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)

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)

In an unusual instance of lay participation in biomedical research, U.S. AIDS treatment activists have constituted themselves as credible participants in the process of knowledge construction, thereby bringing about changes in the epistemic practices of biomedical research. This article examines the mechanisms or tactics by which these lay activists have constructed their credibility in the eyes of AIDS researchers and government officials. It considers the inwlications of such interventions for the conduct of medical research; examines some of the ironies, tensions, (...) and limitations in the process; and argues for the importance of studying social movements that engage with expert knowledge. (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)

Volume 19, Issue 5, May 2019, Page 20-22.

Health care systems can positively influence our personal decision-making and health-related behavior only if we trust them. I propose a conceptual analysis of the trust relation between the public and a healthcare system, drawing from healthcare studies and philosophical proposals. In my account, the trust relation is based on an epistemic component, epistemic authority, and on a value component, the benevolence of the healthcare system. I argue that it is also modified by the vulnerability of the public on healthcare matters, (...) and by the system’s credibility. I apply my proposed analysis of public trust in health care systems to the phenomenon of vaccine hesitancy, a tendency to question vaccine policies, and to seek alternative vaccine schedules or to refuse vaccination. Understanding the role of trust and its components can be key to understanding the phenomenon. (shrink)

In March 1996, the General Accounting Office (GAO) issued the reportScientific 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 cleartoclinicians. 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 (NIH) Director Harold Varmus expressed similar concerns in its assessment of NIH investment in research on gene therapy. (shrink)

Consider the following patient: a 40-year-old man who has had back pain that radiates down his left leg, on and off for 2 months. He performs his normal activities and does not have any “red flag”...

The concepts of placebos and placebo effects refer to extremely diverse phenomena. I recommend dissolving the concepts of placebos and placebo effects into loosely related groups of specific mechanisms, including (potentially among others) expectation-fulfillment, classical conditioning, and attentional-somatic feedback loops. If this approach is on the right track, it has three main implications for the ethics of informed consent. First, because of the expectation-fulfillment mechanism, the process of informing cannot be considered independently from the potential effects of treatment. Obtaining informed (...) consent influences the effects of treatment. This provides support for the authorized concealment and authorized deception paradigms, and perhaps even for outright deceptive placebo use. Second, doctors may easily fail to consider the potential benefits of conditioning, leading them to misjudge the trade-off between beneficence and autonomy. Third, how attentional-somatic feedback loops play out depends not only on the content of the informing process but also on its framing. This suggests a role for libertarian paternalism in clinical practice. (shrink)

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)

The practice of obtaining informed consent has its history in, and gains its meaning from, medicine and biomedical research. Discussions of disclosure and justified nondisclosure have played a significant role throughout the history of medical ethics, but the term “informed consent” emerged only in the 1950s. Serious discussion of the meaning and ethics of informed consent began in medicine, research, law, and philosophy only around 1972.

The advent of population-specific genomic research has prompted calls for invention of informed consent protocols that would treat entire social groups as research subjects as well as endow such groups with authority as agents of consent. Critics of such an unconventional ethical norm of group consent fear the rhetorical effects of approaching social groups with offers to participate in dialogues about informed consent. Addressing a specific population as the collective subject of genomic research, on this logic, adds currency to the (...) potentially dangerous public opinion that such a group is bound by genetic ties. The paper considers the problem of group and individual identity within the rhetorical dynamics of the discourse and politics of consent. (shrink)

Traditionally, there have been few legal actions brought against psychotherapists that allege negligent psychotherapy and negligent treatment of psychiatric disorders. However, in the case of Osheroff v. Chestnut Lodge, a patient-physician (Dr. OsheroE) sued Chestnut Lodge, a private psychiatric facility, for negligence based on the staff's decision to apply a psychodynamic model of treatment (through psychotherapy) and not a biological model. The case sparked a heated debate between adherents of the psychodynamic model and those of the biological model. This article (...) explores the implications of the Osheroff litigation for mental health professionals. It is proposed that an interactive informed consent process be used to protect psychotherapists against Osheroff-type litigation. (shrink)

