Abstract

Acute myocardial infarction (AMI) is a common disease in the Western world and has been the topic of much research. Conducting clinical trials with patients in the acute phase of a myocardial infarction, however, poses an ethical challenge. As patients are often under extreme stress and require urgent medical attention, the process of informed consent is severely constrained. Furthermore, the very procedure of informed consent, which is supposed to protect eligible patients, may be a cause of harm in itself due to the delay in the provision of therapy which it causes. This paper describes how physicians have dealt with the informed consent process in various AMI trials and summarizes the results from empirical studies of the consent process of such trials. Finally, the ethical issues and their implications for future trials involving this particular group of patients are discussed