Part I
Research Ethics
How Should We Justify Ancillary-Care Duties?
Chapter 1
Locating Medical Researchersâ Ancillary-Care Obligations within the Division of Moral Labor1
HENRY S. RICHARDSON
Abstract
Medical researchersâ ancillary-care obligations are obligations to provide medical care that research participants need but that are not morally required by whatâs involved in conducting a study safely and soundly. This essay seeks to deepen and make more explicit the underlying philosophical rationale of the authorâs partial-entrustment model of medical researchersâ ancillary-care obligations by explaining how these should be seen as arising in the context of a complex web of moral obligations that constitutes a social division of the moral labor of beneficence. The model had metaphorically described how a special duty of researchers to engage tactfully with research participants regarding their ancillary-care needs, which flows from special permissions they gave the researchers, provides a âhookâ on the basis of which to specify the general, background duty of beneficence. By going into more depth about the social division of moral labor with regard to beneficence, the chapter seeks to restate this point in nonmetaphorical terms. It argues that a theory specific to the context of medical research reasonably takes as given the broader aspects of this social division of labor. Against that backdrop, the partial-entrustment model offers a well justified way of addressing a vulnerability that has fallen through the cracks.
Over the last dozen years, working first with Leah Belsky and then on my own, I have developed and defended a theory of medical researchersâ ancillary-care obligations.2 âAncillary care,â for these purposes, we defined in a shorthand way as medical care that research participants need but that is not morally required by whatâs involved in conducting a study safely and soundly. The requirements of safety and soundness we interpreted broadly, taking the ideal of doing sound science using human subjects as encompassing not just the requirement to provide the care required to do the proposed science but also an adequate standard of care for the disease or condition under study.3 We also understood the commitment to study safety as requiring some remediation of study-caused harm. What is interesting and practically important about the issue of ancillary-care obligations is that they had been omitted from existing ethical understandings and guidelines pertaining to medical research. Hence the definitionâs negative character: It defines âancillary careâ as care not required by the established and recognized moral grounds for providing medical care to study participants. When Belsky and I started on this work, the question of who is responsible for providing ancillary care to study participants was one that existing guidelines and understandings had left completely open. While there is today some nascent, shared understanding that medical researchers have some responsibility for addressing their study participantsâ ancillary-care needs, official ethics guidelines still treat the issue only rarely. When they do, what they tend to say is rather noncommittal.
Belsky and I approached this issue with two desiderata principally in view. First, seeking to systematize the intuitive responses we were hearing from researchers and patient advocates, we aimed to articulate a reasonable middle position, on which the ancillary-care obligations researchers specially owe to their participantsâtheir âspecial ancillary-care obligationsââare neither null nor unlimited. Second, we sought to locate a position that could be defended on the basis of general moral arguments. On the first score, we sought reasonable limitation both by suggesting that researchersâ special ancillary-care obligations are limited in scope to dealing with issues discovered by carrying out study procedures and by suggesting that any potential claim to ancillary care that falls within the scope needs also to pass a multidimensional test of strength. On the second score, that of providing justificatory arguments, our initial efforts were rather tentative and metaphorical, but we did invoke a metaphor that I later developed into an explicit argument, the metaphor of partial-entrustment. This metaphor has given the view its name: the partial-entrustment view.
This view itself sees researchersâ special ancillary-care obligations as playing a role in a division of moral labor, for these supplement the general duty of rescue. Whereas the former are obligations that hold specially between researcher and participant, the duty of rescue applies to everyone in any situation. It holds that if one can prevent someone from serious suffering or death without any serious sacrifice on oneâs own part, one would be wrong not to do so. The duty of rescue provides a basis for holding many instances of providing ancillary care to be obligatory, such as providing antihelminths (deworming medications) to research subjects in areas where intestinal worms are endemic. The partial-entrustment view assumes that this duty of rescue is in place and seeks to supplement it by defending the existence of a duty that, while more limited in its reach, demands more by way of sacrifice from the research team.
