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

The availability for research of biobanked human biological materials and their derived data is submitted to several legal regulotions, 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 hove 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 biobonk 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 hond, essential information isn't provided about risks and data shoring. Consulting a group of people in poverty situotion is an issue of social justice: if patients with a low level of health literacy ore able to toke ownership of those questions, all the patients would be able to do it.

Automated summary

The study found that patients have difficulty understanding complex information during the process of informed consent for tumor sample collection due to emotional impact of diagnosis, as well as the impact of doctor-patient relationships on patient autonomy in decision-making. The focus group of individuals in poverty situations reported difficulties understanding complex medical terms and a lack of essential information such as risks and data sharing.