Pilot Broad Consent at the Gate

25 February 2020

The Blue Diamond Gallery

In line with the NFU initiative “Broad Consent at the Gate” (Breed Consent aan de Poort), the Radboud Biobank is currently conducting a feasibility study examining consent procedures for the use of residual material for scientific research. Residual material encompasses biomaterials leftover from standard clinical procedures, clinical imaging and medical data. The specific aim of this study is to evaluate the impact of implementing an active consent procedure (i.e. opt-in consent, which requires explicit consent) in place of the passive consent procedure currently used in the Radboudumc (i.e. opt-out consent, which requires explicit objection). Importantly, this study does not override the consent status of previously established research studies.
As of January 13, 2020, each new patient registering for the first time at the Radboudumc is actively asked for consent to use his/her residual biomaterial, clinical imaging and medical data for scientific research. To date, there has been no major organizational obstacles in the implementation of this new consent procedure. However, its impact on available material and data is still under evaluation. In addition to quantitative analyses, qualitative research exploring underlying motivations of patients who consent or do not consent to the use of their material and data will also be performed. This feasibility study will be further expanded to assess the impact of the new consent procedure on vulnerable patient groups, i.e. children (<16 years old), acute care patients, and incapacitated patients.   
For further information, please visit our website, “Use of medical data and leftover biomaterial”  (available in Dutch only), or contact Dr. Jennifer Lutomski, project leader, at Jennifer.Lutomski@radboudumc.nl.
 

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