As disaster events become more frequent, institutional review boards (IRBs) are increasingly asked to review time-sensitive research protocols aimed at collecting short-lived exposure data. A new working group is developing best practices and considerations for research in the immediate aftermath of disasters.
The inaugural meeting of the NIEHS Best Practices Working Group for Special IRB Considerations in the Review of Disaster Related Research drew 70 participants, ranging from community partners, academicians, and emergency responders, to IRB and regulatory officials, grantees, and government agencies. They gathered July 27-29 on the campus of the U.S. Environmental Protection Agency in Research Triangle Park, North Carolina.
Participants focused on how best to protect the welfare and rights of human research subjects and communities after disasters. The discussion and recommendations will be instrumental in preparing IRBs to efficiently review research protocols — detailed plans for a scientific or medical experiment, treatment, or procedure — related to public health emergencies.
The working group, led by Joan Packenham, Ph.D., director of the NIEHS Office of Human Research Compliance and the NIEHS IRB vice chairperson, was established in 2015. It is part of a larger effort at the National Institutes of Health (NIH) to improve research capacity after disasters, called Disaster Research Response Program (see related story).
Supporting time-critical research
Linda Birnbaum, Ph.D., director of NIEHS and the National Toxicology Program, provided opening remarks. “We want to focus on answering the questions as to how we all can come together to support and implement time-critical human health research investigations, while making sure that we do not overburden study populations, or take undue advantage of populations that may be compromised by a disaster,” she said.
Brian Clark, who survived the September 11 disaster, gave a moving testimonial about his experience escaping from the 84th floor of the South Tower of the World Trade Center. He discussed individual vulnerability in the immediate aftermath.
“Everyone is different in how they respond to a particular disaster, and vulnerability during recovery cannot easily be predicted,” Clark said. “All reactions are equally valid.”
Broad range of perspectives
The 2 1/2 day meeting brought together, for the first time, individuals with expertise in disaster response, disaster research, and human regulatory affairs, to focus on protection of human research subjects. According to Packenham, the meeting was an ideal setting for sharing and collecting a variety of perspectives.
Representatives of the following federal agencies were among the participants.
- Centers for Disease Control and Prevention (CDC)
- National Institute of Allergy and Infectious Diseases
- National Institute for Occupational Safety and Health
- NIH Office of Human Subjects Research Protections
- U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response
The event also included presentations by nationally recognized experts in disaster science, emergency management, and human research protections. During the meeting, participants broke into five groups, each focused on a different simulated disaster scenario and research case studies.
Organizers had laid the groundwork for the meeting with a series of webinars addressing basic topics in disaster research, from both the researcher and community perspectives.
(Richard Rosselli is a study manager at Social and Scientific Systems Inc., a contractor for the NIEHS Division of Intramural Research.)