The Life of a Protocol
Humble Beginnings
So just what happens to a protocol as he makes his way through the proverbial "red tape" on his way toward IACUC approval?
Exactly how many hands does he pass through and just WHY does it sometimes take weeks for him to wear the proud title of "Approved Protocol"?
Let's follow him along his path. Hopefully by doing so you will understand a little better what exactly we do here in the IACUC office and who all has a hand in getting your protocol approved.
Meet Persephone Ingnatz
Brilliant scientist, Persephone Ingnatz (hereafter referred to as simply PI) has an idea for a new study that will further her research.
Because this study involves the use of animals, PI knows that she must submit an animal use protocol with the IACUC before the lab can begin any work on her ground breaking idea.
Since the most recent versions of the protocol review forms are always kept on the IACUC website, PI runs to her computer and downloads the latest version of the necessary forms and associated attachments from the IACUC Forms page.
Once PI has filled out the protocol submission form and associated attachments everything is sent off electronically to the IACUC office (iacuc@illinois.edu) where the review process will begin.
Formal Review Process
Once the protocol reaches the IACUC offices here in the Observatory the formal review process begins.
Approval of a new protocol usually takes between two and six weeks, depending on how quickly the PI replies to questions by the IACUC and whether or not the protocol needs to go to Full Committee Review.
The protocol is initially given a once-over by one of the IACUC Specialists.
The IACUC Specialists make sure that all the questions on the protocol form are answered appropriately and that the correct attachments (if needed) are filed with the protocol.
At this point, the protocol submission is logged on our office wall so that we can visually track its progress step-by-step until it is actually approved.
IACUC Specialist Recommendations
If the IACUC Specialist finds that there are unanswered or inappropriately answered questions in the protocol submission the protocol is sent back to the PI with a list of recommended changes.
The recommendations of the IACUC Specialist will help the protocol get through the formal review process more quickly.
Once the PI has made the recommended changes (or declined to do so) and sent the protocol back to the IACUC office it is sent out to the committee members for review.
Ready For Review
Once a protocol is ready for review it is sent out to several members of the IACUC committee. The protocol is sent to a primary reviewer that is a member of the IACUC committee and a veterinary reviewer (or a panel of veterinary reviewers).
The reviewers read through the protocol to make sure that the animal work is well described that all work described complies with both federal and campus regulations.
Reviewer's Questions
If either or both of the reviewers have questions for the PI about the protocol their comments and questions are sent through the IACUC office back to the PI.
The PI answers the questions both in the body of the email and clarifies the wording in the body of the protocol itself (using the most recent version of the Word document). Everything is sent back again to the IACUC office where it is redistributed to the reviewers.
Weekly List
After a protocol has been reviewed by primary and veterinary reviewers and all of their questions have been answered the protocol is presented to the entire IACUC.
Once a week (usually on Friday) all the members of the IACUC are sent a listing of all the protocols that have successfully gone through pre-review and primary review. Each member of the committee is asked to review all the protocols and are then asked to either submit further questions for the PI, call for Full Committee Review of the protocol or to indicate that they approve of the protocol.
If any of the IACUC members have questions for the PI about a protocol on the weekly list their comments and questions are sent through the IACUC office back to the PI.
The PI answers the questions both in the body of the email and clarifies the wording in the body of the protocol itself (using the most recent version of the Word document). Everything is sent back again to the IACUC office where it is redistributed to the committee member(s) that had questions about the protocol.
Full Committee Review (FCR)
Under certain circumstances a protocol will have to go to Full Committee Review (FCR) for discussion and approval. In most cases the protocols that are flagged for FCR are those where exceptions to The Guide are being requested by a PI.
The IACUC meets once a month (usually the first Tuesday of each month) and part of the meeting's agenda is always discussion of those protocols that need Full Committee Review.
The IACUC discusses those protocols brought to the monthly meeting to insure that when exceptions to The Guide are made that they are scientifically justified.
The committee votes on the protocol after discussion and it is then either approved or sent out for more questions to the PI. After those questions are answered the protocol can either be approved by Designated Review (usually by the IACUC chair) or sent back to the IACUC for a vote.
Almost Approved
Once the Committee has approved a protocol it comes back to the IACUC office once again for a final check.
The IACUC staff ensures that the PI has completed all the steps necessary for formal approval of the protocol. This includes making sure that, if needed, all of the following have been completed or updated:
When all of the required forms are attached to the protocol the PI has ONE more step before the protocol is formally approved!
Signature
Once all other requirements for approval have been met, the IACUC office sends the PI a document to sign as an assurance that the protocol is complete and that all regulations and policies regarding animal use and care will be followed.
At this point the protocol is approved. Good Job Persephone!