At the outset, I described both the ancillary-care and incidental-findings issues as raising questions about the positive obligations of medical researchers. It seems that if there are obligations under either rubric, they are, like beneficence obligations more generally, positive ones (i.e., obligations to do something helpful, not merely obligations to refrain from harming). They are obligations specially incumbent on medical researchers, by which I mean that researchers bear these obligations because of some feature (to be explained) of the distinctive professional relationship that researchers have to their study participants.22
To assert the existence of such special, positive obligations is not to deny the existence of more general ones; indeed, in our original ancillary-care articles, Belsky and I made a point of stressing our assumption that there is a general duty of rescue, incumbent on all persons, that comes into play when the need is dire and the needed intervention is comparatively easy to provide and risk-free.23
We see the ancillary-care obligations as additional obligations, specially owed by researchers to their trial participants, over and above any more general positive obligations.
To exhibit the intuitive appeal of this analytic structure, it will help to consider a marginal sort of case in which the general duty to rescue does not apply. Different people, operating intuitively, will locate this boundary differently. Some physicians I have spoken to submit that the case of spotting a melanoma on the back of someone’s neck at a bus stop may invoke a duty of rescue (incumbent on anyone with the ability to diagnose it), whereas other cases cross the line into “unsolicited medical advice” that is not morally required but actually morally prohibited. For instance, while a neurologist at a bus stop might, from closely observing the person next to her, confidently reach the judgment that there is a good chance that the person has a brain tumor, say, or incipient Parkinson’s, many would balk at saying that she has a moral obligation to say something to this stranger.24
Indeed, some would say that it would be an abuse of her power as a physician to intervene — or, that if she were to mask her expertise by saying, “Hey, you’re blinking kinda funny. Did you ever ask your doc about that?” she would not only be abusing her power but also would be acting duplicitously. While it will be controversial where to draw the line between cases imposing a general duty to rescue and those not imposing that duty, it seems clear that there is a line to be drawn.25
Take, then, a case in which you think it is certainly not morally required, and perhaps even morally problematic, for a physician to intervene with a stranger. Perhaps you think that one of my cases of a neurologist observing symptoms at the bus stop (either the brain tumor variant or the Parkinson’s variant) is one in which it would be problematic for the neurologist to say anything. Now take that case and place it in the research setting. That is, suppose that the neurologist notices the relevant symptoms, not at a bus stop, but during an examination that is part of a research study. I suspect you will find that this change in context makes an important moral difference, and that the neurologist has an obligation in the research setting that was missing at the bus stop. If so, then you will have recognized what I am referring to as an obligation specially incumbent on the neurologist in her capacity as a researcher and, specifically, in her capacity as part of this individual’s
In considering the topic of medical researchers’ ancillary-care obligations, then, we are contemplating special obligations incumbent on certain individuals in virtue of their professional role and, specifically, in virtue of their standing in a professional relationship with their research participants. There are several reasons why this is both a difficult topic and one that has not yet been adequately addressed by research-ethics guidelines. One reason is that ancillary-care obligations are positive obligations — that is, obligations to do certain things for people, as opposed to negative obligations, obligations not to do certain things to people. I have already alluded to how little the Common Rule expresses positive obligations — except derivatively, as means of ensuring that researchers’ negative obligations are not violated. For instance, in response to scandals and abuses, the Common Rule imposed the positive duty to obtain informed consent in order to establish a procedural check that would help prevent researchers from manipulating their subjects or exposing them to undue risks. Here, the positive duty created by the regulations is in service of the underlying, negative duties. Positive obligations are generally less well understood than negative ones, and are less well reflected in the Common Rule.
