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Compliance requires communication and cooperation

This scenario could have been avoided with better communication and planning. Although Great Eastern University (GEU) has an institutional policy that requires concurrence with collaborating entity oversight committees, guidance on how conflicts are resolved or negotiated appears lacking. The GEU IACUC should have developed guidelines for collaborative studies with other institutions that included a requirement for a written agreement with the collaborating organization and the responsibilities of each party for the various aspects of the animal care and use program such as protocol review, animal ownership, veterinary care, and IACUC oversight authority1. A written collaboration agreement can also specify oversight responsibilities specific to biohazards and IBC review. The Institutional Biosafety Committee (IBC) from each institution should (promptly) communicate to try to allay the concerns of GEU’s IBC. Considering the close proximity of the two facilities it should even be possible for the GEU IBC or some of its members to visit the Contract Research Organization (CRO) to see if their concerns are justified, or to suggest amendments to the CRO IBC application.

Mayfield was correct when he said that approval by more than one IACUC is not required to meet federal regulatory requirements2, but GEU has an internal policy that requires concurrence with external review, presumably by all appropriate compliance committees. The GEU IACUC’s concurrence with the CRO’s IACUC and IBC may not “override” the requirement for their IBC to also concur.

There are a variety of details missing from this scenario that would help determine the best course of action to take. If the project is funded by an agency that has adopted PHS Policy, both institutions may be required to have a PHS Assurance, but GEU must verify IACUC approval. If both institutions are AAALAC International accredited, that could make the process of dual oversight simpler and may help alleviate the concerns of the GEU IBC. In this case, if the details were included in the written understanding, it would seem more appropriate to have the CRO’s committees be responsible for the protocol approval because the animal work will take place there. Also, their committees are likely to have more experience working with ABSL-3 studies. GEU should ask for the documents associated with IBC approval for the ABSL-3 work as well as follow-up documents such as annual reviews, any noncompliance, etc.

Institutions should develop policies and procedures that allow them to easily resolve issues that arise when collaborative research projects are presented to them. One institution has implemented and published methods for facilitating regulatory oversight for multi-site research. This “could provide a model for a distributed, national network of IACUC reliance3.”

The GEU IACUC and IBC should work collaboratively with each other and the CRO to address both the concerns of the GEU IBC and the researcher to ensure compliance with federal regulations and internal policy while recognizing the priority of the COVID-19 related research.

References

  1. 1.

    Institute for Laboratory Animal Research. Guide for the care and use of laboratory animals. 8th Ed. (Washington, D.C., National Academies Press, 2011)

  2. 2.

    Office of Laboratory Animals, National Institutes of Health. Frequently Asked Questions. PHS Policy on Humane Care and Use of Laboratory Animals. D. Protocol Review. 8. Available from: http://olaw.nih.gov/guidance/faqs.

  3. 3.

    Holthaus, K., Goldberg, D. & Connelly, C. et al. J Clin Transl Sci. 4, 96–101, https://doi.org/10.1017/cts.2019.431 (2020).

    Article  PubMed  PubMed Central  Google Scholar 

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Correspondence to Harry Fyke.

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Fyke, H., King, M.L., Jourdan, M. et al. Compliance requires communication and cooperation. Lab Anim 50, 3–4 (2021). https://doi.org/10.1038/s41684-020-00689-5

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