The debate about the requirements of informed consent in research biobanks has been heated in the last few years. This debate originates from the peculiarity that characterises the condition of tissue stored in a biobank. Unlike in the traditional research setting, tissue stored in a biobank is not only collected for a specific research project but for an undetermined future research projects as well. Therefore, it appears difficult to inform the person (from whom tissue is obtained) about all possible research projects in which tissue could be used. Against this backdrop, the ethical and legal scholarship has started to explore if “less informed” consent models could be considered legally and ethically acceptable in the research biobank context. Many models have been proposed. The range varies from fully informed consent to blanket-consent models, passing through partially restricted consent, and the so-called broad-consent models. In these models, it is not only the “level” of information that changes, but also the aims of the informational process. In the model of “fully informed consent”, the core of the informational process is represented by the specific research project, while in the “broad-consent model”, the information provided aims to illustrate the features of the “governance” of the biobank where tissue is stored. Therefore, from consent on the specific research project, we are moving towards consent on a model of governance.
To determine whether this switch can be legally acceptable, it is crucial to analyse the peculiar interests (legally recognised) at stake, in order to identify if a “broader” consent is also adequate to protect the rights of the person involved. In this contribution, I argue that tissue can be viewed via three different dimensions. Firstly, tissue represents a material res that “occupies a space” and has its own consistency. From this point of view, the main issue is to determine if this res can be owned, who assumes its ownership, and more broadly who maintains its control. Second, human tissue can be seen as a source of data, and in particular of genetic data. In this case, the crucial issue is to establish the rights of a person on the data obtained from tissue. It is likewise necessary to establish if the person has the right to consent for the use of these data in biobanking, if they can limit the access to these data, and if they can withdraw their consent. Eventually, it is also necessary to establish the effects of the withdrawal of such consent on the data and tissue. Third, human tissue derives from the human body. The distinction between these three dimensions (that we will call “material”, “informational” and “relational”) is only theoretical, given that in nature these three dimensions of human tissue are inextricably linked to one another and the bundles of rights originated from them overlap. Therefore, to understand the rights of the human subjects, it is not sufficient to study the characteristics of these three dimensions but it is also necessary to analyse how these dimensions are related to each other.