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 suc

SUBMITTER: Dickert NW 

PROVIDER: S-EPMC3770787 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature