John Tasioulas

Adapting Standards: Ethical Oversight of Participant-Led Health Research

As participant-led health research increases, Effy Vayena and and John Tasioulas examine what ethical questions are raised, and what types of standards need to be developed for appropriate ethical oversight for participant-led research projects.

The ethics of participant-led biomedical research

volume 31 NumBeR 9 SePTemBeR 2013 nature biotechnology process. PLR is enabled by online media that cross national borders, allowing it to achieve international and global participation. PLR may be driven by individuals motivated by noncommercial goals, with the result that it can more easily focus on diseases that have been neglected by commercially oriented researchers. Finally, PLR provides ordinary people with valuable opportunities to contribute to the advancement of medical knowledge and thereby achieve personal empowerment and fulfillment. For all its potential benefits, however, PLR clearly faces scientific and ethical challenges. Issues of bias and scientific validity related to PLR research have been discussed elsewhere6 and we do not intend to discuss them here. Instead, we would like to draw readers’ attention to ethical questions, in particular, the fact that PLR is on the horns of a dilemma. On the one hand, given the risks potentially involved in research with human subjects, PLR’s future sustainability depends upon instituting effective mechanisms of ethical oversight that are capable of securing the trust of participants and other stakeholders. On the other hand, the wholesale imposition of the standard ethics review2 that is legally required in the case of ILR—a procedure involving scrutiny by an institutional review board (IRB) and other forms of ethical oversight—threatens to stifle PLR, subjecting it to a regulatory straitjacket that may act as a disincentive to adoption and innovation. A vivid illustration of the complexity of this dilemma is the recent controversy about the appropriate ethical oversight of the uBiome project, a citizen science, crowdfunded initiative aimed at mapping the microbiome. The project has been heavily criticized for not undergoing IRB review from the beginning, notwithstanding initial protests from those running the project that such review was neither mandatory nor available7,8. Such problem cases are likely to become increasingly common in the future, making it urgent to formulate a principled way of responding to them. Elsewhere, we have advocated a scheme that seeks to meet this challenge by tailoring ethical oversight to the distinctive and pluralistic character of PLR9. If the entity conducting PLR is substantially equivalent to an ILR body, then standard ethical review should be mandatory. Such an equivalence exists when research is carried out by an institutional agent that is either recognized by the state or is profit making in character. Institutions have the power to coerce, exploit or exert pressure on research technology in the future—perhaps even the type of testing without the consent of potential partners as was imagined in the science fiction movie Gattaca. What can be done to remedy this situation? I doubt that regulatory bodies, such as FTC and the World Trade Organization (Geneva) will move swiftly enough to save the day. Ironically, the only solution lies in the hands of consumers. My advice to them would be as follows: feel free to buy 23andMe’s test. But whatever you do, do not provide them with your health data. In doing so, you risk giving away your data into the hands of a monopolistic corporation.

Research led by participants: a new social contract for a new kind of research

In recent years, there have been prominent calls for a new social contract that accords a more central role to citizens in health research. Typically, this has been understood as citizens and patients having a greater voice and role within the standard research enterprise. Beyond this, however, it is important that the renegotiated contract specifically addresses the oversight of a new, path-breaking approach to health research: participant-led research. In light of the momentum behind participant-led research and its potential to advance health knowledge by challenging and complementing traditional research, it is vital for all stakeholders to work together in securing the conditions that will enable it to flourish.

Genetic incidental findings: autonomy regained?

but that has received inadequate attention in clinical medicine. They set out a bold, new vision of how to handle genetic infor-mation. However, they have attracted a critical backlash, largely because they deny patients undergoing sequencing a choice as to whether or not to receive a minimum list of incidental findings. Moreover, the ACMG recommendations were pre-sented, and have been widely perceived, as generating a con-flict between the values of patient autonomy and beneficence. Naturally, any proposed sacrifice of patient autonomy merits serious debate.The major criticism brought against the recommendations is that they unacceptably override patients’ consent, and hence their autonomy, which is the chief value protected by informed consent procedures. On this view, patients are wrongly denied the choice of an analysis confined to the “target” genes, and their “right not to know” is violated when they are informed by the clinician of any incidental findings. This departure from the established informed consent regime has been condemned as a disconcerting throwback to the era of medical paternalism.

