The legal doctrine of informed consent has overwhelmingly failed to assure that the medical treatment patients get is the treatment patients want. This Article describes and defends an ongoing shift toward shared decision making processes incorporating the use of certified patient decision aids.

Patient decision aids enable patients to be better informed about the potential benefits and harms of their healthcare options. Certification of patient decision aids at the national level in the United States is a critical step towards responsible governance—primarily as a quality measure that increases patients’ safety, as mandated in the U.S. Patient Protection and Affordable Care Act (PPACA). Certification would provide a verification process to identify conflicts of interest that may otherwise bias (...) the scientific evidence presented in decision aids. Certification also benefits clinicians who may otherwise face malpractice claims based on harm to patients caused by possible reliance on patient decision aids that are inaccurate, incomplete, or presented in a manner that biases the patient’s decision. Existing work by the International Patient Decision Aid Standards Collaboration could guide the establishment of a certification process within the U.S. This article argues for national certification of patient decision aids and discusses how that may be achieved. (shrink)

Syltern and colleagues argue that we should give parents more time to make difficult decisions about life-sustaining treatment at the margins of viability (Syltern et al. 2022). This thesis is appe...

This “Legal Briefing” column covers recent legal developments involving patient decision aids. This topic has been the subject of recent articles in JCE. It is included in the 2010 Patient Protection and Affordable Care Act. And it has received significant attention in the biomedical literature, including a new book, a thematic issue of Health Affairs, and a recent article in the New England Journal of Medicine. Moreover, physicians and health systems across the United States are increasingly (...) integrating decision aids into their clinical practice. Both federal and state laws play a significant role in promoting this expanded use. On the other hand, concerns about liability could stymie development and implementation. We categorize legal developments concerning patient decision aids into the following five sections:1. Development of decision aids2. Effectiveness of decision aids3. Federal regulation of decision aids4. State regulation of decision aids5. Legal concerns regarding decision aids. (shrink)

Background Recent publications reveal shortcomings in evidence review and summarization methods for patient decision aids. In the large-scale "Share to Care (S2C)" Shared Decision Making (SDM) project at the University Hospital Kiel, Germany, one of 4 SDM interventions was to develop up to 80 decision aids for patients. Best available evidence on the treatments' impact on patient-relevant outcomes was systematically appraised to feed this information into the decision aids. Aims of this (...) paper were to (1) describe how PtDAs are developed and how S2C evidence reviews for each PtDA are conducted, (2) appraise the quality of the best available evidence identified and (3) identify challenges associated with identified evidence. Methods The quality of the identified evidence was assessed based on GRADE quality criteria and categorized into high-, moderate-, low-, very low-quality evidence. Evidence appraisal was conducted across all outcomes assessed in an evidence review and for specific groups of outcomes, namely mortality, morbidity, quality of life, and treatment harms. Challenges in evidence interpretation and summarization resulting from the characteristics of decision aids and the type and quality of evidence are identified and discussed. Conclusions Evidence reviews in this project were carefully conducted and summarized. However, the evidence identified for our decision aids was indeed a "scattered landscape" and often poor quality. Facing a high prevalence of low-quality, non-directly comparative evidence for treatment alternatives doesn't mean it is not necessary to choose an evidence-based approach to inform patients. While there is an urgent need for high quality comparative trials, best available evidence nevertheless has to be appraised and transparently communicated to patients. (shrink)

The objective of this study is to evaluate if use of a patient decision aid, when choosing between a repeat cesarean or a trial of labor after a cesarean, reduces medical liability exposure. The authors conclude that use of a PDA conferred liability protection when potential jurors were presented with a hypothetical malpractice claim against an obstetrician following a TOLAC.

PurposeAdvance directives have been criticized for failing to help physicians make decisions consistent with patients’ wishes. This pilot study sought to determine if an interactive, computer-based decision aid that generates an advance directive can help physicians accurately translate patients’ wishes into treatment decisions.MethodsWe recruited 19 patient-participants who had each previously created an advance directive using a computer-based decision aid, and 14 physicians who had no prior knowledge of the patient-participants. For each advance directive, three physicians were (...) randomly assigned to review the advance directive and make five to six treatment decisions for each of six (potentially) end-of-life clinical scenarios.From the three individual physicians’ responses, a “consensus physician response” was generated for each treatment decision (total decisions = 32). This consensus response was shared with the patient whose advance directive had been reviewed, and she/he was then asked to indicate how well the physician translated his/her wishes into clinical decisions.ResultsPatient-participants agreed with the consensus physician responses 84 percent (508/608) of the time, including 82 percent agreement on whether to provide mechanical ventilation, and 75 percent on decisions about cardiopulmonary resuscitation (CPR).Across the six vignettes, patient-participants’ rating of how well physicians translated their advance directive into medical decisions was 8.4 (range = 6.5-10, where 1 = extremely poorly, and 10 = extremely well). Physicians’ overall rating of their confidence at accurately translating patients’ wishes into clinical decisions was 7.8 (range = 6.1-9.3, 1 = not at all confident, 10 = extremely confident).ConclusionFor simulated cases, a computer-based decision aid for advance care planning can help physicians more confidently make end-of-life decisions that patients will endorse. (shrink)

Patients should not always receive hard data about the risks and benefits of a medical intervention. That information should always be available to patients who expressly ask for it, but it should be part of standard disclosure only sometimes, and only for some patients. And even then, we need to think about how to offer it.

