There are several items that should be included in your submission, along with the ASP and section forms. Frequently, these items are inadvertently omitted, which can slow down the approval process. Please see below for a list of those items that must be included for a protocol to be approved.
- Personnel Qualifications Form
All personnel performing research, training or testing activities with animals must be named as key personnel on the research protocol. A Personnel Qualifications Form (PQF) for each individual listed on the protocol must be submitted with the initial protocol submission and/or with subsequent personnel amendments. This form indicates the skills and expertise the individual has or needs training for, in order to perform work on the protocol. Dates of training completion and Occupational Health Program enrollment must be provided on the PQF (see below). The PQF can be found on IRBnet, under Forms and Templates. When adding personnel to an existing protocol, the online ASP form must be updated to reflect the new personnel working on the project.
- Animal Users Training documentation.
Prior to approval of either new protocols or personnel additions to existing protocols, all key personnel must complete the PI/Animal Users Training course, which provides users with a comprehensive understanding of the laws, regulations, local policies and procedures associated with performing research with animals. All personnel must take refresher training every 3 years.
- Occupational Health Program Enrollment
All personnel working on animal research must submit the Animal Handler’s Risk Assessment form to the University Health Center Occupational Health unit (See also “Occupational Health”). Specific questions regarding occupational health may be addressed to the University Health Center, or the Occupational Health Physician.
- ESSR approvals and training documentation for the use of hazards
At the time of submission, new protocols must include approved ESSR registrations for the use of hazards (e.g., biologicals, radiation) and any associated training (e.g., BSL2, BSL3). The same documents should be submitted for any amendment adding new regulated hazards.
All submissions must be signed by the PI, and new protocols must be signed by the department chair and the facility manager. These signatures ensure that the appropriate resources (housing, husbandry staff, etc.,) are available for the animals that will be housed under the protocol. These signatures are required for protocol approval.
- Protocol Review Worksheets/Checklists and Regulatory Source Language
The Protocol Review Worksheet is a tool to help the IACUC committee review protocols. PIs can use this worksheet to help ensure that their protocol package is complete. The Regulatory Source language Worksheet shows which federal policies, regulations, and guidelines the IACUC uses during protocol review.
Protocol Review Worksheet
Regulatory Language Protocol review