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Research Compliance

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, de novo review and category E protocol will be reviewed by the full committee

The Protocol Review Process

The IACUC must perform a comprehensive review at initial submission and at each 3-year renewal (de novo). The review process has multiple cycles designed to meet regulatory requirements and streamline review as much as possible.

Round 1 – IACUC Manager/Attending Veterinary Pre-Review

All protocols are first reviewed by the IACUC Manager for completeness, to ensure personnel have completed risk assessments and training and for general review. The Attending Veterinarian (AV) will also review and comment on the protocol for appropriate animal use, drug doses, housing and enrichment, etc. 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.

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:

 

IACUC review process

Designated Member Review (DMR)

The Designated Member Review (DMR) process is utilized for amendments and can also be applied to protocol reviews when necessary. This process is conducted electronically and requires a minimum of 10 days to complete.

During the first 5 business days, all committee members are invited to review the protocol and/or request changes. Following this period, the IACUC Chair assigns a designated reviewer to perform the DMR. The reviewer will provide comments, and the protocol will be returned to the Principal Investigator (PI) for modifications as many times as necessary until the reviewer is satisfied.

To ensure the integrity of the review process, the identity of the DMR reviewers assigned to your protocol remains confidential. All comments will be communicated to the PI through the IACUC office.
Review of Protocols at Convened IACUC Meetings or Full Committee Review (FCR)  

New protocols, De Novo submissions (3-year renewals), and Category E protocols, as well as any submissions for which an IACUC member has requested Full Committee Review (FCR) during a Designated Member Review (DMR), are reviewed at the convened monthly IACUC meeting. Common activities that typically require review in this setting include:

  • Procedures involving unrelieved pain or distress.
  • Multiple survival surgeries.

Any IACUC member has the authority to call for FCR of a submission at any time. Once an FCR request has been made, the submission must be reviewed at a convened IACUC meeting unless the request is formally retracted by the member who made it.

The IACUC meets on the second Tuesday of every month.

Protocol review image going over the text above

After the protocol is discussed at the meeting, the following determinations are possible:

  • 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.

Observational Study Review Process

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.

 

Review of Protocol Amendment(s)

The Protocol Amendment Process

Amendments are pre-reviewed by the IACUC Office, then reviewed via one of the three methods listed below. 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.

APPROVALS AND ANNUAL RENEWALS

IACUC approval means that animal work approved in the protocol may begin. The PI may order animals and project personnel may gain access to the animal facilities.

Details about approval:

  • The IACUC approves protocols for a three-year period, even if sponsored funding is for a longer term.
  • A De Novo (new) protocol must be submitted to the IACUC prior to the end of the initial three-year approval period to avoid inactivation or suspension of animal work until a new protocol is approved.
  • Applications are renewed annually (Continuing Review).