What format should be used to submit an amendment to a protocol?
Amendments may be submitted through formal or informal mechanisms provided that all the necessary information if supplied. Institutions with large numbers of approved protocols often use an amendment form to document proposed changes in protocols. Depending on the specific changes requested, questions to be answered for each protocol amendment should include:
- What is the purpose or rational for the protocol amendment?
- Will different people use the animals? If personnel have changed, their qualifications (e.g., education, training and experience) must be documented.
- Will the species, sex of strain of animal change?
- Will there be specialized housing requirements (e.g., housing that is not standard for the species, or housing which does not meet the animal’s physiological or behavioral requirements?
- Will more animals be needed? If so, justification for the increased number must be provided.
- Will additional minor surgical procedures or sampling of body fluids or tissues occur?
- Are animals expected to experience more clinical illness, pain, or distress as a result of the procedures proposed in this amendment? Are there alternatives to the use of animals in painful procedures? How will any pain or distress from this new procedure be minimized?
- Will there be new procedures involving animals? Such changes must be described with the same level of detail as is required for a new
- Will there be a change in the methods of euthanasia, analgesia, or anesthesia?
- Will prolonged restraint of conscious animals be required?
- Will new hazardous agents be used?
- Will the surgical plans change (minor to major, multiple survival surgery, additional procedures)?
Source: “The IACUC Handbook”