The purpose of this policy is to increase the efficiency of the IACUC review and approval for protocol amendments.
USDA and OLAW require IACUC approval of amendments for significant changes to a protocol, however the IACUC has some discretion to define what it considers a significant change.
The IACUC has approved the following categories of protocol amendments as minor changes, therefore acceptable for the IACUC staff to review and approve:
- Relocation to approved animal housing and approved day use areas.
- Roster additions with documented training according to IACUC-02 “Training Requirements for Personnel Exposed to Live Vertebrate Animals” policy.
- Roster deletions.
- Change in source of the animal(s) if it is to an approved vendor. This will be done in consultation with the Health Monitoring Coordinator.
- Changes to the protocol title as long as it does not change the original objectives.
- Addition of a funding agency.
- Changes in blood collection volumes that are within the IACUC approved guidelines and SOPs.
- Modifications to observational studies when there will be no impact on the animals.
- Changes in injection volumes that are within the IACUC approved guidelines and that do not change the dose.
- Changes in disposition for animals that have not been used in any invasive procedures.
Amendments to Animal Care and Use Protocols that involve one of the above changes will undergo the initial review using the established pre-review process, see IACUC-07. Amendments approved by administrative review will be listed on the agenda for the next convened IACUC meeting. If the amendment request is acceptable, the assigned IACUC staff member will process the amendment as approved and notify the Principal Investigator.
- OLAW FAQ http://grants.nih.gov/grants/olaw/faqs.htm#proto_9
- USDA Inspection Guide Appendix 9/8/8/3 http://www.aphis.usda.gov/animal_welfare/2011_Inspection_Guide//9.8.8%20Procedure%20for%20Protocol%20Review.pdf
Date: February 7, 2013
Enabled by: PHS/USDA
Supersedes: April 21, 2011