Gaining informed consent among marginalized groups that include decisionally incapacitated individuals and those outside of the researcher's own geo-social and ethnic background still challenges many researchers. We suggest that there is a need for consideration of a different approach to research ethics in international settings. Based on extensive field work in West Africa on medical knowledge transfers and patient–healer relationships, this paper will discuss the challenges posed in obtaining informed individual consent in international settings. It is argued that while (...) being on the whole convincing, the top-down approach of the proposed solutions, which clearly dominates the participative approach, fails in building sustainable capacity, decision-making competency, and empowerment in the communities in which the research is conducted. Using appropriate decision aids can help resolve these issues. (shrink)

Within the ethical debate on Machine Learning-driven decision support systems (ML_CDSS), notions such as “human in the loop” or “meaningful human control” are often cited as being necessary for ethical legitimacy. In addition, ethical principles usually serve as the major point of reference in ethical guidance documents, stating that conflicts between principles need to be weighed and balanced against each other. Starting from a neo-Kantian viewpoint inspired by Onora O'Neill, this article makes a concrete suggestion of how to interpret (...) the role of the “human in the loop” and to overcome the perspective of rivaling ethical principles in the evaluation of AI in health care. We argue that patients should be perceived as “fellow workers” and epistemic partners in the interpretation of ML_CDSS outputs. We further highlight that a meaningful process of integrating (rather than weighing and balancing) ethical principles is most appropriate in the evaluation of medical AI. (shrink)

In times of person-centered care, it is all the more important to support patients in making good decisions about their care. One way to offer such support to patients is by way of Patient Decision Aids (PDAs). Ranging from patient brochures to web-based tools, PDAs explicitly state the decisions patients face, inform them about their medical options, help them to clarify and discuss their values, and ultimately make a decision. However, lingering discussions surround effectiveness research (...) on PDAs. In this article, I focus on two subjective measures of decision quality that are widely used as outcome measures in effectiveness research on PDAs (i.e., the Decisional Conflict Scale (DCS) and measures of regret). Although these measurement instruments have attracted critical attention in the scientific literature, bioethicists have hardly engaged with them. Therefore, I set myself to analyze the relationship between (the different subscales of) the DCS and measures of regret, on the one hand, and ethical principles such as beneficence and autonomy, on the other hand. In light of that analysis, I will clarify some discussions regarding the use of these measures of decision quality in effectiveness research on PDAs. This should help us to align the way we evaluate PDAs with ethical principles and avoid that our attempts to support patients in making good decisions about their care that is so central to person-centered care point in unethical directions. (shrink)

Since Oregon implemented its Death with Dignity Act, many additional states have followed suit demonstrating a growing understanding and acceptance of aid in dying processes. Traditionally, the patient has been the one to request and seek this option out. However, as Death with Dignity acts continue to expand, it will impact the role of physicians and bring up questions over whether physicians have the ethical obligation to facilitate a conversation about AID with patients during end of life discussions. Patients (...) have the right to make informed decisions about their health, which implies that physicians have an obligation to discuss with and inform patients of the options that will accomplish the patients’ goals of care. We will argue that physicians have an ethical obligation to inform certain patients about AID during end of life care discussions. We will also address what this obligation encompasses and explore guidelines of when and how these conversations should occur and proceed. Earlier guidelines, presented by various palliative care and ethics experts, for proceeding with such conversations have mostly agreed that the discussion of hospice and end of life care with patients should be initiated early and that the individual goals of a patient during the remaining duration of life should be thoroughly examined before discussion of appropriate options. In discussing AID, physicians should never recommend but inform patients about the basics so that they can make an informed decision. If patients express further interest in AID, the physician should open up the dialogue to address the reasoning behind this decision versus other possible treatments to ensure that patients clearly comprehend the process and implications of their decision. Ultimately, any end of life choice should be made by patients with the full capacity to express what they envision for the remaining duration of life and to comprehend the advantages and disadvantages of all the possible options. (shrink)

Research from behavioural sciences shows that people reach decisions in a much less rational and well-considered way than was often assumed. The doctrine of informed consent, which is an important ethical principle and legal requirement in medical practice, is being challenged by these insights into decision-making and real-world choice behaviour. This article discusses the implications of recent insights of research on decision-making behaviour for the informed consent doctrine. It concludes that there is a significant tension between the often (...) non-rational choice behaviour and the traditional theory of informed consent. Responsible ways of dealing with or solving these problems are considered. To this end, patient decisions aids are discussed as suitable interventions to support autonomous decision-making. However, current PDAs demand certain improvements in order to protect and promote autonomous decision-making. Based on a conception of autonomy, we will argue which type of improvements are needed. (shrink)

