It is often necessary for investigators and institutions receiving PHS funds to collaborate with others in the pursuit of knowledge and the advancement of science. However, certain procedural requirements must be met before collaborative work may take place. This page provides basic background information for investigators and research administration on the types of collaborations and the documentation that OLAW may require. While relevant references from the PHS Policy and perspective of OLAW are provided, this page does not provide a comprehensive review of other legal requirements that may apply to a grant or contract award. See the NIH Grants Policy Statement for additional information.
Note on terminology
Quick References
Applicants and offerors should contact their institutional research administration or the NIH Grants and Funding office for questions regarding specific application procedures and status updates.
What are the institution’s responsibilities during collaborations involving animal activities?
Read “What are the institution’s responsibilities during collaborations involving animal activities?” FAQ to learn more about:
- Which IACUC should review activities when two or more institutions collaborate
- Which institution is responsible for reporting noncompliance
- Which institution is responsible for fulfilling the obligations of an award
- What should be included in the collaborative agreement
Sample MOU Template
To help institutions meet the requirements of the Guide and to reduce the administrative burden associated with developing MOUs, the Federal Demonstration Partnership, in collaboration with OLAW, developed an MOU template. The template is intended to prevent problems and misunderstandings which could negatively impact research animals. The use of this template is not required and is provided for the convenience of Institutional Animal Care and Use Committees (IACUC) at Assured institutions.
1. Introduction
The Guide for the Care and Use of Laboratory Animals (Guide) recommends that collaborating institutions involving animal use should have a formal written understanding (e.g., a contract, memorandum of understanding, or agreement) that addresses the responsibility for offsite animal care and use, animal ownership, and IACUC review and oversight (p.15).
To help institutions meet the requirements of the Guide and to reduce the administrative burden associated with developing MOUs, the Federal Demonstration Partnership, in collaboration with OLAW, developed an MOU template. The template is intended to prevent problems and misunderstandings which could negatively impact research animals.
2. MOU Documents
The FDP provides two documents relevant to the MOU template. The documents can be accessed on the FDP "Animal Subjects Subcommittee" webpage and scrolling down to "Committee Resources and Tools."
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FDP IACUC MOU Sample:
- Designed for single projects but could be modified for frequent collaborators
- Covers specific areas of concern for regulators
- Program-wide acknowledgments
- Transportation
- Ownership & oversight
- Investigation & reporting
- Other (blank)
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FDP IACUC MOU User Guide
- Intentionally non-prescriptive
- Provides definitions to "translate" from each office
- Provides considerations for offices in choosing what documentation mechanism to utilize (i.e., MOU, subaward, Interinstitutional Assurance)
- Provides high-level considerations for institutions on how collaborative research is documented
- FAQs highlight specific considerations
3. Quick Answers
No. This example format is not required. This is being offered as a resource to assist institutions if desired.
The exact contents of the formal written agreement may depend on the nature of the collaboration, animal activity involved, and the institution's needs.
Although collaborating institutions are involved in both cases, the MOU and the Interinstitutional Assurance are different documents and do not substitute for one another.
A memorandum of understanding (MOU) is one type of document that may be used as a formal written agreement to meet the Guide statement (p.15) regarding collaborations. The purpose of a formal written agreement is to address the responsibilities for animal care and use and avoid ambiguities that can lead to noncompliance and animal welfare concerns.
The Interinstitutional Assurance is a type of Animal Welfare Assurance issued by OLAW to an awardee institution that does not have its own:
- animal care and use program
- facilities to house animals
- Institutional Animal Care and Use Committee (IACUC); and
- does not conduct animal research on-site.
Resources
- OLAW Knowledge Video: Understanding MOUs and Agreements - May 14, 2025
- MOUs for Collaborating Institutions: New Template from the Federal Demonstration Partnership (FDP) - January 19, 2023 (OLAW Webinar)
NIH Grants Policy Statement (NIH GPS)
This document describes the terms and conditions of NIH grant awards. It also clarifies that these requirements "...apply not only to the recipients of NIH Grant Awards, but also flow down to any subawards as well as to subrecipients unless specified otherwise in the regulation." (NIH GPS "Introduction” Webversion)
Learn more about the NIHGPS Statement and view it in different formats.
