Types of biobank
The NKI knows two categories of biobanks:
- Secondary use biobanks
- De novo biobanks
Secondary use biobank
A ‘secondary use’ biobank is intended for storing biomaterials for its original purpose, typically follow-up diagnostics for the subject. In addition, under strictly defined conditions, this material can be stored and used for scientific research.
All retrospective medical data and biomaterial studies at the NKI were conducted in accordance with Dutch law and international standards. Before May 25, 2018, national data protection legislation applied, as did the International Guideline for ‘Good Clinical Practice’ (GCP). As of May 25, 2018, we also comply with the General Data Protection Regulation (GDPR). Within this framework, patients have been and continue to be informed and have always had the opportunity to object or actively consent to the use of their personal data and biomaterials in research. The procedures therefore comply with both (inter)national legal and ethical standards. In 2018, in response to the implementation of the GDPR, the NKI introduced an opt-in procedure using “consent at the gate (TADP)”. All NKI patients will be asked for consent at their first visit to use their medical data, images, and residual biomaterials collected and noted for care, for research purposes. This consent will be recorded in the electronic patient file. The opt-out procedure was in effect at the NKI before 2018; objections to the use of data and biomaterial submitted before 2018 have been included in the new TADP database.
De novo biobank
De novo biobanks are collections of biomaterials specifically collected for research. Subjects must be informed of the biobank’s creation through a Personal Informed Study (PIF) and must provide written consent for participation through an Informed Consent (IC). The IC will be included in the electronic patient record (EPD-HIX). External de novo biobanks will be subject to the external application and review regulations, which must at least meet the requirements of the NKI.