Abstract
When individual patients' medical decisions contribute to population-level trends, physicians may struggle with how to promote justice while maintaining respect for patient autonomy. This article argues that this tension might be resolved by using the informed consent conversation as an opportunity to position patients as societal stewards.
In the landscape of American health care in the twenty-first century, individual patients' medical decisions cannot be viewed in isolation. Each treatment decision a patient makes is situated within a broad societal context, and thus contributes to population-level trends that have an impact on all participants in the health care system. In the public health sphere, for example, individual decisions about whether to vaccinate can contribute to the resurgence of communicable diseases that were until recently considered eradicated. At a systemic level, individual decisions to pursue resource-intensive treatments can contribute to the rising societal costs of health care, higher insurance premiums, and increases in governmental expenditures on Medicare and Medicaid.
The process of obtaining a patient's informed consent has traditionally involved the disclosure of information about medical risks and benefits. 1 But in an era when patients' health care decisions increasingly affect society as a whole, should physicians' ethical obligations change? This article considers whether the informed consent conversation should be approached as an opportunity to position patients as societal stewards, by sharing information about the impact a patient's choice of treatment may have beyond her own health. Viewing informed consent through this lens is one way for physicians to effectively balance their ethical commitments to the promotion of both justice and patient autonomy.
Background: Ethical Theories of Informed Consent
The primary ethical justification for the physician's duty to obtain a patient's informed consent is that doing so promotes patient autonomy. Autonomy is a principle of self-governance that recognizes a person's right to make choices that further her sense of identity without undue interference or coercion by third parties. Autonomy is understood to be a non-consequentialist good — that is, autonomous decisions are valuable not necessarily because they reach the “right” result, but because they are our own. 2
Physicians, as facilitators of patient decision-making, 3 therefore have an ethical obligation to support patient autonomy. This obligation is not absolute, however, as physicians must also take into account other ethical principles, such as beneficence, non-maleficence, and justice. But in the context of informed consent, supporting patient autonomy is typically viewed as the primary goal.
In order for a person's decision to be autonomous, she must have adequate factual understanding about the decision to be made. 4 In the informed consent process, one of the physician's primary duties is ensuring that the patient has enough information about her medical options to satisfy the factual understanding requirement. This necessitates not only sharing medical information the physician is uniquely qualified to provide, 5 but also recognizing the patient's subjective goals and values and providing the patient with the information needed to make a coherent decision in accordance with these goals and values. 6
It is for this reason that many debates in the context of informed consent have focused on defining the substantive scope of the physician's disclosure duty. 7 If physicians have an ethical obligation to provide patients with the information they need to make autonomous choices, what information must be included?
In defining the scope of disclosure, ethical and legal theorists alike have tended to coalesce around concepts like materiality and relevance. 8 However, these terms are maddeningly unspecific and subject to varying interpretations, ultimately providing little concrete guidance. 9 Moreover, on their face, these terms seem to encompass a much broader range of information than the standard disclosure of medical risks and benefits that physicians typically make (normally including substantive information about the patient's diagnosis and proposed treatment; the treatment's risks and benefits; alternative procedures and their risks and benefits; and the risks and benefits of taking no action). 10
Ethical and legal theories of informed consent are just beginning to recognize that the traditional scope of informed consent disclosure may be inadequate to satisfy patients' informational needs.
Indeed, it is widely understood that patient decisions are based on factors beyond the medical efficacy of a procedure and its likelihood of improving physiological well-being. 11 Their decisions may be driven by personal preferences about risk-taking, cost, the prevention of suffering, and the value of extending life. For example, a surgical intervention may be extremely effective and pose only minor medical risks, but a patient may nevertheless reject this option if it is too costly, requires travel or time off work, imposes significant caregiving burdens on family members, or carries other negative consequences in the social, personal, and emotional spheres. If any of these factors might cause a patient to reconsider a treatment decision, surely it counts as material or relevant to the patient's autonomous decision about what choice of medical treatment best supports her goals and values. However, ethical and legal theories of informed consent are just beginning to recognize that the traditional scope of informed consent disclosure may be inadequate to satisfy patients' informational needs. 12
Societal Impact of Individual Health Care Decisions
When making medical decisions, patients are likely to take into consideration the impact those decisions may have on third parties. An extremely costly treatment may deplete a family's resources, rendering parents less able to provide a financially stable household for their children. A treatment with a long recovery period may interfere with a patient's continued employment, and may require family members to adjust their schedules to satisfy additional caretaking requirements. Decisions about whether to pursue genetic testing are often affected by the impact the results might have on family members. 13 And in a number of unique contexts such as pregnancy, surrogacy, and live organ transplantation, a patient's health care decision (to undergo amniocentesis, to seek a reproductive surrogate, to request a kidney from a family member) may impose medical risks on third parties that the patient takes into account when making her choice.
