Page 204 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 9
Specific prerequisites for deferred consent
1 It is considered possible to continue essential study-related activities, such as additional interventions or follow-up, when patient or proxy informed consent is required to continue study-related activities. For example, patients or proxies are not expected to have a prolonged inability to provide valid informed consent.
2 Patient or proxy informed consent is required for continuation of study- related activities and should be obtained from the patient or proxy at the earliest possible (practicable) opportunity after regaining the ability to provide informed consent. When study continuation is refused, the patient or proxy has the right to refuse the use of already obtained data.
3 There are no pre-study requirements such as community consultation or public disclosure.
Specific prerequisites for exception from consent
1 It is practically impossible to continue essential study-related activities, such as additional interventions or follow-up, when patient or proxy informed consent is required to continue study-related activities. For example, patients or proxies are expected to have a prolonged inability to provide valid informed consent.
2 Written patient or proxy informed consent is not required for continuation of study-related activities if the patient or a proxy never becomes available to engage in an informed consent process despite diligent good-faith efforts by the researchers. Patients or proxies should be informed about their right to refuse the use of obtained data.
3 To increase acceptance of the proposed study protocol, pre-study requirements such as community consultation or public disclosure could be required.
Conclusions and future directions
There is an urgent need to investigate novel therapeutic options that are potentially effective for patients with traumatic brain injury and ischaemic stroke. A thorough consideration of the multidimensional process of informed consent is required to increase the feasibility and quality of future emergency research initiatives. Researchers should be aware of the international legal and ethical conditions and possibilities. Implementing this knowledge could improve study protocol and procedures.
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