Emergency Consent: Patients’ and Surrogates’ Perspectives on Consent for Clinical Trials in Acute Stroke and Myocardial Infarction
Neal W. Dickert, Victoria M. Scicluna, Opeolu Adeoye, Dominick J. Angiolillo, James C. Blankenship, Chandan M. Devireddy, Michael R. Frankel, Sara F. Goldkind, Gautam Kumar, Yi‐An Ko, Andrea R. Mitchell, Raul G. Nogueria, Ruth M. Parker, Manesh R. Patel, Michele Riedford, Robert Silbergleit, Candace D. Speight, Ilana Spokoyny, Kevin P. Weinfurt, Rebecca D. Pentz
Journal of the American Heart Association, 19 January 2019; 8(2)
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.
Category: Biomedical Research
Myth or Magic? Towards a Revised Theory of Informed Consent in Medical Research
Myth or Magic? Towards a Revised Theory of Informed Consent in Medical Research
Bert Heinrichs
The Journal of Medicine and Philosophy, 14 January 2019; 44(1) pp 33–49
Abstract
Although the principle of informed consent is well established and its importance widely acknowledged, it has met with criticism for decades. Doubts have been raised for a number of different reasons. In particular, empirical data show that people regularly fail to reproduce the information provided to them. Many critics agree, therefore, that the received concept of informed consent is no more than a myth. Strategies to overcome this problem often rest on a flawed concept of informed consent. In this paper, it is suggested that informed consent is a communicative act between two persons. The challenge is to elucidate the norms and constraints for successfully performing such a communicative act. The view developed here has major consequences with regard to the standards for information disclosure as well as for the general scope of informed consent.
Uninformed refusals: objections to enrolment in clinical trials conducted under an Exception Room Informed Consent for emergency research
Uninformed refusals: objections to enrolment in clinical trials conducted under an Exception Room Informed Consent for emergency research
Victoria Vorholt, Neal W Dickert
Journal of Medical Ethics, January 2019 – Volume 45 – 1
Original articles
Abstract
Clinical trials in emergency situations present unique challenges, because they involve enrolling individuals who lack capacity to consent in the context of acute illness or injury. The US Department of Health and Human Services and Food and Drug Administration regulations allowing an Exception from Informed Consent (EFIC) in these circumstances contain requirements for community consultation, public disclosure and restrictions on study risks and benefits. In this paper, we analyse an issue raised in the regulations that has received little attention or analysis but is ethically complex. This challenge is when to solicit and honour objections to EFIC trial enrolment, including from non-legally appointed representatives. We address novel questions involving whose objections should be honoured, what level of understanding is necessary for objections to be considered valid and how hard investigators should work to offer an opportunity to object. We present a set of criteria that provide conceptual and practical guidance. We argue that objections should be honoured if they undermine one of the key assumptions that allows for the permissibility of EFIC trials: that individuals would likely not object to enrolment based on their values or preferences. We then clarify the practical implications of this approach through examination of three cases of refusal in an EFIC study.
Center for Informed Consent Integrity 