In recent years, an old challenge to informed consent has been rediscovered: the challenge of ignorance. Several authors argue that due to the presence of irreducible ignorance in certain treatments, giving informed consent to these treatments is not possible. The present paper examines in what ways ignorance is believed to prevent informed consent and which treatments are affected by that. At this, it becomes clear that if the challenge of ignorance truly holds, it poses a major problem to informed consent. (...) The paper argues, however, that from both an empirical and a theoretical point of view, it is not convincing that ignorance prevents informed consent. Still, it seems important that the presence of irreducible ignorance is openly discussed during the informed consent process. (shrink)

As Medicine shifts from a paternalistic practice to a patient-centered approach, the concept of medical informed consent (IC) has evolved to safeguard patient autonomy. However, its current implementation still presents many challenges in clinical practice. We assessed the knowledge and attitudes of the general Lebanese population regarding the IC process as well as their sociodemographic and medical correlates. An anonymous online survey was distributed to the Lebanese population using social media channels. A sample of 500 adults with an average age (...) of 36.2 ± 13.5 years, including 319 females and 181 males, was recruited. Most of the respondents had a university degree (85.8%), reported previous hospital admissions (75.9%) and had signed an IC for surgical procedures (40.7%). Few participants were knowledgeable about IC Lebanese law. Variability in knowledge level was significantly related to gender and a previous hospitalization history. Positive attitudes toward patient autonomy (53.1%) and shared decision-making (57.5%) correlated with older age, female gender, graduate education, and a previous history of signing an IC document. Males were more likely to believe that IC has positive effects on health than females. This is the first study that provides novel findings regarding Lebanese peoples’ awareness of the ethico-legal components of medical IC. (shrink)

Progressing beyond the given has been a key modern tendency. Yet modern societies are currently facing the problem of how to put limits on progress, expansion, and growth, live within them, and preserve (rather than transcend) the present. Drawing on economic sociology scholarship on valuation and morality in economic life, this article develops and applies the term economization to analyze the enactment of limits on progress. The question of end-of-life care—when to stop medical efforts to prolong life, postpone death, and (...) advance the scientific frontier—serves as an illustrative empirical case that sheds light on limit-setting in general. My analysis of this case combines historical, ethnographic, and in-depth interview data on US palliative care clinicians, who specialize in making life-and-death decisions in acute care hospitals. (shrink)

Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid (...) consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials. (shrink)

The COVID-19 Pandemic a stress test for clinical medicine and medical ethics, with a confluence over questions of the proportionality of resuscitation. Drawing upon his experience as a clinical ethicist during the surge in New York City during the Spring of 2020, the author considers how attitudes regarding resuscitation have evolved since the inception of do-not-resuscitate orders decades ago. Sharing a personal narrative about a DNR quandry he encountered as a medical intern, the author considers the balance of patient rights (...) versus clinical discretion, warning about the risk of resurgent physician paternalism dressed up in the guise of a public health crisis. (shrink)

Trust is a core feature of the physician-patient relationship, and risk is central to trust. Patients take risks when they trust their providers to care for them effectively and appropriately. Not all patients take these risks: some medical relationships are marked by mistrust and suspicion. Empirical evidence suggests that some patients and families of color in the United States may be more likely to mistrust their providers and to be suspicious of specific medical practices and institutions. Given both historical and (...) ongoing oppression and injustice in American medical institutions, such mistrust can be apt. Yet it can also frustrate patient care, leading to family and provider distress. In this paper, I propose one way that providers might work to reestablish trust by taking risks in signaling their own trustworthiness. This interpersonal step is not meant to replace efforts to remedy systemic injustice, but is an immediate measure for addressing mistrust in occurrent cases. (shrink)

