Guidance on Working with Subcontractors of Animal Research:
As the Principal Investigator of a primary grant or contract awarded to WFU, who is subcontracting animal research to an institution other than WFU, you are responsible for monitoring the appropriate use of animals at the subcontracting facility. The following is provided to assist you in this task.
1. The subcontracting institution must officially agree to terms similar to the language below in either the subcontract itself or by some other means.
“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 at 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. The subcontractor must complete the form, WFU Subcontracted Research Involving Animals Form.doc, for you as the PI to retain in your files. If the subcontracting facility is either foreign (answers YES on Item 6.e), NOT PHS Assured (NO on 6.b) or NOT AAALAC accredited (NO on 6.a), the WFU PI must submit a copy of the form to the WFU IACUC for review and approval.