Aerial view of the 91次元 campus and buildings around UM's Oval in Missoula, MT.

Research Compliance and Tech Transfer

Use of Contract Research Organizations (CROs) and External Collaborators in Animal Research

Number: IACUC-POL-008

Responsible Office: Office of Research and Creative Scholarship (ORCS) 

Applies to: Principal Investigators Conducting Animal Research 

1. Policy  

The 91次元 (UM) remains responsible for animal activities conducted under its awards, regardless of where the work is performed. If live vertebrate animal work is performed by an external institution—whether a Contract Research Organization (CRO), external collaborator, or foreign site—through an award, subaward, contract, or collaboration, UM is accountable for ensuring full compliance with applicable animal welfare regulations and institutional policies. 

External collaborations involving live vertebrate animals are subject to UM IACUC review and oversight. The extent of review will depend on: 

  • The type and scope of work performed. 
  • Ownership of animals
  • The assurance status and accreditation of the external entity (e.g., OLAW Assurance, USDA registration, AAALAC accreditation). 
  • Whether the external party is domestic or foreign.  

The following do not require oversight by UM IACUC: 

  • Use of commercial suppliers for, animals, or animal-derived materials (e.g., antibodies) considered “off-the-shelf” (i.e., for which the products are available to non-UM Principal Investigators). 
  • Transfer of naïve breeding stock, e.g., genetically-engineered murine (GEM) strains, to a collaborating institution for which animal ownership is specifically transferred does not require IACUC review or approval but may require negotiation via Material Transfer Agreement(s).  

2. Background 

Regulatory agencies recognize that while review of a research project or facility by more than one IACUC is not a federal requirement, “it is imperative that institutions define their respective responsibilities” (1). Under PHS Policy, any performance site associated with a PHS-funded project must hold an approved Animal Welfare Assurance. Research involving USDA-regulated species must be conducted at a facility with a valid USDA research registration. AAALAC International’s Rules of Accreditation apply to all animals owned or housed by an accredited institution, regardless of funding source. 

The primary awardee or funding is responsible for meeting all animal welfare obligations associated with the award and must ensure these obligations are incorporated into formal agreements with collaborating institutions (NIH Grants Policy Statement, ). 

Animal activities conducted outside the 91次元 may still fall under UM’s oversight obligations depending on: 

  • Funding source 
  • Whether UM personnel are engaged in animal procedures 
  • Whether UM retains programmatic or scientific responsibility 
  • Whether animals, tissues, or data are transferred between institutions 

Federal oversight bodies—including OLAW, USDA, and AAALAC International—require institutions to maintain clear lines of authority, responsibility, and documentation when relying on external organizations to conduct animal work. 

The use of a CRO or external collaborator does not eliminate UM’s regulatory responsibilities when UM is considered engaged in animal activities. 

3. Definitions 

Contract Research Organization (CRO): A commercial laboratory or facility performing contracted animal research or testing services for UM. 

External Collaborator: Any non-UM institution or investigator participating in animal activities linked to a UM project. 

Engaged in Animal Activities: OLAW defines engagement as institutions whose employees or agents conduct animal procedures, manipulate animals or their environment, or directly obtain animal tissues or data from live animals for research purposes. 

4. Procedure 

The UM PI must engage the UM IACUC office for any research involving live vertebrate animals performed externally, prior to work being conducted to ensure a protocol, Memorandum of Understanding, Interinstitutional Agreement or Research Collaboration Agreement is not required.  

This includes working involving: 

  • Custom antibody production. 
  • Research being conducted off-site at a domestic institution 
  • Research being conducted with federal/state agencies 
  • Research conducted by foreign collaborators or at foreign institutions. 

The following information must be provided to the IACUC Manager by the PI: 

  • Funding/Award source and information.  
  • The role of UM and the external party in the study. 
  • The animal procedures to be conducted off-site. 
  • Regulatory documentation from the external party: 
    • OLAW Assurance Number (Domestic or Foreign Assurance). 
    • USDA Registration (if applicable). Studies involving USDA-covered species must be conducted at locations registered with the USDA as Research Facilities.
    • AAALAC accreditation status. 
    • Approved IACUC protocol number under which procedures will be performed. 
    • Contact information for the responsible person at the external site.  

