Approval and registration
Legacy HBM collections present at the Health Sciences Campus therefore also have to comply to the law and the UZ/KU Leuven biobank policies. Consequentially, the studies where these collections originate also require biobank approval and the samples should be registered in the biobank registry.
If biobank approval was not obtained in the past, this approval has to be obtained retrospectively. A study application should be submitted to the biobank, including a copy of the EC approval. Dependent on the status of the study (actively collecting HBM or HBM collection ceased), the content of the informed consent (if applicable) and the intended use of the material, additional EC amendments or waivers may be necessary.
Samples belonging to legacy HBM collections also have to be registered in the biobank registry. Currently, it may be opted to register all samples of the historical collection at once or to only register those historical samples that are effectively being used for scientific research. However, in the end, all HBM that is stored with the intention of (future) scientific research has to be present in the Biobank Registry.
Before effectively incorporating legacy collections into the biobank, it may be worthwhile to evaluate a few aspects of the collection:
- Is (a copy of) the informed consent form still available?
- Are the associated data still reliable?
- Is the sample quality sufficient to allow intended future use? e.g. Samples kept in microcentrifuge tubes may have unintentionally freeze-dried into powder (freezer burn).