Office of
Sponsored Programs

Protocol Amendment

GENERAL

 

Purpose

The following Process is established to ensure compliance with Federal regulations and various agency requirements governing the use of live animals in research; and to facilitate the timely consideration of each IACUC protocol.

Administration

The Office of Sponsored Programs is responsible for maintenance and the IACUC is responsible for the review and revision of this Process.

 

PROCESS

A protocol approval is typically issued for 3 calendar years from the original approval date.  On occasion, the PI will find it necessary to amend the existing approved protocol.  In such cases, the following steps and course of action will be followed:

 

  1. The PI will provide an amended version of the approved protocol and highlight sections which have been amended. 
  2. IACUC coordinator will then review the amendment request and initiate the contact with the IACUC Chair and Vice Chair for processing of the amendment for subcommittee review.
  3. The criteria which allow for subcommittee review of the protocol amendment include:
  1. Increase in number of animals
  2. Change of Personnel/Personnel Addition
  3. Change in Animal Strain
  1. If the amendment indicates significant or substantial changes to the approved protocol in terms of animal usage and scope of work, then a dialogue with the IACUC Chair and Vice Chair will be utilized to decide whether an entirely new protocol is necessary.
  2. If a protocol amendment is approved by the subcommittee, the IACUC coordinator will notify the full committee of that approval and allow a 1-week period for full committee members to review the decision and make any objections. 
  3. If no objections are made, a formal approval notice is then issued by the IACUC Chair or Vice Chair.  It is important to note that the protocol amendment only covers the approval of the amendments made, and the existing protocol’s approval dates are still in effect.