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IACUC Protocol Review Process

HOW IT WORKS

• Protocols can be reviewed by either Designated Member Review (DMR) or Full Committee Review (FCR).
• Designated reviews are completed by at least one IACUC member.
• Full Committee Review are performed at a IACUC meeting. Principal Investigators (PIs) are encouraged to attend to help address any questions.
• All new, and de novo submissions will be reviewed by the full committee

Round 1 – IACUC Manager/Attending Veterinary Pre-Review

The IACUC Office will make comments and return the protocol to the PI for modifications as necessary until it is complete prior to being assigned to the IACUC Committee or specific Committee members.

For Observational Study Submissions

Following submission, the IACUC Manager and Attending Veterinarian will perform a Pre-Review. Afterward, the IACUC Committee is given 5 business days during which all committee members are invited to review the protocol and/or any requested changes.

The protocol will be returned to the Principal Investigator (PI) for modifications as many times as necessary until the IACUC Committee is satisfied. Once this review process is complete, the IACUC Manager will administratively approve the protocol and notify the PI of the approval.

Round 2 – IACUC Committee Review

Following the initial Pre- Review, protocols are assigned for either Designated Member Review or Full Committee Review. During this stage of review, all committee members will have access to the submission and the authority to request additional review. 

The protocol may be reviewed by one of the following processes:

Possible outcomes?

• The Committee approves the submission as it was submitted.
• Minor questions and/or clarifications must be resolved by the protocol’s Principal Investigator (PI) to secure final protocol approval. This process may require more than one round of modification requests from the appointed reviewer before final approval of the protocol. This is the most common determination.
• The submission is written in such a way that the Committee cannot complete the review because there are significant omissions and questions that must be resolved to secure approval. A Tabled ruling requires that the revised protocol be resubmitted as a new protocol for FCR at a convened meeting
• If the PI and the IACUC cannot agree on fundamental aspects of the protocol, such as protocol design and animal welfare issues, the Committee may withhold approval. The PI would receive a letter from the IACUC explaining why approval is being withheld.

Review of Protocol Amendment(s)

Amendments can be submitted at any time and must be approved before the work described in the amendment may begin.

Administrative Review

Certain minor protocol changes—such as updates to funding, adding or removing personnel, or increasing animal numbers by less than 10% of the approved total—may be reviewed and approved administratively by the IACUC Manager.

Amendments are approved only after verification that all required training and occupational health requirements have been completed.

Veterinary Verification and Consultation (VVC)

Specific significant changes that do not unduly impact animal welfare or alter study objectives may be handled administratively in consultation with UMs AV. The veterinarian is not conducting Designated Member Review, but is serving as a subject matter expert to verify that the proposed change is consistent with all applicable IACUC approved policies and is appropriate for the species. Examples of eligible changes include anesthesia agents, analgesics, euthanasia methods or housing.

Designated Member Review (DMR) and Full Committee Review (FCR)

Significant experiment related protocol changes, including addition of satellite housing, species, surgery, hazards, SOP exemptions, exceptions to the Guide or Animal Welfare Act (AWA) and changes to the Principal Investigator, will be reviewed by DMR or FCR.