Now I know why so many stories have been written with the theme: “everything changed in one moment.” More than 1,000 days have come and gone, and I still remember one Sunday morning and still follow and feel the effects of one decision.

The author, head of a teaching hospital surgical unit, argues that the medical curriculum must ensure that all students are exposed to a minimum of ethical discussion and decision-making. In describing his own approach he emphasises the need to show students that it is 'an intensely practical subject'. Moreover, he reminds them that moral dilemmas in medicine--perhaps a better term than medical ethics--are unavoidable in clinical practice. Professor Johnson emphasises the need for small group teaching and discussion of real cases, (...) preferably chosen and 'worked up' by individual students. He suggests that ethical issues could profitably be introduced into written, oral and clinical examinations. (shrink)

In _Discrimination Against the Dying_, Philip Reed argues, among other things, that ‘right to die laws (euthanasia and assisted suicide) also exhibit terminalism when they restrict eligibility to the terminally ill’. 1 Additionally, he suggests ‘the availability of the option of assisted death only for the terminally ill negatively influences the terminally ill who wish to live by causing them to doubt their choice’. 1 I argue that on scrutiny, neither of these two points hold. First, we routinely limit a (...) course of treatment to only those for whom we believe the treatment might provide a benefit. Typically, we do not think hastening death provides benefit when an individual is not experiencing a terminal illness. Thus, I conclude, either all treatments are discriminatory, or medical aid in dying is not. Second, I argue that permitting individuals to refuse or remove life sustaining care may very well cause... (shrink)

ABSTRACT This study examined how lifestyle factors and gender affect kidney allocation to transplant patients by 99 British and Singaporean participants. Thirty hypothetical patients were generated from a combination of six factors and randomly paired four times. Participants saw 60 patient pairings and, in each pair, chose which patient would receive treatment priority. A Bradley-Terry model was used to derive coefficients for each factor per participant. A mean factor score was then calculated across all participants for each factor. Participants gave (...) lower priority to patients who drank more, were overweight, smoked more and exercised less. A patient’s diet and gender had no significant effect on allocation. There were no significant cross-cultural differences. There were moderate correlations between participants’ self-reported pre- and post-experiment ordering of decision criteria, and these measures and factor coefficients, suggesting a modest level of decision-making consistency. Between participants, moderate levels of concordance with respect to factor importance were observed for self-reported orderings of factors, and weaker agreement for model-derived coefficients. Very similar results were obtained for both British and Singaporean participants, and the implications of the findings are discussed. (shrink)

A reliable medical image management must provide proper security for patient information. Protecting the medical information of the patients is a major concern in all hospitals. Digital watermarking is a procedure prevalently used to secure the confidentiality of medical information and maintain them, which upgrades patient health awareness. To protect the medical information, the robust and lossless patient medical information sharing system using crypto-watermarking method is proposed. The proposed system consists of two phases: (i) embedding and (ii) extraction. In this (...) paper, we securely share three types of patient information, medical image, electronic health record (EHR), and face image from one hospital to another hospital. Initially, all the three inputs are encrypted and the information is concordant. In order to enhance the robustness of the crypto-watermarking system, the obtained bit stream is compressed, and the compressed bit streams are embedded into the cover image. The same process is repeated for the extraction process. The experimentation result is carried out using different medical images with EHR, and the effectiveness of the proposed algorithm is analyzed with the help of peak signal to noise ratio. (shrink)

The aim of this article is to explore the complex forms of knowledge involved in diagnostic and interventional decision making by comparing the processes in medicine and nursing, including nurse practitioners. Many authors assert that the practice of clinical decision making involves the application of theoretical knowledge (acquired in the classroom and textbooks) as well as research evidence, upon concrete particular cases. This approach draws on various universal principles and algorithms to facilitate the task. On the other hand, others argue (...) that this involves an intuitive form of judgement that is difficult to teach, one that is acquired principally through experience. In an exploration of these issues, this article consists of three sections. A clarification of terms commonly used when discussing decision making is provided in the first section. In the second section, an epistemological analysis of decision making is presented by examining several perspectives and comparing them for their use in the nursing and medical literature. Bunge's epistemological framework for decision making (based on scientific realism) is explored for its fit with the aims of medicine and nursing. The final section presents a discussion of knowledge utilization and decision making as it relates to the implications for the education and ongoing development of nurse practitioners. It is concluded that Donald Schön's conception of reflective practice best characterizes the skilful conduct of clinical decision making. (shrink)

A medical information commons is a networked data environment utilized for research and clinical applications. At three deliberations across the U.S., we engaged 75 adults in two-day facilitated discussions on the ethical and social issues inherent to sharing data with an MIC. Deliberants made recommendations regarding opt-in consent, transparent data policies, public representation on MIC governing boards, and strict data security and privacy protection. Community engagement is critical to earning the public's trust.

