Page:Interim Staff Report on Investigation into Risky MPXV Experiment at the National Institute of Allergy and Infectious Diseases.pdf/28

 Additional Observations

 Inadequate IBC Review Process 

The June 2015 IBC review of the bidirectional MPXV gene transfer experiment is troubling. The IBC approved this proposal, but the documents reviewed by Committee staff in camera at HHS did not reﬂect that the IBC acknowledged and considered the risks entailed with potentially making a much more transmissible MPXV clade with more lethality. Nor did the IBC examine whether a loss-of-function approach would be a viable and safer alternative.

The extent of the IBC’s review was to acknowledge that the NIAID investigators should treat clade II MPXV as a select agent since there would be a gene transfer from MPXV clade I, which is classiﬁed as a federal select agent. There is no evidence in the record made available to Committee staff that shows the IBC assessed the risks of the bidirectional gene transfer experiment. Nor is there evidence in the record showing the IBC assessed the dual-use concerns.

While such reviews may not be apparently required, documents acquired by the Committee in its investigation of NIAID’s management of the EcoHealth Alliance grant showed that during the 2014-2017 gain-of-function research pause, the NIAID DURC GOF committee reviewed projects for DURC and gain-of-function concerns, even though the projects were not covered by the funding pause. The June 2015 IBC review appears to have fallen short of these practices.

 Lack of Ongoing NIAID Oversight 

The MPXV research investigation has revealed other concerns. In addition to the ﬂawed IBC review process, the annual progress reports submitted by the Moss team for four consecutive years simply repeated the same generic summary paragraphs in each year to discuss their research activities. While publications were listed, there was no narrative discussion with updates on research activities.

The language in the “Goals and Objectives” and “Summary” sections were identical to the section language for four consecutive years. For the three years that followed, these sections were also identical but with an additional paragraph in the Summary section