Get this thing out of my body! Factors determining consent for translational oncology research: a qualitative research

Abstract

Background: Depending on the needs of scientific research at a given time, biobanks make biological samples and data available to researchers. In this article, we aim to describe the reasons and underlying logic that determine the decision to grant or deny consent to the conservation of tumour samples in a biological resource platform for research purposes. We make use of the CARPEM biological resource platform model, where broad consent is required.

Methods: The results are based on semi-structured interviews, conducted between 2019 and 2021, with 25 individuals having various profiles.

Results: All the people interviewed readily accepted the principle of conserving a tumour sample for research purposes. They explained their decision by citing the desire to participate in research dedicated to improving therapeutic medicine. Their trust in research institutions or in doctors was an important factor in their consent. The tumorous nature of the samples also played an important role, as did the absence of constraints. Finally, the high level of consent was also based on the difficulty they had in conceiving what the future risks might be once the sample had been taken, whereas the fact that they did not know the nature or purpose of the research to be carried out when they signed the consent form posed some problems. These results stem from a lack of a culture of ethics among the people interviewed.

Conclusion: The information provided in the context of consent at the CARPEM tumour bank seems inadequate for consent to be considered 'informed', given the low level of knowledge that people have of the risks and issues. Information is missing even though we feel it would not change consent or only marginally. This raises questions, since part of the act of granting consent is based on the implicit trust French people have in the hospital that collects the data and in research practices in general. In the minds of those who participate, transparency is the ground on which trust rests. Lack of transparency could be deleterious for future research practices. However, it is not by striving to improve information leaflets that the consent-related information will improve but, rather, by more effectively helping future patients to assimilate that information.

Keywords: Biobank; Broad consent; Consent models; Informed consent; Translational research; Trust.