IACUC Review Process

The information presented below is intended to serve as a resource for overviews of the various IACUC review processes. Keep in mind that the length of protocol review (time to receive a determination) can vary depending on the clarity of the submission, and complexity of the procedures. 

Preparing for Review: Resources, Checklists, and Tips for Efficiency

Review the resources linked below before beginning a protocol or modification submission.

Resources for Researchers including guidance for Alternatives to Animal Use, 3Rs, Literature Searches, Species Specific Resources, Required Facility Inspections, Required Training, Occupational Safety, and more.

New Protocols

• Preparing for Submission
• Submission Checklist
• Tips for Efficient Review

Modifications

• Submission Checklist
• Tips for Efficient Review

Protocol Review

The following steps describe the review process for initial protocols and triennial/de novo protocol review.

1. Principal Investigator (PI) submits protocol, required training certificate(s) and any other additional materials to researchintegrity@wwu.edu.
2. Research Integrity and Compliance staff read through submission to make sure all materials have been received.
3. Protocol routed for pre-review.
   • Pre-reviews dramatically increase the efficiency of IACUC reviews because they identify the need for corrections and clarifications that can be complete before the protocol is submitted to the entire committee for review. For instance, a pre-review may reveal that a protocol is missing information that would delay IACUC approval if not discovered until the time of review (for example, drug doses, complete description of procedures, or an analgesic plan).
   • Keep in mind that the results of a pre-review do not constitute an official action by the IACUC.
4. IF pre-reviewers find need(s) for corrections or further clarifications, protocol will be sent back to the PI
5. IF pre-determined by the pre-reviews, revised protocol routes back to pre-review (steps 4 and 5 can be repeated until pre-reviews are satisfied with protocol).
6. Protocol shared with committee for their review and determination if they would like to proceed with a full committee review (a meeting) or designated member review (DMR)* (via email).
7. Full committee review OR Designated Member Review (DMR)
   • If full committee review, a meeting will be scheduled (only committee members attend this meeting unless PI invited to answer questions).  
     • Three possible outcomes of full committee review: Approval, Require modification(s) (in order to secure approval), Withold approval
   • DMR is conducted via email by a subset of the IACUC members and occurs outside a convened meeting. The DMR process can be used to review and approve new protocols and amendments.
     • Three possible outcomes of DMR: Approval, Require modification(s) (in order to secure approval), Withold approval
8. IF new animal research space(s) are included in the protocol: Initial facility inspections are required for all new spaces used for animal research. See Preparing for IACUC Facility Inspection for more details.
9. IACUC determination issued to PI via email.

*Designated Member Review (DMR) is NOT the same as the Human Research Protections Program's "expedited review." DMR can only occur after all IACUC members had the opportunity to request full committee review.

Protocol Modifications

Modifications can fall into two categories: major modifications and minor modifications. For a more elaborated explanation of the two types of modifications see Protocol Management.

Major Modification*

1. PI submits protocol modification to researchintegrity@wwu.edu
2. Research Integrity and Compliance staff read through submission to make sure all materials have been received (including any required training completion certificate(s).
3. Protocol routed for pre-review.
   • Pre-reviews dramatically increase the efficiency of IACUC reviews because they identify the need for corrections and clarifications that can be complete before the protocol is submitted to the entire committee for review. For instance, a pre-review may reveal that a protocol is missing information that would delay IACUC approval if not discovered until the time of review (for example, drug doses, complete description of procedures, or an analgesic plan).
   • Keep in mind that the results of a pre-review do not constitute an official action by the IACUC.
4. IF pre-reviewers find need(s) for corrections or further clarifications, protocol will be sent back to the PI
5. IF pre-determined by the pre-reviews, revised protocol routes back to pre-review (steps 4 and 5 can be repeated until pre-reviews are satisfied with protocol).
6. Modification (and original protocol) shared with committee for their review and determination if they would like to proceed with a full committee review (a meeting) or designated member review (DMR) (via email).
7. DMR or Full committee review.
8. IF new animal research space(s) are included in the modification: Initial facility inspections are required for all new spaces used for animal research. See Preparing for IACUC Facility Inspection for more details.
9. IACUC protocol modification determination issued to PI via email.

Minor Modification*

1. PI submits protocol modification to researchintegrity@wwu.edu.
2. Research Integrity and Compliance staff read through submission to make sure all materials have been received (including any required training completion certificate(s).
3. Staff review modification (and original protocol).
4. IACUC protocol modification determination issued to PI via email.

*Modifications do NOT extend the end date/expiration date of the protocol.

Continuing Oversight

Semi-Annual Facility Inspections

Animal welfare regulations require that IACUC inspects animal research facilities every six months. The committee members will review regular housing facilities, PI labs, procedure rooms, and transport vehicles. See Preparing for IACUC Facility Inspection for more details. 

Renewal/Extension (Triennial Review)

Triennial review is a complete (de novo) IACUC review of the previously approved protocol every three years that is federally required every three years to receive continued approval of ongoing activities on the protocol. See the Protocol Review section above for an overview of the review process. The PI will receive an email when it is time to complete the de novo submission process. 

Closure

Notify researchintegrity@wwu.edu when your research is complete so that the protocol file can be closed.