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Policy#: 529-225

Title: AUP PROCEDURES: Custom Antibody Production Using Animals at Off-Campus Facilities

Effective: 2/8/2021

Link: http://redit.ucr.edu/OrApps/RED/Policies.aspx?k=135

Background

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

Process

UCR investigators wishing to contract with an external entity to produce custom antibodies must complete the Custom Antibody Production Agreement form. This agreement replaces the standard UCR IACUC AUP form for the use of animals and should be submitted to iacuc@ucr.edu. 

The Office of Research Integrity will contact the Contract Laboratory to request their Animal Use Registration/Animal Welfare Assurance documentation and applicable vertebrate animal protocols. In order to be eligible to produce custom antibodies for UCR, the contract laboratory animal facility must maintain USDA registration (if applicable) and an Animal Welfare Assurance. Foreign institutions without an Animal Welfare Assurance may be approved by IACUC review if they are AAALAC accredited. 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.)

The Custom Antibody Production Agreement form will be reviewed by the IACUC Chair and Campus Veterinarian. The “Custom Antibody Contract – Laboratory” form will be reviewed by the Office of Research Integrity. Any forms indicating a lack of USDA Registration, lack of Animal Welfare Assurance and/or unusual procedures will be referred to the IACUC.

COMPLETION OF UCR ANIMAL CARE AND USE TRAINING

For investigators whose only animal use activity is contracting for off-campus production of custom antibodies, the completion of UCR animal care and training prior requirement is waived.

ENROLLMENT IN THE ANIMAL OCCUPATIONAL HEALTH AND SAFETY PROGRAM

For investigators whose only animal use activity is contracting for off-campus production of custom antibodies, the requirement for enrolling in the animal occupational health and safety program has been waived. 
Originally Adopted: 6/10/2010


NIH Office of Laboratory Animal Welfare, Report Number 95-02 (https://grants.nih.gov/grants/olaw/references/dc95-3.htm) and FAQ A.2: Does the PHS Policy apply to the production of custom antibodies or to the purchase of surgically modified animals?