The IACUC at Great Eastern University (GEU) was correct in identifying that this protocol deviation was not a reportable event to OLAW. The error made by Dr. Matt fortunately would not be considered a serious noncompliance issue, a continuing noncompliance issue, or a serious deviation from the Guide (NIH Guide for Grants and Contracts NOT-OD-05-034)1. Additionally, the IACUC conducted itself accordingly by investigating the protocol deviation in a timely manner and concluded not to suspend this project.
Despite the decision not to report this off-protocol work to OLAW, there are several responses that should be taken by both the IACUC and Dr. Guaio’s staff moving forward. First, the IACUC should be sure to report any minority views that may have been expressed by the committee members on their next Semi Annual Report and OLAW Annual Report. This fulfills their regulatory requirements of the PHS Policy (PHS Policy IV.E.1.D)2 and promotes healthy discussion among the IACUC members. Second, The IACUC should request that Dr. Guaio conducts protocol meetings for his staff covering any newly approved protocols moving forward. Dr. Guaio should also keep a record of these meetings for the IACUC to review if necessary. These protocol reviews will ensure that his staff avoid errors of miscommunication or oversight in the future. The third consideration for the IACUC is to assess the Veterinary Verification and Consultation (VVC) policy, or lack thereof, at GEU. This type of protocol change, if it was made prior to the procedure being conducted by the PI or his staff, would likely qualify for VVC. The method of anesthesia was a previously approved and acceptable method for this species and could have been changed to make both porcine protocols consistent. Updating the policy to include acceptable anesthesia methods for porcine models would be an effective way to limit a potential noncompliance issue in the future. The fourth and final consideration is that the IACUC revisits its own protocol review procedures. The IACUC, veterinary staff, and/or administrator should consider if a new protocol is part of a package of protocols under one researcher. Reviewing each protocol in a vacuum could lead to consistency challenges for a research team, and possible unintended non-compliance situations like Dr. Matt’s.
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