Visual aids can improve comprehension of risks associated with medical treatments, screenings, and lifestyles. Do visual aids also help decision makers accurately assess their risk comprehension? That is, do visual aids help them become well calibrated? To address these questions, we investigated the benefits of visual aids displaying numerical information and measured accuracy of self-assessment of diagnostic inferences (i.e., metacognitive judgment calibration) controlling for individual differences in numeracy. Participants included 108 patients who made diagnostic inferences (...) about three medical tests on the basis of information about the sensitivity and false-positive rate of the tests and disease prevalence. Half of the patients received the information in numbers without a visual aid, while the other half received numbers along with a grid representing the numerical information. In the numerical condition, many patients --especially those with low numeracy-- misinterpreted the predictive value of the tests and profoundly overestimated the accuracy of their inferences. Metacognitive judgment calibration mediated the relationship between numeracy and accuracy of diagnostic inferences. In contrast, in the visual aid condition, patients at all levels of numeracy showed high-levels of inferential accuracy and metacognitive judgment calibration. Results indicate that accurate metacognitive assessment may explain the beneficial effects of visual aids and numeracy --a result that accords with theory suggesting that metacognition is an essential part of risk literacy. We conclude that well-designed risk communications can inform patients about health-relevant numerical information while helping them assess the quality of their own risk comprehension. (shrink)

This paper presents a procedure designed to aid physicians and patients in the process of making medical decisions, and illustrates its implementation to aid pregnant women, who decided to undergo prenatal diagnostic test choose a physician to administer it. The procedure is based on a medical decision-making model of Karni (J Risk Uncertain 39: 1–16, 2009). This model accommodates the possibility that the decision maker’s risk attitudes may vary with her state of health and incorporates other costs, such (...) as pain and inconvenience, associated with alternative treatments. The medical decision problem was chosen for its relative simplicity and the transparency it affords. (shrink)

AIDS has challenged many concepts and practices within nursing. Because of the serious implications attending a positive diagnosis, and because patients with AIDS have become articulate and well informed, familiar principles have been exposed to renewed scrutiny. Anomalies and dilemmas have been revealed. Results from a recent Institute of Medical Ethics survey carried out by the author have illustrated some of the theoretical concepts. Confidentiality has assumed new dimensions. Partnership and mutual empowerment are seen as keys to sound (...) practice involving the patient in decision-making. A vital ingredient relates to the preparation of professionals; they need to be aware of those attitudes and prejudices within themselves which potentially stand in the way of caring well. (shrink)

Where assistance in suicide is readily available to those dying of AIDS, as in the west coast gay communities of the United States and in the Netherlands, we must examine the different roles of physicians and friends (including lovers, spouses, family members, religious advisors, members of support groups, and intimate others) in helping a person with AIDS decide about and carry out suicide. This paper makes a central assumption: that where assistance in suicide is available, it is the (...) moral obligation of others to protect and enhance as much as possible the rationality of that choice. Four components are identified in a rational choice about suicide in AIDS – whether it is a choice for or against suicide. Phrased as questions a person with AIDS might ask him- or herself, they are: (1) "Is suicide an option I want to consider?" (2) "Shall I hold out for the chance of a cure?" (3) "How shall I time my suicide?" (4) "What weight shall I give to the welfare and interests of others?" Although physicians often make assertions relevant to (1), they are appropriately involved only in (3); and although friends or intimate partners often provide the patient with anecdotal information relevant to (3), they should be involved primarily in (1). In short, both physicians and friends often intervene in the wrong parts of choices made by a person with AIDS about suicide. Keywords: AIDS, assisted suicide, euthanasia, rationality, role of friends and physicians, timing CiteULike Connotea Del.icio.us What's this? (shrink)

Decision-making capacity is the gatekeeping element for a patient’s right to self-determination with regard to medical decisions. A DMC evaluation is not only conducted on descriptive grounds but is an inherently normative task including ethical reasoning. Therefore, it is dependent to a considerable extent on the values held by the clinicians involved in the DMC evaluation. Dealing with the question of how to reasonably support clinicians in arriving at a DMC judgment, a new tool is presented that fundamentally (...) differs from existing ones: the U-Doc. By putting greater emphasis on the judgmental process rather than on the measurement of mental abilities, the clinician as a decision-maker is brought into focus, rendering the tool more of an evaluation guide than a test instrument. In a qualitative study, the perceived benefits of and difficulties with the tool have been explored. The findings show on the one hand that the evaluation aid provides basic orientation, supports a holistic perspective on the patient, sensitizes for ethical considerations and personal biases, and helps to think through the decision, to argue, and to justify one’s judgment. On the other hand, the room for interpretation due to absent operationalisations, related ambiguities, and the confrontation with one’s own subjectivity may be experienced as unsettling. (shrink)

Recent evaluation of the practice of euthanasia and related medical decisions at the end of life in the Netherlands has shown a slight decrease in the frequency of physician-assisted death since the enactment of the Euthanasia Law in 2002. This paper focuses on the absence of euthanasia cases concerning patients with dementia and a written advance euthanasia directive, despite the fact that the only real innovation of the Euthanasia Law consisted precisely in allowing physicians to act upon such directives. The (...) author discusses two principal reasons for this absence. One relates to the uncertainty about whether patients with advanced dementia truly experience the suffering they formerly feared. There is reason to assume that they don’t, as a consequence of psychological adaptation and progressive unawareness (anosognosia). The second, more fundamental reason touches upon the ethical relevance of shared understanding and reciprocity. The author argues that, next to autonomy and mercifulness, “reciprocity” is a condition sine qua non for euthanasia. The absence thereof in advanced dementia renders euthanasia morally inconceivable, even if there are signs of suffering and notwithstanding the presence of an advance euthanasia directive. This does not mean, however, that advance euthanasia directives of patients with dementia are worthless. They might very well have a role in the earlier stages of certain subtypes of the disease. To illustrate this point the author presents a case in which the advance directive helped to create a window of opportunity for reciprocity and shared decision-making. (shrink)

