Radboudumc Technology Center Radboud biobank

Expertise and services

Key benefits for customer

• Easy access to biomaterial of well documented patients
• Standards apply from The Parelsnoer Institute (PSI), a unique collaboration of all Dutch University Hospitals on clinical biobanking

Areas of expertise

• Help in realizing biobank projects
• Quality assurance at all levels (e.g. storage of clinical data, biomaterials, ICT, ELSI, logistics and procedures for delivery)
• Standardization and harmonization of the biomaterials

Services

• Delivers high quality samples (DNA, serum, plasma, urine, tissue) of well documented patients to investigators worldwide with a sound research proposal
• Supports investigators in preparing a request, obtaining ethical approval and formulating formal agreements, plus delivery and transport of samples

Secondary use of human biomaterial

Radboud Biobank

At the request of Radboudumc's Board of Directors, the Radboud Biobank is responsible for the implementation of the Dutch Code of Conduct Responsible Use within Radboudumc.

• Employees can access the letter to all departments from the Board of Directors and the Code of Conduct via the research info webpage under the heading 'Scientific Integrity'.
• Patients can read about secondary use of human biomaterial in Dutch: Gebruik van uw medische gegevens en lichaams­materiaal.

• Frequently Asked Questions

  click on question to see answer

• What is the responsibility of the Department head with regards to the 2011 Code of conduct for secondary of human biobmaterial?

  The head of the department ensures that the 2011 Code of Conduct is adhered to and rapports annually regarding the secondary use of biomaterial within the department to the Board of Directors via the Radboud Biobank director.

• What is the responsibility of the researcher who will be making secondary use of biomaterial for scientific research?

  The researcher is obligated to present the scientific research protocol to the local review board (CMO-light) for review. Furthermore the researcher must adhere to the regulations of Good Data Practice as stipulated in the GCP stipulations (Dutch).

• What is the responsibility of the laboratory technician who issues the diagnostic leftovers to researchers?

  The laboratory technician must check the laboratory system to ascertain if the patient has objected to secondary use of their biomaterial and shall only issue coded biomaterial, for which there is no objection to secondary use, to researchers whose research proposal has been reviewed and accepted by the local review board (CMO-light).
  
  Should the laboratory system not yet be connected with EPIC, the laboratory technician can check if the patient has made objection via a list containing the Radboud numbers of patients who object to secondary use of their biomaterial. This list is available each month via the Radboud Biobank. 

• What is the responsibility of the health professional regarding the 2011 Code of Conduct?

  The health professional must be well informed regarding the Code of Conduct because they have an important role in informing the patient. They can explain the secondary use of biomaterial to the patient and answer any questions. If necessary the health professional can indicate the objection in Epic or they can inform the patient on how to make objection via MijnRadboud. 
   

• Where in EPIC can I see if a patient objects to secondary use?

  The word Bezwaar is visible in the field Ter info.
   

• Where in GLIMS can I see if a patient has made objection?

  Under Attributen the question Marks next to Bezwaar at the top of the table will not be visible and the fields  Periode, Eenheid and Startdatum will contain the start date and the number of months since objection was made.
   

• Is signed informed consent necessary for scientific research with diagnostic biomaterial leftovers that are not part of a sub-biobank?

  No, scientific research with diagnostic leftovers may be used without explicit permission from the patient provided the patient is well informed about the secondary use and has made no objection. 

• If parents of a child make no objection to secondary use while the child is still a minor (<16 years of age), does the child need to be informed about secondary use once he/she has reached maturity?

  Yes, the child, on reaching maturity, must be informed and given the opportunity to make objection to secondary use of his/her biomaterial.

• What happens to left-over biomaterials if this patient then decides to object?

  The biomaterial shall be destroyed unless it has been obtained with informed consent for a trial or follow-up study.

• If parents don't object while child is still a minor (<16) is Radboudumc obligated to approach this patient once he/she reaches maturity if a researcher then wants to use the diagnostic leftovers?

  This is dependent on the type of study. For example, can the research only be performed on biomaterial from children? The local medical-ethical review board (CMO-light) will decide per case.  

• How does one deal with samples and data that has already been collected but now falls under objection made by the patient?

  This objection will be made visible in EPIC and will be assimilated into the laboratory systems. The coded medical records and biomaterial from the patient will no longer be available for research.

• What are the regulations regarding historical biomaterial?

  Human biomaterial that has been collected in a period when the different elements of the Code of Conduct were not yet implemented, will only be used for scientific research after review of the research protocol by the local medical–ethical review board (CMO-light). The fact that patients were less well informed at the time of collection will be taken into account. 

• Can a patient also object to the use of medical images, such as photographic or radiological images, ECGs and ultrasound images, for scientific research?

  Yes. Just as the diagnosis, treatment and results of the treatment, the medical images are also part of the medical records.

• What are the regulations for collaboration with other researchers outside Radboudumc?

  It is possible to work with other researchers. Diagnostic leftovers and clinical records may not be shared with external companies for commercial purposes. Material and data should be released on the grounds of a material transfer agreement (MTA) and a data transfer agreement (DTA). Both documents must be approved during the review by the local medical-ethical review board (CMO-light).

