Ethics, legal and privacy
Ethics, legal and privacy
Belgian Law protects patients and donor in an effective way.
Please read here a short summary.
The legal Framework for Biobanks in Belgium is following the Belgian Law from December 19th, 2008, modified on March 19th, 2013 and April 10th, 2014.
This law defines human corporal material (HCM) as any material from human origin including derivatives and transformed products. The same text installs a definition of a biobank as a structure that collects, processes, stores and supplies HCM reserved to scientific research, as well as associated data (relative to donor and HCM). The creation of a biobank requires a positive advice from an Ethical Committee. Specific provisions apply to biobanks while human medical application falls under a different regulation . In terms of people’s rights one can identify mainly two types of situations:
Protection of the donor’s rights and will: the general case.
The first situation is the donation of HCM . In this case, the donor must be adult; his consent must be given freely, willingly and after having been fully informed. The donor must be informed in a systematic way for each purpose for which the HCM is kept and must give his consent prior to its use. The consent must be written and specify its scope and validity. The consent may be withdrawn at any moment prior to the first processing after HCM collection. If the analysis performed on traceable HCM reveals information pertinent to health of the donor, he has right to this information. No use differing from the one to which the donor has explicitly consented is allowed without a new consent from the donor. However, if it is impossible to request specific consent on secondary use of MCH or, if this request would be inappropriate (by exception), secondary use can be granted by a positive advice issued by an Ethical Committee .
Specific provision on the patient’s right:
The second situation is related to a patient. In some cases, residual HCM could be available. Residual HCM is part of the HCM taken during procedures for diagnosis or treatment of the donor and which, after the needed part is kept for diagnosis or treatment of the donor, is redundant and will be destroyed. In case of residual HCM, consent for use of Residual HCM for research purposes is presumed by law as long as the donor does not oppose . The aimed use (research) and the possibility to oppose must have been communicated in written to the donor, prior to the operation. Any use of this Residual HCM for scientific purposes, as well as the scientific aim must have been approved by an Ethical Committee. This system warrants both donor’s and patient’s rights by keeping full decision power at the patient or donor and by favoring availability of samples for biomedical research and by this supporting tomorrow’s health systems.
More reading: the law
Loi du 19 décembre 2008 relative à l'obtention et à l'utilisation de matériel corporel humain destiné à des applications médicales humaines ou à des fins de recherche scientifique, telle que modifiée par les lois du 23 décembre 2009 et 10 avril 2014.
More reading: the BWB Ethical Charter
List of Ethical Committees as published by the Federal Agency for Medicine and Health Products