BackgroundMedical aid in dying was introduced in Quebec in 2015. Quebec clinical guidelines recommend that MAiD be approached as a last resort when other care options are insufficient; however, the law sets no such requirement. To date, little is known about when and how requests for MAiD are situated in the broader context of decision-making in end-of-life care; the timing of MAiD raises potential ethical issues.MethodsA retrospective chart review of all MAiD requests between December 2015 and June 2017 at (...) two Quebec hospitals and one long-term care centre was conducted to explore the relationship between routine end-of-life care practices and the timing of MAiD requests.ResultsOf 80 patients requesting MAiD, 54% received the intervention. The median number of days between the request for MAiD and the patient’s death was 6 days. The majority of palliative care consults came less than 7 days prior to the MAiD request and in another 25% of cases occurred the day of or after MAiD was requested. 35% of patients had no level of intervention form, or it was documented as 1 or 2 at the time of the MAiD request and 19% were receiving life-prolonging interventions.InterpretationWe highlight ethical considerations relating to the timing of MAiD requests within the broader context of end-of-life care. Whether or not MAiD is conceptualised as morally distinct from other end-of-life options is likely to influence clinicians’ approach to requests for MAiD as well as the ethical importance of our findings. We suggest that in the wake of the 2015 legislation, requests for MAiD have not always appeared to come after an exploration of other options as professional practice guidelines recommend. (shrink)

This article enumerates and critically examines the potential grounds on which we might treat the case of a patient with an advance directive who attempted suicide, differently from one whose injuries were the result of an accident. Grounds for differentiation are distilled into two potential justifications. The first addresses the concern that withholding or withdrawing care from a patient with self-inflicted injuries would be aiding and abetting suicide. The second examines concerns about the patient’s decisionmaking capacity. Ultimately, (...) it is argued that while there might be legitimate reasons to hold the advance directive of a suicidal patient to a different standard of scrutiny, the fact that the patient’s medical state was self-inflicted should not, in and of itself, necessarily invalidate the guidance of the directive. Finally, four practical recommendations are offered for negotiating similar cases. (shrink)

Current guidelines and regulatory frameworks create a dilemma that threatens the effectiveness of much needed communication between patients and medical providers: How can patients be presented with detailed facts without creating cognitive “overload”? We explain how this is a false dichotomy and illustrate, using three examples, how fuzzy-trace theory offers a third way of informing patients.

In lieu of an abstract, here is a brief excerpt of the content:Criminal Law, Pain Relief, and Physician Aid in DyingFaye Girsh, Ed.D., Executive DirectorMadam:The article by Cantor and Thomas on “Pain Relief, Acceleration of Death, and Criminal Law” (KIEJ, June 1996) was a tortured attempt to develop criteria for the humane and compassionate physician who tries to serve the needs of a patient in unremitting pain. There are three areas that merit comment.The authors dealt with pain medications that (...) might have the undesirable side effect of causing death. They did not mention tolerance, which usually occurs in a patient with chronic pain and which would require exceedingly high doses to be effective. They did not mention barbiturates, which are preferable to opiates in causing death and which are used increasingly by compassionate physicians to answer the pleas of their suffering patients, but for which there is no excuse about alleviating pain. Would the criminal law just call the prescription of a lethal dose of barbiturates a reckless act and require conviction? Fortunately, juries, as the authors point out, do not balance these formulas on the head of a pin. When they see the circumstances under which these doctors do help their patients, they choose to nullify the law and would ignore the suggestions made in this article.The authors refer to the “consent” of the patient. They do not mention that these doctors are operating with more than consent; they are administering these medications because suffering patients are begging them to put them out of their pain and the indignities of the dying process. The article discusses the process as though it were the same as consent to elective surgery. These patients—with AIDS, cancer, and hopeless neurological degeneration—are not simply agreeing to a procedure; they are desperately seeking a way out. If the criminal law were to develop criteria for physician aid in dying, certainly one of them should be the active, witnessed, repeated request of such a patient for a certain, quick, painless, gentle death.The third point is that physicians do not face prosecution when administering no treatment to a patient whose life could be saved with treatment but who chooses not to receive it. This has been upheld by the U.S. Supreme Court; no criteria for suffering, alternatives, terminality, justifiability, or unbearability are required. The doctor can stand by while the patient dies what may be a protracted, difficult death, but it is within the law. What matters in this situation is the decision of the patient to refuse treatment, and that is absolute. How ironic that the patient who cannot refuse treatment must, with his or her doctor, jump through all these hoops to achieve a peaceful death.One worries that the physician who must balance the risk of “risky pain relief” against the accusation of recklessness will err in the direction of allowing [End Page 103] the patient to bear the pain rather than help with a dose of analgesics that might be considered beyond the stipulated “risk.”Why don’t we just be honest about it? Allow dying or hopelessly ill patients to make the decision about what they want by passing a carefully defined law allowing euthanasia rather than balancing the risk and trying to determine the “purpose” of the physician’s ministrations. We protect some patients from themselves while allowing others almost complete autonomy to make the choice of ending their lives. The authors were right in saying that proponents of rational laws consider this sheer hypocrisy.Faye Girsh, Executive DirectorHemlock Society U.S.A. Denver, COFaye Girsh misconceives our article’s objective as an “attempt to develop criteria” for the humane physician. Our goal in writing the paper was to analyze the current criminal law framework in the hope of sharpening debate and engendering normative critiques. We readily acknowledge tensions in the current legal framework and would support changes in that framework.Copyright © 1997 The Johns Hopkins University Press... (shrink)

