Enrollment in research under exception from informed consent: The Patients’ Experiences in Emergency Research (PEER) study

Abstract

Background Resuscitation research requires an exception from informed consent (EFIC). Despite concerns that patients may find EFIC unacceptable, the views and experiences of patients enrolled in an EFIC study are largely unknown. Methods The Patients' Experience in Emergency Research (PEER) Study was nested within the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) for pre-hospital treatment of status epilepticus. PEER included 61 EFIC enrollees or their surrogates from 5 sites. Interviews used a structured, interactive guide focusing on acceptance of EFIC enrollment in RAMPART and existing regulatory protections. Simple statistics were generated, and textual data were analyzed for common themes. Results 24 enrolled patients and 37 surrogates were successfully interviewed. 49/60 (82%) were glad they or their family member were included in RAMPART; 54/57 (95%) felt research on emergency seizure treatment is important. 43/59 (73%) found their inclusion under EFIC acceptable;10 (17%) found it unacceptable, and 6 (10%) were neutral. There were no statistically significant interactions between enrollment attitudes and demographic characteristics, though there were trends toward lower acceptance among interviewees who were non-white, less educated, or had prior research experience. The most common concerns related to lack of consent prior to RAMPART enrollment. Positive responses related to perceived medical benefits, recognition of the impracticality of consent, and wanting doctors to do what needs to be done in emergencies. Many participants had difficulty understanding the trial and EFIC. Conclusions Most subjects had positive views of enrollment, and acceptance generally correlated with results of community consultation studies.

Patients’ Perspectives of Enrollment in Research Without Consent

“…In total, 21 respondents (25%) illustrated at least one form of misconception regarding ProTECT III. In the PEER-RAMPART study, 62% illustrated misconceptions, typically related to randomization (6). …”

“…This interactive strategy- used in PEER-RAMPART- suits the nature of EFIC research. The guide was designed to maximize respondents’ understanding of key content and to allow respondents time to ask questions and develop views on complicated, unfamiliar content (6, 9, 17). The interview guide (Supplemental Digital Content- Appendix 1) was adapted from PEER-RAMPART and reviewed by content and methodological experts.…”

“…To date, however, only two studies have examined the views of EFIC enrollees. The Patients’ Experiences in Emergency Research (PEER-RAMPART) study found over 70% of enrolled patients and surrogates were accepting of their own EFIC enrollment in a trial of prehospital management of status epilepticus (6). Over 95% of Australian participants in a trial of glucose control in critical illness reported they would have agreed if they could have been asked for consent (7).…”

Patients' views of consent in clinical trials for acute myocardial infarction: impact of trial design

“…Interviewers were trained to probe responses of participants and reasons for views expressed. This strategy is consistent with exploratory goals, is appropriate given the complexity of clinical trial information and has been used in prior work to facilitate mixed quantitative and qualitative aims 11 12…”

Exception From Informed Consent: Ethics and Logistics

“…We have thankfully moved beyond a time when there was controversy regarding whether such research could even be performed, as it has become clear that not only the medical community but also patients, surrogates, and survivors agree that EFIC research is appropriate under the right circumstances. [7][8][9] We are now in an age where we seek to establish best practices and continue to improve them and individualize these practices for each trial. Investigators are encouraged to share more about their experiences with the challenges of conducting EFIC research.…”