@article{14de0ebd55364d3a8dd60398def4cf87,
title = "Getting the Most out of Consent: Patient-Centered Consent for an Acute Stroke Trial",
abstract = "Informed consent for clinical trials in acute stroke is characterized by challenges related to urgency, cognitive impairment, and geographical separation. Context-appropriate approaches are needed for this setting. We conducted a mixed-methods project involving focus groups and interviews as well as collaboration with a patient advisory panel and a central institutional review board (CIRB) to design and implement a patient-driven consent process for a multicenter trial incorporating adaptive randomization. Remote consent was recognized as challenging but acceptable. Adaptive randomization was viewed positively, but significant potential for misunderstanding was appreciated. Collaboration between the patient advisory panel and the CIRB resulted in a shortened, more patient-centered consent form that was approved at all sites with few modifications. An information sheet was developed as a resource for patients and surrogates after enrollment. Collaboration between investigators, patient partners, and a CIRB can facilitate innovation and implementation of patient-centered, context-appropriate consent strategies.",
keywords = "human subjects research, informed consent, institutional review board (IRB), patient advisory panel, patient-centered consent process, stroke, stroke clinical trials, surrogate consent",
author = "Dickert, {Neal W.} and Kathleen Metz and Deeds, {S. Iris} and Linke, {Michael J.} and Mitchell, {Andrea R.} and Speight, {Candace D.} and Adeoye, {Opeolu M.}",
note = "Funding Information: We report here the results of a study that had two primary objectives. First, we aimed to explore views regarding adaptive randomization and remote consent through individual and focus‐group interviews with surrogates for participants who had been enrolled in prior stroke trials. Second, we collaborated with an existing patient advisory panel (PAP) to develop a patient‐centered consent process for the Multi‐arm Optimization of Stroke Thrombolysis (MOST) trial (NCT03735979) and implement the consent process within the StrokeNet network, which is funded by the National Institute of Neurological Disorders and Stroke. (PAP members were paid as consultants.) Funding Information: This project was supported by a Making a Difference Grant from the Greenwall Foundation. The parent MOST Trial is supported by the National Institute of Neurological Disorders and Stroke (NINDS) (with grant 1U01NS100699‐01A1). Funding Information: Dickert received research funding from the Patient‐Centered Outcomes Research Institute, Agency for Healthcare Research and Quality, and National Institutes of Health (NIH). Linke received NIH research funding from the National Center for Advancing Translational Sciences and the NINDS. Adeoye received research funding from the NIH NINDS. Publisher Copyright: {\textcopyright} 2022 by The Hastings Center. All rights reserved",
year = "2022",
month = mar,
day = "1",
doi = "10.1002/eahr.500122",
language = "English",
volume = "44",
pages = "33--40",
journal = "Ethics and Human Research",
issn = "2578-2363",
number = "2",
}