Decision making in health care contexts is often deeply challenging for the patients, their close ones, and those who care for them. All of them have and perceive different forms of responsibilitie...

The principle of individual medical confidentiality is one of the moral principles that Africa inherited unquestioningly from the West as part of Western medicine. The HIV/AIDS pandemic in Southern Africa has reduced the relevance of the principle of individual medical confidentiality. Individual medical confidentiality has especially presented challenges for practitioners among the Bantu communities that are well known for their social inter-connectedness and the way they value their extended family relations. Individual confidentiality has raised several unforeseen problems for persons (...) living with HIV/AIDS, ranging from stigma and isolation to feelings of dejection as it drives them away from their families as a way of trying to keep information about their conditions confidential. The involvement of family members in treatment decisions is in line with the philosophy of Ubuntu and serves to respect patients’ and families’ autonomy while at the same time benefiting the individual patient. (shrink)

Annual and cumulative incidences of HIV + and AIDS in patients reported by the AIDS Surveillance Committee of the Ministry of Health and Welfare are cited to illustrate some characteristics in Japan: nearly 59% of either HIV + or AIDS patients were infected through injection of blood products or by blood transfusion. A number of plaintiffs have sued the Japanese government and pharmaceutical companies since 1989, but no judicial decisions have yet been made. The incidence of HIV (...) decreases for each of the following routes of infection: the second highest route of transmission being heterosexual, followed by bisexual and unconfirmed or unknown cases, and less frequently homosexual, drug use and lastly via vertical transmission. The most serious bioethical problems with HIV + and AIDs patients in Japan is the social segregation of these patients. There are many emotional fears among the general public and medical personnel about AIDS because of their inadequate scientific knowledge of this disease. The Japan Hospital Association is doing The Stop AIDS Campaign and made several surveys. Japan has become increasingly aware of the importance of AIDS education and a great deal of effort is being made to enhance bioethical considerations. (shrink)

In this paper, I set out two ethical complications for Rid and Wendler’s proposal that a “Patient Preference Predictor” (PPP) should be used to aid decision making about incapacitated patients’ care. Both of these worries concern how a PPP might categorize patients. In the first section of the paper, I set out some general considerations about the “ethics of apt categorization” within stratified medicine and show how these challenge certain PPPs. In the second section, I argue for a (...) more specific—but more contentious—claim that proper respect for the autonomy of incapacitated patients might require us to act on reasons which they could endorse and show how this claim places important limits on the categories employed by an ethically acceptable PPP. The conclusion shows how these concerns about apt categorization relate to more familiar worries about Rid and Wendler’s proposals. (shrink)

How can an individual’s Moral Compass address the question of whether or not to help a patient to shorten and end his or her life? Moral Compass has been defined as that set of values and experiences that guides each individual’s decisions and conduct in relation to others and to society. Can a robot be programmed to have a moral compass? If we were only considering rules of conduct, then perhaps yes, that would be possible. We could establish a (...) series of rules and sanctions that a computer assisted robot could rigorously apply for any violation. The state and many religions already do that, and many individuals are quite comfortable with rigorous, unbendable rules. Most rules, however, have exceptions, so perhaps the robots of the future can be designed to be flexible, that is, human. (shrink)

