The impact of disease severity on the informed consent process in clinical research
The impact of disease severity on the informed consent process in clinical research
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DOI：
10.1016/s0002-9343(97)89483-1
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发表时间：
1996-03-01
影响因子：
5.9
通讯作者：
Vinicky, JK
中科院分区：
文献类型：
--
作者：
Schaeffer, MH;Krantz, DS;Vinicky, JK
目的：评估知情同意在疾病严重程度不同的受试者中的有效性，包括立即危及生命的疾病患者和健康志愿者。材料和方法：共有127名受试者参加了4种临床研究方案。结果：健康志愿者保留的风险和副作用信息最多，重病患者保留的信息最少(P<；0.0001)。第一阶段和第二阶段受试者对手术信息的长期保存效果最好，而第三阶段受试者和健康志愿者的长期保存情况最差(P<；0.001)。关于数据的科学目的和机密性的信息在无症状的第三阶段受试者中保存得最好(P<；0.05)。I期受试者进入这项研究主要是为了治疗目的，而同意文件在疾病较晚期的受试者中被认为没有那么有用(P<；0.05)。结论：由于不同的原因，具有不同疾病过程和疾病严重程度的受试者关注并保留了实验方案的不同方面。在知情同意过程中，研究人员应该询问潜在受试者参与实验方案的个人目标，并开发确保受试者了解内在风险和可供选择的干预措施的方法。
PURPOSE: To assess the efficacy of informed consent in subjects differing in disease severity, ranging from those with immediately life-threatening disease to healthy volunteers.SUBJECTS AND METHODS: 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.RESULTS: 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).CONCLUSIONS: 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.