Institutional Review Board Preparedness for Disaster Research: a Practical Approach.

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.

An academic/government partnership to provide technical assistance with pandemic influenza planning to local health departments in North Carolina.

In 2006, the North Carolina Division of Public Health (NC DPH) required all 85 local health departments (LHDs) in North Carolina to develop a pandemic influenza plan. Because few LHDs had experience in developing such plans, NC DPH engaged in a unique partnership with an academic center, the North Carolina Center for Public Health Preparedness (NCCPHP), to provide technical assistance to local planners. This article describes the technical assistance program implemented by NCCPHP, the use of technical assistance by local planners, subsequent completeness of local pandemic influenza plans, and lessons learned throughout the program. We discuss selected topic areas (surveillance, vaccine/antiviral, and vulnerable populations) observed within local pandemic influenza plans to highlight the variability in planning approaches and identify potential opportunities for state and local standardization.

Developing an Environmental Health Sciences COVID-19 Research Agenda: Results from the NIEHS Disaster Research Response (DR2) Work Group's Modified Delphi Method.

Leveraging the community of practice recently established through the U.S. National Institute of Environmental Health Sciences (NIEHS) Disaster Research Response (DR2) working group, we used a modified Delphi method to identify and prioritize environmental health sciences Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and associated Coronavirus Disease 2019 (COVID-19) research questions. Twenty-six individuals with broad expertise across a variety of environmental health sciences subdisciplines were selected to participate among 45 self-nominees. In Round 1, panelists submitted research questions and brief justifications. In Round 2, panelists rated the priority of each question on a nine-point Likert scale. Responses were trichotomized into priority categories (low priority; medium priority; and high priority). A research question was determined to meet consensus if at least 69.2% of panelists rated it within the same priority category. Research needs that did not meet consensus in round 2 were redistributed for re-rating. Fourteen questions met consensus as high priority in round 2, and an additional 14 questions met consensus as high priority in round 3. We discuss the impact and limitations of using this approach to identify and prioritize research questions in the context of a disaster response.

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

SUMMARY: Research involving human subjects after public health emergencies and disasters may pose ethical challenges. These challenges may include concerns about the vulnerability of prospective disaster research participants, increased research burden among disaster survivors approached by multiple research teams, and potentially reduced standards in the ethical review of research by institutional review boards (IRBs) due to the rush to enter the disaster field. The NIEHS Best Practices Working Group for Special IRB Considerations in the Review of Disaster Related Research was formed to identify and address ethical and regulatory challenges associated with the review of disaster research. The working group consists of a diverse collection of disaster research stakeholders across a broad spectrum of disciplines. The working group convened in July 2016 to identify recommendations that are instrumental in preparing IRBs to review protocols related to public health emergencies and disasters. The meeting included formative didactic presentations and facilitated breakout discussions using disaster-related case studies. Major thematic elements from these discussions were collected and documented into 15 working group recommendations, summarized in this article, that address topics such as IRB disaster preparedness activities, informed consent, vulnerable populations, confidentiality, participant burden, disaster research response integration and training, IRB roles/responsibilities, community engagement, and dissemination of disaster research results. https://doi.org/10.1289/EHP2378.

Integrating Health Research into Disaster Response: The New NIH Disaster Research Response Program.

The need for high quality and timely disaster research has been a topic of great discussion over the past several years. Recent high profile incidents have exposed gaps in knowledge about the health impacts of disasters or the benefits of specific interventions-such was the case with the 2010 Gulf Oil Spill and recent events associated with lead-contaminated drinking water in Flint, Michigan, and the evolving health crisis related to Zika virus disease. Our inability to perform timely research to inform the community about health and safety risks or address specific concerns further heightens anxiety and distrust. Since nearly all disasters, whether natural or man-made, have an environmental health component, it is critical that specialized research tools and trained researchers be readily available to evaluate complex exposures and health effects, especially for vulnerable sub-populations such as the elderly, children, pregnant women, and those with socioeconomic and environmental disparities. In response, the National Institute of Environmental Health Science has initiated a Disaster Research Response Program to create new tools, protocols, networks of researchers, training exercises, and outreach involving diverse groups of stakeholders to help overcome the challenges of disaster research and to improve our ability to collect vital information to reduce the adverse health impacts and improve future preparedness.

