[Questioning the informed consent for conservation and research use of human biospecimens]

Abstract

The availability for research of biobanked human biological materials and their derived data is submitted to several legal regulations, including informed consent. Empirical research about the understanding of the information disclosed is limited. The purpose of this paper is to analyze the appropriation of the oral and written information provided when the Informed Consent is collected for participation in tumor collection. Two materials have been collected: the description of the context of consent collecting based on interviews with different actors of one of the hospital sites concerned by the biobank and the analysis of consent forms by a group of individuals in poverty situations, using focus-group method. The description of the context shows the emotional situation related to the announcement of cancer and therefore difficulties understanding complex information in that very moment. They also pointed out the question of the patient's autonomy to give consent in the context of doctor-patient relationships in cancerology. The group insisted on the difficulty to understand the information disclosed, because of numerous and complex words and acronyms. On another hand, essential information isn't provided about risks and data sharing. Consulting a group of people in poverty situation is an issue of social justice: if patients with a low level of health literacy are able to take ownership of those questions, all the patients would be able to do it.

Keywords: Biobank; Biobanque; Consentement éclairé; Ethic; Health literacy; Information; Informed consent; Litéracie en santé; Éthique.