My justification of the partial-entrustment model additionally relies on the duty of rescue in another way, namely as a premise in an argument unpacking the entrustment idea. Two other moral principles are also invoked by that argument. The first affirms that each individual has privacy rights that limit othersâ access to his or her body and medical information. The second is a wide but specifiable general duty of beneficence. In a nutshell, the justifica-tory argument is the following: To proceed permissibly, medical researchers must get special permission from their research participants to touch or scan their bodies, sample their bodily fluids, and take their medical histories. In obtaining these permissions, they are soliciting directed waivers of the kind of privacy right just mentioned.4 When these special permissions are given, thenâby a moral logic that we see also in other contextsâthis gives the researchers a special responsibility vis-Ă -vis these participants to look out for the goods that these waived rights ordinarily protect.5 In this case, this special responsibility would prima facie call for staying tactfully silent about any unexpected ancillary diagnosis that crops up, but where this diagnosis reveals that the participant is in dire peril, the duty of rescue entails a duty at least to warn, making silence impermissible. As a result, the special responsibility is shifted toward being a positive one, a duty of âtactful engagement.â6 This positive responsibility, as I have put it, provides a âhookâ on the basis of which to specify the specifiable duty of beneficence in this instance, generating a special ancillary-care obligation.
The partial-entrustment model had a head start on the competitors in this area, of whom there are now thankfully several. The model has come in for its share of criticism. Some of the criticism has come from a roughly consequentialist or impartialist direction, questioning the focus on and defense of an obligation that holds specially between researchers and their study participants and noting that it will sometimes be more cost-effective to help nonparticipants. Much of the criticism has faulted the scope limitation for narrowing the resulting account of researchersâ ancillary-care obligations. As to the former, impartialist criticism, I would remind you that we set out in the beginning to try to construct and to justify an account of researchersâ special ancillary-care obligations. To the extent that the justification succeeds, it provides a basis for resisting this consequentialist pressure. As to the objections to the scope limitation, I will offer two brief observations. The first is just a reminder that the model presumes that a general duty of rescue also applies. That will cover many cases of needed ancillary care that fall outside the scope limitation. The second is that the scope limitation is entailed by the justifica-tory argument I have summarized, in which the special responsibilities derive from the permissions given to carry out study procedures. The question then arises what would justify a special ancillary-care obligation that is broader in scope? In meeting this justificatory burden, my opponents have not to date gotten very far, so far as I am aware. Some have simply invoked the vague idea of relationship without explaining what sort of relationship is involved.7 Others have simply skipped the step of providing a justificatory argument and move directly from noting that practitioners often find the scope limitation unintuitive to concluding that there is a special ancillary-care obligation unencumbered by the scope limitation.8 This is a case of wishful thinking, which is as fallacious in moral theory as it is in other walks of life. Even if all practitioners were agreed that the partial-entrustment modelâs scope limitation was too narrowâwhich, by the way, not all do9âthat would not constitute an adequate moral justification for holding this to be true.
Here, instead of relitigating this dispute about the scope limitation, I would like to take up in a new way my engagement with my consequentialist and impartialist critics. I hope, at the same time, to provide a way of unpacking a metaphor on which my argument still relies. Having unpacked and defended the metaphor of entrustment, I currently still lean on the idea that the positive special responsibilities that arise provide a hook for specifying the special duty of beneficence. What does this mean?
In order to answer this question, I will set out and briefly defend a general methodological stance toward moral theory and then offer a conception of the division of moral labor seen not merely as an implication of a multiplicity of principles but also as a social achievement. This discussion will, in one sense, take me far afield from medical research ethics; in another sense, however, this broader sort of discussion is forced on us wheneverâas in this instanceâwe are called upon to reflect upon how medical research ethics relates to ethics in general.