Uncertainty and affect are fundamental and interrelated aspects of the human condition. Uncertainty is often associated with negative affect, but in some circumstances it is associated with positive affect. In this paper, we review different explanations for the varying relationship between uncertainty and affect. We identify “mental simulation” as a key process that links uncertainty to affective states. We suggest that people have a propensity to simulate negative outcomes, which results in a propensity towards negative affective responses to uncertainty. We (...) also propose the existence of several important moderators of this process, including context and individual differences such as uncertainty tolerance, as well as emotion regulation strategies. Finally, we highlight important knowledge gaps and promising areas for future research, both empirical and conceptual, to further elucidate the relationship between uncertainty and affect. (shrink)

Prognostication has something of a rich and distinguished history. Hippocrates, for instance, suggests that “the best physician is the one who has the providence to tell to the patients according to his knowledge the present situation, what has happened before, and what is going to happen in the future”. In Hippocrates’s estimation, the truly exceptional physician is one who is able to forecast competently the outcome of a disease or other medical condition and effectively communicate that information to the patient (...) or the patient’s proxy.In addition to influencing therapeutic decisions, an accurate and honest prognosis may serve to manage patients’ expectations and facilitate a frank.. (shrink)

Over the past thirty years, the doctrine of informed consent has become a focal point in discussions of medical ethics. The literature of informed consent explores the evolution of the principle of autonomy, purportedly emerging from the mists of 19th Century medical practice, and finding its earliest articulation in legal cases where wronged citizens asserted their rights against medical authority. A commonplace, if not obligatory, feature of that literature is a reference to the case of Mary Schloendorff and the opinion (...) written by Judge Benjamin Cardozo by which the case is remembered. Commentators today applaud the prescience of Cardozo for an early articulation of what eventually would become bioethical orthodoxy concerning informed consent and its place as a bulwark of patient autonomy. They inevitably quote Cardozo's famous statement, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body.”. (shrink)

In contemporary paternalism literature, persuasion is commonly not considered paternalistic. Moreover, paternalism is typically understood to be problematic either because it is seen as coercive, or because of the insult of the paternalist considering herself superior. In this paper, I argue that doctors who persuade patients act paternalistically. Specifically, I argue that trying to persuade a patient (here understood as aiming for the patient to consent to a certain treatment, although he prefers not to) should be differentiated from trying to (...) convince him (here understood as aiming for the patient to want the treatment) and recommending (the doctor merely providing her professional opinion). These three forms of influence are illustrated by summaries of video-recorded hospital encounters. While convincing and recommending are generally not paternalistic, I argue that persuasion is what I call communicative paternalism and that it is problematic for two reasons. First, the patient’s preferences are dismissed as unimportant. Second, the patient might wind up undergoing treatment against his preferences. This does not mean that persuasion always should be avoided, but it should not be undertaken lightly, and doctors should be aware of the fine line between non-paternalism and paternalism. The fact that my analysis of paternalism differs from traditional accounts does not imply that I deem these to be wrong, but rather that paternalism should be considered as a more multi-faceted concept than previous accounts allow for. (shrink)

After briefly sketching common-morality principlism, as presented in Principles of Biomedical Ethics, this paper responds to two recent sets of challenges to this framework. The first challenge claims that medical ethics is autonomous and unique and thus not a form of, or justified or guided by, a common morality or by any external morality or moral theory. The second challenge denies that there is a common morality and insists that futile efforts to develop common-morality approaches to bioethics limit diversity and (...) prevent needed moral change. This paper argues that these two critiques fundamentally fail because they significantly misunderstand their target and because their proposed alternatives have major deficiencies and encounter insurmountable problems. (shrink)

In 1989, Susan Wolf convincingly warned of a troublesome consequence that should discourage any movement in American society towards physician-assisted death—a legal backlash against the gains made for limiting life-sustaining treatment. The authors demonstrate that this dire consequence did not come to pass. As physician-assisted suicide gains a foothold in USA and elsewhere, many other slippery slope arguments are being put forward. Although many of these speculations should be taken seriously, they do not justify halting the new practice. Instead, our (...) courts, regulatory agencies, journalists, professional organisations and researchers should carefully monitor and study it as it unfolds, allowing continuous improvement just as our society has done in implementing the practice of limiting life-sustaining treatment. (shrink)

