This book is a comprehensive and unique text and reference in medical ethics. By far the most inclusive set of primary documents and articles in the field ever published, it contains over 100 selections. Virtually all pieces appear in their entirety, and a significant number would be difficult to obtain elsewhere. The volume draws upon the literature of history, medicine, philosophical and religious ethics, economics, and sociology. A wide range of topics and issues are covered, such as law and medicine, (...) truth-telling by the physician, research, population policy, genetics, abortion, dying, and individual rights in medical care. The selections span the centuries, beginning with material from the works of Hippocrates, continuing through Thomas Percival, John Stuart Mill, and Claude Bernard, down to modern commentators like Henry K. Beecher, Walsh McDermott, David L. Bazelon, Paul Freund, H. L. A. Hart, John Rawls, Paul Ramsey, Richard McCormick, Rashi Fein, and Bernard Barber. The text has eight major divisions, beginning with sections on the ethical dimensions of the physician-patient relationship in history; the moral bases of medical ethics; and regulation, compulsion, and protection of the consumer in clinical medicine and public health. Each of these sections includes key essays that appear for the first time. All of the book's major divisions contain primary documents: codes such as the Hippocratic Oath, Medieval Law for the Regulation of Medicine, and the first as well as the most recent code of the American Medical Association; court decisions, including those on Karen Quinlan and on abortion in the United States and West Germany; government documents such as the statement of the National Commission on the Protection of Human Subjects, the Tuskegee Syphilis Report, the British Parliamentary debate on euthanasia, and the Council of Europe on rights of the sick and dying; and various published guidelines such as the Harvard Medical School brain death criteria, the American Hospital Association on patient's rights, and Pope Pius XII on the prolongation of life. Cases that illustrate moral dilemmas are provided for discussion purposes. Each section is preceded by a succinct editor's introduction. The documents and essays are of practical value for practitioners and students in medicine, law, ethics, and counselling, and for individual patients and groups concerned with medical care. Through encompassing divergent viewpoints, the essays and primary documents were selected to encourage humane practices and deepen understanding of the multiple traditions that shaped and do shape the development of medicine. (shrink)

AimsThe aim of this study was to assess the psychometric properties of the revised self-rated version of the Dysexecutive Questionnaire (DEX-R) within a non-clinical sample.MethodsThe study was hosted online, with 140 participants completing the DEX-R, GAD-2 and PHQ-2. Sixty participants also completed the FrSBe, with 99 additionally completing the DEX-R again 3 weeks later. Correlations with demographic factors and symptoms of anxiety and depression were conducted. Rasch and factor analysis were also used to explore underlying subconstructs.ResultsThe DEX-R correlated highly (...) with the FrSBe, indicating sound concurrent validity. Internal consistency, split-half reliability and test-retest reliability were excellent. Age and symptoms of depression and anxiety correlated with DEX-R scores, with older age associated with less dysexecutive problems. The Rasch analysis confirmed the multidimensionality of the rating scale, and a three-factor structure was found relating to activation-self-regulatory, cognitive and social-emotional processes. Frequencies of responses on DEX-R items varied, many were not fully endorsed indicating specific relevance of most but not all items to patients.ConclusionInterpretations of DEX-R ratings of dysexecutive problems should consider mood and individual variation. Systematic comparison of DEX-R responses between healthy and clinical groups could help identify a suitable cut off for dysexecutive symptoms. (shrink)

