Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, 401 Quarry Road, Stanford, CA, USA, 94305-5717.
Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, 401 Quarry Road, Stanford, CA, USA, 94305-5717.
J Psychiatr Res. 2018 Aug;103:33-37. doi: 10.1016/j.jpsychires.2018.04.018. Epub 2018 Apr 30.
Clinical research is predicated ethically on the authentic voluntarism of individuals who choose to enroll in human studies. Existing literature has focused on aspects of informed consent for clinical research other than voluntarism. The objective of this study was to compare the perspectives of clinical research participants who are in good health and who are ill regarding voluntarism-related aspects of informed consent and to assess situational influences that enable voluntarism in the process of obtaining clinical research consent. A 23-item written survey, the Informed Consent Questionnaire (ICQ), was administered in a "piggyback" semi-structured interview study of ill and healthy volunteers enrolled in IRB-approved clinical research studies. A total of 150 (60 mentally ill, 43 physically ill, and 47 healthy) clinical research participants participated. Respondents expressed positive views of their experiences with the informed consent processes for their respective clinical research protocols and respondents strongly endorsed items related to voluntarism irrespective of their illness type (range of means = [3.9, 4.8]). Ill participants more highly endorsed items relating to informed consent conditions (mentally ill vs healthy: 0.54 on a 5-point scale, P value = 0.01) (physically ill vs. healthy: 0.47 on a 5-point scale, P value = 0.01). The favorable views of clinical research participants regarding their experience of giving informed consent to enroll in a study were not surprising. Contrary to our a priori hypothesis, healthy individuals did not feel as positively as their ill counterparts.
临床研究从伦理上说是建立在个体自愿选择参加人体研究的基础上的。现有文献主要集中在临床研究知情同意的除自愿性以外的其他方面。本研究的目的是比较健康和患病的临床研究参与者在知情同意的自愿性方面的观点，并评估在获得临床研究同意的过程中使自愿性成为可能的情境影响。一项 23 项的书面调查，即知情同意问卷（ICQ），在对参加 IRB 批准的临床研究的健康和患病志愿者进行的“附加”半结构式访谈研究中进行了评估。共有 150 名（60 名精神疾病患者，43 名身体疾病患者和 47 名健康志愿者）临床研究参与者参加了该研究。受访者对他们各自的临床研究方案的知情同意过程表示了积极的看法，并且无论其疾病类型如何，受访者都强烈支持与自愿性相关的项目（平均得分范围为[3.9，4.8]）。患病参与者更高度认可与知情同意条件有关的项目（精神疾病患者与健康志愿者：5 分制 0.54，P 值=0.01）（身体疾病患者与健康志愿者：5 分制 0.47，P 值=0.01）。临床研究参与者对他们参与研究的知情同意经验的积极看法并不奇怪。与我们的先验假设相反，健康个体的感觉不如患病个体那么积极。
