Associate professor in the Department of Medicine at the Emory University School of Medicine and in the Department of Epidemiology at the Emory University Rollins School of Public Health.
Resident in the Department of Emergency Medicine at Emory University School of Medicine.
Ethics Hum Res. 2022 Mar;44(2):33-40. doi: 10.1002/eahr.500122.
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.
在急性中风的临床试验中，知情同意书的特点是存在与紧迫性、认知障碍和地理隔离相关的挑战。针对这种情况，需要采用相应的方法。我们开展了一项混合方法研究，包括焦点小组和访谈，以及与患者咨询小组和中央机构审查委员会（CIRB）合作，为一项纳入适应性随机化的多中心试验设计和实施患者驱动的同意程序。远程同意被认为具有挑战性，但可以接受。适应性随机化受到了积极的评价，但也认识到存在潜在的重大误解。患者咨询小组和 CIRB 之间的合作促成了更简短、更以患者为中心的同意书，该同意书在所有地点获得批准，仅进行了少量修改。在入组后，还为患者和代理人制定了一份信息单作为资源。研究人员、患者伙伴和 CIRB 之间的合作可以促进以患者为中心、适合背景的同意策略的创新和实施。
