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ORIGINAL ARTICLE
Year : 2021  |  Volume : 7  |  Issue : 4  |  Page : 253-258

Exception from informed consent in the era of social media: The SEGA stroke trial experience


1 Department of Neurosurgery; Department Neurology, Texas Institute for Restorative Neurotechnologies, McGovern Medical School, University of Texas Health Science Center; Department of Biomedical Informatics, School of Biomedical Informatics, University of Texas Health Science Center, Houston, Texas, USA
2 Research Operations and Conduct, University of Chicago, Chicago, Illinois, USA
3 Department of Neurosurgery, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA
4 Department of Neurology, Institute for Stroke and Cerebrovascular Disease, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA
5 Department Neurology, Texas Institute for Restorative Neurotechnologies, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA
6 Department of Anesthesiology, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA
7 Department of Pediatrics, McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA

Correspondence Address:
Peng Roc Chen
6400, Fannin Street, Suite 2800, Houston, TX 77030
USA
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/bc.bc_44_21

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INTRODUCTION: Patients with acute ischemic stroke (AIS) and neurologic deficits are often unable to provide consent and excluded from emergency research participation. Experiences with exception from informed consent (EFIC) to facilitate research on potentially life-saving emergency interventions are limited. Here, we describe our multifaceted approach to EFIC approval for an ongoing randomized clinical trial that compares sedation versus general anesthesia (SEGA) approaches for endovascular thrombectomy during AIS. METHODS: We published a university clinical trial website with EFIC information. We initiated a social media campaign on Facebook within a 50 mile radius of Texas Medical Center. Advertisements were linked to our website, and a press release was issued with information about the trial. In-person community consultations were performed, and voluntary survey information was collected. RESULTS: A total of 193 individuals (65% female, age 46.7 ± 16.6 years) participated in seven focus group community consultations. Of the 144 (75%) that completed surveys, 88.7% agreed that they would be willing to have themselves or family enrolled in this trial under EFIC. Facebook advertisements had 134,481 (52% females; 60% ≥45 years old) views followed by 1,630 clicks to learn more. The website had 1130 views (56% regional and 44% national) with an average of 3.85 min spent. Our Institutional Review Board received zero e-mails requesting additional information or to optout. CONCLUSION: Our social media campaign and community consultation methods provide a significant outreach to potential stroke patients. We hope that our experience will inform and help future efforts for trials seeking EFIC.


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