Submitting a research project to the biobank

Each provision of HBM by the biobank is the subject of a written agreement between the biobank and the person or institution receiving the material.

To obtain biobank approval for the project, you need to register your study at the UZ Leuven clinical trial center (do not forget to indicate the biobank as a supportive department on the CTC-registration form, regardless of the storage location of the HBM).

Once an UZ Leuven internal S-number is assigned to your study, you can submit an application to the biobank.

Document requirements

The biobank requires the following documents to declare your application admissible (this applies to both an initial submission and an amendment).

Mandatory documents

Additional documents

In case of transfer of HBM in or out of UZ/KU Leuven.

  • A (draft-version of a) Human bodily material transfer agreement (HMTA)

In case of HBM obtained from an external provider

  • A collection protocol approved by an EC /IRB and a model of the informed consent form provided by the provider of the HBM.
  • If these documents cannot be made available, explicit and formalized guarantees should be provided by the provider of the HBM, stating that the sample has been taken in accordance with the legislation in force in the country of origin and in accordance with (inter)national standards of ethics and protection of privacy and personal data (e.g. An ethical declaration of a vendor in case of commercially obtained material). Whether or not these guarantees satisfy the legal and ethical requirements is assessed by the biobank on a case-by-case basis. The following vendors provided an ICF or ethical declaration directly to the UZ/KU Leuven biobank, hence it is not required to obtain such document for an individual research project making use of their products:
    • ATCC
    • LONZA
    • PromoCell
    • ScienCell
    • Thermo Fisher

Optional documents

A lab manual or any other relevant documentation that specifies the modalities concerning collection, storage, use and destination of the HBM.

Submission

To the biobank

For studies with a S-number

To ethics committee research UZ/KU Leuven (EC)

For studies with a S-number

  • Starting at S-65075, the biobank application form, signed by the biobank manager, does not need to be enclosed with the submission of the dossier to the ethics committee research UZ/KU Leuven (EC), but is necessary to activate your study by CTC.
  • Lower than S-65075, the biobank application form, signed by the biobank manager, is required to be enclosed with the initial submission of the dossier to the ethics committee research UZ/KU Leuven (EC).
Last edit: 25 January 2022