Page 164 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 7
understanding the study. The apparent lack of integration and harmonization in this context suggests that the efficiency of European research collaborations could benefit from improving knowledge on the existing variation in procedures, inefficiencies and differences in value systems between and within countries.
The duration from protocol submission to required IRB approval was highly variable and ranged from one day up to nearly one year. In literature, differences between IRB procedures were also reported and IRB review durations varied from weeks to several months. 6,17 The difference in total duration between primary central and primary local IRB approval could respectively be overestimated and underestimated by the short primary IRB review times in Serbia and Romania and the missing data of the first review round for the UK. The difference is not necessarily related to the number of review rounds, but might be more explained by the reason and nature (primary central/local review or extensive/marginal additional local review) of the extra review round(s), the accompanying amount of work and the working speed of both IRB and research team. The influence of the latter was substantiated by our data as responding to questions from the IRB seemed to account for an important part of time in several countries (e.g. Denmark and Norway), while the majority of time in other countries (e.g. Belgium, Spain and France) was accounted for by the time taken in primary evaluation by IRBs. The exact reasons for these ‘delays’ could however not be derived from our data and deserves further study. They might be caused by the difficulty of requirements or questions, although, according to the communication records, IRBs mainly requested extra explanation of research procedures. Based on the IRB information requests in this study, special attention should be given to the description of inclusion criteria, informed consent procedures, patient information forms, non- standard care procedures, privacy and data security. A quick response by investigators and agreeing on a maximal turnover time of 1 month to 2 months for IRBs could already minimize substantial delay. This is also in correspondence with literature, where IRB turnover time targets range from 30 to 60 days.17-18
The question whether CENTER-TBI was an observational or an interventional study did not appear to be a clear explanation for differences in number and duration of review rounds. Interventional studies are generally subject to a more extensive review process, where observational study reviews may be more marginal. Nonetheless, duration was short in France and long in the UK. CENTER-TBI is registered as an observational study, in which ‘the investigator is not acting upon study participants, but instead observing natural relationships between factors and outcomes’. 19 Two IRBs considered the study
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