Page 195 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Informed consent procedures for emergency interventional TBI & stroke research
Proxy informed consent before intervention
Proxy informed consent before intervention was the most commonly used alternative for patient consent before intervention and used in most randomised controlled trials on traumatic brain injury (56 [92%] of 61) and ischaemic stroke (63 [89%] of 71; table). Proxy informed consent before intervention is provided by an individual who has the legal right to provide consent on behalf of the patient. There are many descriptions in the literature because the legal base that regulates the selection of individuals to act as proxy is variable: consent by a family member, a relative, an appointed person or legally authorised representative; surrogate or substitute decision maker; guardian permission; and sometimes independent physician consent. Independent physicians could serve as proxies for informed consent decisions in two (3%) of 61 randomised controlled trials on traumatic brain injury and in two (3%) of 71 trials on ischaemic stroke. The conditions listed in panel 1 could also be considered to assess validity of proxy informed consent before intervention. Examples of where proxy informed consent before intervention is approved include Australia, Ethiopia, European Union, Chile, China, India, Japan, North America, South Africa, and New Zealand, and is described as valid in the Declaration of Helsinki 2 and the International Ethical Guidelines for Health-related Research Involving Humans (appendix p 21). 4
The two main barriers to obtain proxy informed consent before intervention in
emergency research are the short therapeutic time window that precludes a consent conversation, and the fact that proxies cannot always be located or contacted. 21,35,36 As 9 with patient consent before intervention, delaying a timely start of study interventions
to obtain proxy informed consent before intervention is undesirable as it can decrease
the efficacy of the acute therapy. 26–28
A third barrier is that proxy decision-making in research is highly complex and, although proxies prefer to be involved, empirical evidence suggests that proxies might not always be suitable as surrogate decision makers. 37,38 Substantial discrepancies are described between decisions of patients and proxies in hypothetical scenarios. 39,40 About 50% of proxies reported to be comfortable with being involved, but many are also emotionally overwhelmed, stressed, distracted, or report symptoms of anxiety and depression. 37,41–43
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