The ancillary-care responsibilities of researchers
Reasonable but not great expectations
It is axiomatic that the first responsibility of researchers, whether they are working in the developed or the developing world, is to (strive to) do no harm to those who participate in their studies or trials. However, on neither side of the Atlantic is there any such settled view with regard to the responsibility of researchers to attend to the ancillary-care needs of their participants – that is, a responsibility to advise or assist participants who have medical condition x in circumstances where the research concerns medical condition y, and the research did not contribute to the presence of condition x in participants, nor did the having of condition x contribute to the research (Richardson and Belsky 2004; Belsky and Richardson 2004). Consider, for example, the following hypothetical posed by Leah Belsky and Henry Richardson: ‘Researchers testing a new treatment for tuberculosis in a developing country discover some patients have HIV infection. Do they have a responsibility to provide antiretroviral drugs?’ (Belsky and Richardson 2004: 1494)
What is the answer? Do the researchers (or their sponsors) have a duty to offer any kind of ancillary assistance to their participants? If so, is their duty simply to inform participants that they are HIV positive, or does their responsibility extend to providing (or covering the cost of) antiretroviral drugs? (Nuffield Council on Bioethics 2002, 2005).
Prompted by such questions, there are three related strands in this paper. First, in Sections 2–4, I develop the proposition that in ‘a community of rights’ – my idea of the benchmark setting for making moral judgments – agents would be treated as having prima facie positive obligations to one another where a four-stage test (relating to placement, capacity, reasonable imposition and fair demand) is satisfied. Second, in Sections 5 and 6, I contend that the application of this test would point to researchers having ancillary-care responsibilities to their participants. Moreover, I argue that researchers would be fixed with such responsibilities regardless of whether the trial is in a developed or a developing country. Third, in Section 7, I suggest that the courts in a community of rights might well set an example for more cautious common law courts by ruling that research participants have a reasonable expectation – whether as a matter of contract or tort law – to ancillary-care advice and assistance.
There is just one other essential introductory remark. In line with the spirit of debate in a community of rights, the emphasis of my discussion is more on the process than on a conclusive product. We are dealing with a difficult case, with many tricky spin-off issues; there are no knock-down answers; and the best that I can do is to suggest how such a matter might be addressed. It follows that, by the end of the chapter, there is still a good deal of unfinished business – but, in a community of rights, there is a sense that this is business as usual.
2 Reasonable expectations: easy cases and more difficult cases
Let us suppose that a participant in a research trial claims to have a reasonable expectation of ancillary-care advice or assistance from the research team. For ethicists and lawyers alike, this would seem to be a novel claim. In the absence of exceptional express undertaking or bespoke legal support (of the kind that simply does not currently exist), how might such a claim be made out?
In what are relatively easy cases, the claimant will appeal to some aspect of practice or protocol, proximate to the trial, which provides the basis for the expectation and characterises it as reasonable. For example, the case is easily made out if the relevant undertaking (assuring advice, assistance or treatment) has been given prior to enrolment, or if it is an explicit term of the contract to participate, or if the responsibility to offer such ancillary care is generally accepted and acted upon as a matter of common custom and practice. However, if there is no such immediate anchoring point in practice, what then? The claimant might, in good faith, have the relevant expectation, but this is little more than a de facto expectation. On what basis is the claimant’s expectation to be presented as reasonable?
A more difficult case might be made out on the basis that, although there has been no direct undertaking or promise, the commitments of the researchers or the larger community imply that such ancillary-care benefit should be provided. For example, it might be argued that, in a community with a commitment to human rights, the expectation is reasonable because it teases out the implicit responsibilities of researchers in such a community. Or, it might be asserted that a rough idea of reciprocal altruism is widely recognised, so that one act of altruism deserves another: thus, where participants enter a research trial knowing that they have nothing to gain from the project itself, the researchers owe some measure of ancillary-care to participants by way of a return act of altruism.
The most difficult case is one that is wholly independent of practice (Brownsword 2003). If the claim is that an expectation is reasonable by reference to some specified standard, it is likely to elicit the sceptical response that, even if the standard indicates that there should be ancillary-care benefit, there is no reason to recognise it as binding. Hence, if it is argued that, (contrary) community practice notwithstanding, human rights set the standard, the sceptic will respond that this smacks of a fresh outbreak of nonsense on stilts.
