This study demonstrates that patients recognize barriers to understanding but value elements of consent. Further research is needed to develop approaches that meet patients' goals while recognizing the limitations inherent to this context.
BackgroundInformed consent for acute myocardial infarction and stroke research is challenging. Time for enrollment decisions is limited, patients and family are usually stressed, and being asked to participate in research is often unexpected. Despite these barriers, patients and surrogates have reported a preference for prospective involvement in research decisions and generally positive views of the consent process. It is unknown what drives positive or negative consent experiences. These data are crucial to making consent processes more context appropriate.Methods and ResultsWe conducted a qualitative interview study with 27 patients and surrogates enrolled in acute myocardial infarction and stroke trials in the past 5 years. Purposive sampling from the P‐CARE (Patient‐Centered Approaches to Research Enrollment) study was based on participant characteristics and responses to initial patient‐centered interviews. In‐depth interviews used open‐ended questions to explore factors influencing consent experiences. Qualitative descriptive analysis was performed utilizing a multilevel coding strategy. Participants identified specific researcher behaviors as important, including expressions of respect, professionalism, and nonpressuring communication. Participants preferred consent conversations focused on risks/benefits and the trial protocol. They had varying views of consent forms and communicated several reasons the form was valuable unrelated to informational content. Participants also valued postenrollment interactions as opportunities to ask questions and learn about the study.ConclusionsBarriers to consent in acute myocardial infarction and stroke trials are unavoidable, but participants identified productive ways to demonstrate respect for patients during enrollment conversations. These include key researcher behaviors, concentrating consent discussions on what participants find most important, and structured postenrollment follow‐up.
In 1996, federal regulations were put into effect that allowed enrollment of critically ill or injured patients into Food and Drug Administration (FDA)-regulated clinical trials using an exception from informed consent (EFIC) under narrowly prescribed research circumstances. Despite the low likelihood that a legally authorized representative (LAR) would be present within the interventional time frame, the EFIC regulations require the availability of an informed consent process, to be applied if an LAR is present and able to provide prospective consent for patient enrollment into the trial. The purpose of this article is to describe a series of unanticipated consent-related questions arising when a potential surrogate decisionmaker appeared to be available at the time of patient enrollment into a trial proceeding under EFIC.ACADEMIC EMERGENCY MEDICINE 2015;22:340-346
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.
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