Page 215 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 7 analysed the process of institutional review board approval around Europe. Major variation was found in how the CENTER-TBI study protocol was reviewed and approved by 66 European institutional review boards. The reported variation between and within European countries with regard to submission and approval requirements, number of review rounds and total duration was not beneficial for study efficiency. It was concluded that future research initiatives could benefit from the implementation of more uniform legislation and regulation while acknowledging local cultural and ethical arrangements between countries.
Chapter 8 and chapter 9 focussed on the use of informed consent procedures in patients with traumatic brain injury with an inability to provide informed consent for emergency research.
Chapter 8 showed variation and discordance between reported and observed informed consent procedures in intensive care patients that were believed to have an inability to provide informed consent between and within European countries from the CENTER- TBI study. Proxy informed consent and deferred consent procedures appeared to be essential informed consent alternatives in studying TBI patients with an acute inability to provide informed consent. However, the deferred consent procedure was only actively used in a third of the centers where it was considered to be a valid method of consent. The study concluded that the reported European variation in informed consent procedures indicated inconsistencies in clear legislation or knowledge of such legislation among researchers. This could be optimized for the benefit of future research initiatives.
10
General summary
Chapter 9 was an extensive overview that discussed all relevant aspects on the use of informed consent procedures in emergency interventional research in patients with TBI and stroke that have an acute inability to provide informed consent. It was found that currently accepted consent alternatives such as deferred consent and exception/waiver of consent appear under-utilized, despite being ethically permissible, socially acceptable, and regulatory compliant. We concluded that when the requirements for medical urgency are properly balanced with legal and ethical conduct, the increased use of these alternatives has the potential to improve efficiency and quality of future emergency interventional studies in patients with an inability to provide informed consent.
The general discussion of this thesis will elaborate on the role of patient outcome and in-hospital costs in the acute treatment decision-making process in patients with s-TBI
213