Joan P Packenham1, Richard Rosselli2, Alice Fothergill3, Julia Slutsman4, Steve Ramsey2, Janet E Hall5, Aubrey Miller6. 1. Office of Human Research Compliance, Clinical Research Branch and Division of Intramural Research, National Institute of Environmental Health Sciences, 111 T.W. Alexander Dr., Mail Drop CRU-02, Research Triangle Park, Durham, NC, 27709, USA. packenhm@niehs.nih.gov. 2. Social & Scientific Systems, Inc., Silver Spring, MD, USA. 3. College of Arts and Sciences, Department of Sociology, University of Vermont, Burlington, VT, USA. 4. Office of Director, Office of Extramural Research, National Institutes of Health, Bethesda, MD, USA. 5. Clinical Research Branch and Division of Intramural Research, National Institute of Environmental Health Sciences, Durham, NC, USA. 6. Office of Director, National Institute of Environmental Health Sciences, Durham, NC, USA.
Abstract
PURPOSE OF REVIEW: Disasters are becoming more common and challenge national and global resiliency and response efforts. As a result, government agencies have increased interest in disaster research to understand their environmental impact and health-related consequences. With the research field greatly expanding, Institutional Review Boards (IRBs) are being asked to review research protocols aimed at assessing health risks, exposures, and outcomes from disaster survivors. Few IRBs have experience reviewing disaster research protocols. This article describes approaches for IRB preparedness in reviewing disaster research. RECENT FINDINGS: From a human research protections perspective, primary attention has focused on vulnerability of individuals and/or populations affected by a disaster who may serve as research participants [3, 4]. From our review of the current literature, there is a lack of best practices and/or guidance for IRBs in the review of disaster research protocols. The growth of the disaster research field has brought more attention to potential ethical concerns of disaster research studies. Disaster survivors, responders, and those that assist in cleanup and remedial efforts may be left with significant unmet needs and long-term physical and emotional challenges as a result of their experiences. It is important for IRBs and investigators to collaboratively address how best to protect the welfare of individuals and communities affected by a disaster. A new approach is needed to systematically consider the various factors relevant to an assessment of human research protection issues following disasters.
PURPOSE OF REVIEW: Disasters are becoming more common and challenge national and global resiliency and response efforts. As a result, government agencies have increased interest in disaster research to understand their environmental impact and health-related consequences. With the research field greatly expanding, Institutional Review Boards (IRBs) are being asked to review research protocols aimed at assessing health risks, exposures, and outcomes from disaster survivors. Few IRBs have experience reviewing disaster research protocols. This article describes approaches for IRB preparedness in reviewing disaster research. RECENT FINDINGS: From a human research protections perspective, primary attention has focused on vulnerability of individuals and/or populations affected by a disaster who may serve as research participants [3, 4]. From our review of the current literature, there is a lack of best practices and/or guidance for IRBs in the review of disaster research protocols. The growth of the disaster research field has brought more attention to potential ethical concerns of disaster research studies. Disaster survivors, responders, and those that assist in cleanup and remedial efforts may be left with significant unmet needs and long-term physical and emotional challenges as a result of their experiences. It is important for IRBs and investigators to collaboratively address how best to protect the welfare of individuals and communities affected by a disaster. A new approach is needed to systematically consider the various factors relevant to an assessment of human research protection issues following disasters.
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