This scenario consists of two distinct issues. The first issue concerns the roles of the IACUC to review and approve, require modifications in (to secure approval), or withhold approval on behalf of the institution1. In order to fulfil its roles, the members of the IACUC need to use their expertise to balance the needs of the ongoing research project with the capabilities of the newly installed human cardiothoracic simulation laboratory.
Although Callahan is new to the committee, he should be provided with the minutes and discussion of the IACUC review of this project. There may have already been a discussion about the project’s ongoing use of pigs and the possibility of using the sim lab to replace live animals.3 For whatever reason(s), the IACUC during its deliberation found that the continued use of the animals was justified. Since the sim lab is a new training device, it may take several months for the students to learn how to use it effectively. Also, the simulation lab may not be applicable to every scenario required to appropriately teach the students.
The second issue involves who has authority to revoke an IACUC decision. Was Callahan named as the Institutional Official listed on the institution’s Assurance? If not, he has no authority to revoke a decision that has been made by a duly appointed IACUC1,2. However, he does have every right to question any protocol that deviates from its IACUC approval. It seems that Callahan is trying to apply the idea of the replacement alternative3—while commendable, this just may not be realistic currently.
The IACUC should review its policies for continuing review to decide if this particular protocol needs to be revisited more frequently to ensure that the requirement for use of animal models is still necessary.
References
Public Health Service. PHS Policy on Humane Care and Use of Laboratory Animals. (U.S. Department of Health and Human Services, National Institutes of Health, Bethesda, MD, 2015).
Animal Welfare Act. Public Law 89-544, 1966, as amended (P.L. 91-579, P.L. 94-279, and P.L. 99-198), 7 U.S.C. 2131 et seq. Implementing regulations are published in the Code of Federal Regulations (CFR), Title 9, Chapter 1, Subchapter A, Parts 1, 2, and 3.
Russell, W. M. S, & Burch, R. L. The principles of humane experimental technique. (Methuen, London 1959)
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Correa-Murphy, R. Rules vs. roles?. Lab Anim 49, 129 (2020). https://doi.org/10.1038/s41684-020-0528-y
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DOI: https://doi.org/10.1038/s41684-020-0528-y