Page 182 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 8
differ substantially.37-42 Second, deferred consent was authorised as valid, but its use was not required because proxy or independent physician consent were used. Last, it is also possible that local researchers were unaware of the possibility of deferred consent.
Current European regulations include The Data Protection Directive and the Clinical Trials Directive, which were applicable at the time when patients were included in CENTER-TBI, are or will be superseded by the General Data Protection Regulation and the Clinical Trial Regulation respectively. However, since the General Data Protection Regulation does not apply to anonymized data and alternatives to patient informed consent are left to the legislation of Member States, large improvements in harmonization are not expected. 19,43 The Clinical Trials Regulation does state that patient informed consent may be deferred in some specific situation and might thereby cause an increase in the use of deferred consent. 17,19,44-46
There is a lack of clear regulations on emergency research in mentally incapacitated patients and lack of harmonization regarding informed consent procedures in European Neurotrauma centres. Performing multinational trials is challenging when variations in acceptance of alternatives for patient informed consent exist.14,47 Potential issues not only include IRB processing and patient recruitment inefficiency and therefore study delay, but also non-homogenous patient inclusion, selection bias, asymmetrical randomisation, and limited external validity of study results. 20,21 Although informed consent procedures are bound by national laws, institutional regulations and cultural factors, it could be beneficial for future research initiatives to harmonize procedures and regulations.
This study has several limitations. First, the majority of the participating centres were academic centres specialized in research and neurotrauma resulting in a possible selection bias. Second, by pragmatically focusing on patients from the ICU stratum with the highest likelihood of an inability to provide informed consent, we might have missed a few patients that were included in the ER or ward stratum. Unfortunately, there was no registered formal assessment of the ability to provide informed consent that could have been used to identify patients. Third, in addition to an analysis of national laws, reported informed consent policies were based on the provider profiling questionnaire rather than on actual policies. Although most responses were provided by seniors, the discrepancies could be caused by provider profiling errors due to variable individual understanding of actual policies and/or regulations. It could however also reflect the centres’ general consensus or IRB specific directives rather
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