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Your Environment. Your Health.

word cloud: Human Health, Global Warming, Sea Level Rise, Climate Change, Infectious Disease, earth,weather, desert Disaster Research Response (DR2) Program Human Studies & Research Ethics

group of scientists in a lab

Disasters and public health emergencies present unique circumstances for conducting human health research, which frequently involves the collection of biological specimens, clinical measurements, and exposure data.

Conducting research during or in the immediate aftermath of a disaster or public health emergency places significant demands on scientists developing research protocols and the people charged with rapidly reviewing and approving them. Part of this approval involves an Institutional Review Board (IRB), which is a committee concerned with research ethics. The IRB reviews and monitors biomedical and behavioral research plans and survey instruments to ensure the privacy, welfare, and other rights of research participants and communities are protected.

To decrease participant and community trauma, researchers and IRBs need to be aware of pre-existing cultural, structural, or population considerations that may affect assessment of health risks of disaster survivors and responders. For instance, people may experience trauma from the event or its consequences (e.g., loss of home, relocation, and separation from family or community).

Disaster research must take place in a timely manner; but, at the same time, research activities must not interfere with health or environmental response efforts. These situations create additional considerations for IRBs as they work through review and approval of research plans and tools. The DR2 program can assist IRB preparedness in advance of the reviews.

DR2 program goals in this area are to:

  • Create guidance around best practices and special considerations for IRBs in their review of disaster research protocols
  • Develop and conduct effective community engagement focused on helping communities understand the importance of disaster research and their rights as research participants
  • Develop, test, and implement evidence-based tools and resources for the review of disaster research protocols
  • Foster collaborative partnerships between researchers and IRBs in developing ethical and effective disaster research protocols
  • Identify the safety and training needs of the IRB, research team, and community partners
  • Increase awareness of the necessity for communicating disaster research results to participants and communities, and the best methodologies for such reporting
  • Increase situational awareness among researchers and IRBs to issues of impacted communities in response to disaster events
  • Increase understanding of ongoing participant and community vulnerabilities, as well as burdens in a disaster or public health emergency situation
  • Minimize research interference in disaster response and aid provision to impacted communities
  • Provide outreach and engagement to researchers and research institutions, government agencies, survivors and impacted communities, and disaster managers around human studies issues and concerns
  • Train IRBs and Investigators in the use of disaster research review tools and preparedness strategies

National IRB Preparedness

Preparing for Disaster Research

NIEHS created the National IRB Preparedness program to develop preparedness and implementation guidance, training, and support for robust human research protections in disaster research. The program engages IRBs and the research institutions they serve; federal, tribal, state, and local governments; first responders and other medical professionals; and communities and research participants.

The program has a comprehensive training curriculum to increase the capacity of investigators and IRBs to develop appropriate disaster research protocols and review processes, and to incorporate these resources into disaster research programs. The curriculum includes an IRB toolkit to support robust ethical review of disaster-related research to ensure protection of study participants.

Disaster Research Protocols

NIEHS Rapid Acquisition of Pre- and Post-Incident Disaster Data (RAPIDD)

NIEHS Rapid Acquisition of Pre- and Post-Incident Disaster Data (RAPIDD) is a protocol containing surveys, checklists, and other documents needed to expedite IRB approval.

RAPIDD addresses collection of data and samples from disaster response workers who may be exposed to environmental contaminants. It can be used as a modifiable template by researchers for different disasters and public health emergencies, as suits their institutions or communities. Some universities, including the University of Texas Medical Branch (see below), Oregon State University, and Texas A&M University, are adapting RAPIDD for use in their own research reviews.

The goals of RAPIDD are to:

  • Provide researchers with a standardized methodology and instruments that have been approved and used in previous disasters
  • Provide researchers with study documents, questionnaires, surveys, supply lists, and staff requirements
  • Help researchers collect biological samples and socio-demographic, health, exposure, and lifestyle information immediately before or after deployment to a disaster area
  • Help researchers establish a well-characterized disaster response worker cohort that will enable future analysis

University of Texas Medical Branch RAPIDD Protocol

The University of Texas Medical Branch has adapted RAPIDD for use in Texas, and obtained IRB approval of the protocol for one-year increments.

Contact

Joan P. Packenham
Joan P. Packenham, Ph.D.
Director, NIEHS Office of Human Research Compliance (OHRC)
DIR CRP OCR CD
Tel 984-287-4413
Fax 919-541-9854
packenhm@niehs.nih.gov
P.O. Box 12233
Mail Drop CU-02
Durham, N.C. 27709
Join the DR2 email list
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