At the end of the 1990s, Brazil was faced with a potentially explosive HIV/AIDS epidemic. Through an innovative and multifaceted campaign, and despite initial resistance from multinational pharmaceutical companies, the government of Brazil was able to negotiate price reductions for HIV medications and develop local production capacity, thereby averting a public health disaster. Using interview data and document analysis, the authors show that the exercise of corporate social responsibility can be viewed in practice as a dynamic negotiation and an (...) interaction between multiple actors. Action undertaken in terms of voluntary CSR alone may be insufficient. This finding highlights the importance of a strong role for national governments and international organizations to pressure companies to perform better. (shrink)

New anti‐obesity medications (AOMs) have received widespread acclaim in medical journals and the media, but they also raise critical ethical, public health, and public policy concerns that have largely been ignored. AOMs are very costly, need to be taken by a patient in perpetuity (since significant rebound weight gain otherwise occurs), and threaten to shift resources and focus away from other crucial efforts at obesity treatment and prevention. Many people may feel less motivated to exercise or reduce their caloric (...) consumption, if they assume that obesity is now medically treatable. Policy‐makers may similarly come to feel that the solution to the obesity pandemic is simply to prescribe medications and that prevention efforts are far less necessary. These drugs raise concerns about justice (since AOMs will disproportionately benefit the wealthy), medicalization, and marketing. Policy‐makers, clinicians, and others need to engage in multipronged educational and policy efforts to address these challenges. (shrink)

Some individuals facing dementia contemplate hastening their own death: weighing the possibility of living longer with dementia against the alternative of dying sooner but avoiding the later stages of cognitive and functional impairment. This weighing resonates with an ethical and legal consensus in the United States that individuals can voluntarily choose to forgo life‐sustaining interventions and also that medical professionals can support these choices even when they will result in an earlier death. For these reasons, whether and how a terminally (...) ill individual can choose to control the timing of their death is a topic that cannot be avoided when considering the dementia trajectory. With a focus on the U.S. context, this landscape review considers the status of provisions that would legally permit people facing dementia to hasten death with appropriate support from medical professionals. This review can be used to plan and guide clinical and legal practitioner discussion and policy development concerning evolving questions not fully covered by existing medical decision‐making provisions. (shrink)

This article aims to offer a fresh analysis of two passages in the extensive necromancy episode in Lucan's Bellum Ciuile: the ritual to reanimate the dead soldier's corpse (6.667–73), and the surgical procedure Erichtho then proceeds to undertake (6.750–7), resembling the practice of a vivisection. The study will focus mostly on the strong connection of magic to medical traditions in antiquity, with a commentary on, and analysis of, these verses through the lenses of medical vocabulary, themes and motifs. It ultimately (...) concludes that Lucan was familiar with the language and characteristics of the medical tradition, enriched his report with them, and was playing with his audience's knowledge of the same. (shrink)

Drug Safety Communications are used by the Food and Drug Administration to inform health care providers, patients, caregivers, and the general public about safety issues related to FDA-approved drugs. To assess patient knowledge of the messaging contained in DSCs related to the sleep aids zolpidem and eszopiclone, we conducted a large, cross-sectional patient survey of 1,982 commercially insured patients selected by stratified random sampling from the Optum Research Database who had filled at least two prescriptions for either zolpidem or eszopiclone (...) between July 1, 2012 and June 30, 2013. Among the 594 respondents, two-thirds reported hearing generally about drug safety information prior to starting a new drug, with the remaining one-third “rarely” or “never” hearing such information. Providers and pharmacists were primary sources of drug safety information. Two-thirds of zolpidem users and half of eszopiclone users reported having heard about the related DSC messages, ability to accurately identify the major factual messages was limited. Respondents reacted to new drug safety information about their sleep aids by reporting that they would want to learn about alternative ways to help them sleep and seek out more information about the safety of their specific sleeping pill. Opportunities may exist for the FDA to work with providers and pharmacies to help ensure the DSC information is more widely received and is more fully understood by those taking the affected medications. (shrink)

This article examines recent developments in the regulation of the medical profession in England, with particular reference to doctors working in the National Health Service (NHS). It is argued that the Health Act 1999 and associated government policies are bringing about a shift from a «light touch», self-regulatory paradigm to a government-driven, interventionist approach. It is suggested that the reason for the change is not simply a governmental concern with the quality and nature of care provided by doctors, but more (...) significantly, a concern with the cost of that care. The article offers a critique of the new regime, drawing on the socio-legal literature on regulation. Some aspects of the reforms ignore the need to persuade doctors to comply, and may therefore result in cheating or «creative compliance»; other aspects of the reforms provide doctors with opportunities to «neutralize» their impact. It concludes with an examination of the wider significance of the change in regulatory paradigm, and of the agenda for future research in this field. (shrink)

Based on research on the increasingly popular unconscious thought effect (UTE), it has been suggested that physicians might make better diagnostic decisions after a period of distraction than after an equivalent amount of time of conscious deliberation. However, published attempts to demonstrate the UTE in medical decision making have yielded inconsistent results. In the present study, we report the results of a meta-analysis of all the available evidence on the UTE in medical decisions made by expert and novice clinicians. The (...) meta-analysis failed to find a significant contribution of unconscious thought to the accuracy of medical decisions. This result cannot be easily attributed to any of the potential moderators of the UTE that have been discussed in the literature. Furthermore, a Bayes Factor analysis shows that most experimental conditions provide positive support for the null hypothesis, suggesting that these null results do not reflect a simple lack of statistical power. We suggest ways in which new studies could usefully provide further evidence on the UTE. Unless future research shows otherwise, the recommendation of using unconscious thought to improve medical decisions lacks empirical support. (shrink)