While these examples focus on the direct impact of patients' medical decisions on identified third parties, the structure of the American health care system in the twenty-first century is such that many patient decisions also have indirect (but potentially signifi-cant) effects on the population as a whole. These effects are most apparent in two contexts — public health and societal resources.
Public Health
In the public health context, individual decisions about vaccination, treatment, and isolation or quarantine for communicable diseases can have a significant impact on the health of others.
California, for example, recently experienced deadly outbreaks of measles and whooping cough (diseases thought to be almost entirely eradicated) as a result of pockets of vaccine refusers in wealthy California counties. 14 The public health consequences were so dramatic that in 2015, the California legislature amended its mandatory vaccination law to eliminate religious and personal exemptions — one of only three states in the United States where such exemptions are unavailable. 15 Similar outbreaks have arisen throughout the United States, affecting tens of thousands of people. 16
Patients' refusal to comply with treatment regimens for communicable diseases can have similar effects. Since the 1980's, public health officials have struggled with the spread of multidrug-resistant tuberculosis. 17 Because effective treatment of tuberculosis requires a six- to twelve-month long course of medication that many populations (for example, patients experiencing homelessness, poverty, or drug addiction 18 ) are unable or unwilling to complete, state and municipal authorities turned to the courts to prevent the spread of resistant strains of disease. 19 In other contexts as well, medical professionals and public health officials have raised concerns about the expansion of antibiotic-resistant strains of bacteria that kill tens of thousands of people each year, resulting from over-prescription and over-use of common antibiotics. 20
Finally, the globalization of modern society and the rise in international air travel mean that communicable diseases are no longer confined to discrete geographic locations. The panic in the United States surrounding SARS (originating in Southeast Asia), Ebola (originating in West Africa), and Zika (originating in Uganda, but most widespread in Brazil) are just a few examples. Media reports of the impact that individual choices can have on public health as a whole in such contexts have abounded in recent years. In 2014, for example, a nurse who was diagnosed with Ebola after treating a patient at a Texas hospital faced widespread public criticism for traveling on commercial airlines and even shopping at a bridal store 21 before reporting her symptoms to authorities. 22 In 2007, an attorney with multidrug-resistant tuberculosis who traveled abroad on a number of commercial airlines became the first person in over forty years to be isolated under federal quarantine and isolation powers. 23
Societal Resources
Individual health care choices also affect others in less obvious ways. With the widespread expansion of modern health insurance in the mid-twentieth century, the responsibility of paying for health care services shifted away from individuals and towards insurance companies. This had two significant effects. First, it meant that the cost of health care services was spread across a broader risk pool, with low utilizers' insurance premiums effectively subsidizing high utilizers' care. Second, insurance helped insulate patients from the true costs of health care by limiting their financial outlays to premiums, deductibles, and copays and coinsurance rather than the full price of medical treatment, thereby increasing the risk of moral hazard. 24
However, it wasn't until the public debates surrounding the 2010 passage of the Patient Protection and Affordable Care Act (PPACA) that the average American had the opportunity to understand the connection between individual health care expenses and insurance premiums nationwide. Widespread media coverage of PPACA, 25 disparities in health care pricing, 26 controversies over dramatic increases in drug costs, 27 and Medicare's impending insolvency 28 drew public attention to the rising cost curve of American health care.
