The Public Health Service (PHS) Policy (IV,B,7) and Animal Welfare Act Regulations (AWAR) require PIs to seek Institutional Animal Care and Use Committee approval for modifications to ongoing animal care and use activities prior to initiation. The protocol amendment process provides an opportunity for an investigator to modify an approved protocol at times other than when regularly scheduled continuing protocol reviews occur.
Significant changes include changes that have, or have the potential to have, a negative impact on animal welfare. Specific significant changes may be handled administratively according to IACUC-reviewed and approved policies in consultation with veterinary staff. An amendment is evaluated in conjunction with the original protocol to adequately determine if a significant change has been proposed. If in doubt whether a proposed change is "significant" from the point of view of animal welfare, please consult veterinary staff or the UAWC Chair.
The UAWC’s procedure for modifying a protocol is the following:
Examples of change in animal use procedures that could affect animal welfare and are generally considered to be major (significant), possibly warranting full UAWC review are:
Examples of changes considered to be minor which can typically be approved administratively are: