The sudden emergence of the SARS-CoV-2 coronavirus pandemic has had a profound global impact. As the virus continues to spread, the search for a vaccine is imperative in mitigating the virus’ devastating clinical and economic effects. Due to the rapid transmission rate of the virus, biomedical research around the world has significantly increased during this crisis to develop prevention and treatment strategies. Researchers such as Dr. Marty Mayfield of Great Eastern University have stepped forward to develop these potential clinical innovations and therapeutics targeting the SARS-Cov-2 coronavirus.
To conduct SARS-CoV-2 research, Mayfield needs access to an ABSL3 facility1; Great Eastern does not have this capacity, so he has partnered with a CRO to perform the SARS-CoV-2 mouse experiments. He is an experienced scientist that has successfully worked within Great Eastern’s IACUC and IBC policies in the past. Given the level of necessary collaboration between Great Eastern University and the CRO, it is paramount that both institutions come to an agreement regarding their respective roles within the scope of the research project.
Without fully knowing who is providing funding for the research, it is difficult to determine each institutions’ specific responsibilities. Regulatory oversight hinges on answers to questions such as who is the actual grantee and which institution owns the animals. According to its Rules of Accreditation, AAALAC International follows animal ownership to determine who is responsible for animals at an offsite program2. The grantee institution in this case is Great Eastern; the animals are thus owned by them. Assuming the funding is from the National Institutes of Health (NIH), the animal work is also covered by the Public Health Service (PHS) Policy.
As the work utilizes a recombinant mouse-adapted strain of SARS-CoV-2, an IBC must review Mayfield’s proposed work for compliance with the NIH Guidelines (Section IV-B-2-b-(1))3. Coverage by NIH Guidelines “includes research collaboration or contractual agreements” (Section I-C-1-a ). The ABSL3 work constitutes a contractual agreement or subaward4; NIH Guidelines must be met at the CRO. An IBC may, based on its home institution’s policies, allow oversight of the work by a second IBC (i.e., at the CRO).
We postulate that the difference in approvals between the CRO and Great Eastern IBC stems from differences in either institutional risk tolerance, a lack of knowledge regarding the CRO’s ABSL3 biosafety features, or both. This risk is not without merit. Failure to adequately identify and mitigate biosafety risks at the CRO could jeopardize both human health (e.g., escaped mouse) and any further NIH funding for the grantee (Great Eastern). To reduce the university’s institutional risk, Great Eastern’s IO and its responsible official (often, but not always the same individual) should create a memorandum of understanding (MOU) between the university and CRO. Without such an MOU, Mayfield’s research cannot proceed. The MOU should clearly state that the onus of all IACUC and IBC regulatory oversight and compliance lies with the CRO. In this way, we believe that University risk is mitigated while allowing Mayfield’s valuable SARS-CoV-2 work to proceed.
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/ (last accessed 10/20/2020)
AAALAC International. Rules of Accreditation. Section 1. Definitions: Animal Ownership. July 2020. https://www.aaalac.org/accreditation-program/rules-of-accreditation/
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
National Institutes of Health. Dec 2019. NIH Grants Policy Statement.
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Robinson, C.K., Taylor, L.A. & Vemulapalli, T.H. Did someone say MOU?. Lab Anim 50, 4–5 (2021). https://doi.org/10.1038/s41684-020-00687-7