Patients' perceptions of informed consent in acute myocardial infarction research: a Danish study
Anne Gammelgaard1, Peter Rossel, O S Ole Steen Mortensen
1Department 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
Insights
Obtaining informed consent from acute myocardial infarction (AMI) patients is challenging. This study found that a brief, concise consent process is morally acceptable and beneficial for AMI clinical trials.
Area of Science:
- Medical Ethics
- Clinical Trials
- Cardiology
Background:
- Informed consent in acute myocardial infarction (AMI) presents ethical challenges due to patient stress and urgent treatment needs.
- The informed consent process itself may delay critical therapy, potentially causing harm.
- Limited understanding exists regarding patient experiences with informed consent during AMI emergencies.
Purpose of the Study:
- To explore patient experiences with the informed consent process in AMI clinical trials.
- To analyze factors influencing patient acceptance of the consent procedure during emergencies.
- To determine the moral soundness and practical implications of seeking informed consent in AMI trials.
Main Methods:
- Qualitative interviews were conducted with 32 patients who participated in a multi-center AMI clinical trial.
- Interviews focused on patient perceptions of the acceptability and influencing factors of the informed consent process.
- Data analysis explored patient experiences within the emergency context of AMI.
Main Results:
- Patients' experiences with the informed consent process in AMI trials were investigated.
- Factors influencing the acceptability of the consent process for AMI patients were identified.
- The study analyzed the extent to which patients found the informed consent process acceptable.
Conclusions:
- It is morally justifiable to implement a brief and concise informed consent process in AMI trials.
- Seeking informed consent from AMI patients in clinical trials is recommended.
- Future AMI trials can be enhanced by addressing patient concerns regarding the consent process.
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.
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