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Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials
dc.contributor.authorBellomo, Tiffany
dc.contributor.authorFokas, Jennifer
dc.contributor.authorTsao, Noah
dc.contributor.authorAnderson, Clare
dc.contributor.authorBecker, Christopher
dc.contributor.authorGioscia-Ryan, Rachel
dc.contributor.authorMeurer, William
dc.date.accessioned2022-08-02T18:55:36Z
dc.date.available2023-08-02 14:55:34en
dc.date.available2022-08-02T18:55:36Z
dc.date.issued2022-07
dc.identifier.citationBellomo, Tiffany; Fokas, Jennifer; Tsao, Noah; Anderson, Clare; Becker, Christopher; Gioscia-Ryan, Rachel ; Meurer, William (2022). "Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials." Ethics & Human Research 44(4): 14-25.
dc.identifier.issn2578-2355
dc.identifier.issn2578-2363
dc.identifier.urihttps://hdl.handle.net/2027.42/173066
dc.description.abstractWe sought to investigate the experiences of researchers in existing active-control trials in acute ischemic stroke comparing investigational therapy to tissue plasminogen activator (tPA) in order to identify the approaches and challenges in obtaining informed consent. Out of 401 articles evaluated, 14 trials met inclusion criteria. Trial representatives were contacted to complete a survey concerning the consent process. None of the 14 trials published materials related to the informed consent process. Trials with 75% to 100% of patients directly consented had shorter door-to-treatment (DTT) times than trials that directly consented less than 50% of patients. Trials that had translators available (for recruiting participants who were not native speakers in the local language) and translated consent documents had longer DTT times. The study findings suggest that differences in the standards of informed consent internationally may allow more patients with moderate strokes to provide direct consent without delaying DTT time. Future trials should emphasize transparency to the public and scientific community in the informed consent process.
dc.publisherWiley Periodicals, Inc.
dc.subject.otherhuman research ethics
dc.subject.otherhuman subjects research
dc.subject.otheracute ischemic stroke
dc.subject.otherinformed consent
dc.subject.otherrandomized controlled trials
dc.subject.otherliterature review
dc.titleEthical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials
dc.typeArticle
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelMedicine (General)
dc.subject.hlbtoplevelHealth Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/173066/1/eahr500133-sup-0001-S1.pdf
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/173066/2/eahr500133.pdf
dc.identifier.doi10.1002/eahr.500133
dc.identifier.sourceEthics & Human Research
dc.identifier.citedreferenceJanssen et al., “ Neurological Deficits in Stroke Patients. ”
dc.identifier.citedreferenceMenon et al., “ Alteplase Compared to Tenecteplase in Patients with Acute Ischemic Stroke. ”
dc.identifier.citedreferenceFinlay, K. A., and C. V. Fernandez, “ Failure to Report and Provide Commentary on Research Ethics Board Approval and Informed Consent in Medical Journals,” Journal of Medical Ethics 34 ( 2008 ): doi: 10.1136/jme.2007.023325; Schroter, S., et al., “Reporting Ethics Committee Approval and Patient Consent by Study Design in Five General Medical Journals,” Journal of Medical Ethics 32 (2006): doi: 10.1136/jme.2005.015115.
dc.identifier.citedreferenceBateman, B. T., et al., “ Conducting Stroke Research with an Exception from the Requirement for Informed Consent,” Stroke 34 ( 2003 ): doi: 10.1161/01.STR.0000065230.00053.B4.
dc.identifier.citedreferenceScicluna, V. M., et al., “ Determinants of Patient and Surrogate Experiences with Acute Care Research Consent: A Key Informant Interview Study,” Journal of the American Heart Association 8, no. 22 ( 2019 ): doi: 10.1161/JAHA.119.012599; Dickert, N. W., et al., “Emergency Consent: Patients’ and Surrogates’ Perspectives on Consent for Clinical Trials in Acute Stroke and Myocardial Infarction,” Journal of the American Heart Association 8, no. 2 (2019): doi: 10.1161/JAHA.118.010905.
