BackgroundDespite much debate, there is little evidence on consequences of consent procedures for residual tissue use. Here, we investigated these consequences for the availability of residual tissue for medical research, clinical practice, and patient informedness.MethodsWe conducted a randomised clinical trial with three arms in six hospitals. Participants, patients from whom tissue had been removed for diagnosis or treatment, were randomised to one of three arms: informed consent, an opt-out procedure with active information provision (opt-out plus), and an opt-out procedure without active information provision. Participants received a questionnaire six weeks post-intervention; a subsample of respondents was interviewed. Health care providers completed a pre- and post-intervention questionnaire. We assessed percentage of residual tissue samples available for medical research, and patient and health care provider satisfaction and preference. Health care providers and outcome assessors could not be blinded.ResultsWe randomised 1,319 patients, 440 in the informed consent, 434 in the opt-out plus, and 445 in the opt-out arm; respectively 60.7%, 100%, and 99.8% of patients’ tissue samples could be used for medical research. Of the questionnaire respondents (N = 224, 207, and 214 in the informed consent, opt-out plus, and opt-out arms), 71%, 69%, and 31%, respectively, indicated being (very) well informed. By questionnaire, the majority (53%) indicated a preference for informed consent, whereas by interview, most indicated a preference for opt-out plus (37%). Health care providers (N = 35) were more likely to be (very) satisfied with opt-out plus than with informed consent (p = 0.002) or opt-out (p = 0.039); the majority (66%) preferred opt-out plus.ConclusionWe conclude that opt-out with information (opt-out plus) is the best choice to balance the consequences for medical research, patients, and clinical practice, and is therefore the most optimal consent procedure for residual tissue use in Dutch hospitals.Trial RegistrationDutch Trial Register NTR2982

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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.

Eine selbständige Gesamtdarstellung der Geschichte des kommunisti-schen Arbeiterbildungsvereins in London, des langlebigsten deutschen Auslandsvereins, ist ein Desiderat der Forschung. Diese Forschungslücke schließt der folgende Aufsatz nicht. Als Teildarstellung beschränkt er sich darauf, die Anfangs- und Konsolidierungsphase des Londoner Arbeiterbildungsvereins vornehmlich auf der Grundlage einer Auswertung bereits publizierten Quellenmaterials darzustellen; eine Ausnahme ist die Auswertung der Statuten und des Bibliotheksverzeichnisses des Arbeiterbildungsvereinsaus dem Jahre 1845–46. Diese bis in das Jahr 1847 reichende Phase wird in der Literatur zur frü Geschichte der Arbeirterbewegung zumeist skizzenuhaft im Rahmen einer Geschichte des Bundes der Gerechten / Bundes der Kommunisten behandelt.4