In response to the issues posed in this scenario, the National Institutes of Health – Office of Laboratory Animal Welfare (NIH–OLAW) provides the following clarification with the assumption that the research is funded by NIH:
In this scenario, two institutions are partnering to conduct SARS-CoV-2 coronavirus research. There are differences of opinion between the Institutional Biosafety Committees about the safety conditions necessary for conducting the research with infected mice. The question asked is what regulatory requirements must the IACUC follow.
As mentioned by other reviewers, NIH grants policy requires that when a grantee institution collaborates with another organization, the primary recipient of the grant funds is accountable for the performance of the project and all other obligations specified in the grants policy1. It also states that the primary recipient is responsible for including these requirements in its agreements with collaborating organizations”1,2.
In addition to the NIH grants requirements above, the institution must adhere to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. The Institutional Biosafety Committee (IBC) must ensure that research conducted at or sponsored by the institution is conducted in compliance with the Guidelines and applicable laboratory safety guidance3,4,5.
In this case, assuming both institutions have an Animal Welfare Assurance with OLAW, there is no federal requirement for dual IACUC review1,6. Agreement between the GEU IBC and the CRO’s IBC is the key to resolving the situation. As highlighted in the Guide for the Care and Use of Laboratory Animals, “interinstitutional collaborations have the potential to create ambiguities about responsibility for animal care and use”7. An expanded written agreement describing IBC and IACUC oversight when disagreements arise would have both institutions well-positioned to quickly resolve the issue. Absent that, the GEU IACUC should make it clear to Dr. Mayfield that work at the CRO may not proceed until the two IBCs agree on necessary safety conditions.
References
Office of Extramural Research, National Institutes of Health. NIH Grants Policy Statement, Part II, Terms and Conditions of Grant Awards, Part A, Section 4.1.1.3, Consortiums. (US Department of Health and Human Services, Bethesda, MD, USA, revised December 2019). https://grants.nih.gov/grants/policy/nihgps/html5/section_4/4.1.1_animal_welfare_requirements.htm#Consorti (accessed, November 16, 2020).
Office of Extramural Research, National Institutes of Health. NIH Grants Policy Statement, Part II, Terms and Conditions of Grant Awards, Part B, 15.2.1, Written Agreement. (US Department of Health and Human Services, Bethesda, MD, USA, revised December 2019) https://grants.nih.gov/grants/policy/nihgps/html5/section_15/15.2_administrative_and_other_requirements.htm#Written (accessed, November 16, 2020).
Office of Extramural Research, National Institutes of Health. NIH Grants Policy Statement, Part II: Part A, Section 4.1.26, Research Involving Recombinant or Synthetic Nucleic Acid Molecules (including Human Gene Transfer Research). (US Department of Health and Human Services, Bethesda, MD, USA, revised December 2019). https://grants.nih.gov/grants/policy/nihgps/html5/section_4/4.1.26_research_involving_recombinant_or_synthetic_nucleic_acid_molecules__including_human_gene_transfer_research_.htm (accessed, November 16, 2020).
Office of Science Policy, National Institutes of Health. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. (US Department of Health and Human Services, Bethesda, MD, USA, revised April 2019) https://osp.od.nih.gov/wp-content/uploads/2019_NIH_Guidelines.htm (accessed November 16, 2020).
Office of Science Policy, National Institutes of Health. FAQs – Interim Laboratory Biosafety Guidance for Research with SARS-CoV-2 and IBC Requirements under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. https://osp.od.nih.gov/biotechnology/interim-lab-biosafety-guidance-for-research-with-sars-cov-2/ (accessed November 16, 2020).
National Institutes of Health. Public Health Service Policy on Humane Care and Use of Laboratory Animals – Frequently Asked Questions. Protocol Review, Question D.8. (US Department of Health and Human Services, Bethesda, MD, USA, revised 2017) https://olaw.nih.gov/guidance/faqs#621 (accessed November 16, 2020).
Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals. 8th edition, p 15, (National Academies Press, Washington, D.C., USA, 2011).
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Brown, P. A Word from OLAW. Lab Anim 50, 5 (2021). https://doi.org/10.1038/s41684-020-00690-y
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DOI: https://doi.org/10.1038/s41684-020-00690-y
