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Informed consent procedures for emergency interventional TBI & stroke research
legal or moral ground for this recommendation. 52 When it remains impossible to get affirmative consent for study continuation for reasons other than death, it could be necessary to withdraw patients from the study. This depends on the specific study circumstances and procedures as reviewed and approved by a responsible institutional review board. When consent for study continuation is provided, already collected data can be used. When study continuation is refused, already collected data can still be used when patients or proxies do not use their right to refuse this.
The procedural particulars depend on local legislation, institutional review board requirements, and their assessment of the relative pros and cons. Respecting local requirements is important, but also has a risk of practice variation and use of different terms or descriptions, both resulting in indistinctness, misunderstanding, and even misuse. 8–10 Researchers should be aware of this possibility and multinational studies therefore need to be flexible enough to tailor their approach to all applicable requirements. 53 Although most researchers use the deferred consent procedure to obtain consent for study continuation, it is sometimes interpreted as a requirement to obtain consent for research activities that have already taken place. However, considering the earlier suggested conditions (panel 1) and the actual meaning of consent (give permission for something to happen or agreement to do something), it can only be concluded that asking and obtaining valid consent is possible only for research activities in the future.
Many patients and proxies report to be willing to participate in a study without 9 previous consent. 42,50,54,55 Although the deferred consent procedure was not always
supported afterwards, 56 most proxies of patients included in acute care studies
(81–100%) without previous informed consent agreed to further participation.49,56–58
Only few patients that refused further participation also denied permission for the use of already collected data. 58 Experienced stress in the setting of an intensive care unit admission was commonly mentioned as reason to endorse the use of a deferred consent procedure. 42
A deferred consent procedure is also being used in three ongoing randomised controlled trials on modifications of endovascular treatment for acute ischaemic stroke (MR CLEAN-MED, MR CLEAN-NO IV, MR CLEAN LATE) within the CONTRAST consortium. 59 On Nov 8, 2019, preliminary data were available for 742 patients of these CONTRAST studies, of whom 664 (90%) patients or proxies provided written consent
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