As I have indicated already, I will assume that the benchmark for such ethically problematic cases is a community of rights. Accordingly, before we address our principal question, we need to say a little more about the nature of such a community.
3 The nature of a community of rights
Given that a community of rights is a particular kind of moral community, it must systematically embed a moral standpoint (in the formal sense); and because it is a community of rights, the substantive moral approach embedded is rights-led. The significance of this latter point is that, by taking a rights-led approach, such a community distinguishes itself from its two principal rivals, namely those communities in which the governing ethic is, in the one case, utility-maximising and, in the other, duty-driven (Brownsword 2008: chapter 2).
Arguably, the assumption of a community of rights is at least encouraged, if not presupposed, by our line of inquiry, for we would scarcely take seriously the possibility of ancillary-care obligations unless it was axiomatic that researchers already have extensive responsibilities to their (rights-holding) participants. It is also an assumption that will not be challenged by those who are of a Rawlsian or Dworkinian disposition (Rawls 1972; Dworkin 1978): taking rights seriously, or privileging the right over the good, entails the rejection of utilitarianism; and while, to this extent, Rawlsians and Dworkinians are with Kant, they prefer to lead with rights rather than (as in Kant’s case) duties. It is also an assumption that is immune to challenge wherever communities have signed up to respect for human rights, because they thereby express their commitment to a rights-led ethic. Having said this, to make out a comprehensive case in favour of treating a community of rights as the benchmark setting for moral and legal judgments would necessitate a major theoretical detour that I cannot undertake in this paper (Beyleveld and Brownsword 1983, 1986; Gewirth 1978, 1996).
An important feature of my specification of a community of rights is that, while all members recognise the fundamental importance of respecting rights, they do not regard themselves as morally omniscient. Accordingly, the community of rights should be viewed as a reflective and interpretive society, not so much a finished product as an ongoing process. These various defining characteristics call for some short elaboration.
3.1 The essential characteristics of a community of rights
First, we are dealing with a moral community. No doubt, there could be considerable debate about the precise specification of the generic characteristics of the formally speaking ‘moral’, whether it is a moral standpoint or a moral community. However, I take it that a community of rights, as a moral community, must hold its commitments sincerely and in good faith; that it must treat its standards as categorically binding and universalisable; and that there must be an integrity and coherence about its commitments as a whole.
Second, as a community that is committed to the protection and promotion of individual rights, its moral approach is rights-led. In this respect, as I have just said, it distinguishes itself from both utilitarian and duty-driven instantiations of moral community. Crucially, this means that the interests of research participants will not be subordinated to the greater good; nor, on the other side, will researchers be constrained by the kind of dignitarian duty-driven concerns that have become so influential in modern bioethics (Brownsword 2006a).
Third, the fundamental baseline value of a community of rights will be to respect the conditions and the context that comprise, so to speak, the agency commons (Brownsword 2009a). We can argue about the details of this context (or commons), but it will include elements pertaining to our well-being (clean air and water, food, environmental integrity, and the like) and our freedom (security, an absence of fear and intimidation, and so on). Not to harm one another directly is fine, but the setting for flourishing agency requires more than this minimal interactive restraint. Ideal-typically, this baseline value and its guiding standards will be regarded as rationally justifiable (members viewing the guidance as a dialectically necessary entailment of agency (Gewirth 1978)). Having said this, for most practical purposes, it matters little how a community that is committed to respect for the generic rights of agents arrives at this position.
Fourth, following on from the previous point, let me repeat that I conceive of a community of rights as a society that views itself as an ongoing process rather than a finished product. By this, I mean that it is a community that constantly keeps under review the question of whether the current interpretation of its commitments is the best interpretation. There is also an awareness by members of their limited knowledge and understanding; members do not regard themselves as morally omniscient; what seems like the best interpretation today might look less convincing tomorrow.
