Informed Consent and Emergencies

Obtaining prospective informed consent from persons prior to their participation in research is the cornerstones of human subjects protection.  In many research studies, the informed consent process involves reading a description of the study, asking questions about the study, and taking sufficient time to reflect on the risks and benefits of the study.

In emergency situations, there may be insufficient time for potential research participants to engage in the usual informed consent process.  Furthermore, the emergency situation may impair the ability of potential participants and their representatives to make informed decisions because of anxiety, pain or impaired consciousness.

Recognizing that there are some treatments, tests or devices that are only ever used in emergency situations, the US Department of Health & Human Services, including the Office of Human Subjects Protection (OHRP) and the Food and Drug Administration (FDA) developed regulations to address research in emergency situations.  These regulations define very narrow exceptions to the usual informed consent process, and create an oversight for emergency research. 

Two types of exceptions from the usual informed consent process have been applied in emergency situations:

(1) Waiver of Informed Consent for Minimal Risk Research.  This situation applies only to research studies that pose no incremental risk to the subject above what they will experience during their usual care.  Examples might include testing a new monitoring device that does not touch the patient or that will not be used to guide care. Learn More...

(2) Exception from Informed Consent for Research in Emergency Situations.  This situation involves testing changes in emergency care.  Because subjects are exposed to some incremental risk, a greater burden of proof and reporting is required of investigators.  Moreover, the study must be advertised and commented on by the community where research will occur.  Learn More...