An additional reason for the unsettled character of the ethical issues surrounding incidental findings and ancillary care is that the profession of medical research sits uneasily at the intersection of two older and better-understood professions: science and medicine. Rhetorically, there are many different ways of getting at this distinctive feature of medical research. In our original ancillary-care article, Belsky and I contrasted two “polar views” about ancillary care: one analogizes medical researchers to personal physicians, and hence sees researchers’ ancillary-care obligations as extending very broadly to all aspects of their study participants’ health; the other analogizes medical researchers to “pure scientists,” and hence denies that researchers have any ancillary-care obligations.26
Here, however, to vary the rhetoric and to engage with an important recent article by Franklin G. Miller and Donald L. Rosenstein on the professional obligations of medical researchers, I will present things differently.
Miller and Rosenstein, writing generally about “The Therapeutic Orientation to Clinical Trials,” decry the confusions that flow from conflating clinical research with medical care. “To avoid exploitation and misplaced trust,” they argue, “an investigator approaching a patient about enrollment in a study should describe his or her own role as primarily that of a scientist in pursuit of knowledge aimed at improving medical
The best way to interpret ancillary-care obligations is to center them on incidental findings. If this is right, then an understanding of ancillary-care obligations provides a good moral basis for tackling the issue of incidental findings.
care for future patients, rather than as that of a personal physician dedicated to promoting the individual patient’s health.” More generally, they suggest, ethical progress would be made over the current “therapeutic orientation” by seeing research on healthy volunteers, in most of which “the vantage point...is solely scientific,” as being paradigmatic.27
Although the rhetoric here differs quite markedly from our own dialectical use of the figure of the “pure scientist,” I actually have no quarrel with these claims of Miller and Rosenstein. I agree that medical researchers occupy a very different role than that of primary-care physicians and other clinicians, and that this difference hinges on the fact that medical researchers aim primarily to contribute to general knowledge. In my papers with Belsky, however, the “pure scientist” had an additional defining characteristic, namely the tendency to assert that because medical researchers are scientists first and foremost, they have no ancillary-care obligations. In arguing against the model of the pure scientist in our articles, therefore, Belsky and I were not disagreeing with Miller and Rosenstein’s sort of characterization of medical research, but instead were targeting the claim that medical researchers have no ancillary-care obligations. That medical researchers lack ancillary-care obligations simply does not follow from the fact that they are scientists, first and foremost. After all, they are scientists involving human subjects in their research.
Miller and Rosenstein concede that the analogy to research with healthy volunteers only takes one so far: “Just as it is inaccurate to conceive of clinical trials as a form of medical care, it is unrealistic to think of research involving patients as the same as research involving healthy volunteers. Unlike healthy volunteers, patient-subjects do need treatment and care.”28
This is fair enough as far as it goes, but the issues of incidental findings and ancillary care show that it does not go far enough. These issues reveal that the idea of a “healthy volunteer” is a misleading abstraction. A non-trivial percentage of the supposedly healthy and indeed asymptomatic volunteers who sign up for brain MRI studies, as we have seen, will be harboring, unbeknownst to anyone, potentially dangerous brain anomalies. A “healthy volunteer” for a study on CT colonography may turn out to have a dangerous aortic aneurysm. Yes, theoretical individuals who are stipulated to be, in a pure and abstract sense, “healthy” will not need treatment or care, but the flesh-and-blood “healthy volunteers” that research medicine actually enrolls may, in fact, not be fully healthy after all, despite the best efforts of the study’s pre-enrollment screening team. When the research discloses their lack of perfect health, we have an incidental finding and a potential claim for ancillary care.
Our argument against the polar view that assimilates ancillary-care obligations to a clinician’s obligations to his patients was essentially the same as Miller and Rosenstein’s central argument against the “therapeutic orientation”: this polar view clashes with the organizing purpose of the research enterprise. The attempt to maintain it in the face of contrary reality thus leads to all sorts of “ethical distortion.”29
But what are the arguments against seeing medical researchers as scientists who, given their primary allegiance to science, have no ancillary-care obligations? This is an issue on which Miller and Rosenstein leave matters open. I see two principal ways of arguing this latter point, one more direct and intuitive and the other working more indirectly, by analogy to other spheres. It was the latter, indirect mode of argument that led Belsky and me to our specific proposal about the content of researchers’ ancillary-care obligations. Before I come to that line of argument, though, let me briefly describe the more direct line.