Agencies Having an MOU with OLAW
OLAW and other agencies have established memoranda of understanding (MOUs) regarding the oversight and care of animals. This extends the requirements of the PHS policy to some activities funded by these agencies that would otherwise not be covered. Currently, these include NSF, NASA and VA. OLAW is available for questions regarding the applicability of the PHS policy to activities that may be affected by these MOUs.
Learn more about Regulatory References and various MOUs
Laws, Policies, and Guidance
Laws and Policies
PHS Policy II: "This Policy is applicable to all PHS-conducted or supported activities involving animals, whether the activities are performed at a PHS agency, an awardee institution, or any other institution and conducted in the United States, the Commonwealth of Puerto Rico, or any territory or possession of the United States. Institutions in foreign countries receiving PHS support for activities involving animals shall comply with this Policy, or provide evidence to the PHS that acceptable standards for the humane care and use of the animals in PHS-conducted or supported activities will be met."
PHS Policy IV.A: "No activity involving animals may be conducted or supported by the PHS until the institution conducting the activity has provided a written Assurance acceptable to the PHS, setting forth compliance with this Policy."
Guidance
| Notice | Description | Date |
|---|---|---|
| NOT-OD-24-075 | Guidance on Flexibilities for Conducting Semiannual Inspections of Animal Facilities | March 22, 2024 |
| NOT-OD-22-006 | Notice of Clarification of Offeror Responsibilities Regarding Contract to Protocol Congruence Review | October 18, 2021 |
| NOT-OD-22-005 | Notice of Clarification of Institutional Responsibilities Regarding NIH Grant to Protocol Congruence Review | October 18, 2021 |
| NOT-OD-01-017 | Guidance Regarding Administrative IACUC Issues (alternate IACUC members, IACUC review at collaborating institutions) and Efforts to Reduce Regulatory Burden | February 12, 2001 |
Documentation
Institutional collaborations can take various forms depending on the legal and financial structure of the partnering institutions, the business sector(s) involved, and the funding that supports the collaborative activity. Collaborative arrangements may be simple or complex and may involve one or more additional parties. Because every collaborative situation is unique, it is important that institutions take special care to ensure that proper procedures are followed and complete documentation is obtained prior to beginning any activities involving animals.
The following list describes the three general types of documentation that OLAW may require. Institutions should also be aware of additional documentation required by the funding component.
- Memorandum of Understanding (MOU): The Guide for the Care and Use of Laboratory Animals (Guide) states that collaborating institutions involving animal use “should have a formal written understanding (e.g., a contract, memorandum of understanding, or agreement) that addresses the responsibility for offsite animal care and use, animal ownership, and IACUC review and oversight”. (p.15) This agreement is established directly between collaborating institutions and is not provided to OLAW. Collaborating institutions should always have a written agreement (such as an MOU) regardless of any additional documentation that may be required by OLAW.
- Animal Welfare Assurance: The MOU does not take the place of an Assurance document. See Obtaining an Assurance for more information on how to ensure that all animal performance sites are covered under an assurance for activities subject to the PHS policy.
Key Takeaways
Collaborations can add an extra layer of complexity when managing an award. Formal written documentation (E.g. MOU, agreement) are established between the collaborating parties.
Need Help? E-mail the OLAW Division of Assurances: [email protected]. See OLAW contacts for a more extensive list.
Investigators should contact their institutional grants administration and/or IACUC office first if they believe one of these documents may be necessary to support their work.
FAQs
- How can the IACUC determine if activities involving privately owned animals constitute veterinary clinical care or research activities?
- What are the institution’s responsibilities during collaborations involving animal activities?
- If an animal activity will be performed outside of the US (either by a foreign awardee or by a foreign institution as a subproject for a domestic awardee), is the awardee’s IACUC required to review and approve that activity?