I: Background and Purpose

If UCR investigators wish to contract with external institutions (public or private) to generate custom antibodies, federal regulations require UCR to confirm that the other institution has appropriate vertebrate animal procedures and regulatory approvals in place.

II: Related Policies and Guidance

• Policy: 529-263 Tumor Production in Rodents
• Policy: 529-266 Use of Tumors, Cell Lines, and Other Biological Materials in Rodents

 

III: Policy

A. UCR investigators wishing to contract with an external entity to produce custom antibodies must submit an AUP using UCR's electronic protocol database. The AUP is specific to outsourced antibody production and cannot be combined with an experimental AUP.

B. To be eligible to produce custom antibodies for UCR, the contract laboratory animal facility must be AAALAC-accredited, maintain USDA registration (if applicable), and have an Animal Welfare Assurance.

 

C. To confirm these requirements, the PI must contact the contract laboratory and confirm they are AAALAC-accredited, request their OLAW Animal Use Registration number, the vertebrate animal protocol associated with antibody production, and the USDA license information (if applicable). Any documents provided to confirm these approvals will be added to the AUP.

 

D. Foreign institutions without an Animal Welfare Assurance or a USDA license may be approved by IACUC review if they are AAALAC-accredited.

 

E. US facilities without an Animal Welfare Assurance may be approved by IACUC review if they are AAALAC-accredited, and if allowable by the funding source (e.g., PHS funds require such facilities to maintain an Animal Welfare Assurance).

F. The IACUC Office will review the submitted AUP, and if all documentation is provided, the AUP can be approved administratively. Institutions that utilize USDA-covered species, but lack USDA Registration or Animal Welfare Assurance, or perform procedures inconsistent with UCR’s animal welfare standards, will be referred to the IACUC Chair and Attending Veterinarian for review.

 

G. Investigators whose only animal use activity is contracting for off-campus production of custom antibodies are waived from completing IACUC training. Occupational Health clearance may also be waived pending EH&S approval.

 

Approved on: 6/10/2010; Reviewed on 2/08/2021; Revised on 11/10/2025