Clinical paperEnrollment in research under exception from informed consent: The Patients’ Experiences in Emergency Research (PEER) study☆
Introduction
Federal regulations allowing an exception from informed consent (EFIC) for research in emergency settings have facilitated pivotal trials, but EFIC research remains challenging and controversial.1, 2 Some challenges stem from requirements for community consultation and public disclosure, but fundamental concerns remain about attitudes of the public and enrolled patients. Patients’ attitudes are particularly relevant, because EFIC regulations are designed to facilitate research in settings where consent is not possible but not to take advantage of incapacity in order to enroll patients against their wishes.3
There is a body of literature addressing attitudes toward EFIC, mostly in the context of community consultation efforts and surveys of the general public.4 Approval of the concept of EFIC ranges widely (from 36% to 81%).5, 6, 7, 8, 9 Acceptance of hypothetical personal EFIC enrollment scenarios has also varied significantly (from 45% to 94%).7, 10, 11 In contrast, several studies involving patients who have survived conditions such as stroke, traumatic brain injury, and cardiac arrest have reported greater support.12, 13 A recent Finnish study similarly found broad EFIC support among individuals, physicians, and surrogates involved in a pre-hospital trial of hypothermia induction after cardiac arrest.14 However, these patients had been enrolled in the hypothermia trial under surrogate consent rather than under EFIC.
While informative, these studies have thus reported hypothetical views on EFIC enrollment. Moreover, most have utilized closed-ended survey instruments offering little insight into reasons for particular views or attitudes. It is unknown whether these data reflect views of patients (or surrogates) actually enrolled in an EFIC trial. The Patients’ Experiences in Emergency Research (PEER) study was nested within the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) by Silbergleit et al. and was designed to address these knowledge gaps.15
Section snippets
Methods
The principal objective was to assess the views of actual EFIC subjects and surrogates regarding acceptability of EFIC enrollment. Other goals were to assess patient and study factors predicting acceptance of EFIC enrollment and to evaluate the accuracy of community consultation in predicting enrollees’ concerns. PEER was nested within RAMPART, a double-blind, randomized, noninferiority trial comparing intravenous lorazepam with intramuscular midazolam in pre-hospital treatment of status
Study population
In total, 62 interviews were conducted. One could not be analyzed due to a recording failure. Two were terminated prematurely for reasons unrelated to interview content, though available data were included. The sample size for most questions is thus 59. The denominator for each question reflects the number of individuals asked that question.
Total RAMPART enrollment at PEER sites was 245; however, accurate contact information was not available for many subjects, and some sites were able to
Discussion
This is the first study to interview individuals and surrogates included in an EFIC study and employed a design allowing insight into respondents’ understanding and reasoning. In these respects, these data are novel and begin to fill an important knowledge gap.
One goal of this study was to assess whether acceptance of EFIC enrollment is similar among EFIC enrollees and participants in community consultation efforts required by U.S. EFIC regulations. The rate of EFIC acceptance almost exactly
Conclusion
This study is the first to report attitudes of actual EFIC enrollees and surrogates. Interviewees were generally accepting of enrollment and, while sometimes concerned about lack of consent, generally accepting of EFIC. Our findings suggest community consultation efforts do not systematically over-represent acceptance among enrollees; however, we caution against over-interpretation of community consultation acceptance rates given prevalent misunderstanding of study content. Important topics for
Conflict of interest statement
Funding for the PEER study and the RAMPART study were received from NINDS as disclosed in the manuscript. The authors report no other significant financial conflicts of interest relevant to this study.
Acknowledgments
The PEER study (1R03NS066378-01) and the RAMPART study (U01NS056975 and U01NS059041) were funded by the National Institute of Neurological Disorders and Stroke, National Institutes of Health. NINDS played no role in the design of the study, interpretation of data, or development of the manuscript.
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2020, Annals of Emergency MedicineCitation Excerpt :There are multiple reports of individuals’ attitudes toward exception from informed consent studies in the context of pretrial community consultation.7-9 What data do exist on attitudes of enrolled patients and surrogates have suggested that they are generally positive and similar to those of community consultation reports.10,11 However, these studies included a small proportion of trial participants and could have been subject to selection bias.
Approaches to community consultation in exception from informed consent: Analysis of scope, efficiency, and cost at two centers
2018, ResuscitationCitation Excerpt :This would have made random-digit-dialing four times as expensive per survey as any other approach. Surveys, both online and in person, have been included in many EFIC trials, and compare favorably to community meetings and random-digit-dialing [6–11,14–21]. Survey data exist in the literature for comparison, its costs are substantially lower, and the public is more likely to participate since it takes less time than a community meeting [14] and is less personally disruptive than random digit dialing.
Research in the emergency care environment
2017, Clinical and Translational Science: Principles of Human Research: Second Edition
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A Spanish translated version of the abstract of this article appears as Appendix in the final online version at http://dx.doi.org/10.1016/j.resuscitation.2013.04.006.