A Randomised Controlled Trial of Consent Procedures for the Use of Residual Tissues for Medical Research: Preferences of and Implications for Patients, Research and Clinical Practice

Rebers, Susanne; Vermeulen, Eric; Brandenburg, Alexander; Stoof, T.J.; Zupan-Kajcovski, Biljana; Bos, Willem Jan W.; Jonker, Margreet; Bax, C.; Driel, Willemien J. van; Verwaal, Victor J.; Brekel, Michiel W. M. van den; Grutters, Jan C.; Tupker, Ron A.; Plusjé, Leon G. J. M.; Bree, Remco de; Leeuwen, Jules H. Schagen van; Leeuw, Robert de; Brohet, Richard M.; Aaronson, Neil K.; Leeuwen, F.E. van; Schmidt, Marjanka K.

doi:10.1371/journal.pone.0152509

Cited by 7 publications

(14 citation statements)

References 18 publications

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“…In the opt-out arm, the control group, patients were not actively informed about residual tissue use. The main intervention outcome, i.e., the percentages of residual tissue samples that can be used for medical research in these three procedures (60.7, 99.8, and 100%, respectively), was reported previously [14].…”

Section: Methodsmentioning

confidence: 69%

“…Characteristics of all patients and respondents to the 6-week questionnaire, divided by trial arm, were published earlier [14]. The majority of patients was female (61%), between 61 and 80 years of age (47%), and treated in an academic hospital (62%).…”

Section: Resultsmentioning

confidence: 99%

“…A detailed description of the methods of the RCT can be found in Rebers et al [14]. Briefly, 1,319 cancer and noncancer patients, both male and female, aged 18-80 years, were randomized to one of three arms.…”

Section: Methodsmentioning

confidence: 99%

“…Without this information, patients will not be aware that they can object to the use of their tissues. Informing patients in an adequate manner respects their autonomy [8], may decrease anxiety if patients need to be recontacted for specific research uses that do require informed consent [9], and is preferred by the large majority of patients [10][11][12][13][14]. Second, patients should be aware of what will be done with their tissue if they do not act, namely that their tissue may be used for medical research [9].…”

Section: Introductionmentioning

confidence: 99%

“…In this trial, we compared patients who were exposed to an active informed consent procedure with those exposed to an "opt-out plus" procedure, which is a standard opt-out procedure with the addition of specific verbal and written information, and those exposed to a standard opt-out procedure [14]. The results indicated that a similar percentage of patients in the opt-out plus and the informed consent arms of the trial (approximately 70%) felt that they had been well informed, as compared to only 31% in the opt-out arm.…”

Section: Introductionmentioning

confidence: 99%

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Recall and Retention of Consent Procedure Contents and Decisions: Results of a Randomized Controlled Trial

Rebers

Vermeulen

Brandenburg

et al. 2018

Public Health Genomics

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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.

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Section: Methodsmentioning

confidence: 69%

Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Recall and Retention of Consent Procedure Contents and Decisions: Results of a Randomized Controlled Trial

Rebers

Vermeulen

Brandenburg

et al. 2018

Public Health Genomics

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Observational health research in Europe: understanding the General Data Protection Regulation and underlying debate

Veen¹

2018

European Journal of Cancer

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Insights into the incidence and survival of cancer, the influence of lifestyle and environmental factors and the interaction of treatment regimens with outcomes are hugely dependent on observational research, patient data derived from the healthcare system and from volunteers participating in cohort studies, often non-selective. Since 25th May 2018, the European General Data Protection Regulation (GDPR) applies to such data. The GDPR focusses on more individual control for data subjects of 'their' data. Yet, the GDPR was preceded by a long debate. The research community participated actively in that debate, and as a result, the GDPR has research exemptions as well. Some of those apply directly; other exemptions need to be implemented into national law. Those exemptions will be discussed together with a general outline of the GDPR. I propose a substantive definition of researchdabsent in the GDPRdwhich can warrant its special status in the GDPR. The debate is not over yet. Most legal texts exhibit ambiguity and are interpreted against a background of values. In this case, those could be subsumed under informational self-determination versus solidarity and the deeper meaning of autonomy. Values will also guide national implementation and their interpretation. The value of individual control or informational selfdetermination should be balanced by nuanced visions about our mutual dependency in healthcare, as an ever-learning system, especially in the European solidarity-based healthcare systems. Good research governance might be a way forward to escape the consent or anonymise dichotomy.

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What the public think about participation in medical research during an influenza pandemic: an international cross-sectional survey

et al. 2019

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A Randomised Controlled Trial of Consent Procedures for the Use of Residual Tissues for Medical Research: Preferences of and Implications for Patients, Research and Clinical Practice

Cited by 7 publications

References 18 publications

Recall and Retention of Consent Procedure Contents and Decisions: Results of a Randomized Controlled Trial

Recall and Retention of Consent Procedure Contents and Decisions: Results of a Randomized Controlled Trial

Observational health research in Europe: understanding the General Data Protection Regulation and underlying debate

What the public think about participation in medical research during an influenza pandemic: an international cross-sectional survey

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