PI Notification

PIs are notified regarding continuing review and 3-year review deadlines via e-mail two months prior to the protocol expiration date. PIs also receive periodic reminders as the expiration date draws near, giving the PI an opportunity to submit his/her continuing review for the next IACUC meeting prior to protocol expiration.

Annual Review

New protocols have a maximum duration of three years, but are approved for one-year intervals.
The PI will need to complete the IACUC Continuing Review Form completely and submit to IACUC@marquette.edu.
All approved protocols will be reviewed annually by a designated member review.
Procedures for full committee review are similar to those for new protocols.
If approval of the annual review cannot be given before the expiration date of the protocol, the PI will be notified in writing by the Office of Research Compliance that animal activities associated with the protocol must stop after the expiration date and that any animals currently in the facility will be maintained by ARC staff until the annual review protocol is reviewed and approved by the IACUC. If the annual review submission is not received prior to the expiration date, the PI must submit a new protocol for review and approval.

3-Year Review/Renew

After three years from initial approval date (three-year renewal), a new protocol must be submitted by the investigator. If the new protocol cannot be approved before the expiration of the previous protocol, the PI will be notified in writing by the Office of Research Compliance that animal activities associated with the previous protocol must stop until the new protocol is approved.

Modification of IACUC approved Protocol

Investigators must submit amendments to protocols for changes in animal activities. The best way to submit this change is to take the existing IACUC approved protocol and highlight the changes that are modified to the protocol. This will allow the IACUC reviewers to distinguish what they modifications are. Once the modifications have been made submit the protocol to IACUC@marquette.edu.
Major changes will be reviewed by a Designated Member Reviewer, unless it is requested that the modification be sent to full committee review.
Minor changes will be reviewed by the IACUC Chair or Veterinarian.
The Chair or the Veterinarian will make the determination as to whether a modification is major or minor.
Examples of major (significant) changes.
- changes in the objectives of a study
- proposals to switch from non-survival to survival surgery
- changes in the degree of invasiveness of a procedure or discomfort to an animal
- changes in species or in the number of animals used by more than 10%
- changes in anesthetic agent(s), the use or withholding of analgesics, and methods of euthanasia
- changes in the duration, frequency, or number of procedures performed on an animal
Procedures for full committee review of major modifications are similar to those for new protocols.

What is Designated Review?

Designated review is a protocol review procedure conducted by one or more reviewers, rather than by the full committee.
Designated reviewers are IACUC members who are appointed by the IACUC Chair.
The designated reviewer assumes the responsibility of the full committee in granting approval, requiring modification, or sending the protocol for full committee review.
The designated review and approval has equal validity to full committee approval and does not require subsequent re-approval by the full committee.
Designated review is the default review process for all continuing reviews and protocol modifications unless the IACUC determines otherwise. Full review is the default review process for all new protocols and three-year reviews.
The following procedures will be followed when a continuing review or modification to a protocol is received by the ORC

The ORC will send a copy of the protocol to all IACUC members for initial review.
Members will have five (5) business days to review the protocol. If any IACUC member objects to designate review, the protocol will go to full review. A non-response at the end of the five days is considered agreement with the designated review process.
If no member objects to designated review, the protocol will be sent either electronically or via mail to designated reviewer(s) chosen by the Chair.
The designated reviewer(s) will have five (5) business days to review the protocol and respond to the ORC with a determination.
The designated reviewer(s) can approve the protocol as written, require revisions, or bring the protocol to full review. Designated review may not result in withholding of approval.
If multiple reviewers are assigned, the reviewers must be unanimous in decision and must review identical versions of the protocol. If revisions are requested by one or more of the reviewers, then the other reviewer(s) must be aware of and agree to the revisions. If reviewers do not agree, the protocol will be reviewed by the full committee.

The IACUC will be informed of the outcome of all designated reviews.

What is Deferred Review?

Deferred Review is a review process for protocols from Marquette University PIs that have been approved at another institution for work being conducted at the other institution.
The Marquette IACUC does not need to review the protocol, but must keep the protocol and the other institution’s approval letter on file.
The Marquette IACUC must be informed of any problems encountered during the other institution’s semi-annual inspections related to the protocol.
The Marquette IACUC must be informed of the outcome of annual reviews of the protocol at the other institution.
It will be the responsibility of Marquette University’s Office of Research Compliance to obtain these documents from the other institution.

PROTOCOL

GENERAL INFORMATION

FOR RESEARCHERS

FOR IACUC MEMBERS