Continuing Review of Research Protocols
Delve into the regulatory requirements and procedures for conducting continuing reviews of research protocols as mandated by the IACUC. Explore different perspectives and ways to fulfill these requirements effectively. Understand the intervals and depth of reviews, including annual updates and triennial assessments. Distinguish between regulatory obligations and supporting activities for continuing reviews across various protocols.
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Presentation Transcript
IACUC members will understand continuing review of protocols.
Delineate what constitutes a continuing review Assess alternate conceptions about continuing review
Write ways to fulfill requirements for continuing review One idea per sticky note Three stickies/person
The IACUC shall conduct continuing reviews of activities covered by this subchapter at appropriate intervals as determined by the IACUC, but not less than annually. Animal Welfare Regulations Chapter 2.31(D)(5)
The IACUC shall conduct continuing review of each previously approved, ongoing activity covered by the policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with IV.C.1-4 at least once every three years. PHS Policy IV.C.5
Continuing protocol review typically consists of an annual update or review as well as the triennial review required by the PHS. The depth of such reviews varies from a cursory update to a full committee review of the entire protocol. The Guide, Eighth Edition, 2011 (Postapproval Monitoring pg 34 )
Distinguish the regulatory requirements for continuing review from the activities that support continuing review. Tables NIH Funded Protocol Mouse, lab bred (Mus musculus) Tables 1 & 1 & 5 5 Tables Privately Funded Protocol Spotted hyenas (Crocuta crocuta) Tables 2 & 3 2 & 3
conduct continuing reviews at appropriate intervals determined by the IACUC, but not less than conduct continuing reviews at appropriate intervals as determined by the IACUC, but not less than annually. as annually. Animal Welfare Regulations Chapter 2.31(D)(5)
conduct continuing review at determined by the IACUC, including IACUC approval] at least once every three year conduct continuing review at appropriate intervals as determined by the IACUC, including a a complete review [and IACUC approval] at least once every three years. s. appropriate intervals as complete review [and PHS Policy IV.C.5
typicallyan review as well as the triennial The update to a full committee review of the entire protocol. typically an annual update or review as well as the triennial review The depth varies update to a full committee review of the entire protocol. annual update or review from a cursory depth varies from a cursory The Guide, Eighth Edition, 2011 (Postapproval Monitoring pg 34 )
Objectives Delineate what constitutes a continuing review Assess alternate conceptions about continuing review
F F ___ Annual renewal of a protocol is required. F F ___ PAM is required for continuing review. T T ___ A laboratory mouse protocol must be approved every three years. F F ___ All parts of continuing review must be conducted by the IACUC.
Prepare a plan for continuing review for our institution that you would feel comfortable defending to our regulatory agencies. Bring it to the next IACUC meeting. Bring it to the next IACUC meeting.
ICARE TRAIN-THE-TRAINERS INSTITUTE May 1-4,2017 Rachel Cameron, University of California, Berkley Laurence Istvan, University of Washington Elisabeth Koncza, University of Miami Allison Overmyer, Missouri State University