In this paper, I address the question of whether it is ever permissible to grant a request for physician-aid-in-dying (PAD) from an individual suffering from treatment-resistant depression. I assume for the sake of argument that PAD is sometimes permissible. There are three requirements for PAD: suffering, prognosis, and competence. First, an individual must be suffering from an illness or injury which is sufficient to cause serious, ongoing hardship. Second, one must have exhausted effective treatment options, and one’s prospects for recovery (...) must be poor. Third, the individual must be judged competent to request PAD. I argue that many cases of treatment-resistant depression meet the first two requirements. Thus, the key question concerns the third. I consider four features of depression that might compromise a person’s decision-making capacity. Ultimately, I conclude that PAD requests from depressed patients can be permissibly granted in some circumstances. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Criminal Law, Pain Relief, and Physician Aid in DyingFaye Girsh, Ed.D., Executive DirectorMadam:The article by Cantor and Thomas on “Pain Relief, Acceleration of Death, and Criminal Law” (KIEJ, June 1996) was a tortured attempt to develop criteria for the humane and compassionate physician who tries to serve the needs of a patient in unremitting pain. There are three areas that merit comment.The authors dealt with pain medications that (...) might have the undesirable side effect of causing death. They did not mention tolerance, which usually occurs in a patient with chronic pain and which would require exceedingly high doses to be effective. They did not mention barbiturates, which are preferable to opiates in causing death and which are used increasingly by compassionate physicians to answer the pleas of their suffering patients, but for which there is no excuse about alleviating pain. Would the criminal law just call the prescription of a lethal dose of barbiturates a reckless act and require conviction? Fortunately, juries, as the authors point out, do not balance these formulas on the head of a pin. When they see the circumstances under which these doctors do help their patients, they choose to nullify the law and would ignore the suggestions made in this article.The authors refer to the “consent” of the patient. They do not mention that these doctors are operating with more than consent; they are administering these medications because suffering patients are begging them to put them out of their pain and the indignities of the dying process. The article discusses the process as though it were the same as consent to elective surgery. These patients—with AIDS, cancer, and hopeless neurological degeneration—are not simply agreeing to a procedure; they are desperately seeking a way out. If the criminal law were to develop criteria for physician aid in dying, certainly one of them should be the active, witnessed, repeated request of such a patient for a certain, quick, painless, gentle death.The third point is that physicians do not face prosecution when administering no treatment to a patient whose life could be saved with treatment but who chooses not to receive it. This has been upheld by the U.S. Supreme Court; no criteria for suffering, alternatives, terminality, justifiability, or unbearability are required. The doctor can stand by while the patient dies what may be a protracted, difficult death, but it is within the law. What matters in this situation is the decision of the patient to refuse treatment, and that is absolute. How ironic that the patient who cannot refuse treatment must, with his or her doctor, jump through all these hoops to achieve a peaceful death.One worries that the physician who must balance the risk of “risky pain relief” against the accusation of recklessness will err in the direction of allowing [End Page 103] the patient to bear the pain rather than help with a dose of analgesics that might be considered beyond the stipulated “risk.”Why don’t we just be honest about it? Allow dying or hopelessly ill patients to make the decision about what they want by passing a carefully defined law allowing euthanasia rather than balancing the risk and trying to determine the “purpose” of the physician’s ministrations. We protect some patients from themselves while allowing others almost complete autonomy to make the choice of ending their lives. The authors were right in saying that proponents of rational laws consider this sheer hypocrisy.Faye Girsh, Executive DirectorHemlock Society U.S.A. Denver, COFaye Girsh misconceives our article’s objective as an “attempt to develop criteria” for the humane physician. Our goal in writing the paper was to analyze the current criminal law framework in the hope of sharpening debate and engendering normative critiques. We readily acknowledge tensions in the current legal framework and would support changes in that framework.Copyright © 1997 The Johns Hopkins University Press... (shrink)

In this paper, we aim to stimulate ethical debate about the morally relevant connection between ectogenesis and the foetus as a potential beneficiary of treatment. Ectogenesis could facilitate foetal interventions by treating the foetus independently of the pregnant woman and provide easier access to the foetus if interventions are required. The moral relevance hereof derives from the observation that, together with other developments in genetic technology and prenatal treatment, this may catalyse the allocation of a patient status to the (...) foetus. The topic of foetal medicine is of growing interest to clinicians, and it also deserves due attention from an ethical perspective. To the extent that these developments contribute to the allocation of a patient status to the foetus, normative questions arise about how moral responsibilities towards foetal interests should be balanced against the interests of the pregnant woman. We conclude that, even if ectogenesis could facilitate foetal therapy, it is important to remain sensitive to the fact that it would not circumvent the key ethical concerns that come with in utero foetal treatment and that it may even exacerbate potential conflicts between directive treatment recommendations and the pregnant woman's autonomous decision to the contrary. (shrink)

