Page 174 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 8
for exemptions from patient informed consent procedures for observational research by leaving room for national legislation, informed consent in clinical emergency research is not mentioned in national law in 12 EU Member States.13,18
The lack of clear directions in European and national legislation may be expected to result in substantial practice variation in consent procedures for patients with an acute inability to provide informed consent.19 The use of different informed consent procedures in international multi-center studies could cause recruitment inefficiency, non-homogenous patient inclusion, selection bias, asymmetrical randomisation, and limited external validity of study results.20,21 Clearly, optimization of informed consent procedures and harmonization of regulations is important for future research initiatives.
The aim of this study is to inform researchers and policymakers on the use and challenges of informed consent procedures in a large prospective observational study including patients with an acute inability to provide informed consent due to TBI. Therefore, we investigated local policy and observed practice of informed consent procedures in the Collaborative-European-Neuro-Trauma-Effectiveness-Research in Traumatic Brain Injury (CENTER-TBI) study.22
MATERIALS AND METHODS
CENTER-TBI and study sample
The CENTER-TBI project includes a large prospective observational study on TBI conducted in 63 neurotrauma centres across Europe and Israel. 20-21 CENTER-TBI had a follow up period of 12 to 24 months and required extra blood samples and, in a subpopulation, MRI scans in addition to standard care. For this particular study, we excluded four centres with low inclusion rates (<five patients) and 2 centres from Israel, because we focussed on European centres. All remaining centres (N=57) from 17 European countries obtained IRB approval and were analyzed.(See Suppl Table 1).
Policy: Provider profiling and national legislation
Investigators of each study center completed “Provider Profiling” questionnaires prior to recruitment to the CENTER-TBI Core study. The questionnaires aimed to characterize general healthcare processes and, specifically for this present study, the use of informed consent procedures. (see Suppl file 1). These questions were about the acceptance and
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