Background: Only data of published study results are available to the scientific community for further use such as informing future research and synthesis of available evidence. If study results are reported selectively, reporting bias and distortion of summarised estimates of effect or harm of treatments can occur. The publication and citation of results of clinical research conducted in Germany was studied.Methods: The protocols of clinical research projects submitted to the research ethics committee of the University of Freiburg in 2000 were (...) analysed. Published full articles in several databases were searched and investigators contacted. Data on study and publication characteristics were extracted from protocols and corresponding publications.Results: 299 study protocols were included. The most frequent study design was randomised controlled trial , followed by uncontrolled studies , laboratory studies and non-randomised studies . 182 were multicentre studies including 97 international collaborations. 152 of 299 had commercial funding and 46 non-commercial funding. 109 of the 225 completed protocols corresponded to at least one full publication ; the publication rate was 48%. 168 of 210 identified publications were cited in articles indexed in the ISI Web of Science. The median was 11 citations per publication .Conclusions: Results of German clinical research projects conducted are largely underreported. Barriers to successful publication need to be identified and appropriate measures taken. Close monitoring of projects until publication and adequate support provided to investigators may help remedy the prevailing underreporting of research. (shrink)

Critics of attention-deficit/hyperactivity disorder (ADHD) have repeatedly argued that there is no proof for the condition being symptomatic of an organic brain disease and that the current "ADHD epidemic" is an expression of medicalization. To this, the supporters of ADHD can retort that the condition is only defined as a mental disorder and not a physical disease. As such, ADHD needs only be a harmful mental dysfunction, which, like other genuine disorders, can have a complex and obscure etiology. This article (...) argues that such a line of argument fails to save ADHD as a valid diagnostic category. Given the general diagnostic logic of the DSM-IV and how ADHD has been defined in terms of everyday (male) child behaviors, there are compelling grounds to disbelieve that ADHD can be a true medical syndrome united by some type of harmful dysfunction. Indeed, strong logical and empirical reasons will be adduced to show that people may qualify for ADHD diagnosis without suffering from any type of underlying pathology. (shrink)

Legislation enabling pharmacists to prescribe is being drafted and passed in Canada and internationally. But is it a good idea for pharmacists to be prescribing psychotropic medications? In this discussion, the term “pharmacist prescribing” is dei ned, the issues of the potential conl ict of interest of pharmacists discussed, and the education and training of pharmacists reviewed. Finally, an experienced psychiatrist weighs in on the discussion with a personal rel ection on this important discussion, concluding that “we should move (...) forward cautiously but in a spirit of collaboration, mutual respect and above all in the best interests of the patient. (shrink)

Summary Principles Timely support for patients and people close to them, and effective, sensitive communication are essential. Decisions must be based on the individual patient's circumstances and reviewed regularly. Sensitive advance discussion should always be encouraged, but not forced. Information about CPR and the chances of a successful outcome needs to be realistic. Practical matters Information about CPR policies should be displayed for patients and staff. Leaflets should be available for patients and people close to them explaining about CPR, how (...) decisions are made and their involvement in decisions. Decisions about attempting CPR must be communicated effectively to relevant health professionals. In emergencies If no advance decision has been made or is known, CPR should be attempted unless: the patient has refused CPR; the patient is clearly in the terminal phase of illness; or the burdens of the treatment outweigh the benefits. Advance decision making Competent patients should be involved in discussions about attempting CPR unless they indicate that they do not want to be. Where patients lack competence to participate, people close to them can be helpful in reflecting their views. Legal issues Patients' rights under the Human Rights Act must be taken into account in decision making. Neither patients nor relatives can demand treatment which the health care team judges to be inappropriate, but all efforts will be made to accommodate wishes and preferences. In England, Wales and Northern Ireland relatives and people close to the patient are not entitled in law to take health care decisions for the patient. In Scotland, adults may appoint a health care proxy to give consent to medical treatment. Health professionals need to be aware of the law in relation to decision making for children and young people.IntroductionWhy policies are neededCardiopulmonary resuscitation can be attempted on any person whose cardiac or respiratory functions cease. Failure of these functions is part of dying and thus …. (shrink)

Results: We analyzed 1,402 surveys and 15 in-depth interviews. Many (32%) CL participants reported greater difficulty refilling medications and a minority (14%) reported greater difficulty accessing HIV care during the pandemic. Most (99%) Opt4Mamas participants reported no difficulty refilling medications or accessing HIV/pregnancy care. Among the CL participants, older women were less likely (aOR = 0.95, 95% CI: 0.92–0.98) and women with more children were more likely (aOR = 1.13, 95% CI: 1.00–1.28) to report difficulty refilling medications. (...) Only 2% of CL participants reported greater difficulty managing FP and most (95%) reported no change in likelihood of using FP or desire to get pregnant. Qualitative analysis revealed three major themes: (1) adverse organizational/economic implications of the pandemic, (2) increased importance of pregnancy prevention during the pandemic, and (3) fear of contracting COVID-19. (shrink)

The standard approach to treatment decision making for incapacitated patients often fails to provide treatment consistent with the patient’s preferences and values and places significant stress on surrogate decision makers. These shortcomings provide compelling reason to search for methods to improve current practice. Shared decision making between surrogates and clinicians has important advantages, but it does not provide a way to determine patients’ treatment preferences. Hence, shared decision making leaves families with the stressful challenge of identifying the patient’s preferred treatment (...) option. To address this concern, the present paper proposes to incorporate the use of a “Patient Preference Predictor” (PPP) into the shared decision-making process between surrogates and clinicians. A PPP would predict which treatment option a given incapacitated patient would most likely prefer, based on the individual’s characteristics and information on what treatment preferences are correlated with these characteristics. Use of a PPP is likely to increase the chances that incapacitated patients are treated consistent with their preferences and values and might reduce the stress and burden on their surrogates. Including a PPP in the shared decision-making process therefore has the potential to realize important ethical goals for making treatment decisions for incapacitated patients. The present paper justifies this approach on conceptual and normative grounds. (shrink)

