HUMAN BODY MATERIAL


DEFINITIONS

Human Body Material (HBM): any human biological material, including human tissue and cells, gametes, embryos, foetuses and substances extracted therefrom, and regardless of their degree of transformation (except substances of non-human origin).

The HBM can be used in:

- Primary use : any use of human body material for which the donor has specifically given consent in the context of collection.

- Secondary use : any use of human body material other than that for which the donor has given consent in the context of collection.

Residual human body material (RHBM) : the part of body material collected for donor diagnosis or treatment which, after a sufficient and relevant part has been retained to establish, perfect or complete the donor's diagnosis or treatment on the basis of new scientific data, is redundant with respect to these objectives and could therefore be destroyed.

Biobank: the structure which, for scientific research purposes, with the exception of research with human medical applications, obtains, processes, stores and makes available human body material, as well as, where applicable, data relating to human body material and the donor associated with it. The operation of a biobank is, in accordance with Article 22, § 1, paragraph 1, of the Act, subject to prior notification to the Federal Agency for Medicines and Health Products (FAMHP). The objectives and activities of each biobank are the subject of a favourable opinion from an ethics committee. The biobank of the Cliniques universitaires Saint-Luc received the FAMHP notification number: BB190044.


ROLE OF BIOBANK AND LEGAL PROVISIONS

Following the Royal Decree on Biobanks of 9 January 2018 amending the Act of 19 December 2008 on the procurement and use of human body material for human medical applications or scientific research purposes, the legal requirements for registering and tracing (R)HBM have been amended as follows:

The biobank must now keep a record of all (R)HBM used for scientific research purposes in order to ensure traceability, while ensuring the confidentiality of the donor and associated clinical data, in accordance with the General Data Protection Regulations (GDPR).

The biobank has a legal obligation to send the EC an activity report containing any (R)HBM that is stored or transits through the biobank. It is essential that the biobank records any (R)HBM collected for research in order to be able to continue its activities and allow the use of (R)HBM in research activities.

All (R)HBM must pass through a biobank (CUSL or external). The only exception is for primary use HBM in a clinical trial (drug study) for which these regulations do not apply. Any use of primary HBM outside clinical trials, secondary HBM and/or (R)HBM is therefore by definition subject to regulation.

The transit of (R)HBM can be:

- Physical: the (R)HBM is stored at the biobank, located in the pathological anatomy department of the CUSL (Franklin tower, level -1).

- Virtual: the collected (R)HBM is sent directly to the relevant department for immediate use, or to a biobank or external third party. The necessary information is transmitted to the biobank for the correct virtual registration of the (R)HBM.


DIFFERENT TYPES OF STUDIES USING (R)HBM

The type of study depends on the type of data associated with the human body material.

The RHBM label corresponds to the identification data of the body material, i.e. the patient's age, sex and pathology.

HBM

Studies using HBM are by definition prospective interventional

RHBM

+ label only

RHBM study

+ label and medical file data already available before CEHF approval

Retrospective study

+ label and medical file data available after CEHF approval

Prospective study


CONTRACT TEMPLATES AND RELATED DOCUMENTS

Any (R)HBM that will be used for research purposes must be recorded virtually or actually in the biobank using the appropriate document. An internal agreement between the requesting department and the biobank will be established by the CoFi.

Document 1 or the simplified submission form (depending on the type of study) required by the CEHF must be signed by the biobank manager.

Any transfer of (R)HBM to an external entity (UCLouvain or other) requires the establishment of a Material Transfer Agreement.

- Material Transfer Agreement

- Material Transfer Agreement CUSL/UCL


INITIAL SUBMISSION PROCEDURE

The central desk responsible for the submission depends on the study sponsor:

PROMOTER

PAGE CONCERNED

Cliniques universitaires Saint-Luc Academic Study
UCLouvain Academic Study UCLouvain
Other university or hospital Academic Study
Pharmaceutical companies Commercial Study
Student dissertation Student dissertation


The documents required for the submission of the study and practical information are available on the page of the central desk concerned.

Update: October 2019