PROTOCOL SUBMISSION
Forms for submission of a research proposal for IACUC review
The Federal Animal Welfare Act (P.L. 89-544) and amendments, the Institute of Laboratory Animal Resources (ILAR) Guide for the Care and Use of Laboratory Animals, the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching, and the PHS Policy on the Care and Use of Laboratory Animals shall be used as basis for review of protocols.
Principal Investigator (PI)
The principal investigator conducting research or teaching involving live vertebrate animals shall submit a typed and signed protocol for the use of live vertebrate animals. Protocols requiring full review received less than ten (10) working days before the scheduled IACUC meeting shall be reviewed the following month.
Animals may not be procured until the protocol has been approved by the IACUC. Reseach involving animals may not begin until the PI is notified in writing that the protocol has been approved. Only those persons listed on the protocol are authorized access to the animal facilities. Additions or substitutions to this list require a protocol amendment.
IACUC Committee Chair
The IACUC Committee Chair accepts the protocol, stamps the completed protocol form with the date received, assigns an IACUC number, and ensures that appropriate signatures are provided. The IACUC Committee Chair reviews the protocol for clarity and completeness. The protocol is forwarded to the Veterinarian or their designate within one working day of receipt for veterinary review. If the protocol is incomplete, the IACUC Committee Chair notifies the principal investigator and immediately returns the protocol with a listing of information or sections needed.
Veterinarian
The Veterinarian or designate assigns a category of ethical concern, performs veterinary review, and assigns the application for expeditable or full committee review. The Veterinarian may obtain additional information relative to the use of animals before assigning a reviewer. Non-survival surgical procedures and procedures that involve no pain or have a minimal potential for pain, distress, or discomfort can be approved by the Veterinarian or their designate for expedited review. The Veterinarian shall return the protocol to the IACUC Committee Chair when veterinary review is completed
Expeditable Protocol
If the Veterinarian determines that a protocol is expeditable, the Committee Chair makes copies of the cover page and the non-technical summary and circulates them to all members of the IACUC for review. Copies of the complete protocol shall be available to any member who requests it. Any member may request a full committee review. The deadline for voting on expedited protocols is 10 working days from mailing. If a quorum of all members votes by the deadline, all vote for approval and none request full Committee review, the expedited protocol is approved. An approval letter is mailed to the principal investigator. Protocols are approved for a maximum of three years. After three years, the PI will rewrite and resubmit the protocol for review. Expeditable protocols are those that are defined under Categories A and B, and C
Full Committee Review
If full committee review is requested for an expeditable protocol, or if the protocol is not expeditable, the IACUC Committee Chair assigns the protocol to a member of the IACUC for review and sends full copies of the protocol to the reviewer. Copies of the cover sheet and the non-technical summary are circulated to all other IACUC members. The designated reviewers shall receive the protocol at least ten (10) working days before the scheduled meeting. If the reviewers are unable to complete the review before the meeting, the reviewers shall notify the Committee Chaie within forty-eight hours of receipt.
- Reviewer: After initial review, the reviewer will communicate with the principal investigator and attempt to clarify any questions and resolve any minor problems. If major unresolvable problems exist, the principal investigator may be asked to attend the meeting. If more than one reviewer is assigned, they should discuss the protocol before the IACUC meeting. This communication may raise discrepancies in the protocol or resolve misunderstandings.
- Approval of protocols assigned for full committee review: Approval of protocols assigned for full committee review may be granted only after review at a convened meeting of a quorum of the IACUC and the approval vote of a simple majority of the quorum present. Protocols are approved for a maximum of three years. After three years, the PI will rewrite and resubmit the protocol for review.
Revisions
- Revisions must be submitted to the IACUC Committee Chair in writing.
- Revisions consisting of minor changes may be approved by the Chair or designate
- Significant revisions will require a full or expedited review. Material from both the and the revised protocol will be distributed to the IACUC members and reviewer(s).
Procedures for the Annual Review of Protocols
- Approved protocols must be reviewed at least annually. Therefore, at least four (4) weeks prior to the anniversary date of an approved protocol, the Secretary shall send to the principal investigator an Annual Review of Protocol for Use of Live Vertebrates Form indicating that the annual review form must be completed and submitted to the IACUC Committee Chair before the first day of the anniversary month.
- The annual reviews approved by the Chair on behalf of the Committee will be listed on the agenda and minutes of the next monthly meeting..