OBJECTIVES: Life-sustaining treatment at the end of life gives rise to many ethical problems in Japan. Recent surveys of Japanese physicians suggested that they tend to treat terminally ill patients aggressively. We studied why Japanese physicians were reluctant to withhold or withdraw life-support from terminally ill patients and what affected their decisions. DESIGN AND PARTICIPANTS: A qualitative study design was employed, using a focus group interview with seven physicians, to gain an in-depth understanding of attitudes and rationales in Japan regarding (...) medical care at the end of life. RESULTS: Analysis revealed that physicians and patients' family members usually make decisions about life-sustaining treatment, while the patients' wishes are unavailable or not taken into account. Both physicians and family members tend to consider withholding or withdrawing life-sustaining treatment as abandonment or even killing. The strongest reason to start cardiopulmonary resuscitation- and to continue it until patients' family members arrive-seems to be the family members' desire to be at the bedside at the time of death. All physicians participating in our study regarded advance directives that provide information as to patients' wishes about life-sustaining treatment desirable. All expressed concern, however, that it would be difficult to forego or discontinue life-support based on a patient's advance directive, particularly when the patient's family opposed the directive. CONCLUSION: Our group interview suggested several possible barriers to death with dignity and the appropriate use of advance directives in Japan. Further qualitative and quantitative research in this regard is needed. (shrink)

Anna Chavlovski,1 Greg A Knoll,1–3 Timothy Ramsay,4 Swapnil Hiremath,1–3 Deborah L Zimmerman1–31University of Ottawa, 2Ottawa Hospital, 3Kidney Research Centre, Ottawa Hospital Research Institute, 4Ottawa Methods Centre, Ottawa, ON, CanadaBackground: In patients with end-stage renal disease, use of vitamin D and calcium-based phosphate binders have been associated with progression of vascular calcification that might have an impact on renal transplant candidacy. Our objective was to examine management of mineral metabolism in patients wait-listed for renal transplant and to determine the impact on (...) cardiac perfusion imaging.Methods: Data was collected retrospectively on patients wait-listed for a renal transplant, being either active and on hold. Demographic data, medications, serum concentrations of calcium, phosphate, parathyroid hormone, and cardiac perfusion imaging studies were collected from the electronic health record. Chi-square and Student’s t-tests were used to compare active and on-hold patients as appropriate. Logistic regression was used to examine variables associated with worsening cardiac imaging studies.Results: The wait-listed patients were of mean age 56 ± 14 years and had been on dialysis for 1329 ± 867 days. On-hold patients had received a significantly greater total dose of calcium and were more likely to have developed worsening cardiovascular imaging studies. Total doses of calcium and calcitriol were associated with worsening cardiovascular imaging studies.Conclusion: Patients on hold on the renal transplant waiting list received higher total doses of calcium. A higher total dose of calcium and calcitriol was also associated with worsening cardiovascular imaging. Time on dialysis before transplant has been associated with worse post-transplant outcomes, and it is possible that the total calcium and calcitriol dose received contributed to these inferior outcomes.Keywords: dialysis, calcium, cardiac, transplantation. (shrink)

BackgroundLittle is known about teaching medical ethics across cultural and linguistic boundaries. This study examined two successive cohorts of first year medical students in a six year undergraduate MBBS program.MethodsThe objective was to investigate whether Arabic speaking students studying medicine in an Arabic country would be able to correctly identify some of the principles of Western medical ethical reasoning. This cohort study was conducted on first year students in a six-year undergraduate program studying medicine in English, their second language at (...) a medical school in the Arabian Gulf. The ethics teaching was based on the four-principle approach (autonomy, beneficence, non-malfeasance and justice) and delivered by a non-Muslim native English speaker with no knowledge of the Arabic language. Although the course was respectful of Arabic culture and tradition, the content excluded an analysis of Islamic medical ethics and focused on Western ethical reasoning. Following two 45-minute interactive seminars, students in groups of 3 or 4 visited a primary health care centre for one morning, sitting in with an attending physician seeing his or her patients in Arabic. Each student submitted a personal report for summative assessment detailing the ethical issues they had observed.ResultsAll 62 students enrolled in these courses participated. Each student acting independently was able to correctly identify a median number of 4 different medical ethical issues (range 2–9) and correctly identify and label accurately a median of 2 different medical ethical issues (range 2–7) There were no significant correlations between their English language skills or general academic ability and the number or accuracy of ethical issues identified.ConclusionsThis study has demonstrated that these students could identify medical ethical issues based on Western constructs, despite learning in English, their second language, being in the third week of their medical school experience and with minimal instruction. This result was independent of their academic and English language skills suggesting that ethical principles as espoused in the four principal approach may be common to the students' Islamic religious beliefs, allowing them to access complex medical ethical reasoning skills at an early stage in the medical curriculum. (shrink)

As part of an effort to improve the teaching of medical ethics in the College of Medicine, Lagos University two-day workshops were organised. Participants included people from various walks of life, for example politicians, lawyers, doctors, and patients. The workshops were quite successful, and have led to more extensive teaching of medical ethics in the college.