Psychotic-like experiences are a phenomenon that occurs in the general population experiencing delusional thoughts and hallucinations without being in a clinical condition. PLEs involve erroneous attributions of inner cognitive events to the external environment and the presence of intrusive thoughts influenced by dysfunctional beliefs; for these reasons, the role played by metacognition has been largely studied. This study investigates PLEs in a non-clinical population and discriminating factors involved in this kind of experience, among which metacognition, as well as (...) psychopathological features, seems to have a crucial role. The aim of this study was to extend the knowledge about the relationship between metacognition, psychopathology, and PLEs, orienting the focus on metacognitive functioning. The sample consisted of 207 Italian participants voluntarily recruited online, who gave consent to participate in the study. The average age of the sample was 32.69 years. Subjects affected by psychosis, neurological disease, and drug addiction were excluded from the analyses. The following scales were used to investigate PLEs: Peters et al. Delusions Inventory, Launay-Slade Hallucinations Scale-Extended Revised, Prodromal Questionnaire-Brief, and Revised Hallucination Scale. To assess general psychopathological features, the Behavior and Symptom Identification Scale was administrated. The Metacognition Self-Assessment Scale was chosen to evaluate metacognitive functioning. From hierarchical regression analyses, it emerged that the presence of anxiety, depression, and impulsive/addictive symptoms constitute a remarkable vulnerability factor for PLEs, in line with previous evidence regarding the relationship between general psychopathology and PLEs. Metacognition negatively predicts PLEs, and its presence does not affect the significance of psychopathological variables, suggesting that metacognitive abilities seem to play a protective role for the occurrence of PLEs among non-clinical individuals, and such ability operates as an independent predictor along with other variables. These results are explained by the role of metacognitive functions, which allow individuals to operate many mental processes such as interpreting sensorial events as real or illusory, understanding behaviors, thoughts, and drives of others, and questioning the subjective interpretation of facts. (shrink)

Visual narratives like comics often are used as materials in clinical testing under a belief that they are transparent materials for individuals who may struggle with language, such as those with autism spectrum disorder (ASD), developmental language disorder (DLD), or aphasia. This review shows that this “Visual Ease Assumption” is largely unsupported, warranting reconsideration of the ways visual narratives are used with clinical populations.

Recent research has shown that cultural, linguistic, and sociodemographic peculiarities influence the measurement of trait emotional intelligence. Assessing trait EI in different populations fosters cross-cultural research and expands the construct’s nomological network. In mental health, the trait EI of clinical populations has been scarcely researched. Accordingly, the present study examined the relationship between trait EI and key sociodemographic variables on Trait Emotional Intelligence Questionnaire datasets with mental healthcare patients from three different Spanish-speaking countries. Collectively, these datasets comprised (...) 528 participants, 23% from Chile, 28% from Peru, and 49% from Spain. The sociodemographic variables we used for trait EI comparisons were gender, age, educational level, civil status, and occupational status. Analyses involved Multigroup Exploratory Structural Equation Modelling and analysis of covariance. Our results revealed significant between-country differences in trait EI across the studied sociodemographic variables and interactions between these variables. Measurement invariance across the datasets was attained up to the scalar level regarding gender and education, although analyses on age, civil status, and occupation displayed non-invariance. The resultant psychometric evidence supports the suitability of the TEIQue-SF for the accurate cross-cultural assessment of trait EI in mental health settings. It also highlights the importance of incorporating trait EI into extant psychotherapeutic frameworks to enhance non-pharmacological treatment efficacy. (shrink)

The objective of this work was to construct and validate an instrument for assessing resilience to suicide attempts in a Spanish clinical population that has made a previous attempt, and to verify its efficacy for predicting future suicide reattempts at 6 months. For the construction of a Scale of Resilience to Suicide Attempts the theoretical-rational strategy was used. The constructed SRSA-18 consisted of 18 items and 3 subdimensions, had high internal consistency and a high positive correlation with the Suicide (...) Resilience Inventory-25, SRI-25, and to a lesser extent with general resilience scales such as the Connor-Davidson Resilience Scale, CD-RISC and the Resilience Scale of 14 items, RS-14. Additionally, a specific SRSA-18 score predicted future suicide reattempts 6 months after the first attempt. This new scale assesses in a brief and rapid way, through protective factors rather than risk factors, the level of resilience to the suicide attempt in specific clinical subpopulations in hospital emergency services, being able to prevent suicide reattempts with higher lethality. (shrink)

Different forms of mindfulness meditation are increasingly integrated in the clinical practice in the last three decades. Previous studies have identified changes in the neurophysiology and neurochemistry of the brain resulting from different mindfulness meditation practices in the general population. However, research on neural correlates of different types of meditation, particularly on the clinical outcomes, is still very sparse. Therefore, the aim of this article is to review the neural impact of mindfulness meditation interventions on different mental disorders (...) via the classification of main components of mindfulness meditation. The clearer classification of mindfulness meditation may inform future clinical practice and research directions. (shrink)

Through qualitative surveys, a team of law students, law professors, physicians, and residents explored the perceptions of neurology residents towards referral to appropriate legal resources in an academic training program. Respondents reported feeling uncomfortable screening their patients for health-harming legal needs, which many attributed to a lack of training in this area. These findings indicate that neurology residents would benefit from training on screening for social factors that may be impacting their patients’ health.