Getting human rights right in global health policy

Global health policy advocates have repeatedly called for a post-2015 development agenda in which global health policy goals are embedded in a human rights framework. This appeal echoes the insistence on the part of a wide range of agents—including the UN, non-governmental organisations, governments, and ordinary citizens—that human rights should be a fundamental basis for the new development goals in general. Interpreted sympathetically, this emphasis on human rights embodies a vital insight into their distinctive moral signifi cance. The adoption of goals concerned solely with the promotion of human welfare, such as our interests in health, prosperity, and education, is not suffi cient. Human rights inject a distinctive moral dimension into policy objectives, and one that is especially responsive to the plight of victims of injustice worldwide. Human rights are universal moral rights that all people possess merely by virtue of their humanity. They mark the threshold at which each individual person’s interests generate obligations on the part of others to respect, protect, and promote those interests in various ways. The violation of an obligation is a moral wrong; however, by contrast, no wrong is committed by the mere impairment of another’s interests or by leaving them unpromoted. For example, neither beating a rival applicant for a coveted job nor failing to give someone your spare healthy kidney for a transplant necessarily involves any wrongdoing. Human rights are a distinctive moral register of critical assessment, beyond evaluations that merely track rises and falls in welfare. A well-established doctrine of international human rights law now exists. However, the morality of human rights is independent of its legal recognition. Moreover, not even a presumptive case always exists for the enactment of human rights as (enforceable) legal entitlements. Law is just one mechanism of implementation that exists alongside others, including social conventions, public opinion, and the instillation of a rights-respecting ethos. Whether or not human rights should be legalised depends on what works in all circumstances. To make human rights legally enforceable can sometimes even be counter-productive. For example, in Brazil, the legalisation of the right to health seems to have led to a transfer of health resources to the wealthier people who can aff ord the cost of litigation. Although human rights are extremely important for global health policy, in this Viewpoint we contest two widespread assumptions about their signifi cance. The fi rst assumption—exclusivity—is that human rights should be the sole or exclusive basis of global health policy. The second assumption—inclusivity—is that insofar as human rights are relevant to global health policy, they are included within the right to health. Both exclusivity and inclusivity are, we believe, highly problematic assumptions. We cannot rely exclusively on human rights to develop global health policy; and to the extent that human rights are relevant, we cannot restrict ourselves to the right to health.

The dynamics of big data and human rights: the case of scientific research

In this paper, we address the complex relationship between big data and human rights. Because this is a vast terrain, we restrict our focus in two main ways. First, we concentrate on big data applications in scientific research, mostly health-related research. And, second, we concentrate on two human rights: the familiar right to privacy and the less well-known right to science. Our contention is that human rights interact in potentially complex ways with big data, not only constraining it, but also enabling it in various ways; and that such rights are dynamic in character, rather than fixed once and for all, changing in their implications over time in line with changes in the context we inhabit, and also as they interact among themselves in jointly responding to the opportunities and risks thrown up by a changing world. Understanding this dynamic interaction of human rights is crucial for formulating an ethic tailored to the realities—the new capabilities and risks—of the rapidly evolving digital environment. This article is part of the themed issue ‘The ethical impact of data science’.

