Abstract
Conducting Research in Disease Outbreaks
Highlights
In an outbreak situation, public health authorities undertake a rapid response in an effort to document the existence and magnitude of a public health problem in the community and to implement appropriate measures to address the problem [1]
Other individuals engaged in public health practice have voiced concern that subjecting their work to the routinely required ‘‘regulatory constraints imposed on research’’ would prevent flexible and timely approaches to situations such as disease outbreaks [3]
For researchers and public health agencies, the question is how to comply with the ethical requirement that research be approved by a properly constituted, independent ethical review committee (ERC) but still enable a prompt response when an outbreak occurs
Summary
Conducting research in an emergency situation, such as an outbreak of disease, poses ethical challenges. Consent may be waived only when of kin or a guardian is not present or cannot be reached in sufficient time before initiating the research It is clear that the exception from informed consent requirements applies only to research in which individual patients in life-threatening situations must receive immediate treatment, and not the type of research conducted in an emergency response to an outbreak of infectious disease. One reason studies that fall under the umbrella of the final rules are not exempt from IRB review is that they involve a foreseen and common emergency situation where there is ample time to prepare a full research protocol and have it approved by a committee Potential participants in these studies are unfortunate but not unexpected members of communities where the disease or occurrence in question (e.g., major trauma, cardiac arrest) takes place at some known frequency. The FDA emergency rules are inapplicable to research conducted in disease outbreaks
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