Lessons learned from North Carolina public health regional surveillance teams' regional exercises.

All-hazards exercises bring together emergency response partners at the local, regional, state, and federal levels for the primary purposes of testing response plans, defining roles and responsibilities, assessing capabilities, and making necessary improvements prior to an actual incident. To better understand the benefits and challenges of conducting regional (ie, multicounty) exercises, a study was carried out by the North Carolina Preparedness and Emergency Response Research Center at the University of North Carolina Gillings School of Global Public Health. This article describes 5 all-hazards regional exercises conducted by Public Health Regional Surveillance Teams (PHRSTs) in North Carolina in 2009 and highlights 4 unique benefits that resulted from the exercises beyond meeting explicit objectives to test plans and identify areas for improvement: (1) building relationships among response partners, (2) promoting public health assets, (3) testing multiple communications systems, and (4) training exercise evaluators. Challenges of planning and conducting regional exercises also are addressed, followed by recommendations for maximizing the effectiveness of regional public health exercises.

Evaluation of the implementation of the H1N1 pandemic influenza vaccine in local health departments (LHDs) in North Carolina.

INTRODUCTION: Effective conduct of vaccination campaigns by public health authorities can reduce morbidity and mortality associated with influenza. The emergence of the pandemic H1N1 influenza in April 2009 resulted in an unprecedented vaccination campaign in the US during the 2009-2010 influenza season. The variety of methods local health departments (LHDs) utilized to cope with a mismatch between public demand and supply and ever-changing guidelines have gone unexamined thus far. The purpose of this research is to identify and share lessons learned related to H1N1 influenza vaccination activities at LHDs. METHODS: In April 2010, a comprehensive survey was developed to evaluate 2009-10 LHD H1N1 vaccination practices and document lessons learned. A stratified random sample was selected from NC's 85 LHDs. Interviews were conducted with key personnel involved in LHD vaccination campaigns. Results were analyzed to identify quantitative trends and qualitative themes. RESULTS: Twenty-five of 26 LHDs (96% response rate) participated in our survey. Each LHD utilized a different approach to address the challenges they faced during their H1N1 vaccination campaign. Variation between LHDs was found in terms of the types of vaccine-dispensing methods implemented and in the selection of outside organizations LHDs partnered with to assist with vaccinations. CONCLUSION: Having a Continuity of Operations Plan (COOP) and pandemic influenza plan, hiring temporary staff, building on existing community partnerships, implementing a variety of vaccination strategies and using a variety of sites are strategies that will help LHDs deal more effectively with challenges posed by future pandemics.

Isolated case of bioterrorism-related inhalational anthrax, New York City, 2001.

On October 31, 2001, in New York City, a 61-year-old female hospital employee who had acquired inhalational anthrax died after a 6-day illness. To determine sources of exposure and identify additional persons at risk, the New York City Department of Health, Centers for Disease Control and Prevention, and law enforcement authorities conducted an extensive investigation, which included interviewing contacts, examining personal effects, summarizing patient's use of mass transit, conducting active case finding and surveillance near her residence and at her workplace, and collecting samples from co-workers and the environment. We cultured all specimens for Bacillus anthracis. We found no additional cases of cutaneous or inhalational anthrax. The route of exposure remains unknown. All environmental samples were negative for B. anthracis. This first case of inhalational anthrax during the 2001 outbreak with no apparent direct link to contaminated mail emphasizes the need for close coordination between public health and law enforcement agencies during bioterrorism-related investigations.