by Jon Fleetwood, Jon Fleetwood:
NIH records show Ren’s institute was designated to manage the grant’s human-subject work—and its new Chinese human protocol—months before her December 28 SARS-CoV-2 submission.
Federal records place the submitter of the earliest recovered SARS-CoV-2 genome inside NIAID’s pre-COVID human coronavirus-surveillance operation—and reveal that, months before her submission, the program’s new Chinese human-subject research protocol was being routed through her institute.
That first-acknowledged SARS2 genome also has a massive provenance hole: the raw sample reads and intermediate computational records needed to independently reproduce its construction have never been made public.
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On December 28, 2019, Lili Ren had submitted the earliest recovered SARS-CoV-2 genome to NCBI.
Ren was already a named investigator at the Institute of Pathogen Biology (IPB) on the NIAID bat-coronavirus grant renewed that July.
Months earlier, EcoHealth Alliance had told NIH that the renewal’s new human-subject protocol would be reviewed through Ren’s institute.
The Dec 28 GenBank file annotated one coding sequence.
Spike.
That spike sequence matched Wuhan-Hu-1 spike.
Congress disclosed Ren’s deposit.
Congress investigated the grant.
Congress did not publicly put those records together.
The investigator NIAID placed inside its pre-COVID human coronavirus-surveillance operation became the person who submitted the earliest recovered SARS-CoV-2 genome to the U.S. government’s sequence database.
NIH Moves the Human Protocol to Ren’s Institute
On November 5, 2018, EcoHealth submitted its renewal application for NIAID grant R01AI110964, “Understanding the Risk of Bat Coronavirus Emergence.”
Human subjects were listed.
IRB approval was pending.
IPB was included as a performance site, Ren was named, and an IPB support letter committed the institute to providing new and archived human samples.
The proposed work explicitly used spike and receptor-binding-domain sequence information to assess SARS-related coronaviruses and included clinic-based surveillance following acute illness.
Then, on May 6, 2019, EcoHealth told NIAID that the renewal required a “new human subject research protocol.”
The existing Chinese ethics approval ran through Wuhan University.
The new protocol would instead be reviewed through IPB/CAMS, under Federalwide Assurance FWA00016236.
EcoHealth said it would submit the protocol by June 1 and obtain approval by July 31.
NIAID issued Year 6 of the award on July 24.
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