Fifth, in a community of rights, the discourses of ethics and of regulation are regarded as both contiguous and continuous. Debates about the ethics of rights flow straight into the regulatory consciousness; and regulatory reflection on rights flows back into ethical debate. It is not enough that regulation is effective and fit for purpose; the first priority is that regulators should have the right purposes (rights-respecting purposes) and that the regulatory standards are legitimate relative to the community’s rights values. In a community of rights, regulation, like ethics, is an enterprise that is dedicated to doing the right thing; and the right thing is the protection, preservation and promotion of the community’s commitment to rights.
Sixth, in a community of rights, a will (or choice) theory of rights, rather than an interest theory of rights, is adopted (Hart 1973; MacCormick 1977) and, as a corollary, the paradigmatic bearer of rights is one who has the developed capacity for exercising whatever rights are held, including making choices about whether to give or to refuse consent in relation to the rights that are held.
Finally, it should be said that, even with these shared characteristics, there is considerable margin for each community of rights to express and articulate its commitments in its own way – for example, from one community to another, there might be different views about the status of non-paradigmatic rights-holders, and especially so in relation to the details of the array of recognised rights (Beyleveld and Brownsword 2006).
3.2 Questions for a community of rights
Without attempting to be exhaustive, some of the more pressing and recurring questions to be addressed, debated and (at least, provisionally) resolved within a community of rights are the following.
First, there is a large cluster of questions concerning which rights, negative and positive, are to be recognised and what the scope of those particular rights is (Brownsword 2009b). If research participants and patients have a right not to be harmed, do the former also have a right to ancillary-care advice and assistance? If so, how far does this right extend, for how long does it endure (e.g. only for the length of the trial), and so on?
Second, there are questions arising from conflicts between rights as well as from competition between rights-holders. Sometimes the conflict might be between one kind of right and another – for example, between the right to privacy and the right to freedom of expression. At other times, there might be competing rights– that is, cases where two rights-holders conflict over the same general right. If relative need is the criterion, this might facilitate an easy resolution where, say, a seriously ill person claims a right to the one available hospital bed in competition with a less ill person; but how should we decide whether the claims of needy research participants are prior to the claims of needy non-participants, or if the claims of HIV-positive agents are prior to the claims of agents with tuberculosis (TB)?
Third, because consent is an extremely important dynamic in a community of rights, the community needs to debate the terms on which a supposed ‘consent’ will be recognised as valid and effective. In particular, how does the community interpret the requirement that consent should reflect an unforced and informed choice, and how is consent to be signalled (will an opt-out scheme suffice, for instance), and so on (Brownsword 2004; Beyleveld and Brownsword 2007)?
Fourth, a community of rights must debate whether there are limits to the transformative effect of the reception of rights (Beyleveld and Pattinson 2002). In particular, this invites reflection on the relationship between one community of rights and another.
Finally, there is the vexed question of who has rights. Do young children, foetuses or embryos have rights? What about the mentally incompetent or the senile? And what about non-human higher animals, smart robots, and, in some future world, hybrids and chimeras of various kinds? Each community of rights must debate such matters and respond to the encompassing question (who has rights?), as well as determine an approach to those life-forms that are to be excluded.
Even though the members of a community of rights have a shared moral outlook, there is still plenty to debate. It is in this spirit that such a community would approach the question of researchers having ancillary-care obligations towards participants.
4 Positive rights and responsibilities
Two questions that present themselves to a community of rights are: (a) whether positive rights should be recognised at all within the background set of standards; and (b) if so, what kind of limiting principles govern the range of an agent’s positive responsibilities. It is important to emphasise that we are dealing here with background rights and responsibilities, with rights and responsibilities that are imposed rather than freely assumed by promise or agreement, for I assume that it will be readily accepted in a community of rights that one agent may freely put himself under a positive obligation to another.
To deal with the first question, let us suppose that A, who is an experienced swimmer, observes B, who is a novice, getting into difficulty. Does A now have a positive responsibility for B’s safety? Certainly, it would seem to be insouciant in the extreme if A were to shrug off any responsibility for B’s well-being. But, would a community of rights fix A with a positive obligation as a matter of its background (imposed) moral standards?