Genetics offers real opportunities for public health actors. Increased understanding of genetics will illuminate some of the factors that affect disease and, in many cases, will lead to more effective treatments. The recognition that phenylketonuria was caused by a metabolic defect that led to the accumulation of toxic levels of phenylalanine, an elevation that could largely be averted by adopting a low-phenylalanine diet, is an early example. Some cases of what was thought to be Sudden Infant Death Syndrome, a diagnosis (...) used when no etiology is known, now appear to have been caused by metabolic defects in fatty acid oxidation and sodium channel defects. One of the tasks that has already been undertaken by the public health sector is to ensure that genomic information is incorporated into clinical care when the robusmess of findings and their clinical utility have been well defined. (shrink)

Informed consent is ethically incomplete and should be redefined as empowered consent. This essay challenges theoretical assumptions of the value of informed consent in light of substantial evidence of its failure in clinical practice and questions the continued emphasis on autonomy as the primary ethical justification for the practice of consent in health care. Human dignity—rather than autonomy—is advanced from a nursing ethics perspective as a preferred justification for consent practices in health care. The adequacy of an ethic of obligation (...) (namely, principlism) as the dominant theoretical lens for recognising and responding to persistent problems in consent practices is also reconsidered. A feminist empowerment framework is adopted as an alternative ethical theory to principlism and is advanced as a more practical and complete lens for examining the concept and context of consent in health care. To accomplish this, the three leading conceptions of informed consent are overviewed, followed by a feminist critique to reveal practical problems with each of them. The need for a language change from informed to empowered consent is strongly considered. Implications for consent activities in clinical practice are reviewed with focused discussion on the need for greater role clarity for all involved in consent—beyond and inclusive of the patient‐physician dyad, as the practice and improvement of consent is necessarily a transdisciplinary endeavour. Specific concrete and practical recommendations for leveraging nursing expertise in this space are presented. Perhaps what is most needed in the discourse and practice of consent in health care is nursing. (shrink)

Is conscientious objection necessarily incompatible with the role and duties of a healthcare professional? An influential minority of writers on the subject think that it is. Here, we outline...

Rufus of Ephesus's treatise Quaestiones Medicinales is unique in the known corpus of ancient medical writing. It has been taken for a procedural handbook serving an essentially operational purpose. But with its insistent message that doctors cannot properly understand and treat illnesses unless they supplement their own knowledge by questioning patients, and its distinct appreciation of the singularity of each patient's experience, Rufus's work shows itself to be no mere handbook but a treatise about the place of questioning in the (...) clinical encounter. This paper concentrates on two aspects of Rufus's thought that are unusual by comparison with other ancient medical texts: his distinctively person-centred rather than disease-based concept of questioning, and his extension of ‘habits’ beyond the dietary and occupational to include an indeterminate range of individual characteristics whose relevance to illness is not immediately obvious. In his quest for subjective information to set alongside ob.. (shrink)

Too many patients are injured in the course of care. Clinicians may mistakenly cause new harm to a patient or fail to take established steps to improve the presenting condition. Medical institutions within which they work may lack mechanisms to reduce errors or prevent them from harming patients. Many, perhaps even most, injuries are preventable, probably numbering in the hundreds of thousands a year for hospital care alone. Long ignored by medical practitioners and health-care payers and little appreciated by the (...) public, the problem of medical injury is finally receiving high-level policy attention. Much credit goes to the Institute of Medicine for its landmark report of November 1999, which marshaled the evidence about medical injuries and highlighted new approaches to systematic improvement of safety within systems of care. (shrink)

