Academic journal article Environmental Health Perspectives

Conducting Science in Disasters: Recommendations from the NIEHS Working Group for Special IRB Considerations in the Review of Disaster Related Research

Academic journal article Environmental Health Perspectives

Conducting Science in Disasters: Recommendations from the NIEHS Working Group for Special IRB Considerations in the Review of Disaster Related Research

Article excerpt

Introduction

Public health emergencies and disaster events have challenged the world's preparedness and response capabilities for decades (Figure 1). Since the attack on the World Trade Center in 2001, U.S. government agencies have redoubled their efforts to strengthen national preparedness, response, and recovery. With this national multiagency effort and continued exposure to new public health emergencies and disasters, the field of disaster research has evolved and has become commonplace in the post-disaster setting.

From a government agency perspective, disaster research is the study of individual, community and organizational preparedness, response, and recovery from a broad range of disaster types. Disaster research is essential to understanding how to prepare for and respond to catastrophic events such as hurricanes, earthquakes, disease outbreaks and pandemics, hazardous material spills, and large-scale acts of terrorism, as well as understanding their impact on human health.

A unique feature of most disaster studies is the urgency of initiating data collection soon after the event to capture ephemeral baseline data that may be lost or subject to recall bias if collected later. Although the value of well-designed research studies in the immediate aftermath of disasters is recognized, there remain significant challenges that must be addressed to facilitate their administration. Some key challenges include time pressures related to the development of protocols and study materials, acquisition of rapid funding to support research work, concerns of the study team interfering with life-saving disaster response activities, and compromising a frail community (Lurie et al. 2013; Miller et al. 2016).

Despite its recognized value, research involving human subjects after disasters may pose ethical concerns (Ferreira et al. 2015; O'Mathuna 2009). For example, the lack of coordination across investigators conducting research after a disaster can result in survivors being approached to join research by multiple research teams asking similar questions and requesting duplicative sample collections. In addition to the burden this may place on survivors, it can lead to unnecessary confusion when representatives from aid organizations offering direct assistance are in the field at the same time (Taylor 2016). Most importantly, concerns about the vulnerability of prospective disaster research participants have been raised and evaluated (Macklin 2014; Levine 2004).

Although the Code of Federal Regulations (45 CFR Part 46--Protection of Human Subjects; DHHS 2009) does establish research protections for certain groups such as children, prisoners, women, and fetuses, there is no explicit protection for potentially vulnerable disaster survivor research participants. These human subject concerns led the National Institute of Environmental Health Sciences (NIEHS) to create an initiative to consider how institutional review boards (IRBs) can play a role in the preservation of ethical standards in the conduct of disaster research.

Objective and Approach

To address ethical and regulatory challenges in the oversight of post-disaster research, the Office of Human Research Compliance at NIEHS formed the new Best Practices Working Group for Special IRB Considerations in the Review of Disaster Related Research, as part of a larger effort at the National Institutes of Health (NIH) to enhance research oversight capacity after disasters. This effort, called the Disaster Research Response (DR2) program (Lurie et al. 2013; Miller et al. 2016), began as a trans-NIH initiative in 2013 with the aim of developing a national framework to guide and facilitate research on the medical and public health aspects of disasters and public health emergencies. The working group was officially formed in September 2015 with the goals of exploring factors relevant to potential research participation in disasters and preparing IRBs for the review of disaster research protocols. …

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