In few other areas of bioethical inquiry exists as close a connection between bioethical professional advice and policy development as is the case with HIV and AIDS. Historically, the reasons for this have much to do with one of the groups initially affected most severely by HIV and AIDS, namely well-educated middle-class gay men in developed countries. This particular group of people, highly sophisticated and used to political activism in its pursuit of civil rights-related objectives, engaged the medical (...) profession as well as regulatory agencies such as the US Food and Drug Administration, and legislators (more so in the USA than in other countries) in a number of bioethically interesting policy areas. Many of the controversies of the times were framed as civil rights and/or ethical disputes. The initial areas of concern and inquiry focused on: informed consent to HIV testing and trial participation, the confidentiality of HIV test results, access to trials as a means of access to experimental drugs, the length of time it took to get an experimental drug to the market approval stage, and end-of-life decision-making. This line-up of issues explains why AIDS has become such an interesting topic for bioethicists. Bioethicists concerned about the traditional breadand- butter themes of medical ethics themes of the doctor - patient relationship (e.g., Daniels, 1991; Boyd, 1992), as well as bioethicists more concerned about policy and regulatory issues in the drug research and approval process (e.g., Edgar & Rothman, 1990; Salisbury & Schechter, 1990), found research topics worthy of vigorous pursuit. No surprise, then, that HIV/AIDS led to a probably unprecedented number of books and articles in professional journals (Manuel et al., 1990). HIV/AIDS has become a permanent fixture in all major mainstream bioethics textbooks (e.g., Kuhse & Singer, 1998; Arras & Steinbock, 1999). Reference series in medicine, ethics and law provide for dedicated volumes on AIDS.1 Even specialist bioethics textbooks, for instance those directed at dentistry students, carry chapters on HIV/AIDS (Ozar & Sokol, 2002). 128 Udo Schuklenk AIDS, designated by the medical profession a pandemic lives up to its classification. It did not stop at the borders of developed countries. As one would expect of a primarily sexually transmitted illness in the age of globalisation, it spread rapidly across the globe. Indeed, in many countries it has become one of the main causes of death, as in sub- Saharan Africa (Shisana & Simbayi, 2002). Dramatic increases in the number of AIDS cases are predicted for many Eastern European countries as well as for the two most populous nations on earth, India and China. Some of the HIV/AIDS-related bioethical and policy issues of concern to developed countries remain the same for developing countries. However, in ethically important ways they are dwarfed by concerns over drug prices, intellectual property rights, and affordable access to essential AIDS drugs for the impoverished masses of infected people in such countries. Of increasing importance have become ethical issues pertaining to the ever-growing research industry associated with clinical trials undertaken in developing countries. Indeed, major funding initiatives both in the USA and UK have brought clinical research in developing countries into focus. Some have questioned whether this attention is appropriate, considering other bioethical problems of arguably greater importance to developing countries (Chadwick & Schuklenk, 2003). Standards of clinical care in a study, and after a trial has concluded, as well as community benefits and access to the trial regime after the trial’s conclusion remain contentious issues. It is worth noting that more often than not it was an AIDS-related trial or policy decision that led to a great deal of bioethical analysis, yet the issues discussed almost always have ramifications far beyond AIDS. For instance, decisions about the question of what (if any) standards of care failures in preventive trials (of HIV vaccines or microbicides) ought to receive have important implications for non-AIDS prevention trials. (shrink)

Annual and cumulative incidences of HIV+ and AIDS in patients reported by the AIDS Surveillance Committee of the Ministry of Health and Welfare are cited to illustrate some characteristics in Japan: nearly 59% of either HIV+ or AIDS patients were infected through injection of blood products or by blood transfusion. A number of plaintiffs have sued the Japanese government and pharmaceutical companies since 1989, but no judicial decisions have yet been made. The incidence of HIV decreases for (...) each of the following routes of infection: the second highest route of transmission being heterosexual, followed by bisexual and unconfirmed or unknown cases, and less frequently homosexual, drug use and lastly via vertical transmission. The most serious bioethical problems with HIV+ and AIDS patients in Japan is the social segregation of these patients. There are many emotional fears among the general public and medical personnel about AIDS because of their inadequate scientific knowledge of this disease. The Japan Hospital Association is doing The Stop AIDS Campaign and made several surveys. Japan has become increasingly aware of the importance of AIDS education and a great deal of effort is being made to enhance bioethical consideration. (shrink)

Annual and cumulative incidences of HIV + and AIDS in patients reported by the AIDS Surveillance Committee of the Ministry of Health and Welfare are cited to illustrate some characteristics in Japan: nearly 59% of either HIV + or AIDS patients were infected through injection of blood products or by blood transfusion. A number of plaintiffs have sued the Japanese government and pharmaceutical companies since 1989, but no judicial decisions have yet been made. The incidence of HIV (...) decreases for each of the following routes of infection: the second highest route of transmission being heterosexual, followed by bisexual and unconfirmed or unknown cases, and less frequently homosexual, drug use and lastly via vertical transmission. The most serious bioethical problems with HIV + and AIDs patients in Japan is the social segregation of these patients. There are many emotional fears among the general public and medical personnel about AIDS because of their inadequate scientific knowledge of this disease. The Japan Hospital Association is doing The Stop AIDS Campaign and made several surveys. Japan has become increasingly aware of the importance of AIDS education and a great deal of effort is being made to enhance bioethical considerations. (shrink)

What's not to like about shared decision‐making? These programs employ specially crafted decision aids to educate patients about their treatment options and then merge the newly informed patient preferences, both general and treatment‐specific, with guidance from physicians to optimize medical decisions. Sounds great, right? Even better, recent evidence indicates that shared decision‐making programs may also help bend the proverbial cost curve by reducing the use of medical interventions that patients, now properly educated about their options, (...) often say they do not want. The notion that programs to inform and elicit patient choice might also help to align health care delivery with patient preferences for less invasive and therefore less costly treatment options seems the rarest of mutual wins in health care, in which what is best for the individual might also benefit the whole. Yet there has been scant attention to how the goals of patient care and cost‐containment, and perhaps even profitability, coincide or conflict. (shrink)

An Institute of Medical Ethics working party argues that an ethically desirable relationship of mutual empowerment between patient and clinician is more likely to be achieved if patients understand the ground rules of medical confidentiality. It identifies and illustrates ambiguities in the General Medical Council's guidance on AIDS and confidentiality, and relates this to the practice of different doctors and specialties. Matters might be clarified, it suggests, by identifying moral factors which tend to recur in medical decisions about (...) maintaining or breaching confidentiality. The working party argues that two such factors are particularly important: the patient's need to exercise informed choice and the doctor's primary responsibility to his or her own patients. (shrink)

