Donating bodily material: the Nuffield Council report

There is a give and take to the flux of life that most of us would recognize as a signature of our interactions with others. Indeed, ‘Give and take’ was the title of the Nuffield Council on Bioethics' public consultation document on the donation of bodily material for treatment and research. In the end, however, the Working Party set up by the Council to look into this matter thought the phrase implied too immediate or direct an expectation of reciprocity. It might give the wrong idea in a field where those who receive may not themselves be able to make any return and where those who give are not necessarily looking for any return to themselves. Better, rather, to consider the long-term circulation of needs and response to need – to the indirect reciprocity entailed, for example, when someone responds to a national campaign or gives for the hope of medical development that will benefit future others. Whether or not what comes back to them can be traced to the specific contributions of others, it may matter very much that their actions have helped create the kind of society in which they would like to live.

For an investigation that focuses on the donor, who is always an individual person, ‘society’ looms larger in our report than might have been expected. It is there when we describe the values that people give voice to and the way expectations of medical practice have changed over the last generation; it is there in the role our recommendations give to one of society's instruments, the stewardship state. We consider the state has a crucial part to play in regulation and (public health) education, and that these together make the case for continuing to look to it for measures for encouraging or facilitating donations. The welfare of the donor, a paramount ethical concern, depends in fact on procedures that can be scrutinized not just nationally but internationally.

For one of the backcloths against which we were working was knowledge of what happens outside regulated contexts – as in the case of the organ retention scandals that influenced public opinion in this country or the exploitation of poverty in black markets overseas. That does not mean that the state can act as though it ‘owned’ people's bodies, a fear some consultation respondents voiced; rather that it should be alert to the unique relationship persons have with their bodies.

Party to a debate

This was not how the Working Party began. What was before us were the stark figures of need, especially of solid organs, ^A the calls for increase, the impressive levels already accomplished by NHS Blood and Transplant, alongside questions not laid to rest by current regulations: disagreement about appropriate incentives, controversy over opt-out schemes, proposals for a regulated market … in other words an up and running debate about supply and demand. While organs were most prominent here, a similar debate in relation to gametes had never gone away either. And new developments meant that there were all kinds of bodily materials, from the living or deceased, being put to use in both treatment and research. What also was before the Working Party was the Nuffield Council's imaginative approach. It wanted us to bring into one frame blood, organs, other tissues, gametes and volunteering in first-in-human trials: all examples of how a person may put their body, in part or whole, at the disposal of others.

The Working Party came very quickly to the view that this breadth of approach was a gift. The deployment of ethical values invariably takes place in specific lived contexts – this would allow comparisons to be made across contexts. It meant that we could not brush aside the complexity of the field. With it came a clear steer from the Council that our focus was to be on the donor and not an overview of systems of procurement, storage and distribution as such. But the donor and the idea of donation were quite complex enough, and took us beyond the UK in considering not just international protocols but the effects that regulations here have on people seeking opportunities overseas. We were also conscious of the fact that whereas the donor of (his or her) bodily material is necessarily one person, the material can be divided up, and ‘recipients’ may be many and (in the case of donation for research) diffuse to vanishing point.

Nonetheless the focus on the donor and the already existing debate drew us early on into considering motivation and the role of incentives in encouraging donations. Here we were met by something else already in place: an assumption that any argument was going to be about money, about whether people should be paid. Money is an emotive issue, and tends to drive anything else out – if someone accepts money that is then seen as the reason for their actions. These are social or cultural rather than ethical matters as such, but we found it necessary to be quite explicit about what ‘payment’ might mean in this or that context.

What kind of ethical framework?

Much might already be in place, but then one of our tasks was to examine both the status quo and the reasons people were seeking development and change. This is in the sturdy tradition of Nuffield Council reports. An unlooked-for intervention came with the announcement of sweeping reforms to health-care provision in the UK, including the principal statutory bodies (Human Tissue Authority, Human Fertilisation and Embryology Authority) that regulate much donation. While this did not affect our ethical thinking, it foregrounded a strong appreciation of the vital work currently being done. What needed attending to was the role of organizations generally in ensuring best use is made of material people are willing to donate, the special case of gametes, and the significance of donation for research and how the ‘research donor’ (including the trial volunteer) is to be regarded. Across the range, we had recommendations to make about the part payment could play in specific circumstances.

Altruism emerged from our discussions as a value we would want to endorse, but we would like to think that the way the report has finessed it pays some respect to the give and take of life. Generally speaking, altruism does not have to go out of the window when money enters – in fact when is brought in to reimburse or compensate people for their efforts the focus is still on the donor as a person. Nor, even when there is an element of reward, should we discount the multiple motives people may have to donate (and we have deliberately retained the term ‘donation’). What the Working Party did not countenance was a situation in which it was possible to regard bodily material as up for sale. Regardless of any subsequent circulation as a commercial product, it is important at the point of extraction to recognize the uniqueness of the person's bodily identity. We did not think a purported ‘freedom to sell’ would be an improvement on the present protocols about soliciting consent (though we think consent procedures should be modified). ^B

In an earlier report, ^C the Nuffield Council had set out the idea of an ‘Intervention Ladder’ as a way of thinking about the acceptability of, and justification for, a number of public health policies. In considering the question ‘How far should society go in attempting to encourage or facilitate the donation of bodily material?’ the Working Party concluded that, here too, an Intervention Ladder would provide a useful tool when analysing the justification required for different means of encouragement and persuasion to donate.

