Synthesized answer
To evaluate Dr. Moss's proposal, critical questions would revolve around the specifics of the proposed gene transfer from clade I to clade II of the mpox virus. It would be essential to understand the exact genes intended for transfer, the rationale behind selecting those specific genes for enhancing virulence, and how this transfer is expected to contribute to understanding mpox virus virulence [5]. Additionally, clarity would be needed on the experimental design and expected outcomes of such an experiment, particularly concerning the rodent model mentioned [3].
Regarding biosafety and biosecurity measures, a rigorous evaluation would necessitate adherence to established guidelines. This includes compliance with the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, the Biosafety in Microbiological and Biomedical Laboratories (BMBL), and USG Policies involving Dual Use Research of Concern and the USG P3CO framework [1, 2]. Specific measures would likely be based on the proposed experiments and could include enhanced containment procedures, surveillance protocols, and waste management strategies commensurate with the potential risks associated…
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From the book
olving recombinant or synthetic nucleic acid molecules, are reviewed and assessed by the IBC and if applicable, the IRE. Together, these committees review submitted proposals to ensure compliance with the NIH Guidelines, the BMBL, USG Policies involving Dual Use Research of Concern and the USG P3CO framework. The NIH has been a leader in this effort starting back in 2009 and most recently, evaluating our review process against the proposed recommendations of the NSABB. Dr. Moss does not have approval to perform the specific experiments identified as the “Clade I study”. If Dr. Moss formally…
nd the proposal would need to undergo the rigorous review process described in this letter before it could be initiated. By way of background, NIH intramural projects are required to follow all applicable NIH policies and procedures, including adherence to biosafety and biosecurity guidance as outlined in the current edition of the Biosafety in Microbiological and Biomedical Laboratories, the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), the Federal Select Agent Regulations, and other applicable regulations as appropriate. All NIH…
s from the less virulent clade IIa to see if he could diminish the virulence of the more severe virus in a rodent model. This is the most cautious approach, trying to attenuate the virulent strain, and this was the approach that Dr. Moss has taken. He has not at any point pursued transferring genes from the more virulent strain (clade I) into the less virulent strain (clade II), nor has he made specific plans to do so. If the latter strategy were to be pursued in the future, it would be preceded extensive consultation and rigorous evaluation and review by the committees that Jeff Potts will…
t Dr. Moss “does not have approval” in the fall of 2023 omits that he did have approval from 2015 until May of 2023. Dr. Moss was emphatic during this meeting that the MPXV experiment involving the transfer of genes from clade I to clade II as described in the September 2022 Science article was merely aspirational. At one point, he analogized his consideration of the gene transfer idea to discussing trips that one would want to take as in a “bucket list.” He insisted that no steps had been taken to advance this idea, such as writing and/or planning the experiment, even if not conducted. All…
, I will consider additional gene exchanges that might include transfers in the opposite direction or involve clade IIb. I have not planned or proposed such experiments for approval since we have not completed the current experiments and therefore do not yet know which genes might be best to transfer. However, should it appear in the future that such an experiment would greatly contribute to understanding the basis for mpox virus virulence, then I may make such a proposal and would abide by the decision of the Institutional Biosafety Committee. Lastly, with respect to the Science magazine…
More questions about this book
- How would you explain, in simple terms, *why* transferring genes from a more deadly virus clade into a more transmissible clade raises such significant alarm among scientists and warrants a Congressional investigation? Focus on the practical implications if such a modified virus were to escape a lab.
- The report states the experiment "appeared to qualify as gain-of-function research." Define "gain-of-function research" in your own words, and then articulate the specific ethical and biosecurity dilemmas presented by *this particular MPXV experiment* falling into that category.
- The Committee on Energy and Commerce has jurisdiction over public health agencies and a history of investigating risky research. Explain the *tension* that might exist between scientific autonomy (researchers like Dr. Moss) and governmental oversight (E&C Committee) when dealing with experiments that could have severe public health consequences.
- What broader lessons about balancing scientific advancement with public safety and biosecurity can be drawn from the details of this investigation? How might such incidents influence public trust in scientific institutions and regulatory bodies responsible for oversight?