Informed Consent Toolkit

Research Researchers

According to the American Medical Association, informed consent is more than simply getting a patient to sign a written consent form. It is, instead, a process of communication between a patient and healthcare provider that ultimately results in the patient’s authorization or agreement to undergo a specific medical intervention or participate in a clinical trial. Informed consent is at the forefront of a battery of protections aimed to ensure that research participants are fully respected as human beings and made aware of the purpose, procedures, risks, and benefits of a study.

But what happens in the emergency care setting? When patients face time-sensitive and potentially life-threatening conditions, it may be impossible to achieve this level of understanding prior to medical interventions or study enrollments. This is especially true among pediatric patient populations: depending on their age, cognitive capabilities, and clinical conditions, children may be in no position to authorize potentially life-saving experimental treatments.

The result is that children experiencing health emergencies are rarely the subjects of research trials. This means that EMS procedures routinely practiced in the field may have little or no evidence base corroborating their efficacy; in fact, some may even present more risks than benefits to pediatric patients. In order to increase the scientific evidence behind emergency medical care, “exception from informed consent” becomes tantamount to research efforts.

This concept amounts to a waiver of the informed consent requirement under certain conditions when conducting clinical trials in the emergency setting. Patients may be eligible for exception: if their medical condition preclude assent, if the intervention must be administered before consent can be obtained from their legally authorized representative, and/or if it is not feasible to prospectively identify whether they are likely to become eligible for study participation.