The UM IACUC will assess the adequacy of oversight at the external institution. UM may accept another institution’s IACUC approval, but retains full responsibility for the activities under its award, or an UM IACUC-approved protocol might be requested prior to commencement of research related activities. Additional documentation or review may be requested. A written agreement outlining roles and responsibilities (e.g., inter-institutional agreement, contract language, MTA, IAA, or subaward terms) 

Work Conducted Outside the U.S. 

When UM is the prime awardee and work is conducted by a foreign institution: 

  • The foreign site must complete the Animal Welfare Assurance for Foreign Institutions (Foreign Assurance) with OLAW. 
  • UM’s IACUC must review and certify that the animal activities at the foreign site are acceptable to UM. 
  • UM IACUC may accept the foreign entity's IACUC or oversight body’s approval, but remains responsible for compliance. UM IACUC may also require UM protocol be submitted and approved.  

If UM is a sub-awardee to a foreign institution, and animal activities are performed at the foreign prime awardee site, UM IACUC review is not required, per PHS FAQ D13. 

Custom Antibody Production and Surgery 

If UM contracts a third party (domestic or foreign) to perform: 

  • Custom antibody production using UM-supplied antigen(s), or 
  • Custom surgery on animals at the request of the UM investigator, 

then: 

  • That work is covered by PHS Policy.
  • The organization performing the work must: 
    1. Have an OLAW Assurance or be covered under UM’s Assurance.
    2. Provide evidence of IACUC approval for the specific procedures. 
  • The UM PI must submit verification to the UM IACUC for review and record-keeping. 

If UM is the awardee, it retains primary responsibility for ensuring compliance with PHS Policy. [, ]  

3. Institutional Agreements,Memorandum of Understanding and Research Collaborative Agreements.  

UM and any collaborating institution must have a written agreement such as a Memorandum of Understanding (MOU) or Interinstitutional Agreement (IIA), Research Collaborative Agreement (RCA) that: 

  • Specifies which IACUC will be responsible for protocol review and oversight. 
  • Identifies responsibilities for: 
    • Animal care and ownership.
    • Semiannual inspections. 
    • Reporting of concerns and adverse events.
    • Maintaining IACUC records and approvals. 

In domestic collaborations, when both institutions have an OLAW Assurance, only one IACUC is required to conduct review. However, documentation of that review must be available to both IACUCs. 

In foreign collaborations, UM remains responsible for ensuring IACUC approval and compliance with PHS Policy, and must obtain documentation confirming: 

  • The foreign site’s approval of the animal activities. 
  • The foreign Assurance and agreement to follow international guiding principles and ideally, the Guide.  

4. PI Responsibilities

Communication & Oversight: The UM PI must ensure continuing oversight of external animal activities and compliance with institutional and federal regulations.  

Reporting: The PI must promptly report any serious animal welfare concerns, protocol deviations, or regulatory citations to the UM IACUC, even if those issues occur at an external site. 

5. IACUC Oversight Authority

  • The UM IACUC may request additional information or documentation from PIs or external sites as needed.
  • Approval to use an external collaborator or CRO may be revoked if: 
    • Accreditation or regulatory status changes (e.g., loss of USDA registration, lapsed OLAW Assurance). 
    • There are findings of noncompliance or welfare concerns. 
    • Required agreements or documentation are not maintained. 

6. References

  1. PHS Policy on Humane Care and Use of Laboratory Animals, OLAW 
  2. Animal Welfare Act, 7 U.S.C. §§ 2131–2159 
  3. Guide for the Care and Use of Laboratory Animals, 8th Edition 
  4. NIH Grants Policy Statement 
  5. OLAW FAQs D8, D13, A2 
  6. FDP IACUC MOU Sample and User Guide (Available at: https://thefdp.org/default/committees/animal-subjects/) 

7. Review, Approval and Version History

Review and approval version history for this policy

Version 

Date 

Description of Changes 

Approved By 

1.0 

June 1, 2015 

Initial policy creation 

IACUC Committee 

2.0 

June 22, 2025 

Review and update  

Hicks