Page 18 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 1
Understanding and generalizing the in-hospital costs of individual TBI patients from available literature however remains difficult because methodological heterogeneity of TBI cost studies is high and study quality often inadequate. 73,74 Input from high quality cost research is essential to achieve a rational and righteous distribution of limited resources, to guarantee the highest quality of care for the lowest costs. 73-75 To achieve this, several difficulties in conducting TBI research have to be improved.
Difficulties in conducting TBI research
Conducting research in patients with TBI is complicated by several factors; largely unknown pathophysiological mechanisms of brain injury, the acute and stressful situation, unavailable necessary information (i.e. trauma mechanism, medical history, use of anticoagulants), and a patients’ inability to provide informed consent. As stated, to meet the need for more high-quality research, the efficiency of future research initiatives needs to be improved. This can be achieved by optimizing several aspects of TBI research. This thesis will focus on the use of informed consent procedures and the process of institutional review board approval.
Informed consent
Physicians and researchers are obligated to inform patients and obtain informed consent before executing diagnostic tests or treatment interventions as part of a clinical study. 76,77 The right to refuse informed consent and thus study participation is internationally recognised and formalised in many declarations, regulations, directives and laws. 76-78 Obtaining informed consent respects the principle of autonomous people and their autonomous choices and actions. It establishes a shared responsibility between professionals and patients.
Obtaining patient informed consent is however not possible in patients with an inability to provide informed consent due to acute TBI. As a result of limited formal guidance in this context, most Institutional Review Boards (IRB) have pragmatically accepted that proxies may provide prior consent on behalf of the patient. Because proxies are frequently unavailable or unable to provide informed consent within the limited time window, potentially eligible patients may not always be recruited, and study progress suffers delays. 79-81
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