dc.identifier.citedreferenceLeira, E. C., et al., “ Lack of International Consensus on Ethical Aspects of Acute Stroke Trials,” Journal of Stroke and Cerebrovascular Diseases 21, no. 3 ( 2012 ): doi: 10.1016/j.jstrokecerebrovasdis.2010.06.008.
dc.identifier.citedreferenceIbid.; Saver, “ Time Is Brain—Quantified.”
dc.identifier.citedreferenceHalkoaho, A., et al., “Cultural Aspects Related to Informed Consent in Health Research: A Systematic Review,” Nursing Ethics (2016): doi: 10.1177/0969733015579312.
dc.identifier.citedreferenceMenon et al., “ Alteplase Compared to Tenecteplase in Patients with Acute Ischemic Stroke”; Dewar, B., and Shamy, M. C., response to letter regarding the article “Deferral of Consent in Acute Stroke Trials: Lessons from the ESCAPE Trial,” Stroke 50, no. 8 ( 2019 ): doi: 10.1161/STROKEAHA.119.026278.
dc.identifier.citedreferenceTu, J. V., et al., “ Impracticability of Informed Consent in the Registry of the Canadian Stroke Network,” New England Journal of Medicine 350 ( 2004 ): doi: 10.1056/NEJMsa031697.
dc.identifier.citedreferenceNys, G. M. S., et al., “ Cognitive Disorders in Acute Stroke: Prevalence and Clinical Determinants,” Cerebrovascular Diseases 23 ( 2007 ): doi: 10.1159/000101464; Kauranen, T., et al., “The Cognitive Burden of Stroke Emerges Even with an Intact NIH Stroke Scale Score: A Cohort Study,” Journal of Neurology, Neurosurgery and Psychiatry 85, no. 3 (2014): doi: 10.1136/jnnp-2013-305585.
dc.identifier.citedreferenceFlaherty, M. L., et al., “ How Important Is Surrogate Consent for Stroke Research?,” Neurology 71 ( 2008 ): doi: 10.1212/01.wnl.0000316196.63704.f5.
dc.identifier.citedreferenceJansen, T. C., et al., “ Deferred Consent in Emergency Intensive Care Research: What If the Patient Dies Early? Use the Data or Not?,” Intensive Care Medicine 33 ( 2007 ): doi: 10.1007/s00134-007-0580-8; Shamy, M. C. F., et al., “Deferral of Consent in Acute Stroke Trials: Lessons from the ESCAPE Trial,” Stroke 50, no. 4 (2019): doi: 10.1161/STROKEAHA.118.024096.
dc.identifier.citedreferenceRose, D. Z., and S. E. Kasner, “Informed Consent: The Rate-Limiting Step in Trials,” Frontiers in Neurology (2011): doi: 10.3389/fneur.2011.00065.
dc.identifier.citedreferenceFlaherty et al., “ How Important Is Surrogate Consent for Stroke Research? ”
dc.identifier.citedreferenceBryant, J., et al., “ The Accuracy of Surrogate Decision Makers: Informed Consent in Hypothetical Acute Stroke Scenarios,” BMC Emergency Medicine 13, no. 1 ( 2013 ): doi: 10.1186/1471-227X-13-18.
dc.identifier.citedreferenceScicluna et al., “ Determinants of Patient and Surrogate Experiences. ”
dc.identifier.citedreferenceRose and Kasner, “Informed Consent”; Flory, J., and E. Emanuel, “Interventions to Improve Research Participants’ Understanding in Informed Consent for Research: A Systematic Review,” Journal of the American Medical Association (2004): doi: 10.1001/jama.292.13.1593.
dc.identifier.citedreferenceSaver, J. L., et al., “ Prehospital Use of Magnesium Sulfate as Neuroprotection in Acute Stroke,” New England Journal of Medicine 372 ( 2015 ): doi: 10.1056/NEJMoa1408827.
dc.identifier.citedreferenceBiros, M. H., et al., “ Balancing Ethical Goals in Challenging Individual Participant Scenarios Occurring in a Trial Conducted with Exception from Informed Consent,” Academic Emergency Medicine 22 ( 2015 ): doi: 10.1111/acem.12602; Dickert et al., “Emergency Consent.”