U.S. health care spending is rising at an unsustainable rate. As of 2015, health care spending accounted for 17.5 percent of the GDP, or approximately three trillion dollars. 29 These figures are even more striking in light of the fact that the United States, which has the highest health care spending of any country in the world, 30 has significantly poorer population health outcomes than other developed countries. 31
The rise in American health care spending can be attributed to a number of factors, but two significant factors are higher overall prices and greater utilization of high-cost services. 32 As Atul Gawande wrote in 2009, “The most expensive piece of medical equipment, as the saying goes, is a doctor's pen.” 33 However, patient expectations also play a significant role — increased medical literacy, easy access to medical information on the internet, direct-to-consumer pharmaceutical marketing, and rising consumerism in the health care industry mean that today's patients (at least to the extent they are insured and therefore insulated from the full cost of treatment) are incentivized to seek more care, rather than less. Physicians report that increases in patients' requests for brand-name drugs, high-tech diagnostic tests like MRIs, and intensive life-sustaining care all likely contribute to the rise in U.S. health care spending — and as utilization of such services increases, so does the expectation that these services are considered the standard of care and ought to be provided to all patients. 34
The “Choosing Wisely” campaign is the most prominent recent example of a proposal to reduce health care costs by increasing patient engagement. Launched by the ABIM (American Board of Internal Medicine) Foundation in 2012, the Choosing Wisely campaign arose in recognition of the fact that many commonly-used medical tests and procedures are not necessary, not supported by evidence-based practice, potentially harmful, and ultimately wasteful. The goal of the Choosing Wisely campaign is to “advanc[e] a national dialogue on avoiding wasteful or unnecessary medical tests, treatments and procedures,” 35 with the dual outcomes of reducing health care costs and improving care quality. The campaign aims not only at changing physicians' practice patterns, but also encouraging dialogue with patients to help them make more informed decisions. 36
Engaging Patients in Conversations about Societal Stewardship
As demonstrated above, individual health care decisions can have significant societal effects in a variety of contexts. For patients choosing among a variety of treatment options, knowing about these potential effects may be relevant to their decision-making. Thus, one might argue that physicians' ethical obligation to support patient autonomy requires disclosure of information about the potential societal consequences of a patient's health care decision.
However, the autonomy-based argument for disclosure may not be satisfactory. First, there is little conclusive empirical evidence that reasonable patients take societal consequences into account when making treatment decisions. Second, a physician presenting information about societal impact must take care to do so in an autonomy-furthering way. Disclosures made in a manipulative or coercive manner may hinder the patient's autonomous decision-making; 37 and even neutral disclosures, depending on the form in which they are made, risk being ineffective. 38
There is, however, a second argument that could be used to support the claim that physicians have a duty to disclose the societal impact of individual treatment decisions as part of the informed consent process. Principles of justice offer an independent ethical justification for disclosure, beyond the principle of respect for patient autonomy, that physicians might consider relevant in the context of informed consent.
The Argument from Justice
Under contemporary theories of medical ethics, health care providers should be guided by the principles of respect for autonomy, beneficence, nonmaleficence, and justice. 39 While the first three principles focus on the patient in need of treatment, the principle of justice has a somewhat broader scope. Whether understood as fairness in opportunity, treatment, or distribution of resources, the justice principle necessarily views the patient as a member of a larger society.
Most often, health care providers' commitment to justice drives them to fight for their patients' rights to access high-quality medical care without regard to race, gender, financial status, disability or any other characteristic upon which discrimination is often grounded — in other words, providers seek to improve the lot of their patients by ensuring fair treatment in an often unfair society.
In the situations described in this article, however, the principle of justice may drive health care providers in a different direction. When a patient's medical decision is likely to have a negative impact on population health or societal resources, the provider should recognize that the patient's failure to take these effects into account when making her decision may result in injustice with respect to others in society.
The relationship between justice and the promotion of social goals is well-recognized in the realm of public health practice. 40 While the ethics of clinical medicine have traditionally focused on the health and welfare of the individual patient, public health ethics focuses primarily on the promotion of health at a population level. 41 Thus, for public health professionals like epidemiologists, policy advisors, researchers, and emergency response experts, societal (rather than individual) needs generally drive decision-making. In the clinical context, however, while “[c]oncern for societal interests has long been recognized as part of physicians' duties,” 42 the historical focus of ethical medical practice has been service in support of individual patients' health needs.