Following up on a 1989 paper on the subject, this essay revisits the question of ethical expertise in the court room. Informed by recent developments in the use of ethics experts, the authors argue 1) that the adversarial nature of court proceedings challenges the integrity of the ethicist's pedagogical role; 2) that the use of ethics experts as normative authorities remains dubious; 3) that clarification of the State's interest in “protecting the ethical integrity of the medical profession” is urgently required; (...) and 4) that the expertise of the ethicist may be more appropriately used in advising the legislature than in influencing the court. (shrink)

The clinical vignette remains the standard means by which medical ethics are taught to students in the healthcare professions. Although written or verbal vignettes are useful as a pedagogic tool for teaching ethics and introducing students to real cases, they are limited, since students must imagine the clinical scenario. Medical ethics are almost universally taught during the early years of training, when students are unfamiliar with the clinical reality in which ethics issues arise. Film vignettes fill in that imaginative leap. (...) By providing vivid details with images, film vignettes offer rich and textured details of cases, including the patient’s perspective and the clinical reality. Film vignettes provide a detailed ethnography that allows for a more complete discussion of the ethical issues. Film can serve as an additional tool for teaching medical ethics to members of the healthcare professions. (shrink)

While protection of autonomy is crucial to the practice of medicine, there is the persistent risk of a disconnect between the notion of self-determination and the need for a socially responsible medical system. An example of unbridled autonomy is the preferential use of costly medications without an appreciation of the impact of using these more expensive drugs on the resource pool of others. In the USA, costly medications of questionable incremental benefit are frequently prescribed with the complicity of (...) both doctors and patients. Limiting self-determination in medication choices via an appreciation of the principle of justice reaches a better moral balance, while at the same time acknowledging the goals of doing good and avoiding harm in patient care. (shrink)

Background Psychiatric electroceutical interventions (PEIs) use electrical or magnetic stimulation to treat mental disorders and may raise different ethical concerns than other therapies such as medications or talk therapy. Yet little is known about stakeholders’ perceptions of, and ethical concerns related to, these interventions. We aimed to better understand the ethical concerns of a variety of stakeholder groups (patients with depression, caregivers of patients, members of the public, and psychiatrists) regarding four PEIs: electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (...) (rTMS), deep brain stimulation (DBS), and adaptive brain implants (ABI).Methods We conducted a national survey of these four stakeholder groups, using an embedded video vignette experiment depicting a patient with treatment-resistant depression and her psychiatrist discussing the possibility of treatment with one of the four PEIs.Results Participants’ ethical concerns varied by stakeholder group, by PEI, and by the interaction of the two. The three non-clinician groups tended to have similar ethical concerns, but to differ from psychiatrists. Similar concerns were raised with regard to the two implantable technologies, DBS and ABI. Overall, there was relatively little concern about the involuntary use of PEIs, though some expressed concern about the adequacy of information provided during the consent process. There was also significant concern that patients may not receive helpful therapies.Conclusions To our knowledge, this is the first national survey that includes multiple stakeholder groups and multiple PEI modalities. A better understanding of the ethical concerns of stakeholders can help to shape clinical practice and health care policy regarding PEIs. (shrink)

There are compelling scientific, political, historical, legal, and ethical reasons why the All of Us research program participants should reflect the population of the United States. Many commentat...

After decades of specialization within the sciences, the development and application of implantable microchips and biosensors are now being made possible by a growing convergence among seemingly disparate scientific disciplines including, among others, biology, informatics, chemistry, and engineering. This convergence of diverse scientific disciplines is the basis for the creation of new technologies that will have significant medical potential. As of today, implantable microchips and biosensors are being used as mental prostheses to compensate for a loss of normal function, to (...) remotely monitor patients' vital signs, to control the delivery of medications, and to communicate with geographically distant healthcare professionals and the outside environment. (shrink)

The aim of this research was to gain insight into the experiences and perspectives of individual members of a Medical Research Ethics Committee regarding their individual roles and possible tensions within and between these roles. We conducted a qualitative interview study among members of a large MREC, supplemented by a focus group meeting. Respondents distinguish five roles: protector, facilitator, educator, advisor and assessor. Central to the role of protector is securing valid informed consent and a proper risk-benefit analysis. The role (...) of facilitator implies that respondents want to think along with and assist researchers in order to help medical science progress. As educators, the respondents want to raise ethical and methodological awareness of researchers. The role of advisor implies that respondents bring in their own expertise. The role of assessor points to contributing to the overall evaluation of the research proposal. Various tensions were identified within and between roles. Within the role of protector, a tension is experienced between paternalism and autonomy. Between the role of protector and facilitator tensions occur when the value of a study is questioned while risks and burdens for the subjects are negligible. Within the role of assessor, a tension is felt between the implicit nature of judgments and the need for more explicit formulations. Awareness of various roles and responsibilities may prevent one-sided views on MREC work, not only by members themselves, but also by researchers. Tensions within and between the roles require reflection by MREC members. (shrink)

The aim of this research was to gain insight into the experiences and perspectives of individual members of a Medical Research Ethics Committee regarding their individual roles and possible tensions within and between these roles. We conducted a qualitative interview study among members of a large MREC, supplemented by a focus group meeting. Respondents distinguish five roles: protector, facilitator, educator, advisor and assessor. Central to the role of protector is securing valid informed consent and a proper risk-benefit analysis. The role (...) of facilitator implies that respondents want to think along with and assist researchers in order to help medical science progress. As educators, the respondents want to raise ethical and methodological awareness of researchers. The role of advisor implies that respondents bring in their own expertise. The role of assessor points to contributing to the overall evaluation of the research proposal. Various tensions were identified within and between roles. Within the role of protector, a tension is experienced between paternalism and autonomy. Between the role of protector and facilitator tensions occur when the value of a study is questioned while risks and burdens for the subjects are negligible. Within the role of assessor, a tension is felt between the implicit nature of judgments and the need for more explicit formulations. Awareness of various roles and responsibilities may prevent one-sided views on MREC work, not only by members themselves, but also by researchers. Tensions within and between the roles require reflection by MREC members. (shrink)