dc.identifier.citedreference“ Federal Policy for the Protection of Human Subjects. Final Rule,” Federal Register 82, no. 12 (January 2017 ): 7149 – 7274; Simonds, V. W., and D. Buchwald, “Too Dense and Too Detailed: Evaluation of the Health Literacy Attributes of an Informed Consent Document,” Journal of Racial and Ethnic Health Disparities 7 (2020): doi: 10.1007/s40615-019-00661-1; Schmidt, T. A., et al., “Confronting the Ethical Challenges to Informed Consent in Emergency Medicine Research,” Academic Emergency Medicine 11 (2004): doi: 10.1197/j.aem.2004.05.028.
dc.identifier.citedreferenceFlory and Emanuel, “Interventions to Improve Research Participants’ Understanding in Informed Consent for Research”; Falagas, M. E., et al., “Informed Consent: How Much and What Do Patients Understand?,” American Journal of Surgery (2009): doi: 10.1016/j.amjsurg.2009.02.010.
dc.identifier.citedreferenceFeldman, W. B., et al., “ Effect of Waivers of Consent on Recruitment in Acute Stroke Trials,” Neurology 86 ( 2016 ): doi: 10.1212/WNL.0000000000002587; Dickert, N. W., et al., “Reframing Consent for Clinical Research: A Function-Based Approach,” American Journal of Bioethics 17, no. 12 (2017): doi: 10.1080/15265161.2017.1388448; Dickert, N. W., et al., “Understanding Preferences regarding Consent for Pragmatic Trials in Acute Care,” Clinical Trials 15 (2018): doi: 10.1177/1740774518801007.
dc.identifier.citedreferenceDickert, N. W., et al., “ Confronting Ethical and Regulatory Challenges of Emergency Care Research with Conscious Patients,” Annals of Emergency Medicine 67, no. 4 ( 2016 ): doi: 10.1016/j.annemergmed.2015.10.026; Scicluna et al., “Determinants of Patient and Surrogate Experiences”; Nishimura, A., et al., “Improving Understanding in the Research Informed Consent Process: A Systematic Review of 54 Interventions Tested in Randomized Control Trials,” BMC Medical Ethics 14, no. 1 (2013): doi: 10.1186/1472-6939-14-28.
dc.identifier.citedreferenceWendler et al., “ Targeted Consent for Research on Standard of Care Interventions in the Emergency Setting. ”
dc.identifier.citedreferenceSchenker, Y., et al., “The Impact of Language Barriers on Documentation of Informed Consent at a Hospital with On-Site Interpreter Services,” supplement, Journal of General Internal Medicine 22, no. 2 ( 2007 ): doi: 10.1007/s11606-007-0359-1; Mendelson, S. J., et al., “Racial Disparities in Refusal of Stroke Thrombolysis in Chicago,” Neurology 90, no. 5 (2018): doi: 10.1212/WNL.0000000000004905.
dc.identifier.citedreferenceKrieger, J. L., et al., “ Linguistic Strategies for Improving Informed Consent in Clinical Trials among Low Health Literacy Patients,” Journal of the National Cancer Institute 109, no. 3 ( 2017 ): doi: 10.1093/jnci/djw233; Nardini, C., “The Ethics of Clinical Trials,” Ecancer 8, no. 1 (2014): doi: 10.3332/ecancer.2014.387.
dc.identifier.citedreferenceCarrera, J. F., et al., “ Delay to Tissue Plasminogen Activator in Hypertensive Stroke Patients: An Analysis of Delay Duration across Agents,” Journal of Stroke and Cerebrovascular Diseases 29, no. 2 ( 2020 ): doi: 10.1016/j.jstrokecerebrovasdis.2019.104525.
dc.identifier.citedreferenceWorld Medical Association, “ World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects,” Journal of the American Medical Association 3 10 ( 2013 ): doi: 10.1001/jama.2013.281053.
dc.identifier.citedreferenceVirani, S. S., et al., “ Heart Disease and Stroke Statistics—2020 Update: A Report from the American Heart Association,” Circulation 141 ( 2020 ): doi: 10.1161/CIR.0000000000000757; Heidenreich, P. A., et al., “Forecasting the Impact of Heart Failure in the United States: A Policy Statement from the American Heart Association,” Circulation: Heart Failure 6, no. 3 (2013): doi: 10.1161/HHF.0b013e318291329a.
