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.
- The principal investigator conducting research or teaching involving live vertebrate animals shall submit an electronic protocol to the Director of Research Integrity at firstname.lastname@example.org 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. Research 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.
- The Director of Research Integrity accepts the protocol, stamps the completed protocol form with the date received, and ensures that appropriate signatures are provided. The Director of Research Integrity 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 Director of Research Integrity notifies the principal investigator and immediately returns the protocol with a listing of information or sections needed.
- 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 Director of Research Integrity when veterinary review is completed.
- If the Veterinarian determines that a protocol is expeditable, the Director of Research Integrity circulates the protocol to all members of the IACUC for review. 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 vote 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
- If full committee review is requested for an expeditable protocol, or if the protocol is not expeditable, the Director of Research Integrity sends an electronic copy to all IACUC members. Along with that electronic copy will be a request for two volunteers to provide a detailed review of that protocol. The review will be provided to the IACUC Committee Chair and discussed at the next IACUC committee meeting. At this point, the IACUC Committee Chair will handle the protocol. If no one volunteers (or more than two volunteer), the IACUC Committee Chair assigns the protocol to two members of the IACUC for review. 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 Chair within forty-eight hours of receipt. After initial review, the reviewer will communicate with the principal investigator and attempt to clarify any questions and resolve any minor problems. If major irresolvable 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 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 must be submitted to the Director of Research Integrity at email@example.com who will then forward the revisions to the IACUC Committee Chair.
- Revisions consisting of minor changes may be approved by the IACUC Chair or designate.
- Significant revisions will require a full or expedited review to be determined by the IACUC Committee Chair.
Procedures for the Annual Review of Protocols
- Approved protocols must be reviewed at least annually. It is the responsibility of the principal investigator to submit an Annual Review form to the IACUC (through the Director of Research Integrity at firstname.lastname@example.org) before the anniversary date of the approved protocol. However, the office of the Director of Research Integrity shall make every effort to send reminders 30 days prior to the anniversary date. The annual review form must be completed and submitted to the IACUC Committee before the first day of the anniversary month.
- The annual reviews will be approved by the Chair on behalf of the Committee, and will be listed on the agenda and minutes of the next monthly meeting..