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 re-focus 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.