Lifting of traceability of samples HBM

This advice was endorsed by the College Board on 14/11/2025.

Question

What should be included in the informed consent form (ICF) regarding lifting of traceability of samples, and what is the rationale for including it?

Answer

Lifting of traceability or the anonymizing of samples means that the samples can no longer be traced back to the donor. It is important to understand that lifting the traceability of samples has legal implications, especially with regard to the rights of the donor.

Donors (patients and/or healthy volunteers) should be informed of the consequences of the lifting of traceability, as it results in the waiver of important rights. An explicit consent process should be in place, ensuring that the donor is fully aware of his/her options regarding the lifting of traceability of his/her samples and the related legal consequences.

This implies that the sponsor should have a system in place to track whether or not the donor has consented to the lifting of traceability of his/her samples.

We rely on several guidelines and legal frameworks for this advice.

Law of December 19th, 2008, regarding human biological material (HBM law)

The central principle of the Law of December 19th 2008 regarding the procurement and use of human biological material intended for human medical applications or for scientific research purposes (hereinafter: “HBM law”), is the principle of traceability of samples. In short, this means that all actors involved should be able to localize and identify human biological material in each and every step of the way. (art. 2, 23 HBM law). In case samples are being anonymized, the traceability inevitably gets lost.

Therefore, the HBM law explicitly requires that the lifting of traceability of samples collected from living
donors is subject to the condition of obtaining the donor’s consent.

This principle is also mentioned as such in the Biobank Compendium.

In addition to the traceability principle, the HBM law also grants the donor the right to be informed of the meaningful information that results from analyses performed on his/her samples. (art. 11 HBM law). If the samples are anonymized, this right to receive meaningful information acquired from the analysis of his/her samples automatically expires.

Art. 22, §7 of the HBM law in that regard states that :

(…) kan de beheerder van het menselijk lichaamsmateriaal in de biobank de traceerbaarheid van het menselijk lichaamsmateriaal te allen tijde opheffen :

1° indien de donor of de persoon die bevoegd is om toestemming voor de wegneming en het gebruik te verlenen hiervoor zijn voorafgaande toestemming heeft gegeven; indien het onmogelijk is om de toestemming te vragen voor het opheffen van deze traceerbaarheid, of indien deze vraag uitzonderlijk ongeëigend zou zijn, dan dient het positief advies te worden verkregen van een volledig erkend ethisch comité (…);

2° De beheerder heft de traceerbaarheid van het menselijk lichaamsmateriaal op indien het bestemd is voor de bewerking tot geartificialiseerd of geëxtraheerd materiaal dat niet bestemd zal zijn voor, of niet zal gebruikt worden in het kader van genetisch onderzoek (…) en waarop artikel 3, § 5, eerste lid, van toepassing zal zijn. De opheffing van deze traceerbaarheid geldt uitsluitend ten aanzien van de donor van wie het menselijk lichaamsmateriaal dat tot bedoeld materiaal wordt verwerkt afkomstig is en geldt niet ten aanzien van de leveranciers van bedoeld materiaal.

Wanneer wordt vastgesteld dat er aanleiding is tot de toepassing van artikel 11, mag de traceerbaarheid slechts worden opgeheven nadat de in dat artikel bedoelde procedure volledig is nageleefd.”

“(…) le gestionnaire du matériel corporel humain au sein de la biobanque peut lever à tout moment la traçabilité du matériel corporel humain :

1° si le donneur ou la personne habilitée à accorder son consentement pour le prélèvement et l’usage a préalablement donné son consentement à cet effet; s’il est impossible de demander le consentement pour la levée de cette traçabilité, ou si cette demande était exceptionnellement inappropriée, l’avis positif doit alors être obtenu d’un comité d’éthique avec agrément complet (…);

2° Le gestionnaire lève la traçabilité du matériel corporel humain si celui-ci est destiné à être traité en vue d’obtenir du matériel artificialisé ou extrait qui ne sera pas destiné à la recherche génétique ou utilisé dans ce cadre et auquel l’article 3, § 5, alinéa 1er, s’appliquera. La levée de cette traçabilité s’applique exclusivement à l’égard du donneur dont provient le matériel corporel humain qui est traité pour obtenir le matériel visé et non à l’égard des fournisseurs du matériel visé.

Lorsqu’il est constaté qu’il y a lieu d’appliquer l’article 11, la traçabilité ne peut être levée qu’une fois que la procédure visée à cet article a été entièrement respectée. ”

Belgian Advisory Committee on Bioethics

In addition, the “Belgian Advisory Committee on Bioethics” states in its advice nr. 45 that the samples do not fall under the donor’s ownership but that the donor always retains a determination right (in Dutch: “bestemmingsrecht”). This means that the donor should always be aware of the purposes for which his/her samples are being used and that he/she has to give his/her consent for any use of its samples. If the donor’s samples are being anonymized, this determination right automatically expires.

Law of August 22nd, 2002 regarding Patients’ Rights

More in general, the Law of August 22nd 2002 on patient rights states that a patient has the right to know all information required to understand his/her health status and the evolution thereof (art. 7 Law regarding Patients’ Rights).

Conclusion

In the light of the above mentioned laws and ethical guidelines, a person participating in prospective clinical research should be able to consent to the anonymization of his/her samples because in case the donor consents, he/she waives several rights (i.e. the traceability requirement, the determination right and the right to be informed of meaningful information). If the donor does not consent to anonymization, this must be recorded in the ICF, and procedures should be in place to ensure that the samples are not anonymized.

In the ICF template for clinical trials in adult patients, the above is included in section 13.2. Although the HBM Law expressly excludes clinical research from its scope under Article 3, §3(f), the underlying principles relating to traceability and its lifting remain relevant and should apply mutatis mutandis to samples collected in clinical trials or other prospective research. The significant implications of lifting traceability for donors’ rights justify requiring prior consent from participants in these contexts.