Nada Gligorov

De Minimis Risk: A Proposal for a New Category of Research Risk

De Minimis Risk: A Proposal for a New Category of Research Risk Rosamond Rhodes a , Jody Azzouni b , Stefan Bernard Baumrin c , Keith Benkov a , Martin J. Blaser d , Barbara Brenner a , Joseph W. Dauben c , William J. Earle c , Lily Frank c , Nada Gligorov a , Joseph Goldfarb a , Kurt Hirschhorn a , Rochelle Hirschhorn d , Ian Holzman a , Debbie Indyk a , Ethylin Wang Jabs a , Douglas P. Lackey c , Daniel A. Moros a , Sean Philpott e , Matthew E. Rhodes f , Lynne D. Richardson a , Henry S. Sacks a , Abraham Schwab g , Rhoda Sperling a , Brett Trusko a & Arnulf Zweig h a Mount Sinai School of Medicine b Tufts University c The Graduate Center, CUNY d New York University Medical School, CUNY e Union Graduate College f Pennsylvania State University g Indiana University, Purdue h University of Oregon (Emeritus)

Telling the Truth About Pain: Informed Consent and the Role of Expectation in Pain Intensity

Health care providers are expected both to relieve pain and to provide anticipatory guidance regarding how much a procedure is going to hurt. Fulfilling those expectations is complicated by the cognitive modulation of pain perception. Warning people to expect pain or setting expectations for pain relief not only influences their subjective experience, but it also alters how nociceptive stimuli are processed throughout the sensory and discriminative pathways in the brain. In light of this, I reconsider the characterization of placebo analgesia as pharmacologically inert and the use of it as deceptive. I show that placebo analgesia exploits the same physical mechanisms as proven analgesics and argue that it should be utilized to relieve pain. Additionally, I describe factors to help identify situations in which clinicians have the obligation to disclose the potential for pain coupled with ways of mitigating the risk of high-intensity pain by setting positive expectations.

A Model for the Assessment of Medical Students’ Competency in Medical Ethics

Background: This article focuses on the goals of our medical ethics education program and our formative assessments of students’ competency at various points during this education. Methods: Because of the critical relationship between a programs goals and the design of an assessment strategy, we provide an overview of the theoretical basis of our curriculum, our programs objectives, and teaching methods. In order to verify that our students had achieved minimum competency in the objectives of our ethics curriculum, we developed assessments that evaluated their ability to identify and apply ethical principles to clinical cases and to use moral reasoning to resolve dilemmas. We verified the reliability of these assessment instruments by correlating two different Mount Sinai raters’ scores of the same assessments with each other and the validity of these assessments with external reviewers. Results: For interrater reliability, paired raters scored the same student written exercise within 5 points of each other on 119 of the exercises (87% rater consensus). Therefore, we found our assessment tools to be reliable. Regarding validity, all three expert external reviewers agreed that our instruments were well suited for evaluating medical student competency in medical ethics and that they measured what we intended to measure. Conclusions: Our efforts in medical ethics education and competency assessment have produced an integrated model of goals, methodology, curriculum, and competency assessment. The entire model is directed at providing students with the ethical knowledge, skills, and attitudes required of an exemplary physician. We have developed reliable and valid assessment tools that allow us to evaluate the competency of students in medical ethics and to identify students who require remediation, and that are useful for other ethics programs.

Saying Privacy, Meaning Confidentiality

Schonfeld et al. touch on the ever-narrowing gap between clinical practice and research as they address issues of privacy (and confidentiality) in the prescreening and review process for research. Although they put forth a number of recommendations about the sharing of information within the medical and research community, their arguments for these recommendations are underdeveloped and conceptually confused. As a result, their recommendations lack adequate support, and in the case of other medical professionals, as we argue below, their recommendations are mistaken. Schonfeld et al’s discussion of privacy is obfuscated by a failure to distinguish between descriptive privacy and the value of privacy. A descriptive account of privacy ought to provide the conditions for what constitutes privacy and what indicates a loss of privacy. For example, privacy could be lost as more people gain access to a piece of information or it could be lost when the individual is no longer able to control the information. An account of the value of privacy ought to explain why privacy rights or interests should be respected or protected. (Gavison, 1980) The conflation of these two aspects of privacy can be seen in the following excerpt: “we grant privacy both to protect patients from the harms associated with others knowing their personal health information (beneficence) and because individuals have a right to determine the use of their person and personal data (respect for persons).” (2) Looking at the second half of this excerpt, Schonfeld et al. could mean: 1) that an individual’s ability to determine the use of personal data is what defines something as private, or 2) it could be that this control is why privacy is valuable. If 1), the loss of privacy occurs if an individual cannot determine the use of personal data, and this loss is problematic because it may lead the individual to harm. If 2), this loss is problematic both because it may lead the individual to harm and because the individual cannot control the use of personal data.

Dilemmas in Surgery: Medical Ethics Education in Surgery Rotation

Mount Sinai School of Medicine, New York, NYMount Sinai School of Medicine provides its studentswith a 4-year curriculum in medical ethics that ishorizontally and vertically integrated into the educa-tional program. In the first 2 years, as part of the Artsand Science of Medicine (ASM) course (ASM 1 andASM 2), students participate in 6 ethics modules, thefirst 5 of which are designed to provide them withan understanding of the basic concepts of medicalethics. Sessions focus on professionalism, fiduciaryresponsibility, truth telling and informed consent,autonomy, surrogate decision making, justice, andresearch ethics. Through readings, minilectures, pan-els, sample cases, and small group discussions, thesessions provide students with the vocabulary andunderstanding to enable them to navigate the ethicalissues of clinical practice. The final module of thesecond year presents students with a model of clin-ical moral reasoning to be used in the resolution ofethical dilemmas.

