Schaeffer M H, Krantz D S, Wichman A, Masur H, Reed E, Vinicky J K
Bioethics Program, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.
Am J Med. 1996 Mar;100(3):261-8. doi: 10.1016/S0002-9343(97)89483-1.
To assess the efficacy of informed consent in subjects differing in disease severity, ranging from those with immediately life-threatening disease to healthy volunteers.
A total of 127 subjects, enrolled in four types of clinical research protocols, were tested. Subjects completed questionnaires before entry into the protocol, within 24 hours of signing the primary protocol's consent document, and 4 to 6 weeks after entry.
Healthy volunteers retained the most information about risks and side effects, and severely ill Phase I subjects retained the least (P <0.0001). Phase I and II subjects had the best long-term retention of information about procedures, whereas Phase III subjects and healthy volunteers retained the least (P <0.001). Information about the scientific purpose and confidentiality of data were retained best by symptom-free, Phase III subjects (P <0.05). Phase I subjects entered the study primarily for treatment purposes, and the consent document was rated less useful by subjects with more advanced disease (P <0.05).
Subjects with differing disease processes and illness severities focused on and retained different aspects of experimental protocols for dissimilar reasons. During the informed consent process, research staff should inquire of potential subjects' personal goals for participating in experimental protocols and develop means for ensuring subjects' understanding of the inherent risks and alternative interventions available.
评估知情同意在疾病严重程度不同的受试者中的效果，这些受试者涵盖从患有即刻危及生命疾病的患者到健康志愿者。
共测试了127名参与四种类型临床研究方案的受试者。受试者在进入方案前、签署主要方案同意文件后24小时内以及进入方案后4至6周完成问卷调查。
健康志愿者对风险和副作用的信息保留最多，而重症I期受试者保留最少（P<0.0001）。I期和II期受试者对程序信息的长期保留最佳，而III期受试者和健康志愿者保留最少（P<0.001）。无症状的III期受试者对科学目的和数据保密性信息的保留最佳（P<0.05）。I期受试者主要为治疗目的进入研究，病情较重的受试者对同意文件的评价较低（P<0.05）。
疾病进程和严重程度不同的受试者因不同原因关注并保留了实验方案的不同方面。在知情同意过程中，研究人员应询问潜在受试者参与实验方案的个人目标，并制定方法以确保受试者理解固有风险和可用的替代干预措施。
