Protocol Amendments, Annual Reports, & Closures


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

Annual continuations and amendments (including the addition of personnel) must be submitted using IRBManager online system. 

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 a 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 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 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.  

Note: the Annual /Continuation form is now live in IRBManager. Submission of the paper-based form will no longer be accepted for IACUC review.  

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.