title: Patients' perceptions of informed consent in acute myocardial infarction research: a Danish study.
abstract: Seeking informed consent from patients in the acute phase of acute myocardial infarction (AMI) poses an ethical challenge due to the fact that these patients are under stress and require urgent medical attention. The very procedure of informed consent, which is supposed to protect eligible patients, may in fact cause harm due to a potential delay in the provision of therapy. Whether or not informed consent can and should be obtained under these particular circumstances is far from evident. Patients participating in various large-scale AMI trials have been enrolled with, as well as without, informed consent in recent years. Little is known, however, about how patients experience the informed consent process in the emergency situation of an AMI. This paper reports the results from qualitative interviews with 32 patients, who had to decide whether or not to participate in a large multi-centre clinical trial in Denmark. We analyse to what extent patients found the informed consent process acceptable as well as how various factors influenced their experience of the consent process. We argue that it is morally sound to involve those patients in a brief and concise informed consent process and that consent should be sought in such trials. Finally, we discuss how future AMI trials may nonetheless be improved by accommodating some of the concerns of the patients.
authors.affiliation: Department of Medical Philosophy and Clinical Theory, Institute of Public Health, University of Copenhagen, Building 22.3, Blegdamsvej 3, Copenhagen N 2200, Denmark. a.gammelgaard@medphil.ku.dk
authors.forename: Anne
authors.initials: A
authors.lastname: Gammelgaard
authors.forename: Peter
authors.initials: P
authors.lastname: Rossel
authors.forename: O S Ole Steen
authors.initials: OS
authors.lastname: Mortensen
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D003657:Decision Making / Q000941:ethics; D003718:Denmark; D005260:Female; D006761:Hospitals / Q000941:ethics; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D010358:Patient Participation / Q000523:psychology*; D016032:Randomized Controlled Trials as Topic; D036302:Therapeutic Human Experimentation / Q000941:ethics*; D015912:Thrombolytic Therapy; D013997:Time Factors