• IRB: ETHICS & HUMAN RESEARCH

Centralized IRB Models for Emergency Care Research

The Emergency Care Coordination Center within the Office of the Secretary for Preparedness and Response in the Department of Health and Human Services hosted a forum entitled Institutional Review Board Options for Emergency Care Research in September 2011. The authors of this article expand upon a number of key issues identified during this forum, to include examining necessary characteristics of acceptable centralized IRB review models for emergency care research. The authors further identify areas of focused fact-finding, research, and evaluation that may be helpful in alleviating some barriers to using a centralized IRB review process for emergency care research.

Conducting research in emergency settings—whether in a prehospital or emergency department or during a disaster—presents many challenges, not the least of which is the involvement of potentially vulnerable populations. Key stakeholders are looking for responsive approaches to the scientific and ethical review and compliance oversight of emergency care research that will foster efficient development of safe and effective new therapeutic modalities. However, working in a time-sensitive environment across multiple institutions and enrolling individuals who are often critically ill or injured in emergency care studies poses daunting challenges for researchers in gaining timely institutional review board (IRB) approval and protocol oversight. The Emergency Care Coordination Center within the Office of the Secretary for Preparedness and Response in the Department of Health and Human Services hosted a forum entitled Institutional Review Board Options for Emergency Care Research in September 2011. The authors of this article expand upon a number of key issues identified during this forum, to include examining necessary characteristics of acceptable centralized IRB review models for emergency care research. The authors further identify areas of focused fact-finding, research, and evaluation that may be helpful in alleviating some barriers to using a centralized IRB review process for emergency care research.

Goldkind SF, Brosch LR, Biros M, Silbergleit R, Sopko G. Centralized IRB models for emergency care research. IRB: Ethics & Human Research 2014;36(2):1-9.