFFILIATE), as the host facility for off-site BSL-3 VA research and defines communication pathways that facilitate this shared responsibility. Both (AFFILIATE) and (VAMC) agree to limit use of (AFFILIATE) BSL-3 facilities for VA research to only those investigator(s) and project(s) that have received written approval from the specific ORD research service; both (AFFILIATE) and (VAMC) recognize that off-site waivers are investigator, project, and funding source-specific. General Stipulations 1. All VA research to be conducted using (AFFILIATE) BSL-3 laboratory space, must be reviewed and approved by the (Affiliate office or committee) and any other applicable (AFFILIATE) research oversight committees to ensure it complies with relevant federal regulations, NIH guidelines, and relevant (Affiliate office or commit

FAQs

What is the scope of this MOU for BSL-3 VA research?

It sets terms for how the Affiliate permits VA research requiring BSL-3 containment in the Affiliate’s BSL-3 laboratory space, including shared oversight responsibilities.

How are approvals and oversight responsibilities handled between the parties?

The Affiliate and VAMC each maintain their NIH-OSP registered IBCs, and VA research must be approved through relevant VAMC and VA research safety processes before initiation.

Are select agents covered under this MOU?

No. The MOU explicitly does not address the use of select agents and toxins; such hazardous agents are restricted to VA-owned or leased space.

What security and incident reporting timelines are required?

The Affiliate must implement appropriate security measures to prevent unauthorized access, and any safety or security incident must be reported within five business days to the Affiliate office or committee and the VAMC SRS.

Sep 1, 2026

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