That said, recognition of the medical profession's obligation to promote justice seems to have grown stronger in recent years — whether due to the unprecedented rise in health care spending throughout the country, the dramatic gap in access to health services between the rich and the poor, or the simple fact that wealth inequality among Americans has been increasing. 43 Many professional societies explicitly recognize that the medical profession bears duties to society that extend beyond the duty to the individual patient. 44 For example, the Charter on Medical Professionalism, identified by one author as “the most widely accepted international declaration of professionalism,” 45 establishes a principle of “primacy of patient welfare” while also recognizing the medical profession's obligation to “promote justice in the health care system, including the fair distribution of health care resources.” 46 In a recent issue of the AMA Journal of Ethics dedicated to the theme of human rights and civil liberties, the editors write, “Social justice is not merely a nice idea but a crucial part of our responsibility to promote health.” 47 Particularly in the context of resource allocation and waste and overuse of medical technology, commentators throughout the medical community have recognized a professional obligation to manage resources responsibly. 48
Indeed, in practice, physicians often find themselves in positions where they must balance their duties to their patients against their duties to serve broader — and at times conflicting — societal or institutional obligations. 49 A physician's legal duties, for example, may require her to report patient information to state agencies, even when the disclosure of that information is likely to adversely affect the patient or family. Such obligations arise in the context of reporting requirements for child abuse, 50 gun violence, 51 drug testing, 52 dementia and driving, 53 and communicable diseases. 54 Physicians who testify as experts in court are bound to tell the truth, even if that truth could result in adverse legal consequences 55 — whether in criminal cases (where testimony is used to evaluate the defendant's mental state), custody cases (where testimony about a parent's mental illness could cause them to lose custody), or civil cases in which the plaintiff suffered physical injury (where medical testimony can affect determinations of causation and damages). Employed physicians may also have institutional obligations that potentially conflict with duties to the patient — consider, for example, restrictions on care imposed on physicians practicing in religiously-affiliated hospitals; limits on resource utilization at underfunded hospitals; duties of military physicians to prioritize military interests; and the involvement of prison physicians in practices like involuntary treatment or even lethal injection. 56 While fidelity to patient interests is a central norm in health care, 57 the reality of medical practice in the 21stf century is that physicians are often practicing medicine in contexts where third-party or societal interests impact their treatment of patients. 58
When a physician's duty to her patients conflicts with broader principles of justice, she has a difficult choice. She might choose a traditional fidelity-based approach, committing herself exclusively to the patient's best interests regardless of societal consequences. Alternatively, she might choose to prioritize her responsibilities to society, even if this approach is in tension with principles of patient autonomy and beneficence. But there is, however, a third option that avoids this kind of absolutism.
Decisions about patient care are rarely made unilaterally. As both traditional theories of informed consent and contemporary models of shared decision-making recognize, patients and physicians are partners in the treatment plan, 59 and both have a role in deciding how a patient's course of treatment progresses. Typically, the physician lays out the scope of medical options so that the patient can evaluate which of the options is most consistent with her own preferences and values. The physician then makes recommendations based on her clinical expertise and experience, and these recommendations play a significant role in the patient's evaluation of risks and benefits. But at the end of the day, there are two independent actors in the decision-making process. The physician's role is to present medically viable options, describe their risks and benefits, and make recommendations based on her understandings of the patient's values and preferences. The patient's role is to evaluate the information provided and make a final decision from within the scope of options discussed.
While the process of informed consent or shared decision-making is the primary means by which a physician serves the principle of patient autonomy, it can also be viewed as an opportunity for the physician to exercise her professional responsibility to promote justice by recognizing its relationship to the care process. 60 In informing a patient about the societal consequences of a health care decision, the physician exercises her moral agency and satisfies her ethical obligations, while still leaving the ultimate choice of action to the patient, the final moral actor. 61 The value of such a proposal is that it strikes a balance between the physician's commitment to promote justice and her commitment to respect patient autonomy.
