Study evaluation process at the biobank

As soon as the submitted dossier is declared admissible the evaluation by the biobank will be initiated within this evaluation process, a distinction is made based on whether the study includes primary use of HBM or secondary use of HBM.

Primary use or secondary use of HBM

If both types of use apply, both review processes with be executed in parallel. In case of secondary use of HBM the dossier will be evaluated by two members of the biobank board as well as the medical staff members of the care program involved in the concerning research domain. In any case the biobank manager will evaluate the dossier. A default approval period of two weeks applies to all submitted dossiers containing solely primary use. In case of secondary use the care program(s) and biobank board members review the dossier in parallel within a two-week period, after which the dossier will be reviewed by the biobank manager during the next study evaluation meeting.

In general the dossier will be checked for:

  • The origin of the HBM
  • The type and quantity of HBM obtained and number of donors
  • The methods that will be applied to safeguard the privacy of the donor
  • The availability of the HBM
  • The use of the HBM, the compliance with the content of the informed consent, the scientific relevance and any interference with the potential diagnostic and/or therapeutic use of the HBM.
  • The location at which the HBM will be retained and retention period while awaiting analysis of the samples within the context of the concerning research project.
  • The destination/fate of the samples after the study has been completed, i.e. the destruction, return or retention of the samples after study completion. In case of retention of the samples (i.e. storage anticipating use within future research), the duration and location must be known in advance.

After approval of the request, the application form will be signed by the biobank manager and sent back to the principal investigator. This document must be added to the dossier that is submitted to the ethics committee research UZ / KU Leuven in order for the dossier being admissible to the ethics committee .

Last edit: 7 August 2020