Concerns about exploiting the poor or economically disadvantaged in clinical research are widespread in the bioethics community. For some, any research that involves economically disadvantaged individuals is de facto ethically problematic. The economically disadvantaged are thought of as “venerable” to exploitation, impaired decision making, or both, thus requiring either special protections or complete exclusion from research. A closer examination of the worries about vulnerabilities among the economically disadvantaged reveals that some of these worries are empirically or logically untenable, while (...) others can be better resolved by improved study designs than by blanket exclusion of poorer individuals from research participation. The scientific objective to generate generalisable results and the ethical objective to fairly distribute both the risks and benefits of research oblige researchers not to unnecessarily bar economically disadvantaged subjects from clinical research participation. (shrink)

The clinical encounter between providers and patients is insufficient: most factors influencing health outcomes occur outside the clinic. Community Health Needs Assessments address this insufficiency via collaboration between hospitals and the communities they serve to address systemic sociological-economic variables impacting health outcomes. Considering this, why are Health Care Ethics Consultation services limited to the clinical setting? We can cultivate better ethics outcomes by addressing systemic sociological-economic factors that cause recurring ethics issues in the hospital. In this article, I (...) argue for the need for a Community Ethics Needs Assessment. CENA is a novel concept; thus, this article is exploratory. I argue for the necessity of a CENA and, more importantly, outline what methodology a CENA would use to both identify and address an ethics need. (shrink)

The definition of the study population for a clinical trial via the criteria for trial eligibility has implications for the validity of the study and its applicability to clinical practice. Though issues of equity regarding the selection of subjects for research have long been a concern of ethicists, issues regarding the impact of subject selection on a trial's generalizability have only recently attracted ethical scrutiny. After a review of the history of the ethics of subject selection, I focus (...) on three empirical questions regarding the generalizability of clinical trials. (1) What proportion of diseased populations are studied in clinical trials? (2) How are subjects selected for clinical trial participation (and what are the main barriers to participation)? (3) Are clinical trial participants comparable to non-participants? Finally, the role of the Institutional Review Board--Research Ethics Board in Canada--in assessing the generalizability of clinical research is discussed. (shrink)

In response to calls to expand the scope of research ethics to address justice in global health, recent scholarship has sought to clarify how external research actors from high-income countries might discharge their obligation to reduce health disparities between and within countries. An ethical framework—‘research for health justice’—was derived from a theory of justice (the health capability paradigm) and specifies how international clinical research might contribute to improved health and research capacity in host communities. This paper examines whether and (...) how external funders, sponsors, and researchers can fulfill their obligations under the framework. (shrink)

In contrast to attempts that have been made to measure the clarity of reporting of the methods of clinical trials in journal articles, we report here an attempt to measure the accuracy of methods reporting. We focus in this article on eligibility criteria as a test case for the reporting of clinical trial methods. We examined the reporting of eligibility criteria in the protocol, methods paper (if applicable), journal article, and Clinical Alert for articles appearing in print (...) between January 1988 and September 1994 for which a Clinical Alert had been issued. Eligibility criteria were further classified into five categories in order to examine the content of information loss, if any. On average, 82% of protocol eligibility criteria were reported in methods papers. Journal articles and Clinical Alerts fared somewhat worse: 63% of criteria were reported in journal articles, 19% in Clinical Alerts. In all three categories of medical communication, the reporting of criteria that defined the study disease tended to be complete; reporting of criteria relating to trial precision, patient safety, legal and ethical concerns, and administrative considerations, was not complete. We found that criteria for clinical trial eligibility are frequently under-reported in medical communications. Moreover, some of the criteria omitted are of considerable clinical importance. We suggest that in the design phase of clinical trials, proposed eligibility criteria be scrutinized closely. Those criteria that survive this scrutiny and that have clinical import must be reported upon fully and accurately when communicating trial results. (shrink)

Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n= 124) obtained low scores (lower than 75%) on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used (...) daily examples from the field of Agriculture because Malawi has an agro-based economy. Methods The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18) and intervention arms ( n =18). The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study. Results The findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75%) during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer’s exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001). Conclusions Potential trial participants can be assisted to understand key clinical trial procedures, their justification and personal implications by using innovative tailored local narratives. (shrink)