There is a paucity of treatment options for cognitively normal individuals with drug resistant genetic generalized epilepsy. Centromedian nucleus of the thalamus deep brain stimulation may be a viable treatment for GGE. Here, we present the case of a 27-year-old cognitively normal woman with drug resistant GGE, with childhood onset. Seizure semiology are absence seizures and generalized onset tonic clonic seizures. At baseline she had 4–8 GTC seizures per month and weekly absence seizures despite three antiseizure medications and vagus (...) nerve stimulation. A multidisciplinary committee recommended off-label use of CM DBS in this patient. Over 12-months of CM DBS she had two GTC seizure days, which were in the setting of medication withdrawal and illness, and no GTC seizures in the last 6 months. There was no significant change in the burden of absence seizures. Presently, just two studies clearly document CM DBS in cognitively normal individuals with GGE or idiopathic generalized epilepsy [in contrast to studies of cognitively impaired individuals with developmental and epileptic encephalopathies ]. Our results suggest that CM DBS can be an effective treatment for cognitively normal individuals with GGE and underscore the need for prospective studies of CM DBS. (shrink)

The due process clause of the Fourteenth Amendment protects the right of terminally ill persons to hasten their inevitable death. In prohibiting physicians from prescribing lethal medications by which such patients might hasten death, Michigan's ban on “assisted suicide” unconstitutionally imposes an “undue burden” on the exercise of that right.

This code of practice for health professionals was prepared by a multi-professional group and reflects good clinical practice in encouraging dialogue about individuals' wishes concerning their future treatment. It has a broad practical approach, considers a range of advance statements, advises of dangers and benefits of making treatment decisions in advance and combines annotated code of practice with a quick pull out guide for easy reference.

As the population in the United States gets older, more people suffer from dementia, which often causes neuropsychiatric symptoms such as agitation and paranoia. This can lead patients to refuse medications, prompting consideration of covert administration (that is, concealing medication in food or drink). While many condemn this practice as paternalistic, deceptive, and potentially harmful, the end result of assuming the “moral high ground” can be increased suffering for patients and families. This article addresses common criticisms of covert medication (...) and presents a detailed algorithm by which to determine whether the practice is ethically permissible in specific cases. It also explores why so little attention has been paid in the U.S. to this presumably common practice, and reviews professional statements from Europe that endorse the practice. Finally, it presents a compelling argument for the role of Ulysses clauses in advance care planning, not only for patients with psychiatric illness but also for those who may suffer from dementia, which is far more common. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:A Brief History of Medical Ethics Code in PolandJacek A. Piątkiewicz (bio)On March 15, 1934 a Parliamentary Act authorized the General Medical Chambers, a body incorporating all Polish physicians, to establish general rules of medical ethics. These rules governed medical conduct in Poland until 1950, when the Communist government dissolved the General Medical Chambers.From 1950 to 1989 the only medical organization in Poland tolerated by the Communist government was (...) the Polish Medical Association, which included about 30% of the country's physicians. In 1967 this group produced the "Collection of Ethico-deontological principles of the Polish Physician" which constituted a kind of code of medical ethics. This collection was a compromise between objective ethical principles and the demands of the Communist regime. For example, Principle 1 of the Collection stated that the physician "had to observe the ethico-deontological principles obligatory in socialist society."During round-table talks in early 1989 with representatives of the Communist government, the Solidarity movement argued for the revival of autonomous medical organizations like the Medical Chambers. On May 17, 1989 an Act of Parliament re-established the group. The Act (article 33, part 1) also stipulated that the National Congress of Physicians, the legislative body of Medical Chambers, establish rules of medical ethics. The Act (article 15, part 1) also states that all practicing Polish physicians are obliged to observe these rules.When the revived Chambers began its work in January 1990, its governing body—the General Medical Council—created a Commission to prepare a draft of a medical ethics code. After a year and a half of work, the Commission completed its draft, which received preliminary acceptance by the General Medical Council. [End Page 361]On December 13-14, 1991 the Extraordinary Second National Congress of Physicians was held in Bielsko-Biala (South Poland) and one of the main items on the agenda was the Code. Every article of the Code was discussed exhaustively throughout the second day of the meeting, and close to midnight the Code, including the Physician' Oath, was approved by an overwhelming majority (449 for, 75 against, 58 abstaining).Some of the liveliest discussion centered on Article 37, which relates to abortion. The delegates realized that the Code was inconsistent with a 1956 Act on abortion then under discussion in the Parliament which was not as restrictive as the Code. They decided to defer implementation of the Code for five months, until May 3, 1992. As described in the following text by Robert Baker, Article 37 has now been appealed and a decision resolving the discrepancy would have to come from Poland's Constitutional Tribunal or its Parliament. [End Page 362]Jacek A. Piątkiewicz Jacek A. Piątkiewicz, M.D., Ph.D., is Chairman of the Legislative Commission of the General Medical Council of Poland in Warsaw.Copyright © 1993 The Johns Hopkins University Press... (shrink)