The term “exceptionalism” was introduced into health care in 1991 when Bayer described “HIV exceptionalism” as the policy of treating the human immunodeficiency virus different from other infectious diseases, particularly other sexually transmitted diseases. It was reflected in the following practices: pre- and post-HIV test counseling, the development of specific separate consent forms for HIV testing, and stringent requirements for confidentiality of HIV test results. The justification for these practices was the belief that testing was essential for prevention and that (...) patients might not seek HIV testing if confidentiality were not guaranteed. Confidentiality was believed to be particularly important given the degree of discrimination and stigmatization associated with the illness. Anonymous testing was a further step in ensuring strict confidentiality, even though such a practice prevented public officials from contacting partners and others who were at risk. (shrink)

Medical practitioners are duty-bound to tell their patients the truth about their medical conditions, along with the risks and benefits of proposed treatments. Some patients, however, would rather not receive medical information. A recent response to this tension has been to argue that that the disclosure of medical information is not optional. As such, patients do not have permission to refuse medical information. In this paper I argue that, depending on the context, the disclosure of medical information can undermine the (...) patient’s ability to exercise her autonomy or have therapeutically detrimental effects. In the light of these insights I go on to develop a context-sensitive approach to medical disclosure. The advantage of this account is that it addresses concerns on both sides of the debate; whilst it acknowledges that patients do not have an exercisable ‘right not to know,’ it allows that in some cases medical information ought to be withheld. (shrink)

(2003). The Ethics and Governance of Medical Research: What does regulation have to do with morality? New Review of Bioethics: Vol. 1, No. 1, pp. 41-58.

Physicians make some medical decisions without disclosure to their patients. Nondisclosure is possible because these are silent decisions to refrain from screening, diagnostic or therapeutic interventions. Nondisclosure is ethically permissible when the usual presumption that the patient should be involved in decisions is defeated by considerations of clinical utility or patient emotional and physical well-being. Some silent decisions—not all—are ethically justified by this standard. Justified silent decisions are typically dependent on the physician's professional judgment, experience and knowledge, and are not (...) likely to be changed by patient preferences. We condemn the inappropriate exclusion of the patient from the decision-making process. However, if a test or treatment is unlikely to yield a net benefit, disclosure and discussion are at times unnecessary. Appropriate silent decisions are ethically justified by such considerations as patient benefit or economy of time. (shrink)

The current interest in and discussion of virtue ethics suggests that this approach to moral decisionmaking has several distinct advantages as applied to ethical issues in healthcare delivery. For the most part, calls to incorporate the virtues of the healthcare provider in discussions of these issues have sought to supplement rather than totally replace traditional ethical theories, such as the utilitarian focus on maximizing the best overall consequences and the Kantian concern to act on the duty of respect for persons. (...) Including virtue-based ethics in such discussions allows for a more eclectic view of what should be considered in resolving difficult moral problems. As many critics of the purely principle-based approach have noted, real moral dilemmas are usually quite messy and are not easily susceptible to satisfactory resolution solely on the basis of abstract moral theories or principles. (shrink)

In this article, I reject the “principlism” of Tom Beauchamp and James Childress and argue that respect for autonomy is, and ought to be, the fundamental value of bioethics. To do so, I offer a reconstruction of what I call the field's “founding myth,” a genealogy that affords primacy to the right to be respected as a human being with dignity. Next, I examine the relationship between this basic right and a derivative right of autonomy. I suggest that principlism has (...) promulgated an uncharitable understanding of respect for autonomy, one that ensures that the principle cannot occupy the central position I claim for it. Finally, I sketch a more plausible understanding of respect for autonomy and explore its implications. (shrink)

