The biobank medical manager is responsible for the various responsibilities imposed by the Royal Decree of 9 January 2018 on biobanks and the Law of 19 December 2008 on the acquisition and use of human body material for medical application to humans or scientific research, in particular:
- Verification of the purpose and scope of the donor’s consent after collection and making available (including the agreement between the biobank and the other biobank or the end user).
- Guaranteeing the traceability of the human body material in the biobank (or lifting it).
- Feedback to the donor.
- Compliance with the objectives and activities as notified to the Ethics Committee and the FAMHP.
- Drawing up a procedure for the (temporary) suspension of the biobank, detailing which other biobank will take charge of the human body material (or how the human body material will be destroyed if no other biobank takes over the material).
- review the agreement between the biobank and another biobank or end user when making human body material available in light of its responsibilities. The biobank medical manager reviews this agreement in light of his responsibilities.
Important to know:
- The biobank medical manager may delegate his/her responsibilities, but remains ultimately accountable.
- Depending on what type of human body material the biobank handles, the biobank medical manager may be a physician or a pharmacist:
- when the biobank handles traceable material, the manager must be a physician who meets the conditions established by Article 7 of Royal Decree 78 of November 10, 1967 on the practice of the health professions or a national of one of the member states of the European Union who is authorized to practice medicine in a member state other than Belgium.
- when the biobank only handles non-traceable material, a pharmacist may take on this role in addition to a physician.
- when the biobank handles traceable material, the manager must be a physician who meets the conditions established by Article 7 of Royal Decree 78 of November 10, 1967 on the practice of the health professions or a national of one of the member states of the European Union who is authorized to practice medicine in a member state other than Belgium.
More information: www.uzgent.be/biobank
UZ Gent Biobank
Entrance 20 / Route 247
C. Heymanslaan 10, 9000 Gent
biobank@uzgent.be
+32 9 332 36 73