Page 200 - DECISION-MAKING IN SEVERE TRAUMATIC BRAIN INJURY PATIENT OUTCOME, HOSPITAL COSTS, AND RESEARCH PRACTICE

Chapter 9
A study 68 reviewed 28 completed and published acute care studies between 1996 and 2018, that used exception from informed consent or waiver of informed consent. 68 Only 359 (0·6%) of 63 947 study enrolments were withdrawn or did not provide consent for continued study participation.68 Acceptance of the exception from informed consent procedure was high and varied by the specifics of the situation. 65,69
Implications for research practice
The difficulties regarding patient and proxy informed consent before study intervention in traumatic brain injury and ischaemic stroke emergency interventional research can result in many lost research opportunities when alternatives for informed consent are not facilitated.43 Based on the sample of randomised controlled trials, patient recruitment without patient and proxy informed consent before study intervention seems to be increasingly used in recent years, but still many studies do not use it. The use and efficiency of consent procedures in traumatic brain injury and ischaemic stroke emergency research should be improved.
Selecting an appropriate informed consent procedure for a study is difficult and depends on many factors, often related to each other. Factors include local legislation, institutional review board requirements, and study details such as methods, interventions, and patient characteristics. We propose use of a flow chart to guide investigators or regulators to select the most appropriate informed consent procedures based on several study particulars (figure). Informed consent procedures should be used as overlapping and complementary strategies to solve different challenges of a study. Researchers should first determine whether the therapeutic time window allows time for an informed consent procedure. If there is time, it should also be determined whether it is feasible to obtain valid patient or proxy informed consent before intervention within the time window. The conditions suggested in panel 1 could be used as a starting point to assess consent validity. If both are not practicable, the determination of a patient’s wishes regarding study participation should be considered not possible. Researchers should then consider the option of using an alternative procedure like deferred consent or exception from informed consent or waiver of informed consent. This choice mainly depends on local legislation and study details. A non-exclusive list of prerequisites of both procedures, based on existing legislation, as listed in appendix p 21, can be found in panel 4. These prerequisites are not intended to be conclusive, but could assist researchers in determining the appropriateness of the procedure. All procedural decisions should adhere to applicable legislation.
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