I take it that no community of rights would reject the very idea of background positive requirements. In which case, the real question concerns the conditions that the community would set for the recognition of background positive obligations. I suggest that the conditions set would reflect the community’s understanding and application of three guiding considerations. First, there are considerations of rational prescription. In any community that accepts the basic canons of rational prescription, an agent will only be required to assist another where ‘ought implies can’ is satisfied. It follows that no agent will be burdened with a positive obligation unless they are capable of rendering assistance. If we are to prescribe that A ought to assist B (by swimming over to assist B, or by throwing a line to B, or by calling a lifeguard, or whatever), then the demands that we make of A should at least be within A’s capabilities. Second, there are considerations of reasonableness. How much can we reasonably demand of A? In the hypothetical, it seems that it would be little more than a minor inconvenience for A to rescue B. However, the circumstances might be very different. Is there a point beyond which it would be unreasonable to impose upon A? For example, if A would put his own life at risk by entering the waters, would we require such a heroic act (or would this be a case of supererogation)? Third, there are considerations of fairness. Even in a community that recognises positive rights, the default position is represented by ‘can implies ought’ – i.e. the default expectation is that those who are capable of helping themselves should do so. So, if the roles were reversed, we would expect B, an experienced swimmer, to rely on his own resources before seeking assistance from others.
Arguably – and I must emphasise that, given my specification of a community of rights, this is no more than arguably – by drawing on these considerations, a four-stage test along the following lines might be formulated for the recognition of particular background prima facie (and, it is important to note that these are simply prima facie) positive rights and responsibilities:
(a) Is A in a position to assist B?
(b) Does A have the capability to assist B in any material respect?
(c) Even though A is in a position to assist B and has the relevant capability, would the burden of responsibility on A be unreasonable relative to A’s own essential interests?
(d) Even though A is in a position to assist B, has the relevant capability, and the imposition of responsibility on A would not be unreasonable (relative to A’s essential interests), would B be taking unfair advantage of A if A were required to assist B?
Quite clearly, there is still a great deal of interpretive work to be done on these general principles, particularly in relation to the pivotal notions of ‘unreasonable imposition’, ‘essential interests’, and ‘unfair advantage-taking’. Let us suppose that the community, recognising that these are slippery notions, tries to stabilise the four-stage test by focusing on the common needs of all agents, irrespective of their particular purposes, plans or projects – for example, the need of all agents for life and a level of basic physical and psychological well-being. With this focus, the community can say that A is not required to attempt to rescue B where this would jeopardise A’s own life (this would be an unreasonable imposition) and, similarly, that A is not required to assist B where B is in no danger but simply wants A to teach him how to do the backstroke (this would be an unreasonable demand that amounts to another example of unfair advantage-taking).
Even with the test stabilised in this way, the community should also be mindful of a troubling pair of puzzles that threaten to undermine the practicability of any regime of positive rights. Stated shortly, one puzzle arises where A is not the only experienced swimmer on the beach. The question then is why we should single out A as the person responsible for assisting B. The converse puzzle arises where it is not just B, but B, C and D who are in difficulty, and A simply cannot assist all three. Here, the question is why we should single out, say, B as the agent to be assisted. For sure, the lesson to be taken from these puzzles is not that A is released from his positive obligation to assist (because, in the first case, others are also able to assist or because, in the second case, he cannot assist all three distressed agents). Rather, the lesson is that the community needs to articulate some principles of relative priority in relation to the bearers of positive duties (for the first kind of case) as well as those who are positive rights-holders (for the second kind of case).
In the light of these framework principles, we can turn to the question of how a community of rights might address the proposition that participants have a reasonable expectation, based on a background positive right – that researchers will attend to their ancillary-care requirements. For this purpose, we can focus on two test cases: first, the vexed question of whether the UK Biobank (see http://www.ukbiobank.ac.uk; McHale 2004) has a responsibility to provide any clinical feedback to participants; and, second, a developing country hypothetical of the kind suggested by Belsky and Richardson.
5 Test case I: the UK Biobank
The UK Biobank Ethics and Governance Framework (EGF, UK Biobank Ethics and Governance Council 2006) seeks to ensure that participants fully understand the purpose of the Biobank – crucially that it is not a healthcare programme but a research resource. At enrolment, participants are provided with some very basic data concerning their blood pressure, body mass index, estimated amount of fat, and the like (at 8, para IB3). However, the overriding message is that “UK Biobank will generally not provide health information to participants …” (ibid.). In the EGF, the rationale for this policy of non-disclosure is put in the following way: