E. Application Review Process
- Review Mechanisms
The IACUC can review new protocols and proposed changes to previously approved protocols via two mechanisms: full committee review and designated member review. In either case, the investigator must submit a complete Application to Use Vertebrate Animals to the committee. Full committee review means that the protocol is reviewed at a convened IACUC meeting. All protocols will be reviewed via full committee review unless a designated member review is specifically requested, in writing, by the primary investigator, a member of the IACUC or the Compliance Manager.
Requests for designated member review are appropriate for:
- Protocols falling under category C of the "Humane Use Categories" described in Section E of the application: Category C- Animals upon which teaching, research, experiments, or tests will be conducted involving no pain, distress, or use of pain relieving agents;
- Amendments to any current protocol that would decrease the pain and distress of the animals involved; or
- The addition of students or staff to the protocol.
When a request for designated member review is received, the protocol is distributed to all IACUC members who are given three business days to review the protocol and decide if they concur with the use of a designated member review mechanism for the protocol. If any member requests full review, the protocol is sent to the next meeting for full review. If a designated member review is to occur, the IACUC Chair or designee will select another committee member to review the protocol. On behalf of the committee and in consultation with the veterinarian when necessary, they will approve, conditionally approve, or refer the protocol for full review at the next meeting. The IACUC chair will notify the investigator in writing of the decision within seven business days of submission.
- Requirements for Approval and Outcomes of Review
In order to approve an initial Application or an amendment to an already approved protocol, the IACUC must determine that the protocol conforms to the requirements set forth in the Public Health Service Policy (PHS) and the United States Department of Agriculture Regulations (USDA). After assessing the protocol in accordance with these requirements, the IACUC will vote to approve, conditionally approve, table, or disapprove.
If all requirements are satisfied, the IACUC will approve the project as outlined in the application and the IACUC chair will notify the investigator of the approval in writing.
- Conditionally Approve
If the IACUC determines that minor changes or clarifications are required that do not pose a significant threat to the care and safety of the animals, it will grant conditional approval of the project. If the project is granted conditional approval, the IACUC chair will inform the investigator in writing, indicating the conditions that must be met to secure final approval. The investigator must reply in writing, explaining how the project will satisfy these conditions. The IACUC chair and/or other designated member(s) will review the revised proposal and determine if the conditions have been met. If all the conditions have been met, the IACUC chair will notify the investigator in writing that the project has been approved and the research may proceed as outlined. Please note that the research may not proceed until the IACUC chair notifies the investigator of final IACUC approval.
If the IACUC lacks sufficient information about whether the project satisfies these requirements or major concerns exist about a threat to the care and use of animals, the IACUC will table the protocol and the IACUC Chair will notify the investigator of this in writing, explaining the reasons for the committee's decision and indicating the conditions that must be met in order to secure approval. The investigator must respond by submitting an original and 10 copies of the revised application; this will be reviewed by the IACUC at a subsequent meeting and the IACUC chair will notify the investigator in writing of the outcome of this review.
If the IACUC believes there are serious concerns related to one or more of the requirements, it will disapprove the project and the IACUC chair will notify the investigator of this decision in writing, explaining the reasons for disapproval.