The inspiration for this blog, the fourth in a series drawing on contributions to the festschrift Law and Legacy in Medical Jurisprudence: Essays in Honour of Graeme Laurie published by Cambridge University Press (CUP), is the chapter therein by Bartha Maria Knoppers, Ruth Chadwick, and Michael J. S. Beauvais entitled: ‘Biomedical Research Policy: Back to the Future?’ When talking about the nature of legacy, the authors contend that we cannot speak properly of a legacy without reference to learning from the past. For them, there is an enduring connectedness between past, present and future. As they say: “today’s policy developments are tomorrow’s legacy.” In terms of biomedical research policy, this has profound implications suggesting that we must simultaneously look backwards as well as forwards if we wish any hope of instituting policies with any worth or enduring impact. I entirely agree. But in this blog, I want to follow this line of reasoning to ask a different question: rather than policies what about the persons involved, particularly those of us who participate in biomedical research? What is the ‘central arc’ that connects past, present and future in terms of our own contributions and obligations when partaking in biomedical research? Put simply, what obligations do we owe to our future selves?
In her recent monograph with CUP, Embodied Narratives: Protecting Identity Interests through Ethical Governance of Bioinformation, my colleague Emily Postan has provided an excellent normative account of the importance of what she calls ‘personal bioinformation’, arguing that access to such information is essential for the construction of narratives about our own identities. Postan posits that access – or non-access – to personal bioinformation can profoundly affect our development capacities to make sense of our lives and ourselves. Moreover, there is ample evidence that we live our lives through narratives – stories about ourselves – and every good story needs good content. Also, to be good a story must be coherent. Personal bioinformation plays an important role both in providing content and cohesion to our own narratives. And, even when that information might impact negatively on our story, this is still part of our identity narrative. Our well-being and future path depend in large part on access to personal bioinformation. This provides a compelling basis for arguing precisely why we should all have more of a say in what happens to data about us, including in the biomedical research context.
This can be contrasted sharply, however, with what actually happens in the biomedical research and policy arena. All too often, research participants are reduced to data points within data sets that are linked to other data sets; the ultimate biomedical value is then derived from the cumulative volume and analytical potential of the eventual biomedical leviathan, such as a biobank or tissue collection. Of course, along the way participants’ privacy and security interests are strongly protected by anonymisation techniques and good governance mechanisms, but this also results in a deep irony: one set of individual interests (identity) are potentially compromised in the name of protecting another set (privacy and security).
But, for a scholar like Postan the human must remain central to how we conduct human health research. Her analysis suggests that good governance must also pay attention to identity interests in terms of how biomedical data is accessed by the persons from whom it was derived. Accordingly, there are responsibilities beyond privacy and security that flow from researchers to participants to protect and promote identity interests. Future uses and access decisions remain connected to past contributions made by the persons to whom the data relates. For present purposes, then, if the normative force of this argument is compelling vis-a-vis researchers and participants, it leads us to ask a further question: what connections also exist between our past and future selves when we take part in biomedical research, and what are the implications of recognising these?
To return to the festschrift contribution of Knoppers, Chadwick and Beauvais, it is important to note that the authors also focus on the ‘human’ in the guise of human rights, mapping how this framing has had considerable impact on the development of biomedical research policy over the decades. The authors argue that this is particularly true in the protection of especially vulnerable persons, such as children, the ‘decisionally vulnerable’, and future generations. There is, indeed, a large and growing literature on the obligations that we owe to future persons through our own conduct in the present, particularly in the environmental and biomedical contexts. I suggest, however, that this is an incomplete picture. I would argue that we are all made potentially vulnerable by the circumstances in which we find or put ourselves. Moreover, this vulnerability might not arise today, but it could be a vulnerability for our future selves. For example, this could be future risks of harm or stigmatisation or epistemic burden from future knowledge generated through our participation in medical research. Thus, as well as considering groups that are routinely seen as vulnerable and taking into account the potential vulnerabilities of future generations, I contend that we must also consider the prospect of vulnerabilities being generated for our own future selves by our own actions.