Determinism and advances in neuroscience.

Neurosciences associations between localized brain activity and specific cognitive tasks is not sufficient evidence for rejecting the notion of free will and absolving individuals of responsibility for their behavior.

Bridging the Gap between Knowledge and Skill: Integrating Standardized Patients into Bioethics Education

Upon entering the examination room, Caitlyn encounters a woman sitting alone and in distress. Caitlyn introduces herself as the hospital ethicist and tells the woman, Mrs. Dennis, that her aim is to help her reach a decision about whether to perform an autopsy on her recently deceased husband. Mrs. Dennis begins the encounter by telling the ethicist that she has to decide quickly, but that she is very torn about what to do. Mrs. Dennis adds, “My sons disagree about the autopsy.” As a standardized patient (SP), a specialized actor, the woman playing Mrs. Dennis has already delivered the same opening lines several times to different learners practicing their clinical ethics consultation skills. An SP encounter is a simulated patient encounter used for educational purposes that requires the standardization of verbal and behavioral responses. In the encounter, the simulator, or “patient,” uses a scripted medical history to enable the learner to employ a certain skill, say, the ability to perform a neurological exam. The use of standardized patients in the evaluation of clinical skills has become a staple in medical education. To tackle the challenge of teaching clinical ethics consultation skills, we have incorporated SP encounters into the curriculum of the Bioethics Program of The Union Graduate College and the Icahn School of Medicine at Mount Sinai. SP encounters are incorporated into one of our onsite classes, the Onsite Clinical Ethics Practicum, and they are part of the capstone examination, which all of our graduates must complete successfully. The inclusion of simulated encounters into the curriculum is one way in which we equip our students with the core competencies specified by the American Society for Bioethics and Humanities Task Force for clinical ethicists.

Free Will From the Neurophilosophical Perspective

et al. (2010) deontological justification of HAT who would have access to treatment and who would pay. Their argument for the “right to injectable heroin” suggests that they would advocate more liberal use of HAT among opioid drug users. But providing HAT as a first-line treatment to anyone seeking treatment for heroin dependence would further reduce the numbers of individuals who could be treated. It would also potentially expose individuals to the harms arising from regular injecting heroin use who might have otherwise responded to standard forms of treatment. Lack of access to treatment for opioid dependence is already a major problem in most developed countries. Patients can wait several months to get into OST, even in countries with well-established programs (e.g., Europe, Australia, and Canada). The provision of HAT to 5–10% of addicted heroin users would significantly reduce the ability of treatment systems to provide oral OST to the vast majority of patients (Lintzeris 2009). A case therefore needs to be made that it is ethically acceptable to use limited health care resources to provide a more expensive treatment for a minority of patients at the expense of providing cheaper treatment that benefits many more. We believe that the inability to provide safe and effective treatment to all those in need is a more significant challenge than a putative right to injectable heroin treatment programs. A complete analysis of the ethical acceptability of HAT therefore needs to go beyond the right of individuals to access it, to consider the impact that its provision may have on access to effective treatment for the majority of opioid-dependent individuals.

Reconsidering the Impact of Affective Forecasting

In the article ‘‘Affective Forecasting and Its Implications for Medical Ethics,’’ Rhodes and Strain present current research documenting a psychological bias that affects our ability to correctly predict future emotional states. The bias they discuss is the wrongful estimation of the emotional impact of significant events. Research on affective forecasting by T.D. Wilson and D.T. Gilbert indicates that people tend to overestimate both the positive and negative impact of events. Rhodes and Strain correctly note that the conclusions derived from the research—that bad events do not seem to affect us as much as previously assumed—has applications for medicine. In a field where doctors are often faced with delivering bad news and offering treatments that will significantly alter the lives of their patients, information that bad events are not as emotionality deleterious as once thought is good news. I argue in agreement with the authors that the research on the impact bias could support an attitude change in terms of how doctors approach and communicate with their patients. It can contribute, also, to a change in attitude when doctors are faced with the grim task of telling patients that they have a chronic illness or that they are faced with making difficult decisions about their health. I disagree, however, that the predicted impact of the biases in emotional forecasting is as all-encompassing as the authors claim. In the next section, I consider the effects of biases in affective forecasting on policymakers. I assert that, although the research on the impact bias reveals misconceptions about what is needed for happiness, it does not provide guidelines for endorsing policies. In the third section, I consider how the bias affects doctors and patients differently. I argue that doctors are not affected by the bias in the same way as patients. In the fourth section, I argue against Rhodes and Strain and claim that affective forecasting does not diminish decisional capacity. I argue further that because the bias is incorrigible, paternalism will not help in restoring patient autonomy.

The Truth About Memory and Identity

The moral condemnation of memory modifying technologies (MMTs) often relies on the view that memory provides a veridical representation of the past and that it can be used to ground personal identity. In this chapter, I present a range of studies that substantiate the claim that autobiographical memory is unreliable and cannot be used to ground narrative identity. I use this evidence to argue that MMTs that have the potential to alter autobiographical memory do not jeopardize personal identity. Given its flexibility, I argue, narrative identity can be maintained despite changes in memory. I further argue that maintenance of particular memories is not required for authenticity. Because of the spontaneous fluctuations of each person’s character traits, values, and preferences over time, I claim that first-person endorsement of core traits or the identification of core memories as formative of narrative identity is required to establish one’s true self. In addition, I dispute the argument that memory modification poses a challenge to authenticity and provide examples of instances where such modification can promote authenticity.