{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,14]],"date-time":"2026-03-14T13:07:32Z","timestamp":1773493652972,"version":"3.50.1"},"reference-count":17,"publisher":"BMJ","issue":"7","license":[{"start":{"date-parts":[[2020,5,7]],"date-time":"2020-05-07T00:00:00Z","timestamp":1588809600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J NeuroIntervent Surg"],"accepted":{"date-parts":[[2020,4,28]]},"published-print":{"date-parts":[[2020,7]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Enrollment in time-sensitive endovascular stroke trials can be challenging because of an inability to consent a debilitated patient. Often the legally authorized representative is not on site. Remote consent procedures in the US are inconsistent with the majority of sites shunning these approaches. The current pandemic with visitor restrictions highlights the need for enhancing these options.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Remote electronic and phone consent procedures specifically for endovascular stroke trials from two comprehensive stroke centers (CSC) are presented. An overview of the genesis of informed consent procedures in the US is also included.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The two CSCs identified as Institution-1 and Institution-2 are large tertiary systems. Institution-1 is a non-profit university-affiliated academic medical center in rural geography. Institution-2 is an HCA hospital in an urban environment. Both serve patients through a spoke-and-hub network, have participated in multiple randomized endovascular stroke trials, and have successfully used these remote options for enrollment. A tiered approach is employed at both institutions with an emphasis on obtaining informed consent in person and resorting to alternatives methods when efforts to that are unsuccessful. A rationale for electronic and phone consent is included, followed by step-by-step illustration of the process at each institution.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Two examples of remote electronic or phone consent procedures from institutions in different geographic environments and organization structures demonstrate that these options can be successfully used for enrollment in stroke trials. The current pandemic highlights the need to enhance these approaches while maintaining appropriate adherence to ethical and legal frameworks.<\/jats:p><\/jats:sec>","DOI":"10.1136\/neurintsurg-2020-016221","type":"journal-article","created":{"date-parts":[[2020,5,8]],"date-time":"2020-05-08T00:07:57Z","timestamp":1588896477000},"page":"654-657","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":15,"title":["A rationale and framework for seeking remote electronic or phone consent approval in endovascular stroke trials \u2013 special relevance in the COVID-19 environment and beyond"],"prefix":"10.1136","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9864-4805","authenticated-orcid":false,"given":"Ansaar T","family":"Rai","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7811-5030","authenticated-orcid":false,"given":"Donald","family":"Frei","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2020,5,7]]},"reference":[{"key":"2024111105002065000_12.7.654.1","first-page":"23191","article-title":"Protection of human subjects; Belmont report: notice of report for public comment","volume":"44","year":"1979","journal-title":"Fed Regist"},{"key":"2024111105002065000_12.7.654.2","doi-asserted-by":"publisher","DOI":"10.11124\/jbisrir-2015-2304"},{"key":"2024111105002065000_12.7.654.3","first-page":"51498","article-title":"Protection of human subjects; informed consent \u2013 FDA. Final rule","volume":"61","year":"1996","journal-title":"Fed Regist"},{"key":"2024111105002065000_12.7.654.4","doi-asserted-by":"publisher","DOI":"10.1158\/2159-8290.CD-NB2016-146"},{"key":"2024111105002065000_12.7.654.5","doi-asserted-by":"publisher","DOI":"10.1197\/j.aem.2005.06.015"},{"key":"2024111105002065000_12.7.654.6","doi-asserted-by":"crossref","first-page":"492","DOI":"10.1016\/j.jstrokecerebrovasdis.2014.09.024","article-title":"Prestroke living situation and depression contribute to initial stroke severity and stroke recovery","volume":"24","author":"Aron","year":"2015","journal-title":"J Stroke Cerebrovasc Dis"},{"key":"2024111105002065000_12.7.654.7","doi-asserted-by":"publisher","DOI":"10.1080\/10903120500541035"},{"key":"2024111105002065000_12.7.654.8","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1414792"},{"key":"2024111105002065000_12.7.654.9","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1414905"},{"key":"2024111105002065000_12.7.654.10","doi-asserted-by":"publisher","DOI":"10.1161\/STROKEAHA.117.018380"},{"key":"2024111105002065000_12.7.654.11","doi-asserted-by":"publisher","DOI":"10.1136\/neurintsurg-2019-015283"},{"key":"2024111105002065000_12.7.654.12","doi-asserted-by":"publisher","DOI":"10.1159\/000247596"},{"key":"2024111105002065000_12.7.654.13","doi-asserted-by":"publisher","DOI":"10.1111\/ijs.12242"},{"key":"2024111105002065000_12.7.654.14","doi-asserted-by":"crossref","first-page":"759","DOI":"10.1111\/acem.12966","article-title":"Telemedicine provides noninferior research informed consent for remote study enrollment: a randomized controlled trial","volume":"23","author":"Bobb","year":"2016","journal-title":"Acad Emerg Med"},{"key":"2024111105002065000_12.7.654.15","doi-asserted-by":"crossref","DOI":"10.2196\/18810","article-title":"Global telemedicine implementation and integration within health systems to fight the COVID-19 pandemic: a call to action","volume":"6","author":"Ohannessian","year":"2020","journal-title":"JMIR Public Health Surveill"},{"key":"2024111105002065000_12.7.654.16","doi-asserted-by":"crossref","first-page":"1679","DOI":"10.1056\/NEJMp2003539","article-title":"Virtually perfect? Telemedicine for Covid-19","volume":"382","author":"Hollander","year":"2020","journal-title":"N Engl J Med"},{"key":"2024111105002065000_12.7.654.17","doi-asserted-by":"crossref","DOI":"10.1093\/jamia\/ocaa037","article-title":"Rapid response to COVID-19: health informatics support for outbreak management in an academic health system","author":"Reeves","year":"2020","journal-title":"J Am Med Inform Assoc"}],"container-title":["Journal of NeuroInterventional Surgery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/neurintsurg-2020-016221","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,11]],"date-time":"2024-11-11T13:00:42Z","timestamp":1731330042000},"score":1,"resource":{"primary":{"URL":"https:\/\/jnis.bmj.com\/lookup\/doi\/10.1136\/neurintsurg-2020-016221"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,5,7]]},"references-count":17,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2020,6,12]]},"published-print":{"date-parts":[[2020,7]]}},"alternative-id":["10.1136\/neurintsurg-2020-016221"],"URL":"https:\/\/doi.org\/10.1136\/neurintsurg-2020-016221","relation":{},"ISSN":["1759-8478","1759-8486"],"issn-type":[{"value":"1759-8478","type":"print"},{"value":"1759-8486","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,5,7]]}}}