Working with a Contract Research Organization

Date Adopted: November 22, 2016

Last Review Date: September 12, 2017

 

I.  Policy

If research with live vertebrate animals is performed by an outside organization (Contract Research Organization, CRO) through an award, sub-award, contract or sub-contract originating from the University of Montana, the University is accountable for ensuring that the work being conducted on the project meets all applicable regulations and University policies regarding the humane care and use of animals.  The University of Montana PI is responsible for the work with live animals that is conducted as part of her/his university research and for ensuring that such research is compliant with UM applicable regulations and policies.  Therefore, such projects are subject to review and approval by the University of Montana IACUC.  The extent of the review will depend upon:

A.  The nature of the proposed work to be conducted at the CRO

B.  A demonstrated ability by the CRO to maintain the highest standards of humane
     care and use of animals as evidenced by a current Animal Welfare Assurance
     Number (PHS Assurance) with the Office of Laboratory Animal Welfare (OLAW),
     and/or an active certification with the United States Department of Agriculture
     (USDA), and/or AAALAC International accreditation.

II.   Procedure

A.  The UM PI on the project submits an IACUC Animal Use Protocol (AUP) which details:
    1. What the collaboration entails (the animal work involved) and the role played by UM in the overall project
    2. The name of a contact person at the CRO
    3. The CRO’s applicable certifications and approvals including:
a.  Current OLAW Assurance Number
b.  Current USDA Registration Number
c.  AAALAC certification status
d.  The CRO’s approved animal use protocol number for the procedures to be
      performed. 
e.  The UM PI on the project submits an IACUC Animal Use Protocol (AUP) which
      details
4.  The UM IACUC will review the AUP and the CRO information for completeness. 
     Further information may be requested before the UM AUP goes through the
     normal channels of approval (DMR or FCR)

B.  PI Responsibilities
When informed of any serious incidents of animal welfare concern or non-compliance issues such as incidents reported to the CRO’s IACUC or external regulatory agencies, the PI will report them promptly to the UM IACUC.

C.  If the UM IACUC has significant concerns about the welfare or humane treatment of
      animals at the CRO, if there is evidence of loss of accreditation, citations by
      regulatory agencies or other such significant events, the UM IACUC may require
      additional details from the PI or CRO or revoke approval of the use of the CRO.