Re-visiting consent for clinical research on acute myocardial infarction and other emergent conditions.

Clinical trials in acute myocardial infarction (AMI) and other urgent or emergent conditions present special challenges regarding informed consent. Available data suggest patients often poorly understand such research when they are offered enrollment, and unalterable factors such as time constraints and emotional and physical distress create barriers to informed consent on the part of patients and surrogates. We examine the challenges to informed consent in AMI trials in particular and suggest that full informed consent may not be a realistic goal. We propose instead a model of informed refusal, offering patients an informed opportunity to refuse participation rather than requesting a positive commitment to participate. Informed refusal may be both more achievable and more respectful of patients, and we describe how such a process might be implemented and evaluated. We also suggest a need for regulatory change in order to maximize effective patient participation in decisions for clinical research in AMI and other acute illnesses.