Page 191 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Informed consent procedures for emergency interventional TBI & stroke research
Panel 1. Prerequisites for obtaining valid patient or proxy informed consent before intervention
Disclosure
The patient or proxy should be provided with complete and understandable information about the purpose, duration, potential risks or benefits, and possible other consequences of the study.
Understanding
The patient or proxy should fully understand all provided information.
Authenticity
The patient or proxy can make a judgement, which is consistent with the patient’s personal values.
Non-control
The patient or proxy should be able to make a decision without coercion, manipulation, or other undue influences.
Capacity
The patient or proxy should be able to oversee the consequences of providing informed consent and thereby study participation.
Intentionality
The patient or proxy should have the intention to participate in the study.
Time
The patient or proxy should be provided sufficient time to decide on informed consent for study participation.
In the context of emergency interventional research in traumatic brain injury and ischaemic stroke, time constraints make it impossible to await recovery to provide valid patient consent before intervention. Although consent is often obtained in parallel with imaging, laboratory tests, or readying an angiographic suite or operating theatre, obtaining patient consent before intervention could further delay treatment. This approach is problematic because study interventions might need to be delivered in a very short therapeutic time window to be effective.24,25 Secondary brain injury after traumatic brain injury can be less severe when treatment is initiated early 26 and stroke outcomes are better when reperfusion therapy is administered at the earliest opportunity. 27,28 A delay of 1 h in reperfusion time in patients with ischaemic stroke is associated with an increase of absolute risk of 6·0–7·7% for unfavourable functional
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