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Developing a Rapid Response Single IRB Model for Conducting Research During a Public Health Emergency.
Lowe, Abigail E; Kraft, Colleen; Kortepeter, Mark G; Hansen, Keith F; Sanger, Kristine; Johnson, Ann; Grein, Jonathan D; Martin, Julie; Rousselle, Rebecca; Garland, Jennifer A; Spotts, Jessica; Lowe, John J; Sauer, Lauren M; Kratochvil, Christopher J; Gordon, Bruce G.
  • Lowe AE; Abigail E. Lowe, MA, is an Assistant Professor, Global Center for Health Security, College of Allied Health Professions, University of Nebraska Medical Center, Omaha, NE.
  • Kraft C; Colleen Kraft, MD, MS, is a Professor, Department of Pathology and Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, and Associate Chief Medical Officer, Emory Hospital, Emory University, Atlanta, GA.
  • Kortepeter MG; Mark G. Kortepeter, MD, is Vice President for Research, Uniformed Services University of the Health Sciences, Bethesda, MD.
  • Hansen KF; Keith F. Hansen, MBA, is Co-Director, Center for Preparedness Education, College of Public Health; Co-Executive Director, Association of Healthcare Emergency Preparedness Professionals; and an Instructor, College of Public Health, University of Nebraska Medical Center, Omaha, NE.
  • Sanger K; Kristine Sanger is Director of Training and Exercise Programs, Center for Preparedness Education, College of Public Health, and Co-Executive Director, Association of Healthcare Emergency Preparedness Professionals, University of Nebraska Medical Center, Omaha, NE.
  • Johnson A; Ann Johnson, PhD, MPH, CIP, is Director, Institutional Review Board and Human Research Program, University of Utah, Salt Lake City, UT.
  • Grein JD; Jonathan D. Grein, MD, is Director, Hospital Epidemiology, Cedars-Sinai Medical Center, Los Angeles, CA.
  • Martin J; Julie Martin, RN, MEd, CIP, is Assistant Director, Institutional Review Board, Emory University, Atlanta, GA.
  • Rousselle R; Rebecca Rousselle, BA, CIP, is Assistant Vice President, Human Research Protection Program, Emory University, Atlanta, GA.
  • Garland JA; Jennifer A. Garland, RN-BC, PhD, CIC, is an Epidemiologist and Special Pathogens Clinical Program Manager, Hospital Epidemiology, Cedars-Sinai Medical Center, Los Angeles, CA.
  • Spotts J; Jessica Spotts, CIP, is a Senior IRB Education and Quality Improvement Analyst, Cedars-Sinai Medical Center, Los Angeles, CA.
  • Lowe JJ; John J. Lowe, PhD, is Co-Principal Investigator, National Emerging Special Pathogens Training and Education Center (NETEC), a Professor, Department of Environmental, Agricultural, and Occupational Health, College of Public Health, and Assistant Vice Chancellor for Health Security Training and Educat
  • Sauer LM; Lauren M. Sauer, MSc, is Director, Special Pathogens Research Network, Global Center for Health Security, and an Associate Professor, Department of Environmental, Agricultural, and Occupational Health, College of Public Health, University of Nebraska Medical Center, Omaha, NE.
  • Kratochvil CJ; Christopher J. Kratochvil, MD, Associate Vice Chancellor for Clinical Research, University of Nebraska Medical Center, Omaha, NE.
  • Gordon BG; Bruce G. Gordon, MD, is Assistant Vice Chancellor for Regulatory Affairs, Executive Chairman of Institutional Review Boards, and Professor in the Department of Pediatrics, University of Nebraska Medical Center, Omaha, NE.
Health Secur ; 20(S1): S60-S70, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1838056
ABSTRACT
Research is foundational for evidence-based management of patients. Clinical research, however, takes time to plan, conduct, and disseminate-a luxury that is rarely available during a public health emergency. The University of Nebraska Medical Center (UNMC) developed a single institutional review board (IRB), with a vision to establish a rapid review resource for a network focused on clinical research of emerging pathogens in the United States. A core aspect of successful initiation of research during a pandemic or epidemic is the ability to operationalize an approach for rapid ethical review of human subject research and conduct those reviews at multiple sites-without losing any of the substantive aspects of ethics review. This process must be cultivated in anticipation of a public health emergency. US guidance for operationalizing IRB review for multisite research in a public health emergency is not well studied and processes are not well established. UNMC sought to address operational gaps and identify the unique procedural needs of rapid response single IRB (RR-sIRB) review of multisite research by conducting a series of preparedness exercises to develop and test the RR-sIRB model. For decades, emergency responder, healthcare, and public health organizations have conducted emergency preparedness exercises to test requirements for emergency response. In this article, we describe 2 types of simulation exercises conducted by UNMC workshops and tabletops. This effort represents a unique use of emergency preparedness exercises to develop, refine, and test rapid review functions for an sIRB and to validate readiness of regulatory research processes. Such processes are crucial for conducting rapid, ethical, and sound clinical research in public health emergencies.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Civil Defense / Emergency Responders Type of study: Prognostic study / Reviews Limits: Humans Country/Region as subject: North America Language: English Journal: Health Secur Year: 2022 Document Type: Article Affiliation country: Hs.2021.0181

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Civil Defense / Emergency Responders Type of study: Prognostic study / Reviews Limits: Humans Country/Region as subject: North America Language: English Journal: Health Secur Year: 2022 Document Type: Article Affiliation country: Hs.2021.0181