The concept of vulnerability is, however, very complex and highly contested. For example, Rogers rejects the knee-jerk tendency in biomedicine to label certain individuals or groups as ‘vulnerable’ and has argued instead that “…we need a definition that acknowledges a universal capacity to be harmed or wronged in various ways related to our embodiment, shared needs and relationality, but that also recognises that the likelihood of those harms and wrongs does not fall equally on all individuals due to varying capacities and circumstances.” This requires us to pay attention to situational contexts that generate or increase risk of vulnerability, present or future. Participation in biomedical research is one such risky endeavour, as suggested above. And, while regulation and governance are replete with obligations on researchers, funders, institutions and states to protect research participants (rightly so), I would argue further that taking seriously the mission to put the human in human health research also requires us to reflect on the obligations that we owe our future selves when we take a decision to participate in human health research. This is because our present selves are complicit in generating circumstances that could render our future selves vulnerable.
So, what might those obligations involve? The existing ecosystem of human health research regulation and governance is driven by risk management and its maximal reduction. Those obligations fall on researchers and their institutions to follow laws and international guidelines, best practices, and scientific protocols. But as a minimum, we owe it to our future selves to ensure that we are fully informed about the risks and likely outcomes of any health research endeavour and to act accordingly, including refusal to participate if future risks are too uncertain or too precarious. And, because health research is riven with uncertainty, that obligation to remain informed about research endures as the research unfolds. The right to withdraw at any time and for any reason is a fundamental tenet of sound biomedical research. We owe it to our future selves to be willing to exercise that right if risks of future harms become too great.
Beyond risks and protection concerns, however, there is also the prospect of benefits to our future selves and to future communities. This is revealed when we consider a more holistic view of research regulation and adopt a whole system approach, as I and other colleagues have suggested elsewhere. By doing this, we widen our lens beyond mere risks to include potential private and public benefits. These might include the cultivation of a positive commitment to promote sound scientific research, e.g. by showing a willingness to share our data or tissue samples; to participate in good governance regimes, e.g through involvement in public engagement exercises; to contribute to the generation of social licence; and, most personally, to pursue the maximal realisation of our own interests, including identity interests as advocated by Postan.
Thus, when we come to think about categories of person who require protection in human health research, we must of course consider the ‘vulnerable’ and ‘future generations’, but I would also argue that we need much more thinking about our future selves as future persons who can be rendered vulnerable by actions with and on our data. Importantly, our own actions, such as deciding to take part in research, implicate us morally in what will come to pass. In terms of the ‘central arc’ spoken of by Knoppers, Chadwick and Beauvais, the decisions of our past selves have implications for our future selves. Equally, the obligations that we owe to ourselves need not been seen only in terms of protection. Fuller engagement with the health research enterprise can also promote significant public interests as well as our own personal interests, including but not restricted to identity interests, thereby enriching the experiences of the person we can become, building on the decisions of the person that we were.
The production of scientific data from human beings is not a morally neutral exercise, and the same is true of the decision to participate in the research that generates this data. The holding, processing, manipulation, and use of this data come with obligations, not just to the persons from whom they were derived but also to the future versions of those persons who might be made vulnerable by such actions. A new biomedical discovery might lead to a new reason to discriminate against persons, just as a novel innovation might lead many persons to be denied access to benefits that their data helped to created. It follows from this that the category of vulnerability is open to all of us at any point in the future, and the recognition of this – in my view – must accompany the custodianship and all uses of human-derived data. The responsibilities that arise must follow the data. Ethics and law impose many obligations on others to protect us when we take part in biomedical research, but the ‘central arc’ of our own connected lives – from our past through our present and to our future – ought not to be ignored. This is a moral obligation that we owe to ourselves.