The more direct line of argument takes off, in effect, from the way in which, as we have just seen, Miller and Rosenstein’s concession needs to be revised. It is not merely that medical research deals with “patients” as well as with “healthy volunteers.” The point, more generally, is that the medical research we are talking about enrolls human beings, on whom it experiments. When one does that with another human being, one naturally comes under particularly close scrutiny by reference to a moral principle that constrains all of our actions, namely the Kantian principle that we ought not treat persons as mere means. Although the general meaning of this principle is notoriously elusive, the context of medical experimentation on human subjects exemplifies the dangers of treating persons as mere means. To treat someone as a mere means to gathering proteins or genes or to observing the interaction between T-cells and viruses is to treat them as a mere means, period. What it takes, in this context, to treat them also “as an end” thus becomes the question. If research participants had full information about their condition and have attained a full understanding of the nature and the risks of the procedures involved in the research, securing their informed consent to participation would probably suffice. Indeed, under those idealized suppositions, interfering with their ability unconstrainedly to enter into researcher-participant relations — say by institutionally imposing an ancillary-care obligation, a level of enforcement the present essay does not reach — would seem to be an objectionable form of paternalism. Equally clearly, however, these idealizations falsify. Research participants generally lack this full understanding. Further, as the case of incidental findings again shows, they enter studies lacking full knowledge about their own medical conditions. Hence, any paternalism here is “soft” because interference is justifiable by reference to what the individuals would choose if they had full information and ideal understanding.30
Given the lack of full information and given the huge average asymmetry in knowledge and understanding between the researchers on the one side and research participants on the other, we should conclude that the procedural safeguard of informed consent does not ensure that research participants are treated “also as ends.”
Concretely, we may confirm this conclusion by imagining a confrontation in which a researcher denies ancillary care to a research participant who otherwise would be unable to get it. Suppose that, in a variant of the Benin microbicide example mentioned above, microbicide researchers discover a dangerous ectopic pregnancy in one of their participants, someone who otherwise would lack any access to surgical care; but suppose that, unlike in the real case, the research team includes a surgeon and has an operating room in its local clinic. Suppose further that they could do the operation needed to save the woman’s life, though with some considerable strain and some diversion of study resources.31
Refusing to do the surgery on the ground that the team is there to do research and not to provide clinical care would be, it seems to me, to treat this woman as a mere source of data about the effectiveness (or whatever) of microbicides, and not also at the same time as an end.
This direct argument, insofar as it is successful, helps explain why there would be ancillary-care obligations that constrain the arrangements otherwise freely arrived at between researchers and study participants, but it does little to help us figure out the specific contours of these obligations. For that purpose, and to confirm the conclusion that these obligations exist, it is useful to consider some analogous situations. There are many potentially illuminating analogies to draw on. Here, to vary and supplement the approach taken in our original articles, I offer one drawn from general beneficence and one drawn from legal ethics.
As I have noted, we all have general duties of beneficence that include at least some limited duty of rescue. Within the context of these general duties, something interesting occurs once one has started helping someone else. As Barbara Herman observes:32
Normally, in providing aid, we take on new responsibilities. You have a headache; I offer aspirin, but by mistake give you antacid. Even if it is now harder to give you the aspirin you need than it would have been, because I started helping I now have to do more. If the aspirin I give you makes you suddenly ill, I am at the front of the line of those who should get you help.
My intuitions align with Herman’s here; but if she and I are right, the question is, why is this so? At the most elementary level, it is obviously relevant that by starting to help a stranger, one enters into a relationship where previously there had been none. If the existence even of this informal and praiseworthy sort of relationship begins to heighten one’s responsibility for helping another, so, too, may the existence of a researcher-participant relationship.
