Many of us doing research with animals have been frustrated with, or confused by, the process of making amendment to protocols. I feel your pain — but I’ve got good news. The IUSM IACUC has approved changes to speed up approval of relatively simple amendments, which can be approved by IACUC leadership within three days.
There are now three levels of amendment review available — and note that you can include as many changes as you need in one amendment. You do not have to submit one amendment per change. Repeat: You do not have to submit one amendment per change.
So here are the levels of amendments, starting with those with the shortest turnaround time:
1. Administrative – These are changes the IACUC staff can approve within 2 days in consultation with the IACUC chair and/or their designee. Administrative amendments include:
- Addition of another strain or genetic background of the same animal species
- Changes in title of protocol
- Change in funding source
- Addition of a qualified student or technician
- Addition of faculty collaborator
- Change in sex of animal to be used
- Small increase (<10%) in the number of animals used
- Change in animal care facility, housing unit, or field site
2. IACUC Leadership Review (ILR) – This is a two to three-day review for minor amendments — modifications to approved activities that aren’t considered significant. Like these:
- Request to repeat an experiment
- Addition of a procedure to be performed on an already anesthetized animal
- Addition of non-invasive sampling
- Addition of sample collection times
- Change in administration of treatment/observation as it relates to timing, dose, route of administration, and/or specific chemical composition
- Change in anesthetic agent
- Addition of testing compound of similar drug class as previously approved
- Refinement in techniques
3. Designated Member Review (DMR) – You need this for significant modifications of approved activities, i.e. those not included above. This is a two-week review by designated members of the IACUC committee. Please note that any necessary approvals by other compliance committees could extend the time to approval. However, if you’re facing an unusual time crunch that demands faster action, explain the situation to the IACUC staff and ask for an expedited review.
Finally, when you submit an amendment, please let the IACUC staff know in what category you believe it belongs.
Questions? Contact the IACUC office at 278-1274 or email@example.com.
And big thanks to the IACUC team, including Chair Joe Unthank and LARC Director Deb Hickman.