Page 166 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 7
Harmonization remains a highly complex process due to variation of national regulations that are based on national customs, culture, ethics, religion and other beliefs. 6 Harmonization of laws is designed to incorporate different legal systems under a basic framework. To overcome the highly complex process of harmonization in the area of research, it has been suggested to combine similarities between legislations and regulations of countries under a basic framework like a European research directive. A framework should acknowledge these local cultural or religious beliefs, as disregarding them is neither feasible nor desirable. While the desirable goal of harmonizing regulation will certainly benefit research in the future, both IRBs and researchers will have to put in efforts until that time. IRBs can accelerate the turnover by only requiring central IRB approval and researchers should respond quicker and more comprehensively to questions from IRBs, preventing the repetition of questions.
Strengths and limitations
The CENTER-TBI study provides a unique opportunity to provide comprehensive insight in the procedural differences between European IRBs. The study benefits from its large size and because the data acquisition process increased the quality and completeness of documents. Despite the quality of the documents, results were still dependent on the recorded information. Therefore, we could not always identify causal factors for variation, which is something to look for in future initiatives. The data on IRB review procedures in an observational study conducted with mentally incapacitated patients in neurotrauma centers might not be generalizable for other research settings.
CONCLUSIONS
This study shows variation between IRB procedures across Europe, which pose major challenges to large European research collaborations. Differences are likely caused by the lack of harmonization, integration and implementation of national legislations and regulations. To optimize efficiency for multinational European studies in context of obtaining IRB approval, the encountered differences and inefficiencies should be studied further and policymakers should evaluate the opportunities to optimize regulatory harmonization, while acknowledging the boundaries of national sovereignty and local cultural preferences.
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