Managed care employs two business tools of managed practice that raise important ethical issues: paying physicians in ways that impose conflicts of interest on them; and regulating physicians' clinical judgment, decision making, and behavior. The literature on the clinical ethics of managed care has begun to develop rapidly in the past several years. Professional organizations of physicians have made important contributions to this literature. The statements on ethical issues in managed care of four such organizations are considered here, (...) the American Medical Association, the American College of Physicians, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics. Three themes common to these statements are identified and critically assessed: the primacy of meeting the medical needs of each individual patient; disclosure of conflicts of interest in how physicians are paid; and opposition to gag orders. The paper concludes with an argument for a basic concept in the clinical ethics of managed care: physicians and institutions as economically disciplined moral co-fiduciaries of populations of patients. (shrink)

Reproductive genetic carrier screening is increasingly being offered more widely, including to people with no family history or otherwise elevated chance of having a baby with a genetic condition. There are valid reasons to reject a prevention-focused public health ethics approach to such screening programs. Rejecting the prevention paradigm in this context has led to an emphasis on more individually-focused values of freedom of choice and fostering reproductive autonomy in RCS. We argue, however, that population-wide RCS has sufficient features in (...) common with other public health screening programs that it becomes important also to attend to its public health implications. Not doing so constitutes a failure to address the social conditions that significantly affect people’s capacity to exercise their reproductive autonomy. We discuss how a public health ethics approach to RCS is broader in focus than prevention. We also show that additional values inherent to ethical public health—such as equity and solidarity—are essential to underpin and inform the aims and implementation of reproductive carrier screening programs. (shrink)

Background: COVID-19 has taken many lives worldwide and due to this, millions of persons are in grief. When the grief process lasts longer than 6 months, the person is in risk of developing Complicated Grief Disorder. The CGD is related to serious health consequences. To reduce the probability of developing CGD a preventive intervention could be applied. In developing countries like Mexico, the psychological services are scarce, self-applied interventions could provide support to solve this problem and reduce the health impact (...) even after the pandemic has already finished.Aims: To design and implement a self-applied intervention composed of 12 modules focused on the decrease of the risk of developing CGD, and increasing the life quality, and as a secondary objective to reduce the symptomatology of anxiety, depression, and increase of sleep quality. The Intervention Duelo COVID follows the principles of User Experience and is designed according to the needs and desires of a sample of the objective participants, to increase the adherence to the self-applied intervention, considered one of the main weaknesses of online interventions.Methods: A Randomized Controlled Trial will be conducted from the 22nd of December of 2020 to the first of June 2021. The participants will be assigned to an intervention with elements of Cognitive Behavioral Therapy, Acceptance and Commitment Therapy, Mindfulness and Positive Psychology. The control group will be a wait-list condition, that will receive the intervention 1.5–2 months after the pre-measurement were taken. The Power Size Calculation conducted through G*Power indicated the need for a total of 42 participants, which will be divided by 21 participants in each group. The platform will be delivered through responsive design assuring with this that the intervention will adapt to the screen size of cellphones, tablets, and computers.Ethics and Dissemination: The study counts with the approval of the Research Ethics Committee of the Autonomous University of Ciudad Juárez, México, and it is registered in Clinical Trials. The article is sent and registered in clinical trials before the recruitment started. The results will be reported in future conferences, scientific publications, and media. (shrink)

