Opt-out versus Opt-In Consent for Residual Samples

17 October 2019

The Blue Diamond Gallery Residual samples, i.e. biomaterial leftover from standard clinical procedures, constitute a critical resource for the biobanking community.

Residual material refers to biomaterials leftover from standard clinical procedures as well as clinical imaging and associated medical data. These types of samples are critical for biobanking research and education within the Radboudumc. To date, the hospital has relied on an opt-out method of consent, which means samples are available for scientific research unless a patient explicitly objects. The Radboud Biobank will be conducting a 6-month feasibility study, as proposed by the Netherlands Federation of University Medical Centers (NFU), to evaluate the impact of migrating to a opt-in method, which requires explicit consent from the patient for use of the residual material. This feasibility study will be restricted to new patients (approximately 500 per week) and will exclude those who are comatose, incapacitated, <16 years of age, or admitted for acute care. Eligible new patients will be asked for their consent while registering at the Central Registration Desk. Their responses will be immediately recorded in their Electronic Health Record (Epic). Patients who are unable to decide during their registration will be contacted by a Radboud Biobank representative within two weeks to clarify concepts and answer remaining questions. All patients will be able to withdraw their consent in their personal electronic chart (MijnRadboud). At pre-defined points during the feasibility study, the Radboud Biobank will examine the distribution of responses by key sociodemographic characteristics to explore obstacles in an opt-in consent process. For more information on the use of residual material in the Radboudumc, please visit the Radboud Biobank website. There is also a poster available with more information.

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