While there is not a regulatory limit to the number of procedures in an IACUC protocol, the Great Eastern IACUC should ensure that they understand how procedures are interrelated and what procedures are performed on an individual animal. White is not that innocent in regards to compliance with her protocol. Even if it was a mistake in oversight, she clearly did not indicate that animals would undergo multiple major survival surgeries. While the IACUC could have clarified this issue during its review, it is ultimately White's responsibility to ensure that the protocol accurately describes what will be performed on each animal. In addition, her stated justification for performing multiple major survival surgical procedures is inadequate according to the Guide1 and the Animal Welfare Regulations and Policies2,3, as all of these require a scientific justification or clinical necessity. They also specify that the surgeries must be essential components of a single research project or protocol. Although the surgeries are on the same protocol, they are not interdependent. At this point, there is no justification in the protocol and when questioned as to why this was necessary, White only stated she was trying to save time and money. If she would like to do this in the future, she will need to provide a scientific justification to the IACUC, which includes how the two procedures are interrelated. The only other option for White would be for the Institutional Official to appeal to the USDA Animal Care Regional Director who will forward it to the Animal Care Deputy Administrator for consideration of a special circumstance. This appeal would need to include several pieces of information: a scientific justification that does not include cost, the procedures proposed, and assurance that the IACUC has approved this exemption2,3.
If White is Public Health Service (PHS) funded and Great Eastern has an assurance on file with OLAW, the IACUC must report this non-compliance to OLAW. According to OLAW's Guidance on Prompt Reporting4, it would meet the criteria of conduct of animal related activities without appropriate IACUC review and approval, as well as failure to adhere to IACUC-approved protocols. If White was not PHS funded, a report to OLAW could still be required if this is written in Great Eastern's assurance. There is no regulatory requirement to report this incident to the USDA, as reporting is only required for the annual report, failure to correct a significant deficiency in the timeline set by the IACUC, and protocol suspension. However, the Great Eastern IACUC may wish to make a courtesy verbal report to their USDA inspector. Verbal reports do not create immunity for the organization in determining if a violation of the Animal Welfare Regulations occurred, but may be considered an act of good faith. Another reason to inform the USDA is that OLAW will share the non-compliance report with the USDA due to the memorandum of understanding between the two agencies5. Therefore, working with the USDA in advance can assist with both the follow-up site visit and public relations issues that may ultimately arise.
This is a preview of subscription content, access via your institution
