title: 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.
authors.affiliation: Emory University School of Medicine, Department of Medicine, Division of Cardiology, 1462 Clifton Road, Suite 508, Atlanta, GA 30322, United States. Electronic address: njr@emory.edu.
authors.forename: Neal W
authors.initials: NW
authors.lastname: Dickert
authors.forename: Victoria A
authors.initials: VA
authors.lastname: Mah
authors.forename: Jill M
authors.initials: JM
authors.lastname: Baren
authors.forename: Michelle H
authors.initials: MH
authors.lastname: Biros
authors.forename: Prasanthi
authors.initials: P
authors.lastname: Govindarajan
authors.forename: Arthur
authors.initials: A
authors.lastname: Pancioli
authors.forename: Robert
authors.initials: R
authors.lastname: Silbergleit
authors.forename: David W
authors.initials: DW
authors.lastname: Wright
authors.forename: Rebecca D
authors.initials: RD
authors.lastname: Pentz
mesh_terms: D000328:Adult; D000368:Aged; D035843:Biomedical Research; D004630:Emergencies; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D010361:Patients; D011795:Surveys and Questionnaires
keywords: Community consultation; Ethics; Research ethics; Research in emergency settings; Resuscitation research