Lesson 12: Protocol Approval and Next Steps Flashcards
During the pre-IACUC meeting portion of the review process:
ORIA staff review the proposed protocol for completeness of information needed for the IACUC to make a decision.
CARE veterinarians examine the proposed animal use, procedures, and housing plans to ensure they meet standards set out in the Guide or the Ag Guide, and make recommendations to the IACUC for PI and staff training.
The AUHSP Working Group conducts the occupational health and safety review and makes recommendations to prevent injury and illness for PIs and protocol personnel.
IACUC members assigned as primary and secondary reviewers review the protocol.
How long do PI’s normally have after the pre-meeting review is complete to make revisions or respond with clarifications?
5 days
Protocols are discussed with whom?
Among committee members present at the scheduled monthly IACUC meeting. Votes of majority are involved.
How long are protocols approved for?
A maximum of three years, with a required yearly review in the form of an annual review.
Can investigators submit amendments to the original proton throughout the study period?
Yes
Does approved protocol from IACUC imply the beginning of the research?
No, additional permissions may be needed before the work with animals can begin, such as AUHSP clearance, training, or SOP related training.
The IACUC conducts continuing reviews of animal activities at least?
Annually and conducts complete reviews of newly revised protocols every three years.
Can under any circumstance grant the approval of a protocol to extend over three years?
No extensions or grace periods. If necessary, PIs must submit a renewal application well in advance of expiration date.
Post-Approval Quality Assurance (PAQA)?
Investigates laboratories are done periodically to ensure that procedures outlined in approved animal use protocols are being followed. They also gave advice and inform researchers on better ways to manage compliance with their approved protocols.
Suspension or termination of approval?
IACUC is empowered by federal law and suspend or terminate approval of any protocol should there be evidence that the procedures used have not been approved or are not being conducted in accordance with the approved protocol.