We have never been so aware of masks. They were in short supply in the early days of COVID-19, resulting in significant risk to health care workers. Now they are highly politicized with battles about mask-wearing protocols breaking out in public. Although masks have obtained a new urgency and ubiquity in the context of COVID-19, people have thought about both the literal and metaphorical role of masks in medicine for generations. In this paper, we discuss three such metaphors—the masks of (...) objectivity, of infallibility, and of benevolence—and their powerful role in medicine. These masks can be viewed as inflexible barriers to communication, contributing to the traditional authoritarian relationship between doctor and patient and concealing the authenticity and vulnerability of physicians. COVID masks, by contrast, offer a more nuanced and morally complex metaphor for thinking about protecting people from harm, authentic and trustworthy communication, and attention to potential inequities both in and beyond medical settings. We highlight the morally relevant challenges and opportunities that masks evoke and suggest that there is much to be gained from rethinking the mask metaphor in medicine. (shrink)

In the spirit of full disclosure, I have been a member of the Delphi panels discussed in this article (Beskow and Weinfurt 2019) since their inception and was one of the people who was recently int...

Repositories of tissues, cell lines, blood samples, and other biological specimens are crucial to genomics, proteomics, and other emerging forms of biomedical research. Creation of these repositories by individual researchers and their affiliated organizations, commercial entities, and even governments has been labeled “biobanking” in the bioethics literature. Biobanking as a metaphor for the collection, transfer, and use of these specimens suggests a framework for the legal response to conflicts that may arise - one embedded in principles of contract law and (...) property ownership with an overlay of legislatively authorized regulation of the “industry.”. (shrink)

:Although recent literature on professionalism in healthcare abounds in recommended character traits, attitudes, or behaviors, with a few exceptions, the recommendations are untethered to any serious consideration of the contours and ethical demands of the healing relationship. This article offers an approach based on the professional’s commitment to trustworthiness in response to the vulnerability of those seeking professional help. Because our willingness and ability to trust health professionals or healthcare institutions are affected by our personality, culture, race, age, prior experiences (...) with illness and healthcare, and socioeconomic and political circumstances—“the social determinants of trust”—the attitudes and behaviors that actually do gain trust are patient and context specific. Therefore, in addition to the commitment to cultivating attitudes and behaviors that embody trustworthiness, professionalism also includes the commitment to actually gaining a patient’s or family’s trust by learning, through individualized dialogue, which conditions would win their justified trust, given their particular history and social situation. (shrink)

The dominant, individualistic understanding of autonomy that features in clinical practice and research is underpinned by the idea that people are, in their ideal form, independent, self-interested and rational gain-maximising decision-makers. In recent decades, this paradigm has been challenged from various disciplinary and intellectual directions. Proponents of ‘relational autonomy’ in particular have argued that people’s identities, needs, interests – and indeed autonomy – are always also shaped by their relations to others. Yet, despite the pronounced and nuanced critique directed at (...) an individualistic understanding of autonomy, this critique has had very little effect on ethical and legal instruments in clinical practice and research so far. In this article, we use four case studies to explore to what extent, if at all, relational autonomy can provide solutions to ethical and practical problems in clinical practice and research. We conclude that certain forms of relational autonomy can have a tangibl... (shrink)

Medicine seeks to overcome one of the most fundamental fragilities of being human, the fragility of good health. No matter how robust our current state of health, we are inevitably susceptible to future illness and disease, while current disease serves to remind us of various frailties inherent in the human condition. This article examines the relationship between fragility and uncertainty with regard to health, and argues that there are reasons to accept rather than deny at least some forms of uncertainty. (...) In situations of current ill health, both patients and doctors seek to manage this fragility through diagnoses that explain suffering and provide some certainty about prognosis as well as treatment. However, both diagnosis and prognosis are inevitably uncertain to some degree, leading to questions about how much uncertainty health professionals should disclose, and how to manage when diagnosis is elusive, leaving patients in uncertainty. We argue that patients can benefit when they are able to acknowledge, and appropriately accept, some uncertainty. Healthy people may seek to protect the fragility of their good health by undertaking preventative measures including various tests and screenings. However, these attempts to secure oneself against the onset of biological fragility can cause harm by creating rather than eliminating uncertainty. Finally, we argue that there are good reasons for accepting the fragility of health, along with the associated uncertainties. (shrink)