Starting with rung 1 at the bottom of our Ladder, the Working Party identified six distinct ‘rungs’:

Rung 1: information about the need for the donation of bodily material for others' treatment, or for medical research;

Rung 2: recognition of, and gratitude for, altruistic donation, through whatever methods are appropriate, both to the form of donation and the donor concerned;

Rung 3: interventions to remove barriers and disincentives to donation experienced by those already disposed to donate;

Rung 4: interventions as an extra prompt or encouragement for those already disposed to donate for altruistic reasons;

Rung 5: interventions offering associated benefits in kind to encourage those who would not otherwise have contemplated donating to consider doing so;

Rung 6: financial incentives that leave the donor in a better financial position as a result of donating.

Rungs 1–4 are categorized as ‘altruistic-focused interventions’: actions and initiatives designed to encourage or prompt people to donate primarily for altruistic reasons, and to recognize and thank them for doing so. Rungs 1, 2 and 3 are straightforward, reflecting the need to make people aware of the role they may potentially be able to play in donation, the courtesy of expressing appreciation of what they have given and the justice of removing barriers that may stand in their way (for example, by reimbursing their out-of-pocket expenses or by providing convenient opportunities for them to donate). Rung 4, on the other hand, may require more explanation. It reflects the Working Party's view that motives to donate will often be mixed, complex and interwoven: an inclination to donate in order to benefit others in need is not necessarily extinguished by token rewards, whether in kind or in cash. Rather, such rewards may act to encourage someone already disposed to donate because of a desire to help others finally to take the plunge; and they may also be perceived as recognition and appreciation for the act of donation.

In categorizing the first four rungs of the Intervention Ladder all as ‘altruist-focused’ interventions, we do not discriminate between them on ethical grounds, although they may involve different degrees of organizational involvement and cost. However, moving to either rung 5 or rung 6 of the Ladder does constitute an ethically significant step because the interventions on these rungs can be classed as ‘non-altruist-focused’: the incentives on offer may be sufficiently attractive to make a person consider donating even if they have no altruistic concern at all for those whom their donation will be benefiting.

What is the relevance of the distinction between ‘altruist-focused’ and ‘non-altruist-focused’ interventions? This distinction, in fact, is at the heart of the Working Party's ethical deliberations. While altruism is a value that the Working Party wishes to endorse, it did not consider that payments that reward a person for donating will necessarily and always be incompatible with altruistic intent. The Working Party concluded that the primary reason for valuing altruism in the context of the donation of bodily materials is for the crucial role it plays in supporting a solidaristic approach to health care: that is, in promoting a collective and communal approach to meeting the health needs of fellow citizens. The need for an organ transplant or a blood transfusion, for example, is not only a ‘private’ matter, but also a proper subject of public concern: although ‘directed donations’ of organs between relatives and friends are rightly valued, few would wish to see a system where only those who could source their own donor could receive donated bodily material. ^D A system that encourages an altruistic approach to the donation of bodily material, by contrast, encourages us all to consider in what ways we can contribute to common health care needs, whether during our lives or after our deaths.

Some important caveats must be noted with respect to this crucial distinction between ‘altruist-focused’ and ‘non-altruist-focused’ interventions. First, and most importantly, the Working Party did not see the rungs of the ladder as moving from ‘ethical’ to ‘unethical’ interventions. Rather, the distinction, as one steps on to the fifth or sixth rung, is that of moving from what is ethically straightforward to what is ethically more complex. There will be circumstances in which non-altruist-focused interventions are ethically indicated: we suggest that these may be found in cases where there is good evidence, first that they will bring significant benefits that cannot be achieved by altruist-focused interventions alone; and second that, in providing reward to donors, they will not cause harm to the welfare of the donor or that of other closely concerned individuals, to the common good, or to the professional responsibilities of the health professionals involved. Such judgements may only be made on a case-by-case basis, and it seems likely that different judgements will arise in connection with different forms of bodily material, and in different circumstances. In particular, we emphasize the contrast between donating for treatment purposes (where identifiable, if unknown, persons will benefit) and for research purposes (where any benefit is uncertain and long term, and a desire to donate in order to contribute to the public good may well exist without being characterized as ‘altruism’).

