Developing a Rapid Response Single IRB Model for Conducting Research During a Public Health Emergency

Affiliations

¹ 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.
² 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.
³ Mark G. Kortepeter, MD, is Vice President for Research, Uniformed Services University of the Health Sciences, Bethesda, MD.
⁴ 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.
⁵ 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.
⁶ Ann Johnson, PhD, MPH, CIP, is Director, Institutional Review Board and Human Research Program, University of Utah, Salt Lake City, UT.
⁷ Jonathan D. Grein, MD, is Director, Hospital Epidemiology, Cedars-Sinai Medical Center, Los Angeles, CA.
⁸ Julie Martin, RN, MEd, CIP, is Assistant Director, Institutional Review Board, Emory University, Atlanta, GA.
⁹ Rebecca Rousselle, BA, CIP, is Assistant Vice President, Human Research Protection Program, Emory University, Atlanta, GA.
¹⁰ 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.
¹¹ Jessica Spotts, CIP, is a Senior IRB Education and Quality Improvement Analyst, Cedars-Sinai Medical Center, Los Angeles, CA.
¹² 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 Education, University of Nebraska Medical Center, Omaha, NE.
¹³ 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.
¹⁴ Christopher J. Kratochvil, MD, Associate Vice Chancellor for Clinical Research, University of Nebraska Medical Center, Omaha, NE.
¹⁵ 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.

PMID: 35544310
DOI: 10.1089/hs.2021.0181

Free article

Developing a Rapid Response Single IRB Model for Conducting Research During a Public Health Emergency

Abigail E Lowe et al. Health Secur. 2022 Jun.

Free article

. 2022 Jun;20(S1):S60-S70.

doi: 10.1089/hs.2021.0181. Epub 2022 May 11.

Authors

Affiliations

¹ 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.
² 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.
³ Mark G. Kortepeter, MD, is Vice President for Research, Uniformed Services University of the Health Sciences, Bethesda, MD.
⁴ 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.
⁵ 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.
⁶ Ann Johnson, PhD, MPH, CIP, is Director, Institutional Review Board and Human Research Program, University of Utah, Salt Lake City, UT.
⁷ Jonathan D. Grein, MD, is Director, Hospital Epidemiology, Cedars-Sinai Medical Center, Los Angeles, CA.
⁸ Julie Martin, RN, MEd, CIP, is Assistant Director, Institutional Review Board, Emory University, Atlanta, GA.
⁹ Rebecca Rousselle, BA, CIP, is Assistant Vice President, Human Research Protection Program, Emory University, Atlanta, GA.
¹⁰ 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.
¹¹ Jessica Spotts, CIP, is a Senior IRB Education and Quality Improvement Analyst, Cedars-Sinai Medical Center, Los Angeles, CA.
¹² 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 Education, University of Nebraska Medical Center, Omaha, NE.
¹³ 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.
¹⁴ Christopher J. Kratochvil, MD, Associate Vice Chancellor for Clinical Research, University of Nebraska Medical Center, Omaha, NE.
¹⁵ 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.

PMID: 35544310
DOI: 10.1089/hs.2021.0181

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.

Keywords: COVID-19; Investigational drugs; Public health preparedness/response; Rapid review; Single IRB review.

PubMed Disclaimer

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions

LinkOut - more resources

Full Text Sources
- Atypon

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Developing a Rapid Response Single IRB Model for Conducting Research During a Public Health Emergency

Affiliations

Developing a Rapid Response Single IRB Model for Conducting Research During a Public Health Emergency

Authors

Affiliations

Abstract

MeSH terms

LinkOut - more resources

Full Text Sources