Guest Editors' introductionFor this special issue of the Journal of Medical Ethics we have assembled articles that reflect some of the newer issues or fresh perspectives. There is a mix of approaches including forward looks, present dilemmas and reflections on the past, now that sufficient time has elapsed to allow a considered view. We are most grateful to our wide range of contributors for their thoughtful analyses of several key areas of contemporary debate. Our own contributions include the following editorials (...) in which each of us has considered, from his own perspective, the impact of AIDS on medical ethics, a case study and a lexicon that allows brief probing of some topics.The impact of aids on medical ethics -1ANTHONY J PINCHINGMedical ethics has been matured through being tested and refined through the multifaceted challenge of AIDS. As with the society and social values from which its moral framework is derived, so medical ethics has been subjected to intense scrutiny by the emergence of this new disease. Few areas of ethical discourse have been untouched. This infection is so intensely private in its transmission, the disease so isolating and so personally devastating in its impact, it readily distinguishes the reality of what people are and do, from the rhetoric of what others may feel they should be and do. AIDS has forced us to recognise that respecting individual rights is a critical safeguard for the health of the community, as well as for the person. These issues are well illustrated by the interweaving issues of patient empowerment, respect for confidentiality, and patient advocacy and activism.EMPOWERMENTPhysicians in this field have been struck by the way in which people affected have wanted to be involved in decision making. While this has often been ascribed to their social groups, it probably was more a reflection of their younger age and a generation change …. (shrink)

This paper analyzes statistical decisions during the interim analyses of clinical trials. After some general remarks about the ethical and scientific demands of clinical trials, I introduce the notion of a hard-case clinical trial, explain the basic idea behind it, and provide a real example involving the interim analyses of zidovudine in asymptomatic HIV-infected patients. The example leads me to propose a decision analytic framework for handling ethical conflicts that might arise during the monitoring of hard-case clinical trials. I (...) use computer simulations to show how the framework can assist in reconciling certain ethical conflicts. The framework is partial, lacking the precision of a complete systematization of statistical monitoring procedures in practice. (shrink)

Title III of the Americans with Disabilities Act (ADA) grants people with disabilities access to public accommodations, including the offices of medical providers, equal to that enjoyed by persons without disabilities. The Department of Justice (DOJ) has unequivocally declared that the law requires effective communication between the medical provider and the Deaf patient. Because most medical providers are not fluent in sign language, the DOJ has recognized that effective communication calls for the use of appropriate auxiliary aids, including (...) sign language interpreters. The final decision on what to offer the Deaf patient is the doctor's, and under current DOJ regulations, the doctor does not have to consult with the patient or give "primary consideration" to the patient's choice of auxiliary aid as long as what the doctor offers results in effective communication. However, given the great variation in people's communication styles and skills, a standard, one-size-fits-all auxiliary aid would fail to achieve effective communication in many cases, harming not only that Deaf patient, but also the medical provider, who would be potentially liable for violating the ADA as well as hamstrung in getting accurate information for purposes of diagnosis and treatment. Moreover, most doctors are not savvy about Deafness and Deaf culture. Thus, the best way to ensure effective communication would be to require the medical provider to ask the Deaf patient for his or her choice of auxiliary aid and to give "primary consideration" to the patient's expressed choice of auxiliary aid. Such an approach is required under Title II of the ADA, which makes it mandatory for state and local governments to consult with people with disabilities and give "primary consideration" to the patient's choice of auxiliary aid. Given that there is no difference between a public doctor and a private doctor that would justify the two different approaches and that cost is not a factor, since under either title, a medical provider cannot pass on the costs to the person with a disability, the DOJ should revise its interpretation of Title III in order to bring in into line with its interpretation of Title II. To fail to do so would operate to frustrate both the letter and the spirit of the ADA. Until the DOJ brings the titles into line, the courts should decline to give controlling weight to the DOJ's interpretation of Title III. (shrink)

Keeping the diagnosis of a client confidential is one of the cornerstones of professional practice. In the case of a diagnosis such as HIV/AIDS, however, the ethics of this action may be challenged. Such a decision has a range of negative effects, for example, the blaming of others, supporting the denial of the client, and complicating the health education and care of the patient. It is suggested that the four ethical principles should be used to explore the (...) ethics of such decisions, and that professional regulatory bodies and organizations should support professionals in situations where the client’s sexual partner is informed against the wishes of the client. (shrink)

Medical ethics could be better understood if some basic theoretical aspects of practices in health care are analysed. By discussing the underlying ethical principles that govern medical practice, the student should also become familiar with the notion that medical ethics is much more than the external application of socially accepted moral standards. Professions in general and medicine in particular have internal values that command their moral virtuosity at the same time as their technical excellence. Three examples where clinical practice can (...) be clearly shown to require an ethical analysis are given: medical praxiology illustrates the motives, means and aims of physicians and patients; clinical decision-making as a practical syllogism that reaches prescriptive conclusions based on medical knowledge and the patient's wishes/intentions. Finally, diagnostics as an ethical bayesian approach is discussed, where the patient informedly decides the benefits and risks of further testing. (shrink)