Page 173 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Informed consent in patients with an inability to provide consent
BACKGROUND
Patient informed consent is one of the basic principles underpinning clinical research. Patients have the right to be informed about a proposed study and should have the opportunity to make an autonomous decision on study participation. It is however impossible to obtain patient informed consent from patients with an acute inability to provide informed consent due to an acute illness such as traumatic brain injury (TBI). 1 Research with TBI patients is however essential to optimize treatments and improve patient outcome. Therefore, several pragmatic alternatives are available in case patient informed consent could not be obtained.2
Proxy informed consent is the most frequently used alternative. Close family members or unrelated appointed legally authorized representatives are selected in accordance with applicable national or local regulations. These so-called proxies have the legal right to provide informed consent on behalf of the patient.3 Proxies are however often unavailable in the acute setting or are unable to make a valid judgment for several other reasons.4-9 This is especially complicated in emergency research where time is scarce.
To overcome this, some research settings allow an independent physician to decide 8 on behalf of the patient. In many European countries, it is also accepted to include
and randomize patients in emergency research settings without prior patient- or
proxy informed consent and ask consent for study continuation later (deferred
consent procedure).3,10 Researchers can also use the so-called ‘exception from consent’ and ‘waiver of consent’ procedures, which allow study start without prior patient- or proxy informed consent without the requirement of informed consent for study continuation.11,12
The relative pros and cons of different informed consent procedures have led to substantial regulatory variation within and between European Union (EU) Member States and globally.13,14 The EU has replaced the Data Protection Directive and the Clinical Trials Directive by the General Data Protection Regulation and the Clinical Trials Regulation to harmonize informed consent procedures.3,15-17 Unfortunately, neither regulation addresses the specific situations of patients with an acute inability to provide informed consent in detail, and neither clearly differentiates between acute or chronic mental conditions. Although the General Data Protection Regulation provides
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