Second, the Working Party was well aware that the interventions included on the Ladder are inputs, not outputs: whether a reward is perceived as ‘token’ or ‘significant’ may depend on the potential recipient. Thus, for example, a fixed amount to recompense donors both for out-of-pocket expenses and inconvenience may, depending on the amounts concerned and the personal circumstances of the potential donor, constitute either rung 4 or rung 6 of the Ladder. Similarly, it is, of course, the case that those who choose to accept an incentive categorized as rung 6 on the Ladder may also have altruistic motives in choosing to donate. The important distinction, however, is that a rung 6 incentive is designed to be sufficient to prompt donation, regardless of altruistic intent. ^E

Third, the question of possible threat to the common good is particularly pertinent in distinguishing between rungs 5 and 6 of our Ladder. In offering rewards that are closely associated with what is being donated (in the case of ‘egg-sharing’ arrangements, for example, the opportunity to access fertility treatment that might otherwise be unaffordable), it may still be meaningful to talk of solidarity or common purpose between donors and recipients. Moreover, rewards in kind that are within the same domain as the donation are also far less likely to be (mis)understood as the straight sale and purchase of bodily material, of the kind rejected by the Working Party.

Finally, it is worth emphasizing that the Intervention Ladder should only be seen as one tool in determining the ethical acceptability of various forms of encouragement to donate bodily material. In some circumstances – for example in the case of directed donation between parents and children – very different considerations will apply. And, of course, it must be remembered that the ways in which individuals are encouraged to come forward to donate is only one part of the donation picture. The role of organizations and the state in facilitating donation, and in making best possible use of the material people are willing to donate, is perhaps even more important. We have alluded to the role of ‘society’ and the ‘stewardship state’: the Working Party came very firmly to the conclusion that action taken by the state, and by state-sponsored institutions such as the NHS, was crucial, both in enabling people to live healthy lives (hence reducing levels of disease that lead to organ failure, say), and in providing accessible services that make donation as easy as possible for those disposed to donate. The example of tissue donation for research is instructive here: there is evidence that the majority of NHS patients are willing to donate tissue for research purposes (for example unneeded tissue that would otherwise be discarded after a diagnostic procedure or operation); but in places the infrastructure needed to make appropriate use of these materials (in terms of seeking consent for future usage, funding arrangements for tissue collections, the willingness of researchers to share ‘their’ tissue collections and so forth) may be absent.

Coming to conclusions

The task given to the Working Party by the Council was very broad – indeed, its breadth was a puzzle to some outside commentators. The composition of the Working Party, too, included diverse professional disciplines (medicine, law, ethics, anthropology, psychology … ), each of which brought subtly different concerns, and a distinct body of literature, to our deliberations. Yet, as we've said, it was the very breadth of our scope that prompted the use of one of our most fruitful lines of enquiry: that of making comparisons, and identifying similarities, distinctions, and apparent incompatibilities of approach between the many different forms and purposes of donation that came within our remit. The diversity of public and professional opinion, which we sampled through public consultation, meetings with experts, a public deliberative event, and a process of peer review, both emphasized the difficulties of our task, and itself constituted a fundamental part of the Working Party's ethical approach: it took as its starting point the position that strong and, at times, conflicting views about the donation of bodily material cannot (and should not) be simply wished or argued away.

Yet while recognizing this breadth of views, the Working Party still, clearly, had to come to its own conclusions. As an aid to clarity, the report is divided into two distinct parts: Part I providing an empirical overview of our subject matter (in terms both of current donation practice and law, and of the principal ethical arguments deployed in this arena); and Part II setting out our proposals for an ethical approach, together with the conclusions with respect to various forms of donation that flow from that approach. Our ethical analysis seeks to bridge this apparent contradiction between recognizing conflicting views and making specific recommendations, by proposing a policy framework based, so far as is possible, on an ‘overlapping consensus’: that is, based on ethical values (such as concern for the welfare of the donor, and the value of a collective approach to the provision of bodily material necessary for ongoing good health) with which many may agree, albeit sometimes for very different reasons.

Summary of recommendations

We conclude with a brief overview of the recommendations set out in Human Bodies: Donation for Medicine and Research (www.nuffieldbioethics.org/donation). Based on conclusions reached by the Working Party with respect to the duties of the stewardship state, the significant role played by altruism in promoting solidarity with respect to the provision of bodily material, the vital public interest inherent in health-related research, concern for the welfare of the donor and the importance of what might be termed ‘professional values’ of trust and respect, the report recommends:

Action to be taken as necessary to protect organ donation services within the current organizational changes in England;

The creation of a national or regional ‘donor service’ to ensure effective facilitation of egg and sperm donation, drawing lessons from the systems already in place for blood donation and deceased organ donation;

More explicit information about the value of donating material for research, as well as for transplantation purposes, after death;

Donors of material for research purposes, and participants in first-in-human trials, to be treated as ‘partners’ in research;

Research on the effects of an ‘opt-out’ system for deceased organ donation, if introduced in Wales, in order to improve the evidence base as to the effectiveness of legislative change to consent defaults;

Living organ donors to continue to receive no payment, other than direct reimbursement of costs incurred in donating;

A pilot scheme in which the NHS would meet the funeral costs of those who sign the Organ Donation Register and subsequently die in circumstances where they could become organ donors;

Lost earnings to be reimbursed in full for those donating gametes for others' treatment; and

A pilot scheme offering payment to reward those willing to donate eggs for research purposes.