BackgroundAs the population of the United States ages, chronic diseases increase and treatment options become technologically more complicated. As such, patients’ autonomy, or the right of patients to accept or refuse a medical treatment, may become a more pressing and complicated issue. This autonomy rests upon a patient’s capacity to make a decision. As more older, cognitively and functionally impaired individuals enter healthcare systems, quality assessments of decision-making capacity must be made. These assessments should be done in a time-efficient manner (...) at a patient’s bedside by the patient’s own physician. Thus, a clinically practical tool to assist in decision-making capacity assessments could help guide physicians in making more accurate judgments.ObjectivesTo create a clinically relevant Bedside Capacity Assessment Tool (BCAT) to help physicians make timely and accurate clinical assessments of a patient’s decision-making capacity for a specific decision.SettingThe Department of Medicine, Division of Geriatrics and Palliative Medicine, Zucker School of Medicine at Hofstra/northwell.ParticipantsGeriatric medicine fellows, palliative medicine fellows, and internal medicine residents (n = 30).MeasurementsSubjects used the BCAT to assess the decision-making capacity of patients described in 10 written, clinically complex capacity assessment vignettes. Subjects’ conclusions were compared to those of experts.ResultsThe subjects’ and experts’ assessments of capacity had a 76.1 percent rate of agreement, with a range of 50 percent to 100 percent. With removal of three complex outlier vignettes, the agreement rate reached 83.2 percent.ConclusionThe strong correlation between the two groups—one of physicians in training utilizing the BCAT and the other of specialists in this area—suggests that the BCAT may be a useful adjunct for clinicians who assess decision-making capacity in routine practice. The range indicates that further refinement and testing of this tool is necessary. The potential exists for this tool to improve capacity assessment skills for physicians in clinical practice. (shrink)

Agitation is one of the most common behavioural and psychological symptoms in people living with dementia. This behaviour can cause tremendous stress and anxiety on family caregivers and healthcare providers. Direct observation of PLwD is the traditional way to measure episodes of agitation. However, this method is subjective, bias-prone and timeconsuming. Importantly, it does not predict the onset of the agitation. Therefore, there is a need to develop a continuous monitoring system that can detect and/or predict the onset of agitation. (...) In this study, a multi-modal sensor platform with video cameras, motion and door sensors, wristbands and pressure mats were set up in a hospital-based dementia behavioural care unit to develop a predictive system to identify the onset of agitation. The research team faced several barriers in the development and initiation of the study, namely addressing concerns about the study ethics, logistics and costs of study activities, device design for PLwD and limitations of its use in the hospital. In this paper, the strategies and methodologies that were implemented to address these challenges are discussed for consideration by future researchers who will conduct similar studies in a hospital setting. (shrink)

Seminary students remain unstudied in the research literature despite their eminent role in caring for the wellbeing of congregants. This study aimed to conduct baseline analysis of their family of origin health, psychological health, and physiological heath by utilizing the Biobehavioral Family Model as a conceptual framework for understanding the associations between these constructs. Statistical analysis utilizing structural equation modeling provided support that the BBFM was a sound model for assessing the relationships between these constructs within a seminary sample. Additionally, (...) seminarians were found to have higher rates of anxiety and depression when compared to the general population. Together, findings indicate that clinical care for seminarians may be best if implemented from a global systemic perspective. (shrink)

Because of historical mistreatment of ethnic minorities by research and medical institutions, it is particularly important for researchers to be mindful of ethical issues that arise when conducting research with ethnic minority populations. In this article, we focus on the ethical issues related to the inclusion of ethnic minorities in clinical trials of psychosocial treatments. We highlight 2 factors, skepticism and mistrust by ethnic minorities about research and current inequities in the mental health care system, that researchers should (...) consider when developing psychosocial interventions studies that include ethnic minorities. (shrink)

Geron recently announced that it had begun enrolling patients in the world's first-in-human clinical trial involving cells derived from human embryonic stem cells (hESCs). This trial raises important questions regarding the future of hESC-based therapies, especially in spinal cord injury (SCI) patients. We address some safety and efficacy concerns with this research, as well as the ethics of fair subject selection. We consider other populations that might be better for this research: chronic complete SCI patients for a safety (...) trial, subacute incomplete SCI patients for an efficacy trial, and perhaps primary progressive multiple sclerosis (MS) patients for a combined safety and efficacy trial. (shrink)

Because the United States has failed to provide a pathway to citizenship for its long-term undocumented population, clinical ethicists have more than 20 years of addressing issues that arise in caring for this population. I illustrate that these challenges fall into two sets of issues. First-generation issues involve finding ethical ways to treat and discharge patients who are uninsured and ineligible for safety-net resources. More recently, ethicists have been invited to help address second-generation issues that involve facilitating the presentation (...) for care of undocumented patients. In the current environment of widespread fear of deportation in the immigrant community, ethicists are working with health care providers to address patient concerns that prevent them from seeking care. I illustrate that in both generations of issues, values implicit within health care, namely, caring, efficiency, and promotion of public health, guide the strategies that are acceptable and recommended. (shrink)

