L’utilisation des éléments et produits du corps humain à des fins scientifiques implique, aux termes du Code de la santé publique, plusieurs types d’opérations tels que la conservation, le transfert et la cession. Ces opérations permettent une circulation entre chercheurs nécessaire à la mise en commun et au partage de leurs connaissances et savoir-faire au bénéfice du développement de nouvelles thérapies. Si l’encadrement juridique de cette utilisation se résume à un contrôle de police administrative, le législateur fait également référence à des opérations évoquant des pratiques contractuelles (transfert et cession). Or, le code civil fait obstacle, par des dispositions qu’il qualifie d’ordre public, à ce que les éléments et produits du corps humain fassent l’objet d’un droit patrimonial. Cette apparente contradiction conduit à s’interroger sur la nature juridique des éléments et produits détachés du corps humain à des fins scientifiques, éléments et produits qualifiés dans le domaine de la recherche de « matériel biologique humain ». L’emploi de cette notion incite à clarifier le régime juridique applicable en vue à la fois de renforcer la protection de la personne « prélevée » et de garantir la sécurité juridique de l’utilisation du matériel biologique humain. / According to the Public Health Code, the use in a scientific purpose of human body components and products implies many operations such as storage, transferring and selling. These operations enable a movement of the components and products, between researchers, which is necessary to the sharing of knowledge and know-how in order to develop new drugs. If the legal framework of this use can be summarized to an administrative control, the lawmaker refers as well to some operations like contractual practices such as transfer agreement. Nevertheless, the Civil Code obstruct, by public policy rules, the components and products to be subject to a right of ownership. This apparent contradiction led to wonder about the legal nature of the components and products detached from the human body for a scientific use. Such components or products are termed in the research field as « human biological material ». The use of this notion incite to clarify the legal system applicable in order to both strengthen the defense of the person from whom the human biological material is taken and the use of this human biological material.

This thesis examines the challenges of considering biological material as records and how its evidential value can be understood. In addition, it examines how the view of evidential value of biomaterial can be transferred to digital material. This is done by interviewing people who work with biological material professionally, thereby using their experience and expertise on the subject matter. The thesis is based on a qualitative approach with focus groups and individual interviews as a collection method for the empirical material. The results are interpreted using the theoretical starting point for how central concepts are defined and how biological material could fit with these and could be understood as records, in order to understand biomaterial from an archival scientific perspective. The result shows that biological material can be a source for both information and evidence, as well as evidence of activities. Furthermore, that the handling and the documentation, and thus the trustworthiness, of the biomaterial is of great importance for its evidential value. The result also implicates that the traditional notions of records is only to some extent applicable when considering biological material as records. Thus, one of the main challenges is the trait of being non-textual.