Page 155 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Institutional review board approval of CENTER-TBI protocol
BACKGROUND
A Research Ethics Committee or Institutional Review Board (collectively referred to as IRB in the remainder of this manuscript) is 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. 1 Although several international models exist to improve the harmonization of ethical principles, the functioning of IRBs are subject to national legislation and regulation, which refine their structure and function to better serve local needs and cultural preferences. 2-3 Approval of research protocols submitted to IRBs is subject to these differences, which may complicate the conduct of international research.
Managing variations in IRB procedures is important because of the increasing number
of research initiatives which involve multiple European Union (EU) Member States. 4-6
Variation could be improved by harmonization of European law, which is the process 7 of creating uniformity in laws, regulations and practices between countries. Regarding
research and IRB procedures, lack of procedural harmonization ‘leads to a complex
and uncertain framework for ethical review and for participant information consent,
resulting in numerous inefficiencies in observational studies’. 7 Greater procedural harmonization is generally considered desirable, because it could improve quality
and efficiency of healthcare research by decreasing costs, increasing statistical validity,
8-10 optimizing data management, 10 allowing choice of relevant and generalizable
outcome variables, 9 promoting uniform product safety regulations 8 and minimizing
waste of resources due to inefficiencies. 8
Although most IRBs have websites that describe the local submission process and provide access to submission guidelines and forms, up to date systematic information on IRB procedures and their level of harmonization in European health-care research is scarce. We are aware of only one previous meta-analysis on IRB procedures across European countries from 2005 to 2007 that was also related to research involving acutely mentally incapacitated individuals. 6 The Collaborative European Neurotrauma Effectiveness Research in Traumatic Brain Injury (CENTER-TBI) study is a large observational study conducted in many countries across Europe that provides a unique opportunity to assess European IRB policies and procedures. 11
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