Annual Reviews, Modifications of Approved Protocols, and 3 year Renewals
Annual Reviews, Modifications of Approved Protocols, and 3-year Renewals
Even though you may be approved for a multiple?year project, the IACUC must review each protocol on an annual basis as required by federal regulations. You will be sent a reminder two months before the anniversary of the original approval date. Updated information and any changes in the animal use protocol should be supplied on the Continuing Review form. Approvals will be extended for another year if there are no major changes in the protocol.
Submitting a Modification (Amendment) to an Approved Protocol
If there are any changes to the protocol during the course of the research project or upon annual renewal, an amendment should be submitted to the IACUC for approval using the Continuing Review form. Minor amendments (see the list below) can be approved by a sub?committee of the IACUC; therefore, you do not have to wait for a full committee meeting to begin your work as long as your amended project has been approved by an IACUC sub?committee.
The following minor changes to an approved animal use and care protocol can be submitted to the IACUC in the form of an amendment:
a) change of title
b) change of funding agency
c) addition or deletion of personnel
d) change of the animal strain
e) change or addition of minor procedures
f) increase in animal numbers with justification
g) addition of a new co?investigator
h) change of research facility
i) change in the method of euthanasia
j) change in anesthetic or drug dosage
The following major changes generally require a submission of a new protocol (a completed Protocol Synopsis Form) for IACUC approval.
a) change of species
b) change of drug classification which will be administered to animals
c) change from type A to type B or C procedures (refer to the protocol instructions (link to protocol instructions) for information on procedure categories)
d) addition of major procedure (i.e. survival surgical manipulation or other procedures requiring anesthesia with recovery, procedures involving hazardous or infectious agents provided the PI also shows evidence of approval from the appropriate safety committee)
e) transfer of the protocol to a new principal investigator
The IACUC reserves the right to request a full protocol if deemed necessary for any protocol.
The Public Health Service policy requires a complete review of activities every three years. To do this, a completed Protocol Synopsis form must be submitted and approved by the IACUC.