Proposal-Protocol Congruency FAQs
Q1. Is it acceptable for institutions to ask each PI to confirm that all animal work described in the grant has been approved by the IACUC?
A. OLAW/NIH discourages this practice as it places the institutions at significant risk, and some of the institutions who have used this practice have been required to return funds to NIH for non-compliance.
Q2. Why can’t the study section review of the Vertebrate Animal Section fulfill the requirement for congruency review?
A. Scientific review group (SRG) or study section is not intended to supersede or serve as a replacement for IACUC. SRG only verifies that the proposed use of animals is scientifically appropriate, whereas IACUC approval indicates that the protocol has been determined to conform to the PHS policy.
A. NIH indicates that this is for the institution to decide. UMMS has a one-to-many/many-to-one system which means one funded proposal can be linked to one or many protocols, and one protocol can be linked to one or many proposals. UMMS has tended to encourage protocols that approve animal use in more than one grant unless the sponsor specifically requires its own dedicated protocol.
A. Yes, but the details provided may be less for the alternative procedures if the PI states in the IACUC protocol that the protocol will be amended if the original plans are changed.
Q5. Since the grants are typically approved for 5 years and the protocols are approved for 3 years, are the PIs required to include in the IACUC protocol experiments proposed to be performed in the 4th and 5th years?
A. Years 1 to 3: During the congruency review, the IACUC-approved protocol is expected to contain details of experiments to be conducted in the first 3 years of the grant application. If the current IACUC-approved protocol is close to its expiration date, it is advisable to submit a new protocol instead of modifying the current protocol prior to the congruency review.
Years 4 and 5: The 4th and 5th year experiments in the grant application should be briefly described in the IACUC protocol with the explanation that details will be added at a later time, typically at the end of the 3-year cycle of the IACUC protocol prior to initiating the studies.
Q6. Does the institution need to do a congruency review for external collaborators or service providers?
A. Animal use studies can be only performed at PHS assured institutions/providers with an IACUC protocol covering the studies requested by the UMMS investigator. The external collaborators can submit a congruency verification or information to UMMS. Information may include a copy of approval protocol, a copy of approval letter and their PHS Assurance number, and UMMS investigators can include information about off-site animal studies in their IACUC protocols.