Reading Room Production — page 201

Information to share with OCPL Background: The attached summary statements are from the Scientific Review Group, also known as peer review, of the initial application (review conducted in 2013) and the review of the renewal application (review conducted in 2019). The summary statement is the official record of these reviews. NIH peer reviewers use a 9-point scale for scoring NIH grant applications. A score of 1 means exceptional and 9 means poor, with 5 considered an average score. Impact scores run from 10 to 90 and are based on the normalized average of all reviewer impact/priority scores. Generally speaking, impact scores of 10 to 30 are most likely to be funded; scores between 31 and 45 might be funded; and scores greater than 46 are rarely funded. The review panel roster is posted publicly on the NIH website. These two rosters can be found: https://public.era.nih.gov/pubroster/preRosindex.era?AGENDA=265100&CID=102597 https: Tough Q/As: Did the NIH grant to EcoHealth Alliance with a subaward to WIV support ePPP research? public.era.nih.gov/pubroster/preRosindex.era?AGENDA=356932&CID=102597 '* As these reviews show the research proposed in the grant application sought to understand how bat coronaviruses evolve naturally in the environment to become transmissible to the human population. This included studying viral diversity in bat reservoirs, surveying people who work in| live animal markets or other jobs with high exposure to wildlife for evidence of bat-coronavirus infection and analyzing data to predict which newly discovered viruses pose the greatest threat I to human health. I '* NIH did not approve funding for research proposing to enhance SARS-CoV transmissibility or I virulence in humans in China or elsewhere. '* The body of science produced under the grant, including the bat coronavirus sequences identified by the researchers and published in the scientific literature, showed that the viruses. studied were evolutionarily quite distant from SARS-CoV-2 and could not have been the source of SARS-CoV-2. i| '* Inthe 2013 review, critique number 3 mentions that a potential overlap with PREDICT was__| noted. '* Inthe same critique, there is a note that the potenti addressed and therefore, raises concerns] © Inthe 2019 review, critique number 2 mentions that the letters from the two Chinese institutions were jdentical. fFisk to human subjects is not fully I } Commented [SE([1]: suggest adding a bullet that reviewer comments including risk to human subjects and potential overlap were address prior to award being made. This was documented in the 2014 Checklist for RO1AI110964-01. Erik Stemmy 2023-03-21 14:30:00 Commented [SE([2]: Overlap was addressed via JIT: fieldwork for the PREDICT program ended in June 2014 and PREDICT fully ended in September 2014. 'This award was funded 5/27/2014. Erik Stemmy [2] 2023-03-21 14:27:00 Commented [SE([3]: It needs to be noted that the "risk" evaluated in the human subjects section is in no way related to the chimeric virus work. This section evaluates whether the risk of the research activities to be performed directly on the human subjects is adequately addressed. In this case it was the blood draws/sample collection and interview questions and did not involve any of the chimeric viruses. The risk noted was the potential financial risk to subjects that may have been involved in illegal wildlife trade potentially losing their source of income. See link below for reviewer guidelines for HS protections: https://gran ov/grants/peer/guidelines_general [Guidelines for the Review of the Human Subjects pdf This risk was addressed in the JIT submission. Erik Stemmy [3] 2023-03-21 14:19:00 Commented [SE([4]: The same general language 'was used for the two letters of support, but the scientific details of the roles of each institution were appropriately included in the other sections of the application. Erik Stemmy [4] 2023-03-21 14:42:00