Page 165 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Institutional review board approval of CENTER-TBI protocol
to be purely interventional. Interventional studies are studies ‘where the researcher intercedes as part of the study design’. 19 An explanation for this opposing classification is that the IRBs did and did not consider the following procedures to be standard-of- care: (1) Different amounts of additional blood draws at presentation and follow-up. (2) Neuropsychological assessments and outcome questionnaires up to a 24-month follow-up. (3) Additional MRIs at sites participating in the MRI sub-study.
Extra work without clear benefits delays projects and should be avoided when possible. An additional IRB review after primary central IRB approval is usually double work and could result in an extra delay of weeks to more than a year, without always having clear benefits over the already obtained primary approval. 17 Cancelling potentially unnecessary (extensive) additional IRB review procedures could not only reduce turnover time, but also reduce costs. The exact costs of European IRB review procedures are unfortunately unknown, but the direct costs of an IRB review and approval in the US have been calculated to be $107.544 ($82.610 in IRB fees and $24.934 in labor). 20
Delays in obtaining IRB approval not only adversely affect study initiation, but are also 7 associated with several other risks. Long procedures with many feedback rounds will
delay study start, frustrate researchers and might even endanger meeting subsidiary
demands. Researchers might attempt to speed up the process by changing the protocol
or submitting the protocol to IRBs that are considered to be less strict but able to process the submission the quickest. This does not necessarily serve primary research objectives and might even hamper quality and generalizability of study results.
Optimization of IRB review procedures is urgently needed as multinational collaborations in healthcare research are increasing and even promoted by multiple European research grants. 4-5,21 Harmonization and adequate implementation of regulatory and ethical standards between European countries could improve the present situation. 7,22 The EU already aims to freely cooperate across borders by defining common standards and removing legal obstacles, but true harmonization of Member State laws in a research context has clearly not been established yet. 21-24 For example, the General Data Protection Regulation (GDPR) aimed to ensure a fair and transparent processing of personal data and aimed to improve patients’ control over their own data. 25 The implementation and use of the GDPR however showed the difficulty of harmonization in the protection of the EU citizens in this context. This was especially caused by the possibility for European countries to use their own national legislation in addition to the GDPR, which does not improve the desired harmonization.
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