This essay examines the interrelationship between legal, medical, and public knowledge in the case of Mary Mallon. The author argues that although Mallon was never convicted of any crime, she was under the constant surveillance of medical authorities because of her characterization as a recalcitrant typhoid carrier. Mallon's physical body became a contested site of controversy as various medical and legal communities fought for the legitimization of their own bodies of knowledge. Modern health care theorists and practitioners still use a (...) plethora of Typhoid Mary narratives in their discussions of the relationship between jurisprudence, ethics, and medicine. (shrink)

Through the 1960s, many people claimed that drug advertising was educational and physicians often relied on it. Continuing Medical Education (CME) was developed to provide an alternative. However, because CME relied on grants, industry funders chose the subjects offered. Now policymakers worry that drug firms support CME to promote sales and that commercial support biases prescribing and fosters inappropriate drug use. A historical review reveals parallel problems between advertising and industry-funded CME. To preclude industry influence and improve CME, we should (...) ensure independent funding by taxing medical industries, facilities and physicians. Independent public and professional authorities should create CME curricula. An independent agency should allocate all funds to educational institutions for approved curricula. (shrink)

Purpose: Explore public attitudes towards the trade-offs between justice and medical outcome inherent in organ allocation decisions.Background: The US Task Force on Organ Transplantation recommended that considerations of justice, autonomy and medical outcome be part of all organ allocation decisions. Justice in this context may be modeled as a function of three types of need, related to age, clinical urgency, and quality of life.Methods: A web-based survey was conducted in which respondents were asked to choose between two hypothetical patients who (...) differed in clinical urgency , age, pretransplant and post-transplant quality of life, and life expectancy.Results: A pool of 1600 people were notified via email about the survey; 623 responded. Respondents preferred giving organs to younger people up to an age difference of <15.4 years and more clinically urgent people up to a difference in urgency of <2.54 months . Priority varied with the quality of life of the worst-off patient and the relative status of the patients. If both had worse than average quality of life, respondents preferred the better-off patient. When both had better than average quality of life, they preferred the worse-off patient. In analysis according to age versus clinical urgency, the older the patient, the more urgency needed to receive priority. In quality of life versus clinical urgency, the better the control’s quality of life, the more urgency the competing patient required. The worse the patient’s post-transplant outcome, the more urgency needed to receive priority.Conclusions: It appears that clinical urgency is only one of many factors influencing attitudes about allocation decisions and that respondents may invoke different principles of fairness depending the relative clinical status of patients. (shrink)

Public policy tries to promote appropriate drug use by allowing firms to market drugs in interstate commerce only for uses that the Food and Drug Administration has found to be safe and effective. Because of their medical knowledge, physicians are authorized to prescribe drugs even for uses unapproved by the FDA. Nevertheless, physicians have relied on drug firms for information on appropriate prescribing despite the inherent tension between drug firm dissemination of information to promote sales and rational prescribing. In the (...) past, physicians often relied particularly on drug firm advertising for information on drug use. Today, physicians rely on drug firms to finance continuing medical education. A historical review reveals connections between these two different ways commercial interests have influenced the information that physicians receive and points the way to needed reforms. (shrink)

Background: The magnitude of bullying and harassment among psychiatrists is reportedly high, yet no peer-review published studies addressing this issue could be found. Therefore, it was decided to conduct a pilot study to assess the degree of the problem, the types of bullying/harassment and to provide some insights into the situation.Methods and Principal Findings: Following multiple focus group meetings, a yes/no response type questionnaire was developed to assess the degree and type of bullying and harassment experienced by psychiatrists. Over a (...) 3-month period the questionnaire was administered to a random sample of 60 psychiatrists. 57 out of the 60 psychiatrists reported harassment and bullying. Frequencies of the following response variables are presented in descending order: rumours 40% ; defamation 20% ; passing remarks 20% ; false accusations 15% ; threats 13.3% ; verbal abuse 13.3% ; unjustified complaints 13.3% ; promotion blocked 13.3% ; humiliation 13% ; bad reference given 10% ; credentials questioned 8.3% ; physical attacks 5% ; termination 5% ; derogatory remarks 1.7% and 1.7% were subjected to personal work. As a result of being subjected to harassment, 66.7% of the psychiatrists did not take any action, whereas 33.3% confronted the person they believed responsible. Asked whether the bullying and harassment caused distress, 18.3% of the psychiatrists did not report any effect, 30% reported mild distress, 40% moderate distress and severe distress was reported by 11.7%.Conclusions: It was concluded that the magnitude of bullying and harassment among psychiatrists may be quite high, as evidenced by this pilot study. There is a need for extensive systematic studies on this subject and to establish strategies to prevent and address this issue at a national and regulatory level. (shrink)

Background: In Switzerland, non-medical right-to-die organisations such as Exit Deutsche Schweiz and Dignitas offer suicide assistance to members suffering from incurable diseases. Objectives: First, to determine whether differences exist between the members who received assistance in suicide from Exit Deutsche Schweiz and Dignitas. Second, to investigate whether the practices of Exit Deutsche Schweiz have changed since the 1990s. Methods: This study analysed all cases of assisted suicide facilitated by Exit Deutsche Schweiz (E) and Dignitas (D) between 2001 and 2004 and (...) investigated by the University of Zurich’s Institute of Legal Medicine (E: n = 147; D: n = 274, total: 421). Furthermore, data from the Exit Deutsche Schweiz study which investigated all cases of assisted suicide during the period 1990–2000 (n = 149) were compared with the data of the present study. Results: More women than men were assisted in both organisations (D: 64%; E: 65%). Dignitas provided more assistance to non-residents (D: 91%; E: 3%; p = 0.000), younger persons (mean age in years (SD): D: 64.5 (14.1); E: 76.6 (13.3); p = 0.001), and people suffering from fatal diseases such as multiple sclerosis and amyotrophic lateral sclerosis (D: 79%; E: 67%; p = 0.013). Lethal medications were more often taken orally in cases assisted by Dignitas (D: 91%; E: 76%; p = 0.000). The number of women and the proportion of older people suffering from non-fatal diseases among suicides assisted by Exit Deutsche Schweiz has increased since the 1990s (women: 52% to 65%, p = 0.031; mean age in years (SD): 69.3 (17.0) to 76.9 (13.3), p = 0.000), non-fatal diseases: 22% to 34%, p = 0.026). Conclusions: Weariness of life rather than a fatal or hopeless medical condition may be a more common reason for older members of Exit Deutsche Schweiz to commit suicide. The strong over-representation of women in both Exit Deutsche Schweiz and Dignitas suicides is an important phenomenon so far largely overlooked and in need of further study. (shrink)

