Abstract

Objective: To analyse how patients in the acute phase of a myocardial infarct experience the informed consent procedure of a clinical trial.

Design: A questionnaire based follow up survey including patients who gave informed consent as well as patients who did not consent to the trial.

Patients: 103 patients who gave informed consent and 78 who did not consent to the second Danish acute myocardial infarction trial (DANAMI-2).

Results: 76% of the trial participants and 63% of the non-participants agreed or mostly agreed that they felt able to make a decision about whether or not to participate in the trial; 50% of the trial participants and 34% of the non-participants found it acceptable that patients in their situation have to make such a decision. Only 28% of the trial participants and 7% of the non-participants read the information sheet before they made the decision.

Conclusions: Informed consent should be sought in acute myocardial infarction trials despite the emergency situation and the medical condition of the patients. Patients’ self assessed ability to make a decision should be explicitly addressed during the informed consent process and patients should not be pressurised into decision making. Physicians and research ethics committees should focus specifically on improving the oral information.