Submission & Review Process
The length of the approval process is influenced by several varying factors, such as the number of protocols submitted to OAW during that review cycle (see calendar) and complexity of protocols. Other factors, such as the completeness of documentation, can be guided by you and will hasten the process.
The information on this page is intended to assist you in completing the forms properly. In all circumstances, early submission combined with accurate documentation will result in an expedited approval.
Your protocol documents may be submitted in hard copy or as a PDF file sent to email@example.com.
Protocol Review Cycle
STEP 1 - Administrative Review
The protocol review cycle is comprised of five phases or steps and may iterate through these steps, if additional revisions are requested by the IACUC. The protocol review work flow is provided in this flow chart and explained in the following sections.
The Administrative Review is done by staff at the University’s Office of Animal Welfare. It is a quick check of the documents for completeness, such as proper signatures, and a chance for OAW to inform the applicant of any additional requirements, such as special staff training or occupational health enrollment. Because of this initial review, the Principal Investigator can begin working on any unfinished protocol requirements while the paperwork is moving towards IACUC review.
Next step: IACUC Review
STEP 2 - IACUC Review
The IACUC reviews the protocol to ensure compliance with applicable regulations. IACUC reviews begin in two week cycles throughout the year (see calendar). During this review, IACUC members submit any questions and comments to the OAW staff, which are then forwarded, by email, to the applicant (Principal Investigator.) The PI needs to respond to questions within two weeks to avoid delays in processing the application.
Only IACUC members can request that a protocol move to a Full Committee Review (FCR). This additional review can happen for a number of reasons, including death as an experimental endpoint, unrelieved pain or distress or unsatisfactory responses to questions asked by the IACUC.
Next step: PI Revision(s)
STEP 3 - PI Revision(s)
The PI responds to the IACUC review questions by revising their protocol and sending this revision to OAW. The PI is asked to submit the response within two weeks. Reminder notices are sent if the paperwork is not forwarded in a timely manner. After the revisions are received, an OAW scientist will review them. The PI may be asked to revise the protocol again or answer additional questions. When all of the pertinent information is gathered, the OAW scientist will consult with the IACUC to determine whether the protocol moves to a Designated Member Review (DMR) or a Full Committee Review (FCR.)
Next step: Designated Member Review (DMR) or Full Committee Review (FCR)
STEP 4a - Designated Member Review
Federal regulations state that all protocols are approved by a Designated Member of the IACUC or Full Committee Review (FCR). The IACUC has appointed three Designated Members. The OAW scientist presents the protocol with revisions to a Designated Member reviewer, who may have additional questions for the PI. The Designated Member reviewer works with the PI on the final revisions and either approves the submission or sends it to FCR. Most protocols are approved by the DMR process.
Next step: Approval or Full Committee Review
STEP 4b - Full Committee Review
A submission may be referred for a Full Committee Review (FCR) during either the IACUC Review (Step 2) or the DMR (Step 4a.) The FCR is a legal obligation whenever it is requested by any single IACUC member.
Full Committee Reviews occur during the monthly IACUC meeting. These IACUC meetings may be canceled due to lack of quorum or other reasons (see calendar.) Examples of situations that may warrant a FCR include: death as an experimental endpoint, unrelieved pain or distress.
The FCR can result in additional questions and follow up with the PI which may add to the length of the review process. The committee can approve the protocol, deny approval, or require modifications for final approval. If modifications are needed the committee can turn it over to a Designated Member to work with the PI to make final revisions. The committee can also require that the revision be reconsidered at another convened meeting. The latter is very rare. Usually a Designated Member is chosen to help the PI make final changes and then the Designated Member approves the protocol.
Next step: Approval or follow-up with PI with FCR questions and/or comments or denial
STEP 5 - Approval
When a protocol is approved, the OAW sends notification to the PI via email. Included in the email is a PDF of these important documents: a signed protocol approval letter, a copy of the protocol documents and a Protocol Profile Report.
The Protocol Profile Report details key information on the protocol, including:
Annual Renewal Process
Protocols must be renewed annually. The OAW notifies the PI three months before the protocol expiration date, which allows for the renewal paperwork to be prepared and submitted. OAW must receive the renewal form 4 weeks before the annual expiration date to allow IACUC time for review and re-approval.
PI's are sent reminder notices, as follows.
Please do not be surprised if you receive an annual re-approval letter with a future approval date. By law, IACUC is permitted to review an annual renewal up to 30 days prior to the annual anniversary date and is permitted to assign the anniversary date as the re-approval date.
Three Year Renewal Process
Regulation requires a complete re-review of your protocol every three years. OAW notifies the PI three months before the protocol expiration date, to allow for the renewal work to be prepared and submitted. OAW must receive your three-year renewal 8 weeks prior to the expiration date to provide OAW and the IACUC adequate time to review and approve your submission
PI's are sent reminder notices, as follows.
Keep in mind, regulations require animal work to stop at the end of three years if the protocol has not been re-approved. By law, administrative extensions of any period of time are not allowed. Therefore if your three year renewal is exceptionally complex, it is strongly recommended to submit the renewal sooner than 8 weeks. Please contact OAW in advance, if you have questions.