Background: In Switzerland, non-medical right-to-die organisations such as Exit Deutsche Schweiz and Dignitas offer suicide assistance to members suffering from incurable diseases.Objectives: First, to determine whether differences exist between the members who received assistance in suicide from Exit Deutsche Schweiz and Dignitas. Second, to investigate whether the practices of Exit Deutsche Schweiz have changed since the 1990s.Methods: This study analysed all cases of assisted suicide facilitated by Exit Deutsche Schweiz and Dignitas between 2001 and 2004 and investigated by the University (...) of Zurich’s Institute of Legal Medicine. Furthermore, data from the Exit Deutsche Schweiz study which investigated all cases of assisted suicide during the period 1990–2000 were compared with the data of the present study.Results: More women than men were assisted in both organisations. Dignitas provided more assistance to non-residents, younger persons : D: 64.5 ; E: 76.6 ; p = 0.001), and people suffering from fatal diseases such as multiple sclerosis and amyotrophic lateral sclerosis. Lethal medications were more often taken orally in cases assisted by Dignitas. The number of women and the proportion of older people suffering from non-fatal diseases among suicides assisted by Exit Deutsche Schweiz has increased since the 1990s : 69.3 to 76.9, p = 0.000), non-fatal diseases: 22% to 34%, p = 0.026).Conclusions: Weariness of life rather than a fatal or hopeless medical condition may be a more common reason for older members of Exit Deutsche Schweiz to commit suicide. The strong over-representation of women in both Exit Deutsche Schweiz and Dignitas suicides is an important phenomenon so far largely overlooked and in need of further study. (shrink)

Much critical attention has been paid to the use of qualitative research in the medical sciences, with proponents advancing discussions of what it is and how it may be appraised, and critics arguing that it is of exploratory use only. Using philosophical analysis, I argue that such discussions are flawed insofar as they endorse the idea that qualitative and quantitative research are epistemically distinct categories involving different types of knowledge. Rather, I claim that such approaches are actually culturally distinct involving (...) different intellectual histories. Thus highlighting that qualitative research may not necessarily be exploratory, and that the qualitative-quantitative divide could be closed through the development of innovative social strategies. This makes possible not only shared standard setting practices, but also novel techniques which could optimise medical research to improve health care and save lives. (shrink)

Fifty-nine years ago, Dr Leo Alexander published his now famous report on medicine under the Nazis. In his report he describes the two major crimes of German physicians. The participation of physicians in euthanasia and genocide and the horrible experiments performed on concentration camp prisoners in the name of science. In response to this gross violation of human rights by physicians, the Nuremberg military tribunal, which investigated and prosecuted the perpetrators of the Nazi war crimes, established ten principles of ethical (...) conduct in medical research in 1949. Foremost among them was the need for voluntary consent of the human subject and that the experiment be conducted to avoid all unnecessary physical and mental suffering. Notwithstanding all these important efforts and impressive achievements in understanding the ethical failings of Nazi physicians, the bioethical community has almost completely ignored the moral challenges facing the victims of the atrocities. These dilemmas and their responses have continued relevance for modern medicine. (shrink)

BackgroundInformed consent as stipulated in regulatory human research guidelines requires volunteers to be well-informed about what will happen to them in a trial. However, researchers may be faced with the challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. This study aimed to find out volunteers’ comprehension of informed consent and voluntary participation in Human Immunodeficiency Virus (HIV) clinical trials during the registration cohort.MethodsWe conducted a qualitative study among volunteers who (...) were enrolled in the registration cohort of HIV clinical trials in Dar es Salaam, Tanzania. A purposive sampling strategy was used to obtain twenty study participants. The data were collected between June and September 2020 using a semi-structured interview guide. In-depth interviews were used to collect the data to obtain deep insights of the individual study participants on the comprehension of informed consent and participation in the clinical trial. A thematic analysis approach was used to analyze the data. Themes and subthemes were supported by the quotes from the participants.ResultsVolunteers described comprehension of informed consent from different perspectives. They reported that various components of the informed consent such as study procedure, confidentiality, risk and benefits were grasped during engagement meetings. Furthermore, the volunteers’ decision to participate in the registration cohort was voluntary. However, trial aspects such as health insurance, free condoms, and medical checkups could have indirectly influenced their reluctance to withdraw from the study.ConclusionEngagement meetings may increase the comprehension of informed consent among potential participants for HIV clinical trials. However, trial incentives may influence participation, and thus future research should focus on the challenges of giving incentives in the study. This will ensure comprehension and voluntary participation in the context of HIV clinical trials. (shrink)