Context is key: ethical considerations related to consent and study design in acute cardiac care research

Context is key: ethical considerations related to consent and study design in acute cardiac care research
Journal Article
Neal W Dickert, Madeline Meer
European Heart Journal Acute Cardiovascular Care, 28 November 2024
Excerpt
    …There is also an important set of ethical issues that arise in cardiac critical care research. By their very nature, acute care studies involve ‘high stakes’ outcomes such as mortality, organ failure, and other major morbidities. Communicating about study enrolment with patients and family members in the context of life-or-death situations is difficult, and research itself is complex and unfamiliar. To make matters worse, decisions often must be made very quickly, because acute care must be delivered rapidly. These issues make consent processes difficult and, in some cases, impossible. Many patients with severe acute cardiac illness lack capacity to engage in decision-making, and surrogate decision makers are often unavailable and may struggle with having to make research enrolment decisions for someone else. The urgency of these situations only compounds baseline challenges related to deciphering patients’ preferences for participating in research.
In this piece, we focus on these ethical challenges and integrate them with practical considerations outlined above. We articulate paths forward for major types of acute cardiac care research, emphasising throughout the importance of attention to critical contextual factors…