As the Wake Forest Principal Investigator, you are responsible for the appropriate use of animals - even at the subcontracting facility. How?
1. Use the right language in the subcontract
The subcontracting institution must officially agree to the language and terms below, or something similar. The Office of Sponsored Programs negotiates subcontract language.
All animal work at subcontractors will be reviewed and approved by an appropriate Institutional Animal Care and Use Committee (IACUC). Wake Forest University (WFU) will provide the oversight monitoring of the animal research performed at its direct subcontractor (SUB), as required by the granting agency, federal regulations and accrediting bodies.
The WFU Principal Investigator (PI) will confirm that the project has been reviewed and approved by the SUB’s IACUC, or other appropriate body, at the outset of the project and at least annually thereafter. Protocol amendments will be reviewed and approved by the SUB’s IACUC prior to the start of work. Any significant deficiencies noted by the SUB’s IACUC or SUB’s PI at semi-annual inspections or any other time that directly affects the study protocol or welfare of the study animals will be communicated in a timely manner to the WFU PI.
SUB will communicate serious and continuing noncompliance with U.S. federal animal welfare regulations to the WFU PI in a timely manner. Changes in status of Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation or Public Health Service (PHS) Assurance must be provided to the WFU PI in a timely manner. SUB will ensure that secondary subcontractors to SUB, under this subaward that perform research on live vertebrate animals, are accredited by the AAALAC. If secondary subcontractor is not AAALAC accredited, then SUB will treat the secondary subcontractor as an offsite facility and provide appropriate oversight, including consideration of site visits to secondary subcontractor.
2. Instruct the contractor to complete this form prior to starting work
Subcontracted Research Involving Animals Form
i. As the PI, retain:
i. The form above
ii. The approval letter from the subcontractor's IACUC, or equivalent
ii. Notify the IACUC if the subcontracting facility is:
i. foreign (answers YES on Item 6.e),
ii. not PHS Assured (NO on 6.b), or
iii. not AAALAC accredited (NO on 6.a)
Query the subcontractor at least annually
Contact the subcontractor each year to confirm that they are complying with the terms in the subcontract, as defined above.
i. You should receive notification from the subcontractor when:
i. modifications are approved by the subcontractor’s IACUC, or equivalent.
ii. annually at the renewal of the subcontractors IACUC approval
ii. Contact the WF IACUC immediately, if the subcontractor reports any of the following:
i. safety events or animal welfare concerns,
ii. noncompliance with animal welfare regulations,
iii. relevant facility problems, or
iv. change in status regarding the USDA, PHS Assurance or AAALAC accreditation.