Background: Residual tissue samples, i.e., samples excised for diagnosis or during treatment, are commonly used for medical research. In the Netherlands, they can be used provided the patient did not opt out of this use. Previous research has shown that recall of the informed consent procedure for tissue use is poor. Here, we investigate recall of three consent procedures: informed consent, opt-out, and opt-out plus (an opt-out procedure with an information procedure similar to that of informed consent). Methods: Patients (n = 1,319) with a variety of diseases were randomized into three trial arms: informed consent, opt-out plus, and opt-out. Questionnaires were administered 6 weeks and 6 months after randomization. Results: Six hundred and seventy-three and 553 patients returned the 6-week and 6-month questionnaire, respectively. In the informed consent arm, recall of having received a brochure (55.3%) or oral information (69.4%) was similar to that in the opt-out plus arm (48.5 and 71.6%, respectively), at the 6-week assessment. Significantly more respondents in the informed consent and the opt-out plus arms versus the opt-out arm recalled that they had been informed about being able to control tissue use and which consent procedure they had experienced (6-week questionnaire range 53.2–75.8 vs. 13.9–16.1%; 6-month questionnaire range 43.5–84.2 vs. 3.2–35.4%). There were no significant differences between the informed consent and opt-out plus arms in this regard. Conclusions: Recall of the consent procedure was similar in opt-out plus and informed consent procedures. Overall, recall was moderate, indicating that there is room for improvement in the quality of information provision.

中文翻译：

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同意程序内容和决定的召回和保留：随机对照试验的结果

背景：残留组织样本，即为诊断或治疗过程中切除的样本，通常用于医学研究。在荷兰，只要患者没有选择退出这种使用，就可以使用它们。先前的研究表明，对组织使用的知情同意程序的回忆很差。在这里，我们调查了三种同意程序的召回：知情同意、选择退出和选择退出加（一种选择退出程序，其信息程序类似于知情同意）。方法：患有多种疾病的患者（n = 1,319）被随机分为三个试验组：知情同意、选择退出和选择退出。在随机化后 6 周和 6 个月进行问卷调查。结果：分别有 673 名和 553 名患者返回了 6 周和 6 个月的问卷。在知情同意组中，在 6 周评估中，收到小册子 (55.3%) 或口头信息 (69.4%) 的回忆与选择退出加组中的相似（分别为 48.5% 和 71.6%）。与选择退出组相比，知情同意和选择退出加组的受访者明显更多地回忆起他们已被告知能够控制组织使用以及他们经历过的同意程序（6 周问卷范围 53.2-75.8 与. 13.9–16.1%；6 个月的问卷范围为 43.5–84.2 与 3.2–35.4%）。在这方面，知情同意和选择退出加武器之间没有显着差异。结论：同意程序的召回在选择退出加和知情同意程序中是相似的。总体来说，召回率中等，