Patients' views of consent for research enrollment during acute myocardial infarction.

OBJECTIVE: The goal of this study was to improve understanding of patients' perspectives of informed consent for clinical trial enrollment during ST-elevation myocardial infarction (STEMI). BACKGROUND: STEMI research poses challenges regarding informed consent due to time constraints, symptom severity, and potential cognitive impairment. METHODS: An interview study was embedded within a clinical trial of an ischemic post-conditioning procedure for STEMI. An interactive, structured interview guide was used. RESULTS: Twenty interviews were conducted (median 1.5 days after initial procedure). Only 11/20 (55%) initially remembered being asked to participate in a trial. Comprehension of study details and the research process was limited; for example, many patients believed their decision was primarily clinical or that the study intervention was clearly superior. Patients described limitations regarding their ability to make a decision, including pain, discomfort, lack of time, and stress. However, patients generally felt they were able to make a decision at presentation and wanted to be the primary decision maker; few supported surrogate decision-making by family or physicians. CONCLUSIONS: This study demonstrates that patients recognize barriers to understanding but value elements of consent. Further research is needed to develop approaches that meet patients' goals while recognizing the limitations inherent to this context.

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.