Many writers suggest that managed care had a brief life and that we are now in a post-managed care era. Yet managed care has had a long history and continues to thrive. Writers also often assume that managed care is a fixed entity, or focus on its tools, rather than the context in which it operates and the functions it performs. They overlook that managed care has evolved and neglect to examine the role that it plays in the health system.This (...) article argues that private actors and the state have used managed care tools to promote diverse goals. These include the following: increasing access to medical care; restricting physician entrepreneurialism; challenging professional control over the medical economy; curbing medical spending; managing medical practice and markets; furthering the growth of medical markets and private insurance; promoting for-profit medical facilities and insurers; earning bounties for reducing medical expenditures; and reducing governmental responsibility for, and oversight of, medical care. Struggles over these competing goals spurred the metamorphosis of managed care internationally. (shrink)

A powerful movement is afoot to create a national computerized system of health records. Advocates claim it could save the health delivery system billions of dollars and improve the quality of health services. According to Lawrence Gostin, a leading commentator on privacy and health records, this new infrastructure is “already under way and [has] an aura of inevitability.” When it is in place, almost any information that is viewed as relevant to a decision in the health care delivery system would (...) be available to a large and yet undetermined number of individuals. The transformation of the collection and communication of health information from texts housed by health care providers and facilities to data electronically transmitted through networks of linked computers has significant implications for confidentiality and for data collection in scientific research. The best evidence clearly indicates that most people in the United States consider confidentiality for health information important and worry that the increased computerization of health records will result in inappropriate disclosure. (shrink)

Physicians treating newly incapacitated patients often must navigate surrogate decision-makers through a difficult course of treatment decisions. Such a process can be complex. Physicians must not only explain the medical facts and prognosis to the surrogate, but also attempt to ensure that the surrogate arrives at decisions that are consistent with the patient's own values and wishes. Where these values and wishes are unknown, physicians must help surrogates make decisions that reflect the patient's best interests.

Too many patients are injured in the course of medical care. This truth is as distressing now as it was four years ago when it began an article in this journal’s last similar symposium. Many or most injuries seem preventable. Yet today’s systems of care and of oversight of care too often fail to prevent them, despite generations of increasing legal intervention. Few injuries are litigated, even fewer addressed through medical peer review or state disciplinary authorities. The Institute of Medicine’s (...) landmark report To Err Is Human brought patient safety to national attention when released in late 1999. Half a decade later, significant reduction of injury remains a distant prospect, despite some apparent progress. (shrink)

In the United States the delivery of health care traditionally has been hierarchical and strictly controlled by physicians. Physicians typically provided patients with little information about their diagnosis, prognosis, and treatment plan; patients were expected to follow their physicians’ orders and ask no questions. Beginning in the 1970s, with the widespread adoption of the doctrine of informed consent to treatment, the physician-patient relationship began to be more collaborative, although the extent of the change has been subject to debate. At a (...) minimum, physicians began to give patients more information and asked them to consent to recommended treatment, the therapeutic privilege to withhold information from patients lost support and eventually was repudiated, and physicians embraced — at least in theory — a more patient-centered conception of health care.More recently, health care and health promotion activities have moved beyond clinical encounters and the strict confines of physician-patient interactions. (shrink)

Courts are divided as to whether abortion informed consent mandates violate the First Amendment. This article argues that given the doctor's and patient's unique expertise, the patient's strong interests in autonomous decision making, and the fact that these laws regulate speech, rather than conduct, heighted or strict scrutiny should apply to such mandates.

Although informed consent is an integral part of clinical practice, its current doctrine remains mostly a matter of law and mainstream ethics rather than empirical research. There are scarce empirical data on patients’ perceived purpose of informed consent, which may include administrative routine/courtesy gesture, simple honest permission, informed permission, patient-clinician shared decision-making, and enabling patient’s self decision-making. Different purposes require different processes.