• Is approval by the local medical-ethical review board (CMO-light) sufficient for multicenter research with diagnostic leftovers?

  No. The local medical-ethical review board (CMO-light) only reviews for Radboudumc. Each participating center may have its own local review procedure that must be met before the diagnostic leftovers can be used for research. However, momentarily a plan for once-only multicenter review is being developed.

Patients an integral role

Without the trust and participation of patients, it is impossible to establish a good collection. The patient provides personal information and biomaterial. With this donation, she/he contributes to the biobank, which makes new scientific research possible about the condition with which the patient is diagnosed. Although this knowledge may come too late to help this individual patient, her/his donation contributes to the development of diagnostics, new successful treatments, better prognosis and more effective prevention strategies for others in the near future.

About the Radboud Biobank and patients

The patient has a permanent voice

The patient receives a permanent, authoritative voice in the Radboud Biobank. The chairperson of the Advisory Council, a prominent role on the council, has been reserved for a patient representative. Moreover, disease-specific foundations and societies continued to be involved in departmental research to provide a non-academic perspective.  There are also plans for an internet portal for donors to the Radboud Biobank and a patient representative is also a member of in the medical-ethical review board (CMO).

Click here for more information for patients (in Dutch).

Frequently Asked Questions

Radboud Biobank FAQs

• Do I have to pay for my own samples now?

  Obtaining samples: all costs are covered by the department
  Radboud Biobank: all costs listed below are covered by the Radboud Biobank
   

  General costs:	Supervision of collection process, organization and maintenance of IT services,  accountability (general, ethical and financial), quality assurance;
  Logistics:	Tubs selection, write and maintain SOPs for handling of monsters, isolation of DNA/RNA, tissue embedding;
  Preparation:	Isolation of DNA/RNA and cells, division into aliquots, tissue selection and embedding, organizing purchase or sharing of apparatus and maintenance thereof
  Storage:	Purchase of freezers, boxes and tubes including  back-up services, monitoring system, calibration, printers, stickers, rent of location and energy costs. In the long term an automated storage system;
  Maintenance:	Maintaining storage system, defrosting freezers;
  Registration:	Purchasing biobank management system;
  Issuance:	procedure for withdrawal of informed consent;

• How can I apply for use of my biomaterial from the biobank?

  Each project using samples from the biobank has to be approved by the CMO-light. In general the CMO-light review takes 2 – 3 weeks.

• Does everyone and anyone have access to my samples?

  To prevent biomaterial and data being delivered to those wishing to use it for other purposes than relevant and well-grounded research the following conditions apply:

  • The application should be made by (or together with) a researcher employed by the Radboudumc from the department that initiated the sub-biobank (Radboudumc colleague cosigns the application and transfer agreement(s) and is responsible for compliance to the contractual provisions);
  • The CMO-light reviews each application on quality and ethical-legal aspects;
  • The head of the sub-biobank is in agreement with the issuance.

• What happens to the biomaterial and data that I collect if it doesn’t get used for research?

  The collected biomaterial and data maintain their value for future research and shall be stored and kept indefinitely.

• Can biomaterial from the Radboud Biobank be used by commercial partners?

  Radboud Biobank and the CMO-light are open to all forms of collaboration with external partners. This is also valid for collaboration between commercial partners and Radboudumc researchers as long as it serves medical-scientific development and innovation. Biomaterial from the Radboud Biobank is issued to external partners under the conditions of a standard Material Transfer Agreement. Biomaterial from the Radboud Biobank will not be used for the production of commercial products.

In the media

• Uitzending TV Gelderland: Trots op Gelderland; Los in het lab (23 mei 2017)
• Ijskoude bank is schatkist voor nieuwe kennis (Radboud 6, 2015)
• The donor as partner / De donor als partner (BBMRI-NL, 2014)
• Interview Labvision (mei 2014)
• Radboud Biobank Geeft Schaalvoordelen (Radbode 1, 20 januari 2012) 
• Hub: Radboud Biobank (Hub 4, 2011)
• Patiënten kennen eigen power niet (Radboud 13, 2 september 2011)

Useful links and information

Radboud Biobank

• Internal Biobank partners

  • Parelsnoer Biobanken
  • AGORA
  • NBS
  • PRISMA
  • HECOVAN
  • Human Functional Genomics
  • IJzercentrum
  • Verily Personalized Parkinson’s Project

• External Biobank partners

  • LifeLines
  • Biobank MUMC
  • Biobank UMCU
  • Biobank VUMC
  • ESBB
  • BBMRI-NL
  • Health-RI
  • BBMRI-ERIC
  • ISBER
  • P3G

• Public

  • Biobanken.nl
  • Biobanken.org

• Other

  • Radboud Technology centers
  • Laboratoriumgeneeskunde
  • Centrum voor Oncologie
  • Genoomdiagnostiek
  • COREON
  • Proeven met mensen (coming soon)
  • HEVAS
  • VSOP