All protocol submissions in HoverBoard go through the workflow displayed in the figure below. This workflow is displayed in the submission workspace for every submission, so there is constant visibility for all users as to where the item is in the review process.
The length of the review process, from submission to approval, depends on several factors. These factors include the complexity of the protocol/amendment, the responsiveness of the research group to questions, and the completion of required ancillary reviews (for example, if a new or updated Biological Use Authorization (BUA) is required, the IACUC protocol item cannot be approved until the BUA is approved).
Here are the average number of workdays (median over a 6-month period) from submission to approval, and how early the items should be submitted, based on past metrics. Note: Please allow additional time for more complex protocol items.
| Submission Type | Median Workdays | Recommended Submission Timeframe |
|---|---|---|
| Amendments | 23 | At least 4-6 weeks (20 – 30 workdays) prior to when approval is needed |
| New Protocols | 58 | At least 10 weeks (50 workdays) prior to when approval is needed |
| Triennial Reviews | 41 | At least 6-8 weeks (30-40 workdays) prior to protocol expiration |
Protocol Submission Workflow
Duration
Indefinite
What happens
Items in pre-submission have been created by the research group, but they have not yet been submitted for review. The Office of Animal Welfare and IACUC are unaware of items in pre-submission unless they are directly notified by the research group. An item can stay in pre-submission indefinitely.
Investigator’s responsibility
Once the item is ready to be submitted, the PI or a PI Proxy must use the Submit button on the left side of the submission’s workspace to move the item forward into Pre-Review.
Duration
On average 2 weeks for amendments and 4-5 weeks for new protocols and triennial reviews, but highly variable depending on the complexity of protocol item and responsiveness of the group to pre-review questions.
What happens
Every submitted protocol item goes through pre-review. The initial step is an administrative pre-review, where it is determined if the item requires IACUC review. All new protocols, annual reviews, and triennial reviews must be reviewed by the IACUC, but some amendments qualify for administrative approval (e.g. adding or removing personnel). Please see the IACUC Policy “Review and Approval of Protocol Amendments“ for more information.
If the item requires IACUC review, it then goes through a mandatory comprehensive pre-review by a Scientific Reviewer within OAW, as well as a mandatory veterinary pre-review. The purpose of the pre-review is to make sure the item is complete and meets all regulatory and institutional requirements. Most questions and revisions occur during this phase.
Investigator’s responsibility
The investigator should be ready to respond to pre-review questions. These are entered as Reviewer Notes during Pre-Review and are available for responses and revisions when the IACUC Coordinator assigns the item to a Clarification Requested state.
Duration
Generally 1 week, plus time necessary to address IACUC questions, UNLESS full committee review is requested in which case duration in this state depends on timing of the next committee meeting and the decision of the committee.
What happens
During this phase, the protocol item is under the review of the IACUC. The majority of protocol items are submitted to the IACUC for on-line review within the HoverBoard system, for approval via the Designated Member Review (DMR) process. Items are sent out every morning in a packet, and the IACUC is typically given one week (5 business days) to access the item and add questions. At the end of the one week period, any IACUC questions are then sent to the research group (Clarification Requested). Once all IACUC questions have been adequately addressed and the response has been submitted by the research group, an assigned IACUC member conducts a final review and submits their decision.
Occasionally, Full Committee Review (FCR) of a protocol item is requested. As required by regulation, all IACUC members have a right to request FCR of any protocol item that is currently under review. The item must then be reviewed at a convened meeting of the IACUC, which occurs once per month.
Investigator’s responsibility
The investigator should be ready to respond to questions from the IACUC. These are entered as Reviewer Notes during IACUC Review and are made available for responses and revisions at the end of the IACUC review period, when the item is assigned to a Clarification Requested state.
Once the responses and revisions have been made in the system, the Submit Response activity must be used to return the item to IACUC Review.
Duration
Generally less than 24 hours, unless there are outstanding holds on the protocol item.
What happens
Post-Review is generally a brief administrative phase, in which the IACUC Coordinator confirms that all required reviews have been completed and there are no outstanding holds on the item (e.g. Biosafety Hold, Radiation Safety Hold, or Occupational Health Hold).
If an item is in Post-Review for an extended period of time and you aren’t sure why, please contact your Scientific Liaison or the OAW office (oawrss@uw.edu) for clarification.
Investigator’s responsibility
Generally no action is needed on the part of the investigator during this phase. However, if the item has a hold, it may indicate that a partner department (e.g. Environmental Health & Safety) is waiting for investigator action. The investigator will be directly contacted by OAW or the partner department if this is the case.
Duration
Permanent
What happens
Items enter this phase once a final action has been taken on that item, which generally means the item was either Approved or Discarded. After entering the Review Complete state, a protocol item cannot be returned to a previous state.