Collaborations with External Entities: Standard Operating Procedure

IACUC SOP: 102-02, Effective Date: 03/27/2015, Last Revision: 11/19/2021

Overview/Purpose

According to the Guide (Eighth Edition):

“Inter-institutional collaboration has the potential to create ambiguities about responsibility for animal care and use. In cases of such collaboration involving animal use (beyond animal transfer), the participating institutions 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 Institutional Animal Care and Use Committee (IACUC) review and oversight Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) 2003. In addition, IACUCs from the participating institutions may choose to review protocols for the work being conducted.”

The IACUC is responsible for oversight of animal activities occurring at Ohio State and for studies in which funding is coming to the university regardless of the location of the activity (i.e., subcontracted to another institution). The intent of this standard operating procedure (SOP) is to define responsibility of oversight to the collaborating entities per federal requirements.

Definitions

• Collaboration: to work with another individual/entity outside Ohio State that involves the joint care, use and/or handling of animals specifically for research or teaching. This does not include the transfer of animals to another facility when there have been no procedures conducted on the animals at the originating facility.
• Memorandum of understanding (MOU): A document indicating responsibilities of respective entities

Requirements

• The Enterprise for Research, Innovation and Knowledge (ERIK) responsible research practices will serve as the coordinating office for collaborations with external entities that involve the Ohio State Animal Care and Use Program (ACUP). Investigators must consult with the ERIK responsible research practices staff to determine the need to complete an Ohio State IACUC protocol, develop a MOU with the collaborating entity, or if submission of the entity’s approved IACUC protocol would be appropriate.
• The ERIK Attending Veterinarian must be notified by the external institution prior to animal movement between institutions to assess the health status and ensure proper medical care, health maintenance, and regulatory compliance.
• The required documents depend on the funding and location of animal use as indicated below: 
  • The animals will be housed in Ohio State facilities:
    • An Ohio State IACUC protocol must be submitted and approved unless an MOU has been signed that indicates only one institution will review the protocol in cases where animals will only be housed at Ohio State. Any animals owned by the university will require an Ohio State IACUC protocol.
    • If animals are to be housed in ERIK University Laboratory and Animal Resources (ULAR) facilities, an online animal order form must be submitted prior to animal movement. For housing in non-ULAR areas, the clinical veterinarian should be contacted directly prior to animal movement into the facility. 
  • No animal activities are performed at Ohio State, but funding for work with animals is subcontracted by Ohio State or teaching activities using animals are associated with Ohio State academic credit.
    • Confirmation of the external IACUC approval for the animal activities being performed at the external institution is required. The external IACUC (or equivalent animal research ethics committee) will be asked to assume full responsibility for the IACUC function and animal activities in its facilities or under its supervision including responsibility for ongoing protocol review and animal facility inspections. This information may be included in the sponsored program agreement between the two entities.
    • If the collaboration is for academic purposes and the external entity does not have an equivalent review committee, a protocol should be submitted to the Ohio State IACUC for ethical review.
    • Animal activities subcontracted to foreign entities which have a review committee will require a submission of the entities’ protocol to the Ohio State IACUC for a review and approval.
  • Animal activities are conducted at Ohio State for less than 24 hours:
    • The Ohio State IACUC will require confirmation of approval by an external institution’s IACUC protocol
    • An MOU will be executed to document the respective responsibilities of Ohio State and the external institution and whether a separate Ohio State protocol is required. The IACUC staff will work with the Ohio State Principal Investigator (PI), the ERIK Attending Veterinarian and institutional officials to secure this agreement.
    • The ERIK Attending Veterinarian must be notified by the external institution prior to animal transfer to assess the health status and ensure proper containment procedures, health maintenance and regulatory compliance.
  • Some animal activities supported with Ohio State funding are conducted at an external entity:
    • The Ohio State IACUC protocol should clearly describe all planned animal research activities to be conducted at the subcontracted site(s). The Ohio State IACUC may rely on the approval of an external IACUC for the animal activities being performed at the external institution. Procedures to be conducted at the external site should be described in the Ohio State protocol timeline section. This can occur when the external institution has an NIH Office of Laboratory Animal Welfare (OLAW) approved Animal Welfare Assurance and, if necessary, an active registration with the U.S. Department of Agriculture (USDA). In most cases, the external IACUC (or equivalent animal research ethics committee) will be asked to assume full responsibility for the animal activities in its facilities including responsibility for ongoing protocol review and animal facility inspections.
    • An MOU will be executed to document the respective responsibilities of Ohio State and the subcontracted institution. The IACUC staff will work with the Ohio State PI, the ERIK Attending Veterinarian and institutional officials to secure this agreement.
  • Animal work funded by National Institutes of Health (NIH) must be conducted at facilities that meet the following requirements:
    • Have an NIH OLAW approved Animal Welfare Assurance or Foreign Assurance
    • Have an active registration with the USDA (if applicable)
    • Are accredited by AAALAC, International. If the facility is not accredited, additional information may be required by the IACUC on a case-by-case basis. The information could include the approved protocol and standard operating procedures at the external entity. The ORRP staff will work with the Ohio State PI, the ERIK Attending Veterinarian and institutional officials to secure these documents. 
  • Names and/or credentials of unaffiliated individuals conducting activities approved on the Ohio State IACUC protocol at external facilities or locations should be indicated in the external collaboration section of the protocol. Additional information may be required if external entities are not overseen by an IACUC.

Applicable Regulations

• Health Research Extension Act of 1985 and Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals
• National Research Council Guide for the Care and Use of Laboratory Animals, Eighth Edition. National Academy of Sciences, 2011
• USDA Animal Welfare Act
• USDA Animal Welfare Inspection Guide page 7-41

Article ID: 41
Created: May 14, 2024
Last Updated: May 14, 2024

Online URL: https://ohiostateresearch.knowledgebase.co/article/collaborations-with-external-entities-standard-operating-procedure-41.html