Some might argue that this approach is too deferential to patient autonomy, and that physicians ought to take a more directive approach when issues of justice arise. This challenge is consistent with long-standing criticism of the dominance of autonomy among ethical principles in medicine — many commentators argue that modern clinical practice over-emphasizes patient autonomy at the expense of other important goals (including beneficence, justice, and community). 62 While there is truth to these criticisms, the fact remains (in the United States, at least) that there is extraordinary public — and often professional — resistance to any limitations on patient choice that might be perceived as paternalism or rationing. While physicians may believe that their ethical obligations are best satisfied by imposing some limits on patient choice 63 — for example, excluding extraordinarily costly diagnostic options from a patient's consideration if more affordable options are available — public opposition to such “bedside rationing” is likely insurmountable. Integrating conversations about justice into the informed consent process offers an opportunity for physicians to maintain their commitment to justice in a way that does not run afoul of these concerns — by shifting the locus of stewardship from physician to patient.
The following examples illustrate how physicians might exercise their duties to promote justice and stewardship using the informed consent process.
In the public health context, a pediatrician speaking with a family that is unsure about whether to vaccinate a child could exercise her moral agency with respect to justice principles by informing them that vaccination not only offers medical benefits to the child, but also supports herd immunity that protects vulnerable members of the community (including others who cannot be vaccinated due to medical contra-indications). In fact, the state of Illinois recently imposed such a legal duty on physicians when it adopted an amendment to its school vaccination law in an effort to improve vaccination rates by making exemptions more difficult to obtain. The law now requires that parents seeking a religious exemption from vaccination submit a certificate signed by a health care provider “confirming that the provider provided education to the parent or legal guardian on the benefits of immunization and the health risks to the student and to the community of the communicable diseases for which immunization is required[.]” 64
In the context of communicable disease, a physician whose patient is reluctant to seek treatment or maintain isolation might encourage compliance by emphasizing the risks the patient poses to the community. According to a 2005 Annals of Internal Medicine article, “[m]ost patients who reject public health measures do not want to infect others.” 65 The article recommends that clinicians “establish common ground with patients” by reminding them of the impact their decisions may have on others, as well as the possibility of adverse (but non-medical) consequences to the patient from failure to protect the community — such as harms to “reputation and business relationships[.]” 66 Indeed, it is widely acknowledged that clinicians' responsibilities in public health contexts include discussion with patients to explain the risks to the public that arise from non-compliance with medical recommendations. 67
Where patients' requests or decisions about treatment implicate cost concerns, physicians might also exercise their ethical responsibility to promote justice by raising issues of resource stewardship with patients. The Choosing Wisely campaign explicitly recognizes the value of such conversations, and many commentators have suggested similar discussions in the context of marginally beneficial diagnostic and treatment techniques. For example, an article about patient demands for non-beneficial treatment uses the example of a man with low back pain and no other clinical indications of a serious disorder requesting an MRI. 68 In this case, the authors suggest that the physician respond by explaining that “medical professionals must utilize health care resources responsibly and that the insured patient's health care costs ultimately affect other patients.” 69
Other commentators have proposed that physicians go beyond conversation, and reference cost concerns in formal informed consent documents as well. In a Journal of Medical Ethics article about the economic impact of individual medical choices, the authors note that many patients are “unaware of the social impact of their medical options,” like the economic impact of choosing a brand name medication over a generic.
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Thus, they suggest that doctors should initiate “dialogue about social justice as part of … the informed consent process.”
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They then offer the following proposed consent form for patients requesting high-cost prescriptions: I, as the patient, am requesting that my provider prescribe drug ___________ for me. I understand there are less expensive medications that are also effective. I understand that by requesting this more expensive medication I am increasing healthcare costs to others, increasing the cost of insurance, using resources that could be used elsewhere in the healthcare system and may be taking an additional risk to my health as all of the side effects of new drugs may be not known. The reason that I am asking for this medication is ________________________. I believe that the benefit to me outweighs the potential risks and resultant harms to others.
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Overall, there are ample opportunities for clinicians to incorporate conversations about social justice within informed consent discussions. While it is ultimately up to the patient to decide how relevant these facts are to her decision, the physician can be satisfied that she has made a legitimate attempt to strike an appropriate balance between principles of patient loyalty and justice.
