Conducting Stroke Research With an Exception From the Requirement for Informed Consent

Bateman, Brian T.; Meyers, Philip M.; Schumacher, Helmut; Mangla, Sundeep; Pile‐Spellman, John

doi:10.1161/01.str.0000065230.00053.b4

Cited by 41 publications

(39 citation statements)

References 33 publications

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“…Further evaluation of the patient’s competency of giving informed consent is needed in urgent stroke clinical trials. Obtaining informed consent for emergency stroke trials is obviously difficult, and the role of the physician in the consent procedure when patients are incompetent and relatives are not available (‘waiver of consent’) remains a matter of debate [9]. …”

Section: Discussionmentioning

confidence: 99%

Ethical Issues of Informed Consent in Acute Stroke

et al. 2005

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Background: Many patients may be mentally incompetent or physically unable to give informed consent at the acute stage of stroke. Accordingly, we aimed to investigate the modalities of informed consent in urgent therapeutic stroke trials, the awareness of patients and relatives regarding stroke clinical trials and the impact of decision making on patients and relatives. Methods: We present a study of 56 acute ischemic stroke patients who were randomized in 4 trials (2 trials testing neuroprotective agents, 1 testing thrombolysis and 1 testing antithrombotic agents). A standardized questionnaire was used to assess the modalities of informed consent in this setting. Results: The mean age was 67.1 (SD 12.6) years. The mean baseline Scandinavian Stroke Scale (SSS) score was 23.8 (SD 10.5). Only 13 patients (23% of cases) gave consent while relatives gave consent for 43 patients (77%). The main reason for not getting consent from the patient was aphasia in 29 patients (67.4%). Multiple logistic regression analysis showed that the two independent factors influencing the ability to give consent are age and baseline neurological deficit as assessed by the SSS score. Concerning the psychological impact of consent, none of the 10 patients who answered our questionnaire declared feeling uncomfortable when giving consent, while 7 out of the 13 relatives who could be reached declared they felt uncomfortable, mainly because of the psychological stress induced by urgent decision making. Conclusions: Our study emphasizes the specific ethical difficulties of informed consent in the setting of acute stroke research. Only a minority of patients are able to give consent at the acute stage. Increasing age and neurological deficit are independent predictors of inability to give consent. Thus, the responsibility for consent usually relies on relatives with potential inaccuracy of decision concerning the patient’s wish or even conflict of interest. Further evaluation of the psychological impact of decision on relatives is needed in this setting of acute stroke.

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Section: Discussionmentioning

confidence: 99%

Ethical Issues of Informed Consent in Acute Stroke

et al. 2005

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“…The standard approach to recruitment in a randomized trial of a non-emergency treatment is to require fully informed written consent after giving the patient sufficient time to consider the matter. This is clearly not practicable in the emergency treatment of acute stroke, where patients may have a variety of neurological deficits which either impair effective spoken or written communication and/or writing (e.g., coma, confusion, paralysis, aphasia) [1, 2]. There is substantial variation between countries in the legal and regulatory requirements for consent procedures for trials being conducted in such patients.…”

Section: Introductionmentioning

confidence: 99%

Impact of Stroke Syndrome and Stroke Severity on the Process of Consent in the Third International Stroke Trial

et al. 2006

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Background: Obtaining informed consent for a patient’s participation in a randomized trial of treatment for use in a medical emergency may be achieved in a variety of ways. We sought to assess the process of consent and to evaluate the influence of the patient’s neurological deficit on the method used to obtain consent in the first 300 patients recruited into the Third International Stroke Trial (IST-3). Methods: IST-3 is the first large-scale randomized controlled trial of intravenous thrombolysis in acute ischaemic stroke. The clinician could use one of four procedures to recruit the patient: written consent, witnessed consent, assent, or a waiver of consent. The patient’s neurological deficits were recorded at baseline. We analysed the relationship between the neurological deficits at baseline and the consent procedure. Results: The method of consent used was written consent in 71 subjects (24%), witnessed verbal consent in 30 subjects (10%), assent by a relative in 197 subjects (66%), and waiver of consent in 2 subjects (1%). Patients with severe neurological deficits (as measured either by their stroke syndrome or their lower predicted probability of being alive and independent at 6 months) were more likely to be recruited by assent. Patients able to give written consent had less severe strokes. Conclusions: Patients with non-lacunar hemispheric stroke syndromes or with a more severe neurological deficit were less likely to give written consent. Excluding such patients from acute stroke treatment trials would eliminate many otherwise eligible subjects, who have a poor predicted outcome without treatment and yet might benefit from acute treatments such as thrombolysis. Flexible consent procedures developed for IST-3 have made it feasible to recruit the target population.

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“…In 1996, the US FDA and Department of Health and Human Services published regulations regarding the enrollment of subjects in emergency research without their own consent or that of a surrogate (21 CFR 50.24). [21][22][23] Some consider exception from informed consent to be more ethically problematic than surrogate consent, and, as a practical reality, it has been difficult to implement in the United States. 24 Our study was not intended to investigate the utility or necessity of exception from informed consent for stroke research.…”

Section: Discussionmentioning

confidence: 99%