Page:Interim Staff Report on Investigation into Risky MPXV Experiment at the National Institute of Allergy and Infectious Diseases.pdf/27

 In a written statement for the September 21, 2023, meeting, Jeffrey Potts, MPH, CBSP, Chief of the Biorisk Management Branch within the NIH Division of Occupational Health and Safety, wrote:


 * “Dr. Moss does not have approval to perform the speciﬁc experiments identiﬁed as the ‘Clade 1 study.’” [Bold added for emphasis].Analysis of the accuracy of the statement by Mr. Potts: This statement contains a material omission of fact.This statement omits the fact that Dr. Moss and his team did get approval in 2015 to perform speciﬁc experiments identiﬁed as the clade I study. Documents viewed show that, in May 2023, the Moss team’s Federal Select Agent Registration for MPXV was amended to exclude approval for gene transfers from clade I to clade II. This raises questions about what led to the revocation of the 2015 approval in May 2023. The May 2023 exclusion of approval was a recent change to the previous approval, and the NIH/NIAID should have been transparent about the history of this research project. Further, the statement that 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 these assertions are contradicted by the 2015 application and subsequent approval by the IBC.

The Moss team’s claims that the submission to the IBC in 2015 was not a formal proposal are unpersuasive. A submission of some kind was made to the NIH IBC, and the researcher had to respond to questions on the record in a meeting with recorded minutes. The IBC took a recorded vote to approve the experiment. It is reasonable to conclude a submission, a question-and-answer session, a meeting with recorded minutes, and a recorded vote constitutes a formal process. Furthermore, the NIH has produced no documentation that draws a distinction between an informal process and formal process before the IBC for approving intramural research experiments.