How do 66 European institutional review boards approve one protocol for an international prospective observational study on traumatic brain injury? Experiences from the CENTER-TBI study.

Marjolein TimmersJeroen T J M van DijckRoel P J van WijkValerie LegrandErnest van VeenAndrew I R MaasDavid K MenonGiuseppe CiterioNino StocchettiErwin J O Kompanjenull null

Published in: BMC medical ethics (2020)

We found variation in IRB procedures between and within European countries. There were differences in submission and approval requirements, number of review rounds and total duration. Research collaborations could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural habits and moral values between countries.

Keyphrases

traumatic brain injury
randomized controlled trial
primary care
mental health
severe traumatic brain injury
quality improvement
decision making