To begin to work out how to understand the idea of “relationship,” here, and for a type of case considerably closer to that of medical research, consider the moral position of a litigation attorney, Marvin, in the following two scenarios:33
Strangers on the Plane
Marvin’s seat mate on the long trip has been chatty. Immediately upon finding out that Marvin is a litigator, the seat mate launches into a complex description of a lawsuit he is intending to file. From the description, Marvin can tell that unless the seat mate files suit within three days, the claim will evaporate. Nonetheless, Marvin is tired, and instead of mentioning this fact, which would require some explanation, he cuts off his seat mate’s conversation as soon as he can, and goes to sleep.
A Stranger in the Office
As soon as the new potential client, who is sitting in Marvin’s office, has finished explaining the matter he wants litigated, Marvin can tell two things: first, that he has no intention of taking on the case himself, and, second, that unless the person files suit within three days, the claim will evaporate. Nonetheless, instead of mentioning the latter fact, which would require some explanation, Marvin cuts off his visitor’s conversation as soon as he can, saying that he is too busy to take on the case, and proceeds to his next appointment.
While these two scenarios are similar, Marvin has a special obligation in the second case that he lacks in the first.34
I gather that this is so as a matter of accepted canons of legal ethics, and it also seems an intuitively clear difference to me; but this differentiation cries out for explanation.
Making explicit the moral difference between these two cases, as I see it, will bring me to the positive proposal Belsky and I have made about researchers’ ancillary-care obligations, our “partial-entrustment model.” In both cases, the stranger offers Marvin information that would otherwise be covered by a right of privacy — that would be privileged, for instance, had the stranger already communicated it to another attorney. Only in the office case, however, has Marvin consented, even implicitly, to be the recipient of such private information. Once having agreed, as a legal professional, to be the recipient of this otherwise private information that he is relatively expert in processing, Marvin may be presumed effectively to have become entrusted with this information. To say this is not to make any claim about the state of mind either of Marvin or of the person in his office. The point, rather, is that in these circumstances, as described without any reference to the parties’ beliefs about entrustment one way or another, Marvin may appropriately, as a moral matter, be deemed to have accepted this information in trust. His having done so gives him some special responsibility to respond to it in a professionally competent manner on this erstwhile stranger’s behalf, whether or not he ends up taking the case. This special responsibility by no means extends to the visitor’s whole welfare, but is delimited by what would count as responding appropriately to this information.
As I now understand our partial-entrustment model of medical researchers’ ancillary-care responsibilities, they are precisely analogous to these special obligations that arise in the office case. To explain this in detail, I need to invite the reader to consider informed consent from a non-standard angle. The Common Rule, with its preoccupation with preventing another Tuskegee, casts informed consent as playing the roles — naturally enough — of adequately informing research participants (as the Tuskegee participants were not) and of securing their voluntary consent. Informed consent thus serves as a substantive ban on duping research participants and as a procedural device to help prevent them from being abused or exploited. In addition to these roles for informed consent, however, there is a third role, one that is, in a way, morally more primitive. Researchers need their participants’ informed consent because they need their participants’ permission to do all sorts of things that would otherwise be impermissible: to touch the participants in certain ways, to collect and study samples of their tissues and bodily fluids, and more generally to collect confidential medical information about them.35
Although permission may be needed for various reasons in each of these cases, a common thread runs through them all: each of these types of action for which medical researchers need special permission is saliently, from the researchers’ point of view, a mode of gathering information from this particular individual information that would otherwise be covered by a right of privacy. By soliciting these permissions, the researchers have implicitly consented to being the recipients of this private information. Accordingly, just as in the office case, medical researchers, via the informed-consent process, become entrusted with special responsibilities pertaining to the information thus gathered. Again, to say this is to make no claim about whether either party believes that any entrustment has occurred or whether either party trusts the other. Rather, it is to make the moral claim that it is appropriate to deem
the researchers to have implicitly accepted an entrustment-style responsibility to respond appropriately and professionally to the information thus gleaned. This special responsibility is the core of their ancillary-care obligations.
