Creating a National IRB Preparedness Training Program for the Review of Disaster-Related Research

Abstract

Disasters, both natural and manmade, are becoming more common and challenge national and global resiliency and response efforts. As a result, many government agencies have an increased interest in disaster research to strengthen preparedness, response, and recovery. With the field of disaster research greatly expanding, Institutional Review Boards (IRBs) are now being asked to review research protocols aimed at assessing health risks, exposures and outcomes from disaster survivors; however, few IRBs have significant experience reviewing disaster research protocols. As the national leaders of disaster research, the National Institutes of Health (NIH) Public Health Emergency and Disaster Research Response (DR2) Program recognized the need to develop IRB disaster-related research training curricula and protocol review tools. Key components of the DR2 program include the creation of a pre-approved disaster research protocol (Rapid Acquisition of Pre- and Post-Incident Disaster Data) and the development of the National Institute of Environmental Health Sciences (NIEHS) Working Group for Special IRB Considerations in the Review of Disaster Related Research, which established the first national recommendations that informed this innovative training program. This training program includes instructor led case studies that walk trainees through using the NIEHS Disaster Research protocol Review checklist, developing IRB Continuity of Operations Plans (I-COOP), and use of the Post-Disaster Researcher Engagement Assessment and Community Template (PD-REACT) that provides a community vulnerability assessment and disaster related contextual considerations for IRB review. These materials have been field tested and developed through mock IRB and training sessions held at the Centers for Disease Control’s (CDC) National Institute for Occupational Safety and Health (NIOSH), University of Arizona, and NIEHS. This training assesses organizations’ disaster research needs, aims to improve IRB preparedness and processes for reviewing disaster-related research and enhances institutional knowledge of best practices for disaster researchers to protect the rights and welfare of study participants. Keywords: Institutional Review Board Ethics Training Best Practices