Minimum Core Obligations: Human Rights in the Here and Now

The doctrine of the ‘minimum core’ (MCD) has in recent decades achieved prominence within international human rights law (IHRL) and practice. This enhanced profile is largely attributable to the activities of the United Nation’s Committee on Economic, Social and Cultural Rights (henceforth, ‘the Committee’). As this origin indicates, the MCD has been articulated in relation to the sub-set of human rights, usually denominated as ‘economic, social and cultural rights’, that are set out in the International Covenant on Economic, Social and Cultural Rights (henceforth, ‘the Covenant’). In addition, some regional and domestic legal regimes, notably in Africa and South America, have recognized some version of the MCD in relation to constitutional or legal rights. However, this report will almost exclusively concentrate on the nature and value of the MCD as it has developed within international law and practice. This Report proceeds in the following manner: (i) introduction; (ii) In section 2, an account is offered of the formative point of IHRL in general; (iii) In section 3, the concept of minimum core obligations of human rights is explored, i.e. what it is that marks out such obligations among other human rights standards; (iv) Section 4 contends that the main gist of the MCD is given by interpretation; (v) In section 5, it is argued that interpretation (a), standing alone, offers the best account of the MCD; (vi) Section 6 addresses the difficult question of how to determine the content of such obligations; (vii) Section 7 responds to two major challenges confronting the MCD; and (viii) Finally, Section 8 briefly examines how indicators and benchmarks are statistical tools that can help monitor and enhance compliance with minimum core obligations.

The place of human rights and the common good in global health policy

This article offers an integrated account of two strands of global health justice: health-related human rights and health-related common goods. After sketching a general understanding of the nature of human rights, it proceeds to explain both how individual human rights are to be individuated and the content of their associated obligations specified. With respect to both issues, the human right to health is taken as the primary illustration. It is argued that (1) the individuation of the right to health is fixed by reference to the subject matter of its corresponding obligations, and not by the interests it serves, and (2) the specification of the content of that right must be properly responsive to thresholds of possibility and burden. The article concludes by insisting that human rights cannot constitute the whole of global health justice and that, in addition, other considerations—including the promotion of health-related global public goods—should also shape such policy. Moreover, the relationship between human rights and common goods should not be conceived as mutually exclusive. On the contrary, there sometimes exists an individual right to some aspect of a common good, including a right to benefit from health-related common goods such as programmes for securing herd immunity from diphtheria.

The Minimum Core of the Human Right to Health

This Report offers a critical interpretation of the idea of ‘minimum core obligations’ associated with the right to health in international, regional and domestic law and practice. Two important methodological complexities affecting this project need to be highlighted from the very outset. First, it cannot be assumed that all uses of expressions such as ‘the human right to health’, ‘the right to health’, or ‘minimum core obligations’ bear the same meaning. Second, in seeking to identify the role played by the idea of minimum core obligations in the law and practice relating to the right to health in various jurisdictions, we must distinguish the concept of such obligations from the use of the words ‘minimum core obligations’. The structure of this report is as follows. In Part II the idea of minimum core obligations corresponding to the right to health is examined as it manifests itself in international law and practice. Parts II and III consider how the same doctrine manifests itself in the context of regional legal orders (II) and state law and practice (III). Given the enormous volume of material potentially relevant here, these latter two parts are necessarily highly selective, with a focus on some of the most fertile cases for grasping the bearing on the minimum core doctrine on the right to health. Finally, in Part IV, the potential role of the minimum core obligations with respect to the right to health are highlighted with respect to development, focusing in particular on their bearing on the Sustainable Development Goals, priority-setting more generally, and the use of indicators.

The dynamics of big data and human rights: The case of scientific research

In this paper, we address the complex relationship between big data and human rights. Because this is a vast terrain, we restrict our focus in two main ways. First, we concentrate on big data applications in scientific research, mostly health-related research. And, second, we concentrate on two human rights: the familiar right to privacy and the less well-known right to science. Our contention is that human rights interact in potentially complex ways with big data, not only constraining it, but also enabling it in various ways; and that such rights are dynamic in character, rather than fixed once and for all, changing in their implications over time in line with changes in the context we inhabit, and also as they interact among themselves in jointly responding to the opportunities and risks thrown up by a changing world. Understanding this dynamic interaction of human rights is crucial for formulating an ethic tailored to the realities—the new capabilities and risks—of the rapidly evolving digital environment. This article is part of the themed issue ‘The ethical impact of data science’.