Review Procedures and Timelines
There are several factors that determine the length of time between submission and final approval. Initially, all submissions are screened for completeness. If any necessary information is missing the Principle Investigator (PI) is notified via email and the submission is held from IACUC review until all requested items are received and/or completed.
Once completeness of the submission can be verified, there are two methods by which it may be reviewed:
- Full Committee Review (FCR)
Any protocol or amendment that involves unrelieved pain or distress (including certain types of restraint), death as an endpoint, multiple major survival surgeries, major survival surgery on a USDA-covered species (all mammals excluding mice of the genus Mus and rats of the genus Rattus bred exclusively for research), or any use of non-human primates must undergo FCR. Full (Convened) Committee reviews are typically held the 3rd or 4th Friday of each month and the deadline for submission for FCR is usually the 1st or 2nd Wednesday of each month. Consequently, one can expect at least a few weeks to pass between submission of a protocol or amendment and the IACUC review if the submission meets any of the criteria for FCR.
- Designated Member Review (DMR)
If the protocol or amendment does not involve any of the mentioned criteria for FCR, it may be reviewed via the DMR process. Typically, any submission qualifying for this process that is received by Thursday of any given week will be sent out to the IACUC reviewers on Friday of that same week. Submissions sent out in this way are held for five business days (until the following Thursday) to allow for any IACUC member to call for a Full (Convened) Committee review of the submission. If no such request is made, the DMR review occurs and the PI is usually notified on that Thursday or Friday if the item has been approved or if it requires further information or clarification. As a result, a submission can potentially be reviewed within a week of receipt if it does not meet the criteria for FCR.
Once IACUC review of the submission has occurred, the outcome of the review determines the remaining length of the review process. The outcomes are as follows:
Outright approval is achieved when the IACUC has concluded that no additional information or clarification is required to approve the submission. An investigator of a submission that has been outright approved will receive an approval letter via email shortly after the date in which the submission was reviewed by the IACUC.
- Requires Further Information:
“Requires Further Information” occurs when the IACUC has decided that clarification or additional information is required before the submission can be granted IACUC approval. An investigator of a submission requiring further information will usually receive an email detailing the required additional information shortly following the day of IACUC review. Once the PI has submitted a response to the IACUC Office, the IACUC Office will forward the response to the IACUC for review. Usually, the PI response can be handled through the DMR process, yet occasionally, the response must be reviewed at the next convened meeting. If the response is processed via DMR, the IACUC Office can usually expect to hear back from the IACUC within one or two days. In turn, the PI can expect to hear from the IACUC Office regarding the review of the response shortly after. If the PI response requires review via FCR, the IACUC will complete the review of the response at the next scheduled convened meeting.
Very rarely the IACUC decides that a submission requires such an extent of clarifications or modifications that it is best to have the submission re-written and re-submitted, known as a deferral. In this instance, an IACUC member is most often assigned to aid the PI in completing a revised submission. Submissions that are deferred and re-submitted are reviewed at the next scheduled convened meeting following receipt at the IACUC Office.
In the event that a submission is disapproved by the IACUC, the IACUC Office will notify the PI and provide further instruction as to how to re-submit to the IACUC if so desired.
The total length of time between the submission and final outcome of any submission relies heavily on the initial review outcome; outright approvals are processed immediately, while requests for further information or deferrals will at least require subsequent response by the PI and additional review by DMR or FCR processes.
Therefore, an item can be approved as quickly as within a day of the scheduled review time or it may be delayed by days or weeks, depending upon the number and nature of clarifications/requirements requested, and speed of the investigator’s response.