Smoom. R. et al. Nat Commun. 14, 6708 (2023)

Wilhelm, M. et al. Nat. Commun. 14, 7016 (2023)

In 2017, Great Eastern University’s (GEUs) IACUC deliberated1,2 on the limits of the application of OLAW’s Guidance on Significant Changes to Animal Activities3 and learned that the veterinary verification and consultation (VVC) process cannot be used for the addition of new procedures that are not previously approved on the protocol. OLAW’s Guidance describes specific significant changes that may

Kravtsova, O. et al. Sci. Rep. 13, 19231 (2023)

The issue at hand pertains to the selection between using VVC, DMR, or FCR for the review and approval of Dr. Silverman’s amendment. VVC is suitable for making significant changes to animal activities that are part of a previously approved protocol. The VVC process may not be used to add new procedures to a previously approved protocol1. All Dr. Silverman’s additional procedures will bring greater

Resseguier, J. et al. Sci. Adv. 9, eadj0101 (2023)

Pronovost, G.N. et al. Sci. Adv. 9, eadk1887 (2023)

The Protocol Review coordinators offer the following compliance considerations: 1. Types of changes to IACUC-approved activities: OLAW’s Guidance on Significant Changes to Animal Activities1 defines the flexibility afforded to IACUCs in the review and approval of changes to animal activities; specifically: a. Significant changes are those “that have, or have the potential to have, a negative impact

Kemmler, C.L. et al. Nat. Commun. 14, 6594 (2023)

Dr. Jerry Silverman learned that the new VVC process should result in his protocol amendments being quickly approved. Consequently, Jerry asked his veterinarian, Dr. Bernie Rollin to authorize his protocol modifications through the VVC process. Except for the request to increase the animal numbers by less than 10%, Dr. Rollin felt that the other modification requests did not qualify for the VVC process

Kirschhock, M.E. & Nieder, A. Proc. Natl. Acad. Sci. 120, e2313923120 (2023)

Zhang, W. et al. Nature (2023) https://doi.org/10.1038/s41586-023-06675-4

Yuan, F. Nature 621, 857-867 (2023)

Salimando, G.J. et al. Nat. commun. 14, 5632 (2023)

Gallardo-Caballero, M. et al. Commun. Biol. 6, 978 (2023)

Koto, A. et al. Nat. Commun. 14, 5493 (2023)

Ino, Y. et al. Sci. Rep. 13, 15768 (2023)

Dr. Thomas Lauke’s NSF funded grant involves work with guinea fowl, a species native to Africa and considered poultry by the United States Department of Agriculture (USDA)1. All animal activities conducted under this grant are subject to the provisions of the PHS Policy2, and the Guide for the Care and Use of Laboratory Animals (The Guide)3. Since the birds were bred in captivity and used for research

Ramadan, A.G. et al. Sci. Rep. 13, 15480 (2023)

Dr. Thomas Lauke, Great Eastern University’s (GEUs) field and wildlife researcher, received a National Science Foundation (NSF) grant to determine if guinea fowl can successfully survive as wild populations in various suburban areas. Guinea fowl are known for eating deer ticks and there are areas, such as in Maine, that have high rates of Lyme disease. The goal is to establish a wild population of

Wu, M.S. et al. Cell Rep. 42, 113207 (2023)

Sato, A. et al. Sci. Rep. 13, 15649 (2023)

Cigliola, V. et al. Nat. Commun. 14, 4857 (2023).

Faust, T.E. et al. Cell. Rep. 42, 113031 (2023)

Hu, B. et al. Sci. Rep. 13, 13554 (2023).

In the scenario presented, the GEU IACUC holds that responsibility for fidelity between procedures performed and those approved ultimately lies with the Principal Investigator (PI). In contrast, Dr. Felelős, whose surname translates from Hungarian to “responsible,” does not dispute that noncompliance with the approved protocol occurred, but, rather, appears to question the existence of any regulatory

Zhang, Z. et al. Nature 621, 196–205 (2023).

Katti, A. et al. Nat. Biotechnol. 2023 https://doi.org/10.1038/s41587-023-01900-x.

Atanas, A. et al. Cell 186, 4134–4151 (2023).

Great Eastern University (GEU) has many faculty that serve as basic research Principal Investigators (PIs) and practicing medical doctors (MDs) with extremely busy clinical hours. These PIs are committed to providing quality care to their patients and to discovering novel treatments for the medical challenges associated with their expertise. Many PIs find it difficult to manage a robust research program

Li, S. et al. Cell Rep. 42, 112980 (2023)

This scenario is not uncommon. In many large research labs, the Principal Investigator (PI) oversees a lab with a large number of research scientists, research staff, postdocs and graduate students. In many cases the PI is not aware of the day-to-day actions of this multitude of staff and trainees, even with a lab manager. Moreover, the oversight of the trainees (postdocs and students) may be lacking

Ail, D. et al. Sci. Adv. 9, eadg8163 (2023)

The Protocol Review coordinators offer the following compliance considerations:

Dr. T. Guaio, an established faculty member at Great Eastern University (GEU), studies animal models of hemophilia with the goal of finding effective gene therapies. Recently, Guaio completed the statistical analyses of 6 months’ worth of data from his rabbit research. Much to his dismay, the results were inconclusive and rather chaotic. This was surprising, and troubling, because prior results were

Guichard, A. et al. Cell Rep. 42, 112842 (2023)

Kleinhappel, T.K., Pike, T.W. & Burman, O.H.P. Sci. Rep. 13, 10576 (2023).

Investigators are often disappointed when a gene is knocked out and animals have “no phenotype”, but genetic modelers often remind them that animals may not have been appropriately challenged to reveal a phenotype and function of the gene of interest. While laudable that Dr. Guaio tried to make use of existing animals being culled by Dr. Virale, the use of “excess” genetically modified animals in unrelated

Bondarenko, V. et al. EMBO J. (2023) https://doi.org/10.15252/embj.2022113280.

The Protocol Review coordinators offer the following compliance considerations:

Lo, Y. et al. Commun. Biol. 6, 716 (2023)

Gloveli, N. et al. Neuron (2023) https://doi.org/10.1016/j.neuron.2023.06.018

This unfortunate mishap is an example of the reproducibility challenges we face in research. The results of their study highlight the confounding genetic variables that may be present in animal models and the need to be aware of such variables. Animal researchers are commonly aware of a range of experimental variables that require monitoring, including age, sex, pathogen status, and diet. Researchers

Sperling, A.L. et al. Curr. Biol. 33, 1–16 (2023)

Bengochea, M. et al. Cell. Rep. 42, 112772 (2023)