Official United States Air Force Website The Pathology department prepares and stores tissue from Radboudumc patients on a large scale. This is carried out in a uniform and well documented manner.Some of the tissue is stored in the Pathology department’s diagnostic archive and some is stored in the Radboud Biobank. The diagram demonstrates how the tissue is sub-divided and further explanation is given below.
1. Opt-outLeft-over tissue in the Pathology Department’s diagnostic archive – from patients who have not signed an informed consent and:
Have not objected to further use of their tissue for research and education purposes via mijnRadboud.
Have objected to further use of their tissue for research and education purposes (this tissue remains available for diagnostic purposes only).
Both resection material and biopsies in this category are stored in the Pathology department’s diagnostic archive.
2. Opt-inLeft-over tissue for the Radboud Biobank – from patients who have signed an informed consent for one of the sub-biobanks accommodated by the Radboud Biobank.
Resection tissue comes from the clinical setting via the central reception of the tissue preparation area and is eventually stored at the Radboud Biobank. In general 4 tissue blocks are stored (2x unaffected tissue, fresh frozen and paraffin embedded) plus 2x affected tissue samples, fresh frozen and paraffin embedded). The blocks are approximately 0,5 cm3. If desired it is possible to store more blocks depending on the size of the resected tissue. The maximum number of blocks is 16 (4x fresh frozen unaffected, 4x paraffin embedded unaffected, 4x fresh frozen affected, 4x paraffin embedded affected).
Biopsies are handled by the Pathology department according to the secondary use protocol, i.e. the tissue is prepared in the routine manner. Should (a part of) a biopsy be desired for research purposes and before the research proposal is presented to the CMO-light, the Radboud Biobank will check if there is enough tissue for the issuance and if both the sub-biobank and the pathologist concerned agree to the issuance.
N.B. Taking extra biopsies for a sub-biobank initiative is not permitted. A concrete research proposal with a specific informed consent that must be reviewed by the Radboudumc CMO commission is required for an extra biopsy (i.e. this research falls under the Dutch WMO legislation).