Regulating biobanks: Another triple bottom line
Authors: Brownsword, R.
In European societies, where there are clear political and legal commitments to respect human rights, it is axiomatic that the regulatory environment for biobanks-by which I mean public health research facilities, such as UK Biobank-should be compatible with those commitments; in particular, it is essential that the rights of participants are respected. During the start-up period for such biobanks, regulators will be expected to ensure: (i) that both participation and the use of participants' samples and data are based on free and informed consent; (ii) that the privacy, confidentiality, and fair data processing rights of participants are respected; and (iii) that the proprietary rights (if any) of participants are respected. While the scope and substance of these rights are much debated, it is broadly agreed that the adequacy of the regulatory environment will be judged by reference, so to speak, to this triple bottom line. In this paper, I will sketch a larger regulatory picture with its own triple bottom line. The larger picture is of a community with rights commitments (a community of rights) for which one of the bottom lines is, indeed, that the rights of its members, including the rights of biobank participants, should be respected. Thus, the early-stage debates about privacy, property, and consent are debates about one of the larger bottom lines as, indeed, are the debates that follow about feedback to participants and third-party access to the collection. In this larger picture, though, there are two other bottom lines: one is that regulators should act as stewards for the agency commons (for the infrastructural conditions that are essential to human life); and the other is that the regulatory environment should not become so reliant on coding, design, and technical fixes that the conditions and context for moral community are compromised. While biobanking for public health purposes might seem to be an unimpeachable act of stewardship, we need to be careful that it does not contribute to the corrosion of the conditions for moral community.