Page 19 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

To allow essential emergency research initiatives, several alternatives are introduced 1 to overcome this problem. It is accepted to start the study without prior patient
or proxy informed consent with (deferred consent) and without (exception from
consent, waiver of consent) the requirement to obtain informed consent for study continuation later. 82-84 As in TBI management, there is substantial practice variation
in used informed consent procedures, within and between EU Member States, and also globally. 85,86 Variation in informed consent procedures complicates multicentre international studies because it may lead to inclusion problems, bias, and delay in institutional review board approval. 87,88
Institutional review boards
An institutional review board is usually appointed to review research protocols to ensure their compliance with ethical standards and national laws. IRBs have an essential role in (clinical) research to protect the dignity, fundamental rights, safety, and well-being of research participants and their formal approval is compulsory before a clinical study can start. 89 Although several international models exist to improve the harmonization of ethical principles, the functioning of IRBs is subject to national legislation and regulation, which refine their structure and function to better serve local needs and cultural preferences. 90,91 Approval of research protocols submitted to IRBs is subject to these differences, which may complicate the conduct of international research.
Lack of procedural harmonization ‘leads to a complex and uncertain framework for ethical review and for participant informed consent, resulting in numerous inefficiencies in observational studies’. 92 Greater procedural harmonization is generally considered desirable, because it could improve quality and efficiency by decreasing costs, increasing statistical validity, 93-95 optimizing data management 93, allowing choice of relevant and generalizable outcome variables, 95 promoting uniform product safety regulations 94, and minimizing waste of resources due to inefficiencies. 94
The efficiency of future research initiatives could be improved by assessing the procedural details, and quantifying the differences, problems and challenges regarding informed consent and IRB procedures. This could improve efficiency and quality of future research initiatives and thereby contribute to the evidence base on patient outcome and treatment cost-effectiveness. This might benefit future treatment decision-making and ultimately patient outcome.
General introduction
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