Page 189 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Informed consent procedures for emergency interventional TBI & stroke research
INTRODUCTION
Health-care professionals and researchers have the legal and ethical responsibility to inform patients before executing procedures as part of a clinical study. 1,2 Each patient has the right to refuse study participation.2 This right is internationally recognised and formalised in many declarations, regulations, directives, and laws. 1–4 For research involving humans, physicians must consider the applicable international norms and standards, as well as their country’s general ethical, legal, and regulatory standards.2 From a legal perspective, obtaining informed consent is focused on liability and establishing a shared responsibility between professionals and patients, while from a moral perspective, the focus is mostly on respecting autonomous choices and actions of the patient. The process of informed consent is a multidimensional process that serves several important ethical functions. 5–7
Obtaining informed consent is especially challenging in patients with acute
medical emergencies with compromised decision-making capacity from traumatic
brain injury and ischaemic stroke because: (1) the short therapeutic time window
necessitates urgent intervention without unnecessary delay, (2) the acute or life-
threatening condition associated with acute cognitive impairment impedes obtaining
valid patient informed consent before intervention, and (3) obtaining consent before
intervention from proxies is not always possible, because they cannot always be located
or contacted within the time window or they are unable to provide consent for other
reasons. These difficulties are probably contributing to the international variation in 9 policy and practice regarding consent procedures for emergency research. 8–11
Investigating novel, potentially effective therapeutic options for these patients is essential because traumatic brain injury and ischaemic stroke are associated with high rates of mortality and morbidity, which is a major burden for patients, proxies, and societies. 12,13 Moreover, many available treatments are still largely unproven or of little benefit. 12–15 To facilitate research to improve health and functional outcome in these patients, several pragmatic solutions are used to overcome the inability of obtaining patient informed consent before urgent medical intervention. However, the legal basis for these solutions is not universally present.
In this Personal View, we outline the theoretical and ethical basis of four different informed consent procedures in emergency interventional research and their use and
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