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A Word from OLAW

Lab Animal volume 50, page 5 (2021)Cite this article

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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.

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References

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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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Authors and Affiliations

  1. Director, OLAW, OER, OD, NIH, HHS, Bethesda, MD, USA

    Patricia Brown VMD, MS, DACLAM

Authors
  1. Patricia Brown VMD, MS, DACLAM
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Corresponding author

Correspondence to Patricia Brown VMD, MS, DACLAM.

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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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