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Chapter 9
REFERENCES
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2 World Medical Association. Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. 2018; 2019. https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical- principles-for-medical-research-involving-human-subjects/2194.
3 Wolf SM, Clayton EW, Lawrenz F. The Past, Present, and Future of Informed Consent in Research and Translational Medicine. J Law, Med Ethics 2018; 46: 7–11.
4 Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). International Ethical Guidelines for Health-related Research Involving Humans, Fourth Edition. Geneva. 2016. https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf.
5 Dickert NW, Eyal N, Goldkind SF, et al. Reframing Consent for Clinical Research: A Function-Based Approach. Am J Bioeth 2017; 17: 3–11.
6 Bruni T, Graham M, Norton L, Gofton T, Owen AM, Weijer C. Informed consent for functional MRI research on comatose patients following severe brain injury: balancing the social benefits of research against patient autonomy. J Med Ethics 2019; 45: 299–303.
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inability to provide informed consent: Policy and practice in the CENTER-TBI study. J Crit Care 2020; 59: 6–15.
12 Maas AIR, Menon DK, Adelson PD, et al. Traumatic brain injury: integrated approaches to improve prevention,
clinical care, and research. Lancet Neurol 2017; 16. DOI:10.1016/S1474-4422(17)30371-X.
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14 Powers WJ, Rabinstein AA, Ackerson T, et al. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019; 50: e344–418.
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16 Mendyk AM, Labreuche J, Henon H, et al. Which factors influence the resort to surrogate consent in stroke trials, and what are the patient outcomes in this context? BMC Med Ethics 2015; 16: 26.
17 Janssen PM, Chalos V, van den Berg SA, et al. Neurological Deficits in Stroke Patients that May Impede the Capacity to Provide Informed Consent for Endovascular Treatment Trials. J Stroke Cerebrovasc Dis 2019; : 104447.
18 Ali M, Lyden P, Brady M. Aphasia and Dysarthria in Acute Stroke: Recovery and Functional Outcome. Int J Stroke 2015; 10: 400–6.
19 Hotter B, Ulm L, Hoffmann S, et al. Selection bias in clinical stroke trials depending on ability to consent. BMC Neurol 2017; 17: 206.
20 Thomalla G, Boutitie F, Fiebach JB, et al. Effect of informed consent on patient characteristics in a stroke thrombolysis trial. Neurology 2017; 89: 1400–7.
21 Stanley RM, Johnson MD, Vance C, et al. Challenges Enrolling Children Into Traumatic Brain Injury Trials: An Observational Study. Acad Emerg Med 2017; 24: 31–9.
22 Mendelson SJ, Aggarwal NT, Richards C, O’Neill K, Holl JL, Prabhakaran S. Racial disparities in refusal of stroke thrombolysis in Chicago. Neurology 2018; 90: e359–64.
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