The principal investigators make a common sense argument: since the specific rabbit surgery was approved by the IACUC in a current protocol under Chen, and Rosen was recognized as being adequately trained to do this same surgery in a previous protocol, Rosen's surgery in the current protocol should also be okay with the IACUC.
This argument fails for a few reasons. First, the IACUC did not approve the use or relevance of Rosen's latest animal work, which is a part of any IACUC's basic charge. Rosen added a proof-of-concept study, which the IACUC must confirm as appropriate. Second, the IACUC reviews personnel for more qualities than just their training. For example, it also assesses a project's risk to occupational health and the current status of personnel. Finally, this scenario hints about other problematic conditions that are managed, at least in part, by the IACUC.
The appropriate way to handle this small add-on project would be to acknowledge that it is not within the approved protocol and to obtain approval from the IACUC either through a formal modification to Chen's protocol or through a new protocol. Relevance could be confirmed by the IACUC at that time. In addition, the IACUC could coordinate with other administrative units to ensure the proper use of grant funding, which might not apply to the costs of the add-on project.
The requirement to assess relevance is set by U.S. Government Principle II of the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training: “Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society”1. This is also upheld by other US regulations2,3. It is a matter of debate, however, just how an IACUC should assess relevance or the related concepts of scientific merit and harm-benefit analysis4,5. Nonetheless, it is clear that the IACUC must confirm that the overall use of animals is relevant, rather than merely approve the surgical component of the protocol, as claimed by the investigators. Chen and Rosen failed to understand that IACUC approval considers more than the question of how animal activities are conducted. Investigators should receive sufficient training so that they can readily spot when IACUC review is required.
References
Research Animal Committee. U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training II (Office of Science and Technology Policy, Washington, DC, 1985).
Animal Welfare Act regulations. 9 CFR. Chapter I, Subchapter A, Part 2, Subpart C.
The Public Health Service Responds to Commonly Asked Questions, ILAR J 33, 68–70 (1991).
Vieira de Castro, A.C. & Ollson, I.A.S. Does the goal justify the methods? Harm and benefit in neuroscience research using animals. in Current Topics in Behavioral Neuroscience, Vol. 19 (eds. Lee, G., Illes, J. & Ohl, F.) 47–78 (Springer, Berlin, 2014).
Carbone, L. In The IACUC Handbook 3rd edn. (eds. Silverman, J., Suckow, M. & Murthy, S.) 215–217 (Taylor and Francis, Boca Raton, 2014).
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Lyons, D., Means, P., Young, R. et al. Response to Protocol Review Scenario: An IACUC reviews much more than training. Lab Anim 45, 210 (2016). https://doi.org/10.1038/laban.1021
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DOI: https://doi.org/10.1038/laban.1021
