In our opinion, this is a clear violation of the requirements set forth in both the AWA regulations (§2.31, d, 1, x, A–B, ref. 1), Animal Care Policy #14 (ref. 2), and the Guide3, and should be reported to the USDA and NIH as protocol noncompliance. Multiple major survival surgeries in one animal are permissible by the AWARs and the Guide under the following conditions: (1) included within one protocol, (2) scientifically justified by the investigator, or (3) necessary for clinical reasons1. Although the IACUC chair is correct in that the survival surgeries must be included on the same protocol, this is not sufficient criteria to avoid reporting this violation to the USDA and NIH. In this scenario, regardless of the original intent of the researcher (White), the IACUC reviewed and approved a protocol that indicated that animals would not be used for two major survival surgeries. As a result, the researcher did not provide scientific justification for multiple major survival surgeries, and the IACUC was not given the opportunity to evaluate the scientific justification for the procedures, or to ensure that the animals would not be subjected to unnecessary pain and distress. Furthermore, the researcher indicated that she used the same animal to save time and money. Cost savings alone is not sufficient justification for using the animal for multiple survival procedures3. The PI is ultimately responsible for the activity that happens on her protocol. Although it is unfortunate that the postdoctoral associate checked the wrong box, if that is indeed the case, White is still responsible for the noncompliance.
Great Eastern University's policy of allowing many separate experiments on the same protocol might have contributed to the scenario outlined here. Eliminating multiple descriptions of the same procedure with slight variations between protocols certainly makes it easier for the faculty to manage their protocols, and in some cases it may also reduce potential noncompliance events. However, this might also have the unintended consequence of increasing noncompliance risk if it is not completely clear which procedures will be used for each experimental group. Protocols written with this ambiguity can lead to post-approval merging of experiments by investigators, under the premise that everything was described on the same protocol as seen here. We suggest the IACUC re-evaluate this practice and refine the criteria under which multiple related experiments can be included on the same protocol. Additionally, if the IACUC does not already have a policy on multiple survival surgeries, we suggest they create one. This will help ensure both IACUC reviewers and researchers are clear on the criteria for which an animal may undergo multiple major survival surgeries.
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