According to the Public Health Service (PHS) Policy, generation of custom antibodies is considered vertebrate animal work if the antibodies are “produced using antigen(s) provided by or at the request of the investigator (i.e., not purchased off-the-shelf)” (Frequently Asked Questions, Applicability of the PHS Policy, Question #2).
If you are submitting a proposal to PHS agency (e.g., National Institutes of Health or NIH) to use a custom antibody or transferring a custom antibody via Material Transfer Agreement (MTA) using funds from a PHS agency:
- The distributing institution or company must have a PHS Approved Animal Welfare Assurance number or be included under UC Berkeley’s Assurance.
- If “species covered by the Animal Welfare Act are utilized, the producer [of custom antibodies] must be registered as a “Research Facility” with the U.S. Department of Agriculture (USDA)” (OPRR Report on Sources of Custom Antibody Production.
Procurement of Custom Antibodies using Grants, Contracts, and Cooperative Agreements
Writing the Proposal: Regardless of the type of producer (e.g., company or institution), you will need to fill out the appropriate vertebrate animal sections (e.g., on the cover page, Research & Related Other Project Information page) of your proposal:
- Check the box indicating that you will use vertebrate animals.
- Enter “Pending” or “Planned” for the IACUC date.
- Fill out and submit a Vertebrate Animal Section (VAS). In the case of companies, a VAS can be specific to the company or more generic. If you know what company you intend to use, the company may be able to help you with the completion of this section. It is important to note that naming a specific company does not allow you to use any other company for the duration of your grant. If you do not want to “lock” into a company (i.e., you don’t know which one will be able to make your antibodies at the time of submission), you should submit a more generic VAS. (NOTE: For proposals where use of custom antibodies is the only vertebrate animal work being done, the applicant must still complete all of the appropriate vertebrate animal sections, including the VAS.)
Proposal/Animal Use Protocol (AUP) Comparison: The comparison process is the same as outlined under Grants, Contracts and Cooperative Agreements with the addition that the lead or mentor UC Berkeley Principal Investigator (PI) will be asked to provide the name and PHS Approved Animal Welfare Assurance number of any company/institution generating custom antibodies. If the institution or company does not have an Assurance number, the custom antibody cannot be used in animals, in vitro or in vivo. Another company/institution with an Assurance number must be chosen as a replacement.
Verification of Animal Care and Use Committee (ACUC) Approval: As outlined under Grants, Contracts and Cooperative Agreements, the Office for Animal Care and Use (OACU) will draft and send an IACUC certification letter to the lead PI and copy Sponsored Projects Office (SPO) if all procedures, including the creation of custom antibodies, are included as approved in the applicant’s AUP or that of a Co-Investigator at another institution. If all procedures are not included, a revision must take place in order for OACU to provide ACUC verification documentation.
If a company is providing the custom antibody, the applicant must request an approval letter from the company. This request cannot come from SPO or the OACU. This letter should contain the company’s name, PHS Approved Animal Welfare Assurance number and most recent date of protocol approval. The letter should be sent directly to SPO, not to the OACU.
If animal work is being done by an institution in addition to a company creating custom antibodies, two letters of verification must to be given to SPO: The IACUC certification letter for the animal procedures (provided by OACU) and the company’s approval letter for the antibodies (provided by the PI).
Procurement of Custom Antibodies using Material Transfer Agreements (MTAs) and Sponsored Research Agreements
As stated above, custom antibodies acquired via Material Transfer Agreement using PHS funds must have a PHS Approved Animal Welfare Assurance number or be included under UC Berkeley’s Assurance. If the institution or company does not have a PHS Approved Animal Welfare Assurance number, the custom antibody cannot be used in animals, in vitro or in vivo.
However, if PHS funds are not used (e.g., use of startup or internal funds), the distributing company or institution does not need a PHS Approved Animal Welfare Assurance number. It is important to note that custom antibodies acquired using non-PHS funds cannot be used in proposals or grants funded by a PHS agency.
ACUC Verification Process: Please refer to the Material Transfer Agreements and Sponsored Research Agreements page for details.