dc.identifier.citedreferencePowers, W. J., 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): doi: 10.1161/STR.0000000000000211; Palaniswami, M., and B. Yan, “ Mechanical Thrombectomy Is Now the Gold Standard for Acute Ischemic Stroke: Implications for Routine Clinical Practice,” Interventional Neurology 4, no. 1-2 ( 2015 ): doi: 10.1159/000438774.
dc.identifier.citedreferenceSaver, J. L., “Time Is Brain—Quantified,” Stroke (2006): doi: 10.1161/01.STR.0000196957.55928.ab; Saver, J. L., et al., “ Time to Treatment with Intravenous Tissue Plasminogen Activator and Outcome from Acute Ischemic Stroke,” Journal of the American Medical Association 309 ( 2013 ): doi: 10.1001/jama.2013.6959; Hacke, W., et al., “Association of Outcome with Early Stroke Treatment: Pooled Analysis of ATLANTIS, ECASS, and NINDS Rt-PA Stroke Trials,” Lancet 363 (2004): doi: 10.1016/S0140-6736(04)15692-4.
dc.identifier.citedreferenceNational Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group, “ Tissue Plasminogen Activator for Acute Ischemic Stroke,” New England Journal of Medicine 333 ( 1995 ): 1581 – 87.
dc.identifier.citedreferenceMendelson, S. J., et al., “ National Practice Patterns of Obtaining Informed Consent for Stroke Thrombolysis,” Stroke 49, no. 3 ( 2018 ): doi: 10.1161/STROKEAHA.117.020474.
dc.identifier.citedreferenceThomalla, G., et al., “ Effect of Informed Consent on Patient Characteristics in a Stroke Thrombolysis Trial,” Neurology 89 ( 2017 ): doi: 10.1212/WNL.0000000000004414.
dc.identifier.citedreferenceMendelson et al., “ National Practice Patterns of Obtaining Informed Consent”; Janssen, P. M., et al., “Neurological Deficits in Stroke Patients That May Impede the Capacity to Provide Informed Consent for Endovascular Treatment Trials,” Journal of Stroke and Cerebrovascular Diseases 28, no. 12 ( 2019 ): doi: 10.1016/j.jstrokecerebrovasdis.2019.104447.
dc.identifier.citedreferenceYanagida, T., et al., “ Causes of Prehospital Delay in Stroke Patients in an Urban Aging Society,” Journal of Clinical Gerontology and Geriatrics 5, no. 3 ( 2014 ): doi: 10.1016/j.jcgg.2014.02.001.
dc.identifier.citedreferenceWendler, D., et al., “Targeted Consent for Research on Standard of Care Interventions in the Emergency Setting,” Critical Care Medicine (2017): doi: 10.1097/CCM.0000000000002023.
dc.identifier.citedreferenceSkolarus, L. E., et al., “ Getting the GIST across Is Enough for Informed Consent for Acute Stroke Thrombolytics,” Stroke 50 ( 2019 ): doi: 10.1161/STROKEAHA.119.024653.
dc.identifier.citedreferencePowers et al., “ Guidelines for the Early Management of Patients with Acute Ischemic Stroke. ”
dc.identifier.citedreferenceBoth PubMed (see https://pubmed.ncbi.nlm.nih.gov/ ) and ClinicalTrials.gov are made available by the U.S. National Library of Medicine.
dc.identifier.citedreferenceSee JPRN Search Portal, https://rctportal.niph.go.jp/en/.
dc.identifier.citedreferenceEurope PMC, https://europepmc.org/.
dc.identifier.citedreferenceEU Clinical Trials Register, https://www.clinicaltrialsregister.eu/.
dc.identifier.citedreferenceAustralian New Zealand Clinical Trials Registry, https://www.anzctr.org.au/.
dc.identifier.citedreferenceWorld Health Organization, International Clinical Trials Registry Platform, search portal, apps.who.int/trialsearch/.
dc.identifier.citedreferencePowers et al., “ Guidelines for the Early Management of Patients with Acute Ischemic Stroke. ”
dc.identifier.citedreferenceRayan, https://rayyan.qcri.org/.
