Community views on neurologic emergency treatment trials.
OBJECTIVE
We improve our understanding of the community consultation process for acute neurologic emergency trials conducted under the federal regulations for Exception From Informed Consent (EFIC) for emergency research.


METHODS
We performed a qualitative study using focus groups to collect data from patients with a previous stroke or brain injury and their families and from young men at risk for traumatic brain injury. Discussions were transcribed, coded, and analyzed for major themes and subthemes.


RESULTS
Five focus groups, involving 40 participants, were convened. Major themes included the awareness and understanding of key clinical trial concepts, including prominent concerns about placebo and therapeutic misconception; inability to obtain informed consent and acceptable surrogate decision-making; EFIC in emergency research and whether existing regulations are acceptable; specific trial design problems, including comparison to standard of care versus 2 competing active therapies; and community consultation and representation.


CONCLUSIONS
In this study sample, EFIC trials were deemed appropriate and acceptable for acute neurologic emergency research. Education, along with open discussion about basic clinical research concepts, disease- and trial-specific information, and potential surrogate decision-making, was essential to determine the acceptability of an EFIC trial. Approval by institutional review boards was highly regarded as a means of human protection and effective community consultation for such trials. A data repository of information gained from similar qualitative research may help investigators and regulators who wish to plan, conduct, review, and provide oversight for acute neurologic emergency trials under EFIC regulations.
Kasner
Scott E
SE
Department of Neurology, University of Pennsylvania, 3400Spruce St., Philadelphia, PA 19104, USA. kasner@mail.med.upenn.edu
Baren
Jill M
JM
Le Roux
Peter D
PD
Nathanson
Pamela G
PG
Lamond
Katherine
K
Rosenberg
Stacy L
SL
Karlawish
Jason
J
D001930:Brain Injuries / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods; D003256:Community Participation; D004632:Emergency Medical Services / Q000331:legislation & jurisprudence / Q000379:methods / Q000458:organization & administration; D005260:Female; D017144:Focus Groups; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D020521:Stroke / Q000628:therapy*; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult