Patients' perceptions of research in emergency settings: A study of survivors of sudden cardiac death

Abstract

Conditions such as stroke, sudden cardiac death, and major traumatic injury are major causes of morbidity and mortality, and there is a need for clinical research to improve treatment for these conditions. However, because informed consent is often impossible, research in these situations poses ethical concerns. Despite growing literature on the ethics of emergency research, little is known about the views of relevant patient populations regarding research in emergency settings conducted under an exception from informed consent (EFIC).In this qualitative study, survivors of sudden cardiac death (SCD)-recruited from an outpatient cardiology clinic in late 2005-were asked their views on scenarios representing different types of EFIC research. Patients were generally accepting of such research, more than previous studies would have predicted. Their concerns focused primarily on study risks and benefits and less on waiving consent or randomization.EFIC research is of international importance and ethical controversy. This study represents the first attempt to assess views of SCD survivors on this type of research and one of the first to assess patients' views in-depth. Findings indicate broad acceptance of EFIC research among this population and refocus discussion on what risks are reasonable for non-autonomous subjects. The study also demonstrates potential for valuable input from patients regarding complicated and ethically challenging issues using a method that allows them to develop opinions on unfamiliar issues.

Systematic review and metasummary of attitudes toward research in emergency medical conditions

“…In an outpatient setting, participants who had a negative reaction to the informed consent language regarding risks were less likely to enrol into a hypothetical trial 43. Further evidence of this sensitivity is revealed in the studies by Dickert  and Kass27 and McClure et al ,31 in which acceptance of studies is higher for diagnostic trials as opposed to interventional trials. As noted in the study by Blixen  and Agich,24 emergency medicine patients are particularly sensitive to any intervention that could result in death, even if the likelihood is remote.…”

Is Emergency Research Without Initial Consent Justified?

“…38 Furthermore, research procedures that pose minimal net risk to the patient do not require excessive sacrifice of wellbeing for the good of others and achieve an appropriate balance between concerns for the patient's wellbeing and the public good.…”

Patient Perspectives on the Learning Health System: The Importance of Trust and Shared Decision Making

“…Studies on patient and public attitudes towards research with stored samples, patient records (Hull et al 2008), and attitudes towards emergency research consent waivers (Dickert & Kass 2009), suggest that although people typically want to be aware of such activities, at least some are willing to forego the traditional approaches to informed consent.…”