Any use of HBM for which the donor has explicitly and specifically given his/her consent in the context of the removal of the material.
Any use of HBM for a purpose other than that for which the donor has given his/her consent in the context of the removal of the material. Any secondary use of HBM requires a new approval by an ethics committee as well as a new informed consent from the donor (with the exception of when this would be impossible or exceptionally inappropriate, as assessed by the ethics committee) prior to the actual use, as the secondary use is not covered by the initial informed consent or ethical approval.
A subtype of secondary use defined as any HBM that has been removed for the purpose of diagnosis or treatment of the donor that - after a sufficient and relevant part is retained for making, refining or completing the diagnosis or treatment of the donor based on evolving scientific knowledge - could be destroyed. For this type of use a presumed consent applies, meaning that, if the donor did not explicitly object to the use of the HBM within scientific research, after he/she has been informed about the potential use of his/her HBM, the donor’s consent is deemed to be given.
Obtaining /use of HBM within the scope of scientific research must be described in a study protocol. This study protocol will be assessed by the clinical trial center, the biobank board and shall be approved by the ethical committee.
For more information regarding informed consent requirements as well as informed consent form templates, please refer to the information on the ethics committee research UZ / KU Leuven website.