Trust-Based Concerns
Although the proposals above ultimately leave health care decisions in the hands of patients, they are likely to be subject to similar criticisms as proposals for bedside rationing — namely, that when making health care decisions, physicians ought to prioritize patient interests over societal needs. As demonstrated above, however, the profession of medicine has long committed itself to the service of societal needs, and the practice of medicine often requires just the types of tradeoffs contemplated here. From the patient's perspective, however, this criticism may carry greater weight. Despite the realities of modern medical practice and the competing interests physicians are asked to serve, many patients still believe that their health care providers' primary loyalty should be to the individual patient. For example, research has demonstrated that patients are “wary” when physicians discuss societal needs in the context of treatment choices. 73 Instead, patients prefer that the conversations be framed in terms of efficacy and safety, rather than in terms of cost, waste, value, or overuse. 74 In the public health context, likewise, patients who pose a risk of spreading communicable disease are often resistant to recommendations about isolation, and may view providers who emphasize public safety as antagonistic to their interests. 75
In effect, incorporating societal or third-party interests into the conversation between physicians and patients risks eroding the trust-based relationship between them. It is widely acknowledged that the physician-patient relationship rests on a foundation of trust and mutual respect, and that patients who lack trust in either individual physicians or the medical profession as a whole may be less inclined to seek medical care and follow medical recommendations. 76 Therefore, it might be problematic if physicians were encouraged to engage in conversations about societal stewardship as part of the informed consent process, and this practice had trust-negating effects.
Adopting legislation that limits citizens' medical choices in public health contexts would likewise shift these difficult decisions away from the clinical encounter. But in the absence of such widespread societal and legal change, the informed consent conversation may offer a useful opportunity through which providers can balance their commitment to patient interests with their commitment to principles of justice.
Proponents of informed consent as societal stew-ardship might argue, in contrast, that patients may actually be well-served by a broader (and arguably more accurate) understanding of physicians' ethical obligations. 77 Modern medicine has changed significantly over the past decades, and many patients are already aware that the health care they receive is provided within a system that does not necessarily value their best interests – examples include insurance company constraints on reimbursements, hospitals that charge uninsured patients higher rates than insured patients, and providers who have financial relationships with the pharmaceutical and device industries. But unlike these examples, the competing interests that are relevant in the context of societal steward-ship are clearly community interests, rather than the financial interests of specific providers or corporations. Framing the conversation as one about justice – in which everyone has an interest – may defuse patients' concerns that their physicians are motivated by personal financial gain. 78 Physicians may also temper trust-negating effects by framing the conversation in a patient-centered way, encouraging patients to recognize how attention (or lack of attention) to societal issues when making health care decisions may affect them personally — for example, positively or negatively impacting a patient's reputation 79 or insurance premiums. 80 Finally, clarifying that the ultimate choice of care remains in the hands of the patient will serve to emphasize that the physician's commitment to justice will not override her patient's autonomy.
Conclusion
Reasonable people will disagree about whether the process of obtaining informed consent ought to be viewed as an opportunity to engage patients in discussions about the societal consequences of individual health care decisions. Those who recognize physicians' professional responsibility to promote justice, but nevertheless believe patients should have the ultimate freedom to make autonomous health care choices, may find such a proposal appealing. Proponents of informed consent as societal stewardship might seek to encourage it as part of the ethical practice of medicine, or potentially even integrate the model into legal standards for patient decision-making (as did Illinois, with its vaccination exemption law). On the other hand, those who believe that conversations about societal impact will irreparably harm the trust-based relationship between physicians and patients will be less likely to support a model of informed consent that reflects anything other than pure fidelity to patient interests. Regardless of the reader's perspective, however, this article should be helpful in elucidating both sides of the argument.
Clearly, there are other ways to reduce the collective harms to society than can arise from individual patient decisions without implicating the relationship between physician and patient. Widespread social change, regulation, and changes in national health policy would minimize the need for such conversations. 81 For example, a restructuring of the health care financing system might reduce patients' interest in pursuing high-cost care. Adopting legislation that limits citizens' medical choices in public health contexts would likewise shift these difficult decisions away from the clinical encounter. But in the absence of such widespread societal and legal change, the informed consent conversation may offer a useful opportunity through which providers can balance their commitment to patient interests with their commitment to principles of justice.
