Has your study been referred to the COVID-19 Scientific Review Committee and Peer Assistance Working Group (COVID-19 SRCWG)? Below you will find information about the group’s purpose and members, as well as submission guidance, expectations, a review sheet, and criteria for evaluation.
The COVID-19 SRCWG reviews any study at UF JAX or UF Gainesville focusing on COVID-19 patients, the response of COVID-19 for UF employees or students, and/or COVID-19 samples/data.
The working group is made up of investigators and service core representatives, as well as UF regulatory team members. The intent was that all studies identified by the UF IRB as COVID-19 related could be reviewed by a single committee serving all of UF (Gainesville and Jacksonville). This also allows for studies to be considered in one campus and not the other if the feasibility matched a patient census in one location but not the other.
David Norton, UF Vice President for Research, and David R. Nelson, Senior Vice President for Health Affairs and President of UF Health, enlisted the CTSI to construct a COVID-19 taskforce addressing research needs, clinical research operational challenges and solutions, and to create a rapid-response RFA for funding COVID-19 focused research pilots. Within that request was to build a scientific feasibility and review committee to address the concerns from physicians and the IRB.
There was a sincere concern by both physicians and the IRB that there were only “so many” COVID positive patients, and albeit that was a good situation – we didn’t need each patient being presented with an unlimited number of possible COVID-related studies. The focus was on interventional clinical trials for the treatment of patients undergoing mild to severe impacts of the disease. The committee expanded to include tissue, data, and other limited resources being considered in the feasibility review.
If you have submitted your study to the UF IRB, the COVID-19 SRCWG will receive an ancillary review request from the IRB.
Click below to email us the submission so we can process it for review.
When the committee coordinator receives the request, the study is added to the COVID-19 SRCWG agenda (as space allows on the agenda) according to the following timeline:
- Studies received Monday – Wednesday are scheduled for review/discussion the following Tuesday
- Studies received Thursday – Sunday are scheduled for review the following Thursday
Every effort is made to ensure that the study investigator or study team member is available to attend the review/discussion. COVID-19 SRCWG notices are either uploaded to myIRB as an ancillary review or provided to the study team for WIRB submission via email.
How are reviews conducted?
The COVID-19 SRCWG makes recommendations for prioritization of COVID-19-related research based on objective criteria considering institutional priorities, limited resources, limited research subjects, investigator interests, and community needs in response to the COVID-19 pandemic.
Reviewers assign an Institutional Priority Score to COVID-19 human subjects research protocols or protocols requesting samples from COVID-19 patients or define as No Human Subjects Research or Samples involved.
Reviewers also conduct a Scientific Merit Review and assign individual criterion scores (1 – High to 4 – Insufficient).
Institutional priority scores
UF investigator-initiated study in which UF serves as the lead institution and has NIH, PCORI, or equivalent nationally recognized, peer-reviewed funding source.
UF investigator-initiated study in which UF serves as the lead institution with other extramural funding source (i.e. pharma sponsored) or prioritized institutional resources (i.e. institutional pilot awards).
Study in which UF investigator/institution is not lead institution but participation expands clinical trial opportunities, interventions, or supportive care options for patients in a meaningful way.
Study in which UF investigator/institution is not lead institution but participation contributes to generalizable knowledge in a meaningful way. Unfunded research by UF investigators.
Will be reviewed by SRCWG Chair, Vice Chair or approved designees, without needing full board review. Studies may be brought for full board review at discretion of assigned reviewer(s).
Scientific Review Merit for COVID-19 Research
Two scientific reviewers and a statistical reviewer will be assigned to each protocol. Reviewers will evaluate and assign a numerical score for projects in six categories.
Scientific merit of the project and underlying hypothesis
Impact on the care of COVID-19 affected subjects and COVID-19 response operations
Innovation and novelty of the proposed work
Innovation and novelty of the proposed work
Resources & Feasibility
Resource utilization and feasibility of the proposed study – Does UF have adequate resources (patient population, data, and specimens) to support the study? Does it overlap with or potentially detract from higher priority studies? Is the environment where research is proposed amenable to the intervention?
Integrity and rigor of the research design and approach – Compelling hypothesis, likely to produce meaningful results, or important new data?
Advancement of the overall goals of UF’s research mission – Does the study advance UF investigators’ and the institution’s national and international research contributions in a meaningful way?
Taking into account Institutional Priority and Scientific Merit
- Approved with High Priority: Go forward now
- Approved with Normal Priority: Might wait until i.e. we know size and availability of repository (will go to IRB but allocation of resources may not occur)
- Approved pending required modifications: Will likely approve, but need fix or clarification: Once revisions are complete, the study is presented to original reviewers and Vice Chair for approval
- Approved with Low Priority: Possible to approve, but given competing higher-priority studies, it’s unlikely to be supported
- Not Approved: Flawed premise, approach, inconsistent with institutional priorities, or not supportable based on existing patient population
Scientific Review Committee and Peer Assistance Working Group Members
Director | UF Clinical and Translational Science Institute (CTSI)
Assistant Director | UF CTSI Biorepository
Director Of Cancer Informatics | EHealth Core & Associate Professor | Department of Health Outcomes & Biomedical Informatics | UF College of Medicine
Professor of Medicine | Vice Chair of Research | Division of Pulmonary, Critical Care & Sleep Medicine | Department of Medicine | UF College of Medicine | Alpha-1 Foundation Research Professor
Pete and Carolyn Newsome Urologic Oncology Professorship | Associate Professor | Associate Chair of Clinical Affairs | Institutional Principal Investigator with NRG Oncology | UF Health Cancer Center Scientific Review & Monitoring Committee Chair | Department of Urology | UF College of Medicine
Coordinator | UF Environmental Health & Safety
Assistant Professor & Associate Medical Director | Pediatric Emergency Medicine | Director of the Center for Data Solutions | Department of Emergency Medicine | UF College of Medicine
Assistant Professor | Department of Health Outcomes & Biomedical Informatics | UF College of Medicine
Professor | Chief Research Information Officer | Department of Health Outcomes & Biomedical Informatics | UF College of Medicine
Professor & Chair | Department of Pediatrics | Chief | Division of Neonatology | Associate Medical Director | NICU Wolfson Children’s Hospital | Associate Dean for Managed Care | UF College of Medicine – Jacksonville
Associate Professor Of Medicine | Hospital Epidemiologist | Division of Infectious Diseases & Global Medicine | Department of Medicine
Biosafety Officer | UF Department of Environmental Health & Safety
Professor | Department of Health Services Research, Management & Policy | UF College of Public Health & Health Professions
Director of Inflammation Biology & Surgical Science | Department of Surgery | UF College of Medicine
Associate Professor | Department of Community Healthy & Family Medicine | UF College of Medicine
Professor | Senior Associate Dean for Research | Office of Research Affairs | UF College of Medicine – Jacksonville
Associate Professor | Department of Epidemiology | UF College of Public Health & Health Professions | UF College of Medicine
Associate Professor | Department of Epidemiology | UF College of Public Health & Health Professions
Professor | Associate Dean | UF College of Nursing | Office for Research Support
Program Director | Professor | Department of Biostatistics | UF College of Public Health & Healt Professions | UF College of Medicicne