Protocol Submission Process Overview
Use of vertebrate animals in research, teaching or testing at Purdue University or its affiliated sites requires approval of a protocol by the Institutional Animal Care and Use Committee (IACUC).
Before preparing a protocol for review:
- Be certain that all qualifications and training requirements for each participating researcher are met. https://www.purdue.edu/research/oevprp/regulatory-affairs/animal-research/qualifications-training/qualification-training.php
- Consider all facilities, housing and Laboratory Animal Program requirements for description in your protocol. IACUC protocols cannot be approved without detail about housing and study design. For content-related questions on IACUC applications: lap@purdue.edu.
Prepare an IACUC Application
Access the Coeus Lite System
The IACUC reviews protocols submitted electronically as attachments through the Coeus Lite system. www.purdue.edu/coeus
* For technical system support or access to the on the Coeus Lite system: coeushelp@purdue.edu
Create a Submission
For Coeus Lite Instructions: Please visit:
https://www.purdue.edu/business/coeus/IACUC_Protocols/Investigator_Guide_IACUC/index.html
Begin your protocol record and submit the IACUC protocol application as an attachment. Incomplete submissions will not be processed.
Criteria for Protocol Completion and Review
This document is required for protocol submission: Please visit: https://www.purdue.edu/research/oevprp/regulatory-affairs/animal-research/iacuc/forms.php and click on "IACUC Protocol Application Attachment."
* Please download the form each time you submit, as versions of the IACUC forms are updated periodically.
Protocol Review and Outcomes
Review Types
Based on federal review standards, IACUC protocols may be reviewed in one of two ways:
Designated Member Review (DMR) – Protocols reviewed by Designated Member Review are processed on a rolling basis.
Full Committee Review (FCR) – Protocols that do not meet DMR criteria must be reviewed during a convened meeting of the Institutional Animal Care and Use Committee. The committee meets once per month on these dates: https://www.purdue.edu/research/oevprp/regulatory-affairs/animal-research/iacuc/meeting-dates.php
Outcome of Review
Following review, the Principal Investigator will receive correspondence about the decision and any next steps for the application.
Revisions to protocol - Protocols may require one or more rounds of revisions prior to a final determination. Depending on the extent of the revisions, they may be reviewed by either the designated review method or by the full board. Timely responses to the committee’s concerns are an important part of calculating the anticipated timeframes for review.
Board Decision - When the protocol review is complete, the Principal Investigator will receive a letter with the IACUC determination. A letter of approval will contain the study’s approval and expiration date.
Items to Consider After Approval
Renewal and Triennial Rewrite
Protocols require continued update and maintenance. Annual review of the protocol status is required. Every three years, a rewritten protocol must be submitted to the IACUC for review.
Protocol Amendments or Reporting
It is the Principal Investigator’s responsibility to report any adverse events, incidents, animal care concerns to the IACUC and LAP staff. Please contact the LAP staff and/or IACUC Administrator.
Protocol changes (e.g. housing, procedures, numbers, species) require an amendment to protocol. Submit the amendment request in the Coeus Lite system prior to the onset of any changes. The IACUC reviews protocol amendments in through either the Designated or Full review process.
Post Approval Monitoring
All approved protocols are subject to Post Approval Monitoring processes to ensure proper care and records management is occurring. To learn more about the Post Approval Monitoring process, please see this link. https://www.purdue.edu/research/oevprp/regulatory-affairs/post-approval-monitoring/