In this paper, I claim that the doctor-patient relationship can be viewed as a vessel of trust. Nonetheless, trust within the doctor-patient relationship has been impaired by managed care. When we conceive of trust as social capital, focusing on the role that it plays in individual and social well-being, trust can be viewed as a public good and a scarce medical resource. Given this, there is a moral obligation to protect the doctor-patient relationship from the cost-containment mechanisms that compromise its (...) ability to produce trust. (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)

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)

In medical practice, the doctrine of informed consent is generally understood to have priority over the medical practitioner’s duty of care to her patient. A common consequentialist argument for the prioritisation of informed consent above the duty of care involves the claim that respect for a patient’s free choice is the best way of protecting that patient’s best interests; since the patient has a special expertise over her values and preferences regarding non-medical goods she is ideally placed to make a (...) decision that will protect her interests. In this paper I argue against two consequentialist justifications for a blanket prioritisation of informed consent over the duty of care by considering cases in which patients have imperfect access to their overall best interests. Furthermore, I argue that there are cases where the mere presentation of choice under the doctrine of informed consent is detrimental to patient best interests. I end the paper by considering more nuanced approaches to resolving the conflict between informed consent and the duty of care and consider the option of permitting patients to waive informed consent. (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.

For over 20 years the medical literature has carefully documented the undertreatment of all types of pain by physicians. During this same period, as the field of bioethics came of age, the phenomenon of undertreated pain received almost no attention from the bioethics literature. This article takes bioethicists to task for failing to recognize the undertreatment of pain as a major ethical, and not merely a clinical, failing of the medical profession. The nature and extent of the problem of undertreated (...) pain is examined, as well as possible reasons for its disregard by bioethicists. The factors contributing to undertreated pain in the clinical setting are considered, as well as the hazards posed by recent failures to address ethically questionable clinical practices. Finally, suggestions are offered for refocusing the attention of bioethicists to this significant problem. (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...

November 2009’s announcement of the USPSTF’s recommendations for screening for breast cancer raised a firestorm of objections. Chief among them were that the panel had insufficiently valued patients’ lives or allowed cost considerations to influence recommendations. The publicity about the recommendations, however, often either simplified the actual content of the recommendations or bypassed significant methodological issues, which a philosophical examination of both the science behind screening recommendations and their import reveals. In this article, I discuss two of the leading ethical (...) considerations at issue in screening recommendations: respect for patient autonomy and beneficence and then turn to the most significant methodological issues raised by cancer screening: the potential biases that may infect a trial of screening effectiveness, the problem of base rates in communicating risk, and the trade-offs involved in a judgment of screening effectiveness. These issues reach more broadly, into the use of “evidence-based” medicine generally, and have important implications for informed consent. (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)

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)

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.

This paper suggests that medical education be revised to assist in diffusing potential ethical dilemmas that arise during health care provision. A revised medical education would emphasize the role of the humanities in the training of physicians, especially in light of recent critiques of the canonical scientific model in general, and more specifically in the use of that model for medical training and practice.

An implicit rationale for ethics in medical schools is that there is a perceived need to teach students how not to think and how not to act, if they are to avoid a lawsuit or being struck off by the GMC. However, the imperative to keep within the law and professional guidance focuses attention on risks to patients that can land a doctor in trouble, rather than what it means to treat a patient humanely or well. In this paper I (...) explore the gap between learning how not to think and act as a doctor, and learning to be reflective and responsive to patients as fellow human beings. This gap is exposed by the difference between a GMC web resource for doctors, and a detailed ethical discussion by Gawande in his book Complications. The latter raises fundamental questions of meaning, and exemplifies an approach to ethical thinking as the appropriate management of doubt that, according to the argument of this paper, is of utmost importance for doctors. (shrink)