McMaster University
Animal Research Ethics Board

Major Amendments and Annual Reviews will be reviewed by the Protocol Review Sub-Committee consisting of a veterinarian, scientist and lay member who will meet prior to the AREB meeting.  A CAF veterinarian (normally the Director or Associate Director) will review these in advance.  The original AUP will be made available.  The content of a written report on each protocol will be agreed upon by the Sub-Committee, and comments will be reported at the AREB meeting as to whether the Amendments and Annual Reviews were approved or tabled for further review and why.

Amendments will be divided into two groups–minor and major.

• Definition of a Minor Amendment includes non-substantive changes such as:
  • addition of personnel
  • increase in numbers of animals of less than 10 percent without significant changes in procedures and providing adequate justification is given
  • change in minor procedures such as blood collection, injection routes or type of gaseous anaesthesia to be used
• Definition of a Major Amendment includes a change of species (this can result in significant changes in methodology) or addition of new invasive procedures for a CCAC Category of Invasiveness of C or higher.

It is understood that those Amendments approved by the Sub-Committee can be activated.  However, between that AREB meeting and the next AREB meeting, a written report on all of the Amendments and Annual Reviews will be prepared and sent out with the pre-read package of the subsequent AREB meeting.  This will provide the opportunity for each and every AREB member to read the report on the Annual Reviews and Amendments listed and commented on at the previous meeting, and they can bring forward any questions at the subsequent meeting.

This process will also allow for, under extenuating circumstances, an additional urgent Amendment to be reviewed by the Sub-Committee.