To obtain biobank approval, an application must be submitted to the biobank as soon as the study is registered (i.e. S-number available) at the UZ Leuven clinical trial center (Indicate the biobank as an “ondersteunende dienst” on the CTC-application form, regardless of the storage location of the HBM).
The following components should be included in the submitted dossier in order for the application to be admissible:
Required for all dossiers
- The biobank application form
- A copy of the study protocol
- A copy of the CTC application form.
- A model of the Informed consent form if required according to the applicable regulation
- Human bodily material transfer agreement, if available
In case of HBM obtained from an external provider
- A collection protocol approved by an EC /IRB and 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 ethical declaration directly to the UZ/KU Leuven biobank, hence it is not required to obtain such document for an individual research project making us of their products:
- Thermo Fisher
A lab manual or any other relevant documentation that specifies the modalities concerning collection, storage, use and destination of the HBM.
All documents must be submitted electronically.