The American Medical Association's Code of Ethics prohibits physicians from giving substances they believe are placebos to their patients unless the patient is informed of and agrees to use of the substance. Various questions surround the AMA policy, however. One of these has to do with what should be disclosed. The AMA holds that any treatment that the physician believes is a placebo should be identified as such to the patient. But consider a more restrictive policy that requires physicians to (...) defer to the medical community's consensus view about which treatments have a specific effect on the condition being treated. In light of the ethical goals that the AMA identifies—namely, concerns about patient trust, autonomy, and benefit—there are potential advantages to the more restrictive policy. (shrink)

S. Matthew Liao's paper (2005) exemplifies what I characterize as the third stage in the lifecycle of bioethics, “bioethics as co-PI,” in which bioethics asserts a role in directing the biomedical...

The concept of paternalism is intricately tied to the concept of autonomy. It is commonly assumed that when paternalistic interventions are wrong, they are wrong because they impede individuals’ autonomy. Our aim in this paper is to show that the recent shift towards conceiving of autonomy relationally highlights a separate conceptual space for a nonpaternalistic kind of interpersonal intervention termed maternalism. We argue that maternalism makes a twofold contribution to the debate over the ethics of interpersonal action and decision-making. Descriptively, (...) it captures common experiences that, while not unusual in everyday life, are largely absent from the present discussion. Normatively, it describes a type of intervention with justification conditions distinct from the standard framework of paternalism. We explicate these contributions by describing six key differences between maternalism and paternalism, and conclude by anticipating and responding to potential objections. (shrink)

To understand the future of informed consent, we should pay attention to two ethical-legal sources in addition to the revised Common Rule. Physicians acting as investigators and patients serving as research subjects bring to that relationship a long history regarding consent to treatment, and everyone dealing with research ethics needs to be aware of the Nuremberg Code and other human-rights documents. These three streams make separate and distinctly different contributions to informed consent doctrine.

In March 1996, the General Accounting Office issued the report Scientific Research: Continued Vigilance Critical to Protecting Human Subjects. It stated that “an inherent conflict of interest exists when physician-researchers include their patients in research protocols. If the physicians do not clearly distinguish between research and treatment in their attempt to inform subjects, the possible benefits of a study can be overemphasized and the risks minimized.” The report also acknowledged that “the line between research and treatment is not always clear (...) to clinicians. Controversy exists regarding whether certain medical procedures should be categorized as research.”This problem currently plagues gene transfer research. A few months prior to the GAO report, an ad hoc committee appointed by National Institutes of Health Director Harold Varmus expressed similar concerns in its assessment of NIH investment in research on gene therapy. (shrink)

As the millennium approaches, the United States is on the verge of major health care reform. While swallowing scarce national resources, our health care system produces unenviable results and major inconsistencies. In 1992, $838.5 billion were spent on health care, biting more than 14 percent out of our gross national product. From 35 to 37 million Americans, or approximately 14 percent of the populationn, are uninsured. Our health care system is inherently inconsistent: We have the highest birthweight-specific survival rate of (...) any country in the world, yet we rank 19th worldwide in infant mortality rate, i.e., state-of-the-art medical technology allows us to save a 500-gram infant, yet the mother of that infant may not have had access to basic, minimal prenatal care. (shrink)

Mrs. K is a thirty-one-year-old Russian-speaking mother of two, who was brought in by ambulance after attempting suicide by jumping in front of train. Probable depression x months. Stressor: lost custody battle over older child. Current status: deep coma, ventilator-dependent, and prognosis grim. Next of kin is estranged husband; he demands participation in medical decision making. Legal proxy is patient's boyfriend; forcibly removed from the intensive care unit for agitated behavior and alcohol intoxication.I magine the difficulty for the ICU staff (...) as it tries to patch together the broken body of Mrs. K, described above. If, as appears likely, the physicians’ efforts begin to fail, who will speak for this patient, who can no longer speak for herself, and determine the appropriate goals and limits of intensive medical care? (shrink)