INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE

HOW LONG IS THE PROTOCOL APPROVAL PROCESS?

For full review protocols the process can take 4 to 6 weeks for approval. In certain cases designated review protocol may be approve in 3 to 4 weeks.
Case IACUC Protocol Review Process

• Protocol is received by the IACUC Office.
• Protocol is assigned to a primary reviewer and attending veterinarian.
• The primary reviewer and attending veterinarian send their concerns to the IACUC coordinator.
• The IACUC coordinator sends the concerns to the primary investigator.
• The principal investigator sends their responses to the IACUC coordinator.
•  The IACUC coordinator in turn sends the responses to the primary reviewer and attending veterinarian.
• If the responses satisfy both the primary reviewer and attending veterinarian the protocol goes on for Chair approval. 

            1) If designated review the protocol may go directly for approval. (link criteria of designated review)

2) If full review the protocol must wait until the next scheduled meeting of the IACUC (link to meeting dates); (link to criteria of full review).
Protocol submissions are checked for completeness, assigned to one of two tracks for review. Protocols potentially involving pain or distress are assigned to full review, and others are assigned to designated review link to criteria for review. The processes of full and designated review are the same, except that full review involves discussion of the protocol before the full committee. All protocols are distributed to all committee members for them to read. Each protocol is assigned to a primary reviewer and a veterinarian reviewer. The primary and veterinarian reviewers prepare questions for the investigator, and either the primary reviewer or the IACUC coordinator submits the questions to the investigator. The primary and veterinarian reviewers determine if the investigator responses are satisfactory. The primary and veterinarian reviewers make a recommendation on approval. For full review, the primary reviewer makes a brief presentation at the next IACUC meeting on the protocol and leads the discussion. The committee members vote on protocol approval. All protocols are reviewed and signed by the chair.

Insight into the principles which guide the reviewers in their examination of protocols can be gained from the "Guide for the Care and Use of Laboratory Animals" in the section on Animal Care and Use Protocols and from the Case IACUC's Reviewer Checklist. In essence, the reviewers are required to ensure that alternatives which might improve the welfare of the animals, reduce their pain or distress, or reduce the numbers of animals used have been explored, and have been adopted, or have been found to be unsatisfactory for scientific reasons.
Roles of the Participants in the Review Process - IACUC Office

• Determines if protocol is subject to full or designated review, based on list of criteria. Protocols subject to full review are discussed at the monthly IACUC meeting, protocols subject to designated review are not, and otherwise the two processes are the same.
• Assigns a primary reviewer and an attending veterinarian to each protocol.
• Reviews protocols, addenda and annual reviews for completeness and reconciliation of the following items with the principal investigator:

• Signatures (investigator, department chair and personnel)
• Plain language description
• Safety forms
• Facility Access and Occupation Health Form
• Pain classification
• Alternatives
• Conflict of Interest
• GLP
• Environmental Enrichment
• Training Requirements

Primary Reviewer

• May ask for full review of any protocol
• Reviews assigned protocol within five (5) days of receipt
• Submits questions
• Reviews responses
• Presents full review protocols at IACUC meeting
• Signs protocols reviewed

Committee Member

• May ask for full review of any protocol
• Reads all protocols
• Submits questions to primary reviewer or to IACUC office
• Participates in the discussion of full review protocols at IACUC meetings

Attending Veterinarian

• May ask for full review of any protocol
• Consults with investigator

• Provides guidance in design
• Trains research personnel
• Advises on animal model development and appropriate procedures
• Advises on selection and use of pain relieving and euthanasia methods and agents

• Reads all protocols
• Reviews assigned protocols within five (5) days of receipt
• Submits questions to the primary reviewer or IACUC office
• Presents full review protocols at IACUC meeting in absence of primary reviewer
• Signs protocols reviewed

IACUC Chair

• May ask for full review of any protocol
• Reads all protocols
• Reviews protocol review and investigator responses to questions
• Signs all protocols
• Presents full review protocols at IACUC meeting in absence of both the primary reviewer and attending veterinarian