A Biobank is a systematic collection of human biological samples and associated data which can be used for research. The scientific research goal of the collection is yet unspecified.
A Biobank is a systematic collection of human biological samples and associated data which can be used for research. The scientific research goal of the collection is yet unspecified.
A biobank doesn’t fall within the scope of the WMO. The WMO states that it concerns medical/scientific research and/or participants are subject to procedures or are required to follow rules of behaviour. A biobank has yet to formulate a (medical) scientific hypothesis/objective.
The UMC Groningen has drafted a general regulation for setting up and maintaining a biobank. In this cover regulation guidelines are described, in general terms, on collecting, saving and distributing the tissue samples. The tissue samples are collected only for scientific purposes but a specific scientific objective is not yet formulated.
Besides the cover regulation, there has to be a regulation specific for only this biobank. This document should describe i.e. the informed consent procedure, the procedure for collecting the tissue sample(s), the conditions in which the samples are stored, who acts as a manager/administrator and the procedure for request of use of the samples by researchers.
The researcher must have a scientific hypothesis for which access to the samples and/or data is necessary. An application must be submitted to the manager or committee of the biobank before the samples are released to the researcher/applicant.
The METc UMCG currently plays a small part in the application for a new biobank. A few members of the METc, the chair and official secretary verify the regulations pertaining to the new biobank, mainly the regulation specific to the biobank. The distribution of the tasks and responsibilities of the parties involves must be clear and consistently described. Also the informed consent procedure is checked. Questions such as, how is consent from the donor of the tissue sample obtained and filed? Who decides when the samples are released? Are the samples saved anonymously or identifiable via a code? Are patients (donors) informed sufficiently about the purpose of the collection and storage of their tissue samples?
The application for the framework of a new biobank must be directed to the Board of Directors UMCG. The Board of Directors will decide on approval after consultation with the METc UMCG.
The application should at least include:
A databank is the systematic collection of data, specifically generated for scientific research, be collected as part of patient care and made usable for scientific research, or can result from scientific data processing.
Every medical scientific research generates research data that will be stored in a database. Depending on the effort (burden) required by the participant in light of the scientific purpose, an assessment is made whether or not the research falls within the scope of the WMO.
The use of already existing (patient)data for scientific purposes, collected retrospectively, is a type of medical research that doesn’t fall within the scope of the WMO, a so-called non WMO research. For this type of research other legal regulations apply, such as the Treatment Agreement Act (in Dutch: WGBO) and, in some cases, the Data Protection Act (in Dutch: Wbp, as of 28 May 2018 General Data Protection Regulation, in Dutch: Algemene Verordening Privacy).
More information on review of a non WMO research proposal you can find on our non WMO page.
Research data and collected tissue samples must be stored in such a way that personal data of the patient/donor are not identifiable. This means that when information is extracted from a patient file and transferred to a research database (databank), this information must be stored fully anonimised or coded (identifiable via a code).
The method of storing the research data should be reported to the Data Protection Officer of the UMCG.