Can the conscious patient in the midst of a medical emergency provide adequate informed consent for a clinical research protocol? Adequate consent is crucial to the ethical conduct of clinical trials, including those performed in emergency settings. We examine the problem of emergency informed consent. As an illustrative case, we discuss a pilot trial of prehospital thrombolytic therapy for myocardial infarction. Federal regulations for clinical research do not provide clear guidelines on emergency research in the conscious patient. Clinical investigators currently approach emergency consent in four ways: (1) avoid such research, (2) omit the consent process, (3) obtain deferred consent, or (4) obtain customary consent. We suggest a fifth alternative, two-step consent, which permits the conduct of emergency research while protecting the rights of the emergency research subjects. Such a process may serve as an alternative solution for future studies faced with the problem of informed consent in emergencies.
KIE: The problem of informed consent to research in emergency care is examined, using as an example a pilot trial of prehospital administration of thrombolytic therapy for acute myocardial infarction. Current federal regulations governing emergency care research are reviewed, along with four ways in which investigators currently approach emergency consent. The authors' use of a two-step process to resolve the problem of emergency consent is described. This approach allows the conduct of emergency research while protecting the rights of research subjects, and may offer a solution to the the ethical conduct of other studies faced with the problem of consent to emergency care.