Emergency Consent: Patients’ and Surrogates’ Perspectives on Consent for Clinical Trials in Acute Stroke and Myocardial Infarction

Abstract

Background Emergent informed consent for clinical trials in acute myocardial infarction (AMI) and stroke is challenging. The role and value of consent are controversial, and insufficient data exist regarding patients’ and surrogates’ experiences. Methods and Results We conducted structured interviews with patients (or surrogates) enrolled in AMI or acute stroke trials at 6 sites between 2011 and 2016. Primary domains included trial recall, consent experiences, and preferences regarding involvement. Descriptive and test statistics were used to characterize responses and explore relationships between key domains and characteristics. Multivariable logistic regression was used to examine associations between key covariates and consent preferences. There were 176 (84 stroke, 92 AMI) completed interviews. Most stroke respondents (82%) were surrogates; all AMI respondents were patients. Average time from trial enrollment to interview was 1.9 years (stroke) and 2.8 years (AMI); 89% of stroke and 62% of AMI respondents remembered being in the trial, and among these respondents, 80% (stroke) and 44% (AMI) remembered reading some of the consent form. Over 90% reported not feeling pressure to enroll, being treated in a caring way, and being treated with dignity. A minority (16% stroke and 26% AMI) reported they would have preferred not to be asked for consent. Just over half (61% stroke and 53% AMI) recalled a postenrollment conversation about the study. Conclusions Most respondents felt they were treated respectfully and were glad they had been asked for consent. Trial recall was relatively low, and many respondents recalled little postenrollment discussion. Further development of context‐sensitive approaches to consent is important.

Transplant candidates’ perceptions of informed consent for accepting deceased donor organs subjected to intervention research and for participating in posttransplant research

“…Accordingly, they expressed support for discussions about organ donor intervention research while on the waitlist. 29 Finally, research on organ donors (rather than directly on organs) raises the issue of risks to bystander organs that were not the intended target of the intervention. These patients' preferences validate the National Academy of Science committee's recommendations that transplant programs inform candidates about intervention organs at multiple times (eg, at waitlisting, and at the organ offer).…”

“…28 Approaches to consent outside transplantation show that there are promising avenues for respecting these values, while minimizing some burdensome features (eg, a long paper form; extensive time for discussion, as needed) typical of research in other clinical settings. 29 Finally, research on organ donors (rather than directly on organs) raises the issue of risks to bystander organs that were not the intended target of the intervention. Most participants preferred providing informed consent to accept a bystander organ given the potential for additional risks.…”

Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials

“…Informed consent is a mechanism for patients to exercise autonomy in trial enrollment, but patients and their surrogates also derive value from informed consent discussions. (35,36) As such, the manner of patient participation is intrinsically an ethical factor in trials without straightforward informed consent processes, such as trials of acute stroke or other emergency treatments. Investigators surveyed from the AbESTT II trial indicated that obtaining informed consent produces unnecessary delays, but simultaneously felt an exemption for informed consent was inappropriate.…”

“…Phone consent is important when no proxy is available within the time window due to geographic constraints. (36,50) However, it can be challenging to reach patient families with distressing information and ask for a decision when they are most vulnerable. Another solution to consider in the case of acute stroke trials may be a waiver of consent, known as an exception from informed consent (EFIC) in the USA, as delays in treatment due to the time it takes to achieve informed consent can lead to worse outcomes for patients.…”

“…Phone consent is important when no proxy is available within the time window due to geographic constraints. (36,50) However, it can be challenging to reach patient families with distressing information and ask for All rights reserved. No reuse allowed without permission.…”