UMass Boston

Now that you have received your IACUC approval, here are the steps to take to manage your protocol. 

Minor Modifications

Minor modifications can be submitted to the IACUC administrator for review and approval. Some examples of minor modifications are a change (≤ 10%) in animal numbers, addition/deletion of procedure that is less invasive than already approved,  transfer of animals to another PI (if same strains are approved for both PIs),  and addition/removal in project personnel.

Note - for a timely approval for project personnel to be added to a protocol, please ensure CITI trainings have been completed and Occupational Health and Safety form has been submitted. 

Significant Modifications

Per federal regulations, once an IACUC protocol has received approval, any subsequent changes to the study must be reviewed and approved by the IACUC prior to implementation. An updated protocol should be submitted with changes requested highlighted.

3 Year Re-write

IACUC protocols are approved for a total of 3 years. If the study is ongoing, a new application needs to be submitted to the IACUC for review. IACUC protocols will expire on its expiration date if a three-year renewal application has not been reviewed and approved. During a lapse in approval, animals are placed on a holding protocol and are off limits to investigators and research personnel. No experimental use or observation of animals may take place during a protocol lapse period.

Postapproval Monitoring

Monitoring of animal care and use is required by the PHS Policy. The Guide (p. 33) describes methods for postapproval monitoring to include “continuing protocol review; laboratory inspections (conducted either during regular facilities inspections or separately); veterinary or IACUC observation of selected procedures; observation of animals by animal care, veterinary, and IACUC staff and members; and external regulatory inspections and assessments.”