Page 205 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE
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Informed consent procedures for emergency interventional TBI & stroke research
Supported by an extensive literature base, we conclude that obtaining patient or proxy informed consent before intervention is often not possible in emergency interventional research in patients with traumatic brain injury or ischaemic stroke. This impossibility is primarily caused by the importance of very narrow therapeutic windows, the inability to provide informed consent, or the frequent absence of surrogate decision makers. Generally accepted alternatives, such as deferred consent and exception from informed consent or waiver of informed consent, appear underutilised in traumatic brain injury and ischaemic stroke emergency interventional research, despite being ethically permissible, socially acceptable, and regulatorily compliant. Not being able to use these alternatives complicates emergency interventional research in these patients. Being able to use them, when appropriate, has the potential to optimally test interventions earlier in a patient’s course when they are most likely to be effective. If done properly, it also creates an opportunity for more generalisable and equitable clinical trial participation and results. Using these alternatives appears consistent with the desires of most patients most of the time.
Institutional review boards have an important role to prevent misconduct and protect
patient safety by reviewing and approving study protocols. Study procedures should be
overseen during the study. Researchers should aim to optimise the use of overlapping
and complementary informed consent strategies based on the particular circumstances
of a study, especially the requirements and constraints on obtaining patient or proxy
informed consent before intervention. Harmonisation of laws and regulations between
countries should be pursued, while respecting national sovereignty and local cultural 9 preferences. All measures will further improve the efficiency and quality of emergency
research initiatives involving patients with an inability to provide informed consent before medical intervention, regardless of disease.
Supplementary files
Available online: https://www.thelancet.com/cms/10.1016/S1474-4422(20)30276-3/ attachment/5b005065-3e21-4ff7-ab02-887d63f0d4e9/mmc1.pdf
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