Page 196 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 9
Proxies aim to make a decision that is authentic to the person they represent by balancing factors such as patients values, preferences, and wellbeing. 38,44–47 Other factors that affected decisions include the time sensitivity of the decision, perceived study risk or benefit, uncertainty of possible outcomes, the complexity of the patient’s condition, the use of medical terminology, and communication with physicians and nurses. 37,47,48 Study participation is often declined because proxies feel unable or unwilling to consider it. 49,50 Other common reasons to decline consent were being too anxious (67%), fear of experimental treatment (37%), and concerns about risks (33%). 44 Reasons to provide consent were wanting to help others (91%), contributing to medical progress (88%), and trusting (87%) or not wanting to disappoint the medical team (10%). 44
In summary, alternatives to patient or proxy informed consent before intervention are sometimes needed in traumatic brain injury or ischaemic stroke emergency interventional research because of the short therapeutic time windows, the deficits caused by traumatic brain injury or ischaemic stroke, and the frequent lack of available proxies. All factors preclude determining a patient’s preferences. When patient or proxy informed consent before intervention are not practicable, the use of consent alternatives is imperative.
Deferred consent
This procedure allows participants to be included in studies when patients and proxies are unable to provide valid previous consent within short time frames. The approach was infrequently reported as an option in our analysed sample of randomised controlled trials on traumatic brain injury (eight [13%] of 61) and ischaemic stroke (three [4%] of 71), nearly always in addition to patient and proxy informed consent before intervention (table). It is usually described as deferred patient or proxy consent, retrospective consent, delayed consent, implied consent and consent to continue, or reconsent from patient, and is allowed and practised in places such as Australia, European Union, China, India, Japan, and South Africa. It is described as valid in the Declaration of Helsinki 2 and in the International Ethical Guidelines for Health- related Research Involving Humans. 4 After starting study procedures without patient informed consent before intervention or proxy informed consent before intervention, consent must be obtained for study continuation as soon as patients or proxies regain the ability to provide consent. Some authors recommend a time limit of 72 h to prevent unauthorised use of conducting research without previous consent, 41 but there is no
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