Animal Care and Use Protocols must be approved by the IACUC before any activities (research, teaching, or testing) are conducted on live, vertebrate-animals. The IACUC's typical turn-around time is less than six weeks.
Protocols are submitted to the IACUC through the IACUC's online protocol system. the Principal Investigator (PI) can authorize certain personnel to initiate a protocol, but it is always submitted in the PI's name. The PI is notified when a new protocol is submitted to the IACUC, irrespective of who submitted the protocol on behalf of the PI.
The online protocol system will present a customized protocol form to the investigator based on the information provided by the investigator when beginning to complete a protocol. For example, if a protocol will not involve surgery or painful procedures, there will not be a box about analgesics. The PI and alternate contact can make revisions to the protocol while the rest of the personnel on the protocol roster have view only access.
Amendment to Protocol
If you need to make minor changes to a currently approved protocol, you can file an amendment using the online form, rather than submit an entirely new protocol. Changes to the protocol need to be approved by the IACUC prior to being implemented. Conducting procedures not approved in your protocol may lead to suspension of your protocol. The IACUC's typical turn-around time for amendments is less than four weeks.
Protocol and Amendment Review Process
Once a protocol or amendment is received by the IACUC office it is assigned to an IACUC staff member and a Veterinarian. Questions from this review are sent to the PI and Alternate Contact listed on the protocol via email. Once the questions have been responded to and reviewed by IACUC staff, either more questions will be sent by the IACUC staff member for further clarification or the protocol or amendment will be placed on the next IACUC meeting agenda as either a Full Committee or Designated Review assignment. In either case protocols and amendments are assigned to a primary and secondary reviewer. IACUC meetings are scheduled every-other Thursday, although assignments may only be added to the next agenda up until one week before the meeting. If the protocol or amendment is assigned for Full Committee Review (protocols and amendments that involve survival surgery, selected non-human primates procedures and category E procedures) it will voted on at the assigned IACUC meeting. If the amendment is assigned for Designated Review, it must remain on the agenda for two business days so that all members of the IACUC have a chance to review the protocol or amendment and request Full Committee Review if they wish. After the 48 hour waiting period the protocol or amendment may be approved if both the primary and secondary IACUC members approve. However if there are any IACUC reviewer questions they will sent to the PI and Alternate Contact via email. Once the responses are reviewed and approved by the designated reviewers, the protocol or amendment can be approved.
Protocol Personnel Rosters
In order to add a person onto a protocol roster, that person must first meet the ACU 101 training requirement as well as enroll in the Occupational Health program for animal care and use. If these two requirements are not met, that person cannot be added onto a protocol's personnel roster. The IACUC's typical turn-around time for roster modifications is a few days.
Protocols and Grants
Most, but not all, granting agencies accept grant applications before the protocol has been approved by the investigator's IACUC. If your protocol has been submitted, but is not yet approved, indicate to the granting agency that the protocol is "pending". NIH and NSF normally allow sixty days for protocol approval after the deadline date for the grant. If no approval from the IACUC follows within sixty days of the deadline date for the grant application, the agency will normally discard your grant application.
Some funding agencies (such as American Heart Association) require a corresponding IACUC-approved protocol before the grant application is submitted. Investigators are responsible for knowing the requirements of their particular agency.