Page 203 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Informed consent procedures for emergency interventional TBI & stroke research
Proposed flowchart to guide investigators or regulators to select the most appropriate informed consent procedure based on several traumatic brain injury or ischaemic stroke study particulars. Studies could use multiple informed consent procedures in their informed consent strategy. Informed consent procedures should be used as overlapping and complementary strategies to solve different challenges of a study. This flowchart could be best seen as a legal and ethical framework that could be considered in any research setting. It is not binding, and a chosen informed consent strategy should always follow applicable legislation and must be evaluated and approved by the responsible institutional review boards. *Some emergency interventional studies on traumatic brain injury and ischaemic stroke use a very narrow therapeutic time window (ie, mins) that does not allow any time for an informed consent procedure. Obtaining patient or proxy informed consent before intervention is not possible in these situations, because the intervention is immediate. Obtaining informed consent can delay the study intervention. In some studies, any delay of study intervention is problematic because it could compromise the potential effect of the experimental treatment, making the fair interpretation of results difficult. Obtaining informed consent and delaying the study intervention could also be considered unethical because patients would be exposed to unnecessary risk. In other studies, where the therapeutic time window of traumatic brain injury or ischaemic stroke intervention is wider (ie, several hrs), there might be an opportunity to obtain patient or proxy informed consent. †There are many reasons why it could not be possible to obtain patient or proxy informed consent before intervention even when this could have been possible within the therapeutic time window. Reasons include an absence of available proxies, and a patient’s or proxy’s inability to provide informed consent. ‡Strategies to optimise and support patient or proxy decision-making could help to optimise informed consent procedures. §The use of deferred consent or exception from consent or waiver of consent procedures depends on study particulars and local legal frameworks, including requirements from institutional review boards. Details can be found in the main text of the manuscript and cited references. Their use should be carefully considered and evaluated by researchers and institutional review boards. ¶Informed consent to continue study-related activities should be obtained as soon as the patient or a proxy can provide informed consent. In case a proxy provided informed consent first, informed consent should be verified with the patient when this becomes possible.
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6 It is reasonably impossible to prospectively identify individuals that are likely to become eligible for study participation in the future, in such a way that patient or proxy informed consent before intervention could be obtained.
7 It is practically impossible to undertake the emergency research when patient or proxy informed consent before intervention is required to start study-related activities.
8 A comprehensive disclosure of study information and study participation to patients and proxies is required at the earliest possible (practicable) opportunity.
9 If the patient dies during the study before informed consent has been obtained, the already collected data can be used according to the study protocol, without the need for proxy informed consent. Proxies should be informed about study participation at the earliest possible (practicable) opportunity.
10 The use of this alternative for patient or proxy informed consent before intervention is accepted by local legislation. Institutional review boards have reviewed and approved the study protocol to prevent misconduct and ascertain patient safety.
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