Basics

The IACUC application will undergo a preliminary review by the Research Compliance Office to ensure all necessary aspects of the application are present. The PI will be contacted and the IACUC application returned for revisions if anything is missing or if any revisions are needed to improve the clarity of particular aspects of the IACUC proposal. 

1. Once the protocol had undergone preliminary review, the protocol will be sent to the Attending Veterinarian (AV) for review.
2. The AV will examine the protocol for veterinary and specific animal care and use issues to ensure the well-being of the proposed vertebrate animals is properly maintained.
3. If the AV has any comments or questions about the specifics of the methodology for the care and use of animals for the project, the protocol will be returned to the PI by the Research Compliance Office for revisions that need to be addressed before moving forward with the IACUC review process.

Following the preliminary and veterinary review of the IACUC application, the protocol will be sent to the IACUC for a complete review of the entire protocol. 

A review of the protocol can be conducted in one of two ways:

• Designated Member Review (DMR) - If a review of the protocol by the full committee is not requested, at least one member of the IACUC, designated by the Chairperson and qualified to conduct the review, shall review the research project(s). The DMR has the authority to approve, require modifications (to secure approval), or request a full committee review of the research project. 
• Full Committee Review (FCR) - The IACUC proposal will be reviewed at a convened meeting of a quorum of the IACUC. Approval may be granted only after committee review with the approval vote of a majority of the quorum present.  
  • When a vote is called for, there can be several possible outcomes. Outright approval requires an affirmative vote by a majority of the convened quorum present.
  • In the event that substantive questions prevent final approval, the committee can wait until the next meeting for revisions to be reviewed by the full committee. 
  • Alternatively, the committee can decide to handle the resubmission by the designated-member review process, with appropriate notation in the minutes.

Final approval and initiation of animal research may not begin until all outstanding concerns have been adequately addressed and approved by either the full committee or using the designated member review process. 

Amendments

The PHS Policy on Humane Care and Use of Laboratory Animals and Animal Welfare Regulations define the responsibilities of the IACUC regarding the review and approval of proposed significant changes to animal activities. Changes to approved research projects must be conducted in accordance with the institution’s Assurance, the US Department of Agriculture (USDA) Animal Welfare Act, and Animal Welfare Regulations, and must be consistent with the Guide unless an acceptable justification for a departure is presented. Additionally, IACUCs are responsible for assuring that the changes to approved animal activities meet the requirements described in the PHS Policy. It is the responsibility of PIs to amend their active protocols, adding all new and incoming personnel to the project.

IACUC approval is required for all proposed changes to an approved application prior to the commencement of activities and the implementation of proposed changes to the approved protocol. 

Annual Continuation Reviews & Protocol Closures  

All IACUC protocols are approved for three (3) years. Radford IACUC policy requires the submission of an Annual Protocol Review (APR) form for each active protocol, to be submitted and reviewed no less than annually. 

1.  While it is the responsibility of the PI to maintain his/her IACUC protocol in an active status, researchers will receive an email reminder via IRBManager of the upcoming need for an Annual Continuation submission 60, 30, and 7 days prior to the due date noted on the IACUC approval letter.  
2. If the protocol has reached its expiration date and no annual continuation has been submitted and approved, the protocol is said to have lapsed. At this time, all animal research must cease. No new experimental procedures may be initiated and no orders for animals may be placed until the submission and approval of the Annual Report/Continuation. However, data analysis or tissue manipulation may occur after this date. 
3.  The completed APR/continuation form should be submitted to the Research Compliance Office at irb-iacuc@radford.edu using the paper form in advance of the expiration date.  
4.  If the study has been completed or you wish to close the protocol early, please complete the IACUC Closure form in IRBManager.  

Protocol Continuations & DeNovo Review  

Once a protocol has reached its third (and final) Annual Review, a final Annual Protocol Review form must be submitted for the closure of the protocol. If the project is to continue, a new IACUC application must be submitted for IACUC review and approval using IRBManager. 

Protocol continuations should be submitted a minimum of 30 days prior to the expiration of the original application for IACUC review in order to avoid any lapse in approval periods.