COVID-19 Scientific Review Committee and Peer Assistance Working Group

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.

Jay Steiner, STAT RN Justin Lewis, MD, MICU Resident Harsh Kallahalli, MD, Attending Jennifer Brooks, STAT RN

Background

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.


Submission Guidance

If you have submitted your study to the UF IRB, the COVID-19 SRCWG will receive an ancillary review request from the IRB.

wirb submission

If you are submitting your study through WIRB

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

Priority 1

UF investigator-initiated study in which UF serves as the lead institution and has NIH, PCORI, or equivalent nationally recognized, peer-reviewed funding source.

Priority 2

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).

Priority 3

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.

Priority 4

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.

No Human Subjects Research or Samples Involved

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.

number 1

Premise

Scientific merit of the project and underlying hypothesis


number two

Significance

Impact on the care of COVID-19 affected subjects and COVID-19 response operations


number 3

Innovation and novelty of the proposed work

Innovation and novelty of the proposed work


number four

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?


number 5

Integrity

Integrity and rigor of the research design and approach – Compelling hypothesis, likely to produce meaningful results, or important new data?


number 6

Mission Advancement

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?


Final Recommendation

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

chair

Duane A. Mitchell, MD, PhD

Director | UF Clinical and Translational Science Institute (CTSI)

Amer Abouhamze, MHA

Assistant Director | UF CTSI Biorepository

Amer Abouhamze, MHA

Jiang Bian, PhD

Director Of Cancer Informatics | EHealth Core & Associate Professor | Department of Health Outcomes & Biomedical Informatics | UF College of Medicine

Jiang Bian, PhD

vice chair

Scott Brakenridge, MD, MSCS

Assistant Professor of Surgery | UF Health Acute Care Surgery Team | Department of Surgery | UF College of Medicine

Scott Brakenridge, MD, MSCS

vice chair

Mark Brantly, MD

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

Mark Brantly, MD

Paul Crispen, MD

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

Paul L. Crispen, MD

Melissa Crowder, MS, CIH, COHC

Coordinator | UF Environmental Health & Safety

Melissa Crowder, MS, CIH, COHC

Marie-Carmelle Elie, MD

Critical Care Research And Clinical Trials Liaison | Division Of Critical Care Medicine | Clinical Associate Professor | Chief Medical Officer | Haven Hospice & Medical Group | Department of Medicine | UF College of Medicine

Marie-Carmelle Elie, MD

Jennifer Fishe, MD

Assistant Professor & Associate Medical Director | Pediatric Emergency Medicine | Director of the Center for Data Solutions | Department of Emergency Medicine | UF College of Medicine

Jennifer Fishe, MD

Yi Guo, PhD

Assistant Professor | Department of Health Outcomes & Biomedical Informatics | UF College of Medicine

Yi Guo, PhD

vice chair

Christopher Harle, PhD

Professor | Chief Research Information Officer | Department of Health Outcomes & Biomedical Informatics | UF College of Medicine

Christopher Harle, PhD

vice chair

Mark Hudak, MD

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

Mark Hudak, MD

Nicole Iovine, MD, PhD

Associate Professor Of Medicine | Hospital Epidemiologist | Division of Infectious Diseases & Global Medicine | Department of Medicine

Nicole Iovine, MD, PhD

Sharon Judge, PhD

Biosafety Officer | UF Department of Environmental Health & Safety

Arch Mainous, PhD

Professor | Department of Health Services Research, Management & Policy | UF College of Public Health & Health Professions

Arch Mainous, PhD

Lisa Merck, MD, MPH, MA, FACEP

Associate Professor | Vice Chair Of Research | Department of Emergency Medicine | UF College of Medicine

Lisa Merck, MD, MPH, MA, FACEP

Lyle Moldawer, PhD

Director of Inflammation Biology & Surgical Science | Department of Surgery | UF College of Medicine

Lyle Moldawer, PhD

Ray Moseley, PhD

Associate Professor | Department of Community Healthy & Family Medicine | UF College of Medicine

Ray Moseley, PhD

Alexander Parker, PhD

Professor | Senior Associate Dean for Research | Office of Research Affairs | UF College of Medicine – Jacksonville

Alexander Parker, PhD

Mattia Prosperi, MEng, PhD

Associate Professor | Department of Epidemiology | UF College of Public Health & Health Professions | UF College of Medicine

Mattia Prosperi, MEng, PhD

vice chair

Catherine Striley, PhD, MSW, MPE

Associate Professor | Department of Epidemiology | UF College of Public Health & Health Professions

Catherine L Striley, PhD, MSW, MPE

Michael Weaver, PhD, RN, FAAN

Professor | Associate Dean | UF College of Nursing | Office for Research Support

Michael Weaver, PhD, RN, FAAN

Samuel Wu, PhD

Program Director | Professor | Department of Biostatistics | UF College of Public Health & Healt Professions | UF College of Medicicne

Samuel Wu, PhD