First, then, the general methodological stance, which concerns how moral theory responds to the contingent facts of our situation. One way that I think any reasonable ancillary-care theory should respond to these facts is by being a nonideal theory. It seems quite plausible that a fully just human society that enjoys our levels of technology and access to resources would be marked by an absence of severe poverty and by an effective universal guarantee to access to health care.10 The most poignant and prevalent needs for ancillary care result from ways in which the world is currently unjust. Presaging the point about the division of moral labor, I suggest that it is pointless, as a response to the question about medical researchersâ ancillary-care responsibilities, to reply by insisting that the world be made just. (Whether medical researchers working in certain localities have any obligation to serve as a vanguard of justice is a separate question.)11
The contingent facts about current injustices are but one example of the many contingent facts that moral theory ought to recognize as it proceeds. There is no reason to demand that moral theory proceed on an a priori basis. As John Rawls famously put it, â[M]oral theory must be free to use contingent assumptions and general facts as it pleases.â12 Furthermoreâand not simply as a corollary of Rawlsâs assertionâmoral theory must be free to draw on and deploy nonderivative principles whose relevance or validityâor bothâis contingent. Here I take a stand against G.A. Cohenâs criticism of âfact-sensitiveâ principles, which I have rebutted elsewhere.13 As Hegel influentially argued, our moral understandings are the product of our contingent history and have been shaped by concrete, contingent social practices. It would be a particularly rash theorist of medical research ethics who resisted this relevance of contingent historical forms, for medical research is itself a contingent development, a practice that arose only recently and might never have arisen.
Now, my consequentialist or impartialist opponents may object that there is no call to have a theory of medical research ethics: All one needs is a general ethical theory. To respond to this objection, I now turn from these fully general characterizations of my methodological stance to the idea of the moral division of labor.
The idea of a moral division of labor has lately been prominent in the discussion of one quite special case, namely Rawlsâs defense of the difference principle as applying to the basic structure of society and not to an individualâs economic decisions within that set of basic institutions. Cohen vigorously contested this differentiation between these two âsitesâ of distributive justice. In this context, the idea of a division of moral labor has been invoked by Rawlsâs defenders. Prominent among them is Samuel Scheffler. In his 2005 contribution to an Aristotelian Society symposium on the division of moral labor, Scheffler introduces a distinction between two kinds of division of labor.14 Schefflerâs distinction is both useful and potentially misleading for a broader examination of the idea of the moral division of labor. The first kind is what Rawls called âa division of labor between two kinds of social rules, and the different institutional forms in which these rules are realized.â15 Here, the disputed example is the differentiation between the basic structure of society, on the one hand, which ought to assure background justice via the provisions of the tax code and the systems of property and contract law, for example, and on the other hand, the rules applying to individual conduct in seeking and selecting employment and making consumer decisions. Because Rawlsâs theory of the justice of the basic structure of society is set up to maintain considerable freedom in the labor market, there are not going to be many such rules. Because these latter so-called rules might be better described as an absence of rules, this example is not a great case of the institutional division of labor. I will come to better examples after discussing the second kind of division of labor Scheffler highlights in Rawls, namely a proper âmoral division of laborâ between two sets of moral principles. As Scheffler puts it, âWhereas the basic structure of society should be designed in such a way as to satisfy the principles of distributive justice, both individual conduct and other groups and associations should in general be guided by other principles and should strive to realize other virtues and ideals.â16 Schefflerâs defense of Rawls proposes that we see the controversial institutional division of labor as being grounded in a distinction among a multiplicity of distinct moral principles and moral or morally important values. Some of these principles and values, Scheffler suggests, are of central importance in some spheres or contexts and others of them in other spheres and contexts.
If we step back from the Rawlsian example but hold on to this sensible pluralism about principles and values, we can locate some cases of a division of moral labor that are somewhat less controversial. The values of love and intimacy, as well as the principles supportive of them, are more central to and important for our practices of friendship and romantic attachment than are the values of justice and legality and the principles that realize them. The latter have their core application to the law and the state. To be sure, this ...