Abstract
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
Highlights
Human tissue, stored after clinical procedures, e.g. after histopathological examination of a surgical specimen, is an important resource for medical research [1]
We conclude that opt-out with information is the best choice to balance the consequences for medical research, patients, and clinical practice, and is the most optimal consent procedure for residual tissue use in Dutch hospitals
We found that 1) the opt-out and opt-out plus procedures resulted in high availability of bias-free tissue for medical research, 2) patients were well-informed in the informed consent and opt-out plus procedures, 3) patients indicated a preference for informed consent in the questionnaire, but a preference for opt-out plus in the interviews, 4) health care providers’ (HCPs) were most satisfied with the opt-out plus procedure, and 5) HCPs preferred the opt-out plus procedure (Table 5)
Summary
Human tissue, stored after clinical procedures, e.g. after histopathological examination of a surgical specimen, is an important resource for medical research [1]. Dutch hospitals use an opt-out procedure for the use of these residual tissues Both the proposed Dutch Control of Human Tissue Act and the proposed European Commission’s General Data Protection Regulation may change the current system to one in which patients’ explicit informed consent is necessary for the pseudonymised use of residual tissue and accompanying data [3, 4]. It is uncertain what the consequences of a change to a more restrictive consent regimen would be [5, 6]. We investigated these consequences for the availability of residual tissue for medical research, clinical practice, and patient informedness
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