dc.identifier.citedreferenceAngde Biotech Pharmaceutical Co., “A Phase II of Injection for Recombinant Human Tissue Plasminogen Kinase Derivative in Treatment of Acute Ischemic Stroke,” ClinicalTrials.gov, identifier: NCT04028518, 2019, accessed January 3, 2020; Menon, B. K., et al., “Alteplase Compared to Tenecteplase in Patients with Acute Ischemic Stroke,” ClinicalTrials.gov, identifier: NCT03889249, 2019, accessed January 3, 2020; General Hospital of Shenyang Military Region, “Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke,” ClinicalTrials.gov, identifier: NCT03661411, 2020, accessed January 3, 2020; Tasly Biopharmaceuticals Co., “Study of rhPro-UK in Patients with Acute Ischaemic Stroke in 4.5 Hours after Stroke Onset,” ClinicalTrials.gov, identifier: NCT03541668, 2020, accessed January 3, 2020; Melbourne Health, “Tenecteplase versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance,” ClinicalTrials.gov, identifier: NCT04071613, 2020, accessed January 3, 2020; Haukeland University Hospital, “The Norwegian Tenecteplase Stroke Trial 2,” ClinicalTrials.gov, identifier: NCT03854500, 2019, accessed January 3, 2020; Anderson, C. S., et al., “ Low-Dose versus Standard-Dose Intravenous Alteplase in Acute Ischemic Stroke,” New England Journal of Medicine 374 ( 2016 ): 2313 – 23; Campbell, B. C. V., et al., “Tenecteplase versus Alteplase before Thrombectomy for Ischemic Stroke,” New England Journal of Medicine 378 (2018): 1573-82; Ciccone, A., et al., “Endovascular Treatment for Acute Ischemic Stroke,” New England Journal of Medicine 368 (2013): 904-13; Haley, E. C., et al., “Phase IIB/III Trial of Tenecteplase in Acute Ischemic Stroke: Results of a Prematurely Terminated Randomized Clinical Trial,” Stroke 41, no. 4 (2010): 707-11; Huang, X., et al., “Alteplase versus Tenecteplase for Thrombolysis after Ischaemic Stroke (ATTEST): A Phase 2, Randomised, Open-Label, Blinded Endpoint Study,” Lancet Neurology 14 no. 4 (2015): 368-76; Khatri, P., et al., “Effect of Alteplase vs Aspirin on Functional Outcome for Patients with Acute Ischemic Stroke and Minor Nondisabling Neurologic Deficits: The PRISMS Randomized Clinical Trial,” Journal of the American Medical Association 320 (2018): 156-66; Logallo, N., et al., “Tenecteplase versus Alteplase for Management of Acute Ischaemic Stroke (NOR-TEST): A Phase 3, Randomised, Open-Label, Blinded Endpoint Trial,” Lancet Neurology 16, no. 10 (2017): 781-88; Sen, S., et al., “IV vs. IA TPA in Acute Ischemic Stroke with CT Angiographic Evidence of Major Vessel Occlusion: A Feasibility Study,” Neurocritical Care 11, no. 1 (2009): 76-81.
dc.identifier.citedreference“ Revised Common Rule Q&As,” U.S. Department of Health and Human Services, Office for Human Research Protections, 2018, https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html.
dc.identifier.citedreferenceHaley et al., “ Phase IIB/III Trial of Tenecteplase in Acute Ischemic Stroke ”; Anderson et al., “Low-Dose versus Standard-Dose Intravenous Alteplase in Acute Ischemic Stroke”; Sen et al., “IV vs. IA TPA in Acute Ischemic Stroke with CT Angiographic Evidence of Major Vessel Occlusion”; Logallo et al., “Tenecteplase versus Alteplase for Management of Acute Ischaemic Stroke (NOR-TEST)”; Angde Biotech Pharmaceutical Co., “A Phase II of Injection for Recombinant Human Tissue Plasminogen Kinase Derivative in Treatment of Acute Ischemic Stroke”; Haukeland University Hospital, “The Norwegian Tenecteplase Stroke Trial 2.”
dc.working.doiNOen
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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