Because this talk of waivers of the right to privacy may seem rather highfalutin’, it may help to go back to Herman’s observation about what happens when one starts to help a stranger. From the point of view of this notion of partial entrustment, we can see that, once one offers a stranger an aspirin, one willingly enters into aspects of the stranger’s life that would otherwise have been none of one’s business. Once one starts finding out intimate details about someone’s headaches — or tumors, or aneurysms — by a process that (unlike in “Strangers on the Plane”) one has voluntarily accepted, one starts to accrue special responsibilities to deal with the follow-up.
Every incidental finding thus falls within the scope of the ancillary-care obligation and therefore counts as giving rise to a potential ancillary-care claim, unless a stricter basis of obligation, such as the requirement to conduct studies safely or the requirement to fulfill one’s promises, already covers it.
I have just said that this idea of partial entrustment captures and explains the “core” of medical researchers’ ancillary-care obligations. I do not believe, however, that it is the whole story. Medical research is a tremendously varied enterprise, and studies differ radically one from another. Many of the differences of study design, conduct, and context play some role in shaping the specific ancillary-care obligations that apply to a given study. In order to mark these two aspects, our original articles labeled the core concern a matter of the “scope” of the ancillary-care obligation, provisionally lumping the remaining factors together under a test of the obligation’s “strength.” A given aspect of a participant’s health is rightly deemed to have been entrusted to the researchers’ care — and so to be within the scope of the special ancillary-care obligation, only if the researchers needed permission to collect information pertaining to it in order to proceed permissibly with their study.36
The factors affecting the ancillary-care obligation’s strength in the context of a given potential claim (within the scope of the obligation, as just defined) and a given study include the following: (1) how much difference getting care would make to the welfare of the individual (“vulnerability”); (2) how dependent such an individual is on the research team for getting that care (“dependence”); (3) how intense and long-lived the relationship expectably is between researcher and participant (“engagement”— recall the case of starting to help a stranger); (4) whether the researchers owe the participants any debt of gratitude for their willingness to undergo procedures that may be risky, painful, or inconvenient (“gratitude”); and (5), countervailingly, the cost to the research enterprise of providing any ancillary care.37
For a given claim to ancillary care to succeed, it must pass both tests, scope and strength.
On this analysis, all of the factors that shape medical researchers’ ancillary-care obligations can be assessed at the stage of initial protocol review, on the basis of the study’s general design, though of course there may always be some surprise needs for ancillary care. One might not be able to predict an ectopic pregnancy, but one would be able to say in advance that if a researcher conducting physical exams as part of a vaginal microbicide trial discovered an ectopic pregnancy, dealing with that would fall within the scope of the research team’s ancillary-care obligation. In this case, the difficult question will be whether the ancillary-care claim passes the test of strength. In the actual case in Benin, where the closest surgical facility capable of doing the needed surgery was in the capital of a neighboring country, the cost to the research enterprise of diverting resources to the necessary evacuation would probably have justified omitting to ensure that this woman receive the operation she needed, tragic as that outcome would be. Judging by his inspiring commitment to the poor in Haiti, Dr. Paul Farmer would have insisted on finding some way to get her there, and in so doing would have taught the world a lesson about the injustice of a world in which this predicament arises; but it seems to me doubtful that these researchers had a moral obligation to take such a step. We should not forget, however, that in many cases the test of strength will be easily met. If, for example, infectious-disease researchers find worms in the African children they are studying, they have, over and above any duty of rescue, an ancillary-care obligation to provide them with de-worming pills, which are cheap and effective. And very many cases will fall in between the Benin case and the de-worming case.