Relatively little has been written about the ethics of conducting early phase clinical trials involving subjects from the developing world. Below, I analyze ethical issues surrounding one of gene transfer’s most widely praised studies conducted to date: in this study, Italian investigators recruited two subjects from the developing world who were ineligible for standard of care because of economic considerations. Though the study seems to have rendered a cure in these two subjects, it does not appear to have complied (...) with various international guidelines that require that clinical trials conducted in the developing world be responsive to their populations’ health needs. Nevertheless, policies devised to address large scale, late stage trials, such as the AZT short‐course placebo trials, map somewhat awkwardly to early phase studies. I argue that interest in conducting translational research in the developing world, particularly in the context of hemophilia trials, should motivate more rigorous ethical thinking around clinical trials involving economically disadvantaged populations. (shrink)

BackgroundClinical ethics consultations can be complex interventions, involving multiple methods, stakeholders, and competing ethical values. Despite longstanding calls for rigorous evaluation in the field, progress has been limited. The Medical Research Council proposed guidelines for evaluating the effectiveness of complex interventions. The evaluation of CEC may benefit from application of the MRC framework to advance the transparency and methodological rigor of this field. A first step is to understand the outcomes measured in evaluations of CEC in healthcare settings. ObjectiveThe primary (...) objective of this review was to identify and map the outcomes reported in primary studies of CEC. The secondary objective was to provide a comprehensive overview of CEC structures, processes, and roles to enhance understanding and to inform standardization.MethodsWe searched electronic databases to identify primary studies of CEC involving patients, substitute decision-makers and/or family members, clinicians, healthcare staff and leaders. Outcomes were mapped across five conceptual domains as identified a priori based on our clinical ethics experience and preliminary literature searches and revised based on our emerging interpretation of the data. These domains included personal factors, process factors, clinical factors, quality, and resource factors. ResultsForty-eight studies were included in the review. Studies were highly heterogeneous and varied considerably regarding format and process of ethical intervention, credentials of interventionist, population of study, outcomes reported, and measures employed. In addition, few studies used validated measurement tools. The top three outcome domains that studies reported on were quality, process factors, and clinical factors. The majority of studies examined multiple outcome domains. All five outcome domains were multidimensional and included a variety of subthemes.ConclusionsThis scoping review represents the initial phase of mapping the outcomes reported in primary studies of CEC and identifying gaps in the evidence. The confirmed lack of standardization represents a hindrance to the provision of high quality intervention and CEC scientific progress. Insights gained can inform the development of a core outcome set to standardize outcome measures in CEC evaluation research and enable scientifically rigorous efficacy trials of CEC. (shrink)

ABSTRACTRelatively little has been written about the ethics of conducting early phase clinical trials involving subjects from the developing world. Below, I analyze ethical issues surrounding one of gene transfer’s most widely praised studies conducted to date: in this study, Italian investigators recruited two subjects from the developing world who were ineligible for standard of care because of economic considerations. Though the study seems to have rendered a cure in these two subjects, it does not appear to have complied (...) with various international guidelines that require that clinical trials conducted in the developing world be responsive to their populations’ health needs. Nevertheless, policies devised to address large scale, late stage trials, such as the AZT short‐course placebo trials, map somewhat awkwardly to early phase studies. I argue that interest in conducting translational research in the developing world, particularly in the context of hemophilia trials, should motivate more rigorous ethical thinking around clinical trials involving economically disadvantaged populations. (shrink)

Introduction: Clinical practice guidelines (CPGs) are an important source of justification for clinical decisions in modern evidence-based practice. Yet, we have given little attention to how they argue their evidence. In particular, how do CPGs argue for treatment with long-term medications that are increasingly prescribed to older patients? Approach and rationale: I selected six disease-specific guidelines recommending treatment with five of the medication classes most commonly prescribed for seniors in Ontario, Canada. I considered the stated aims of these (...) CPGs and the techniques employed towards those aims. Finally, I reconstructed and logically analysed the arguments supporting recommendations for pharmacotherapy. Analysis: The primary function of CPGs is rhetorical, or persuasive, and their means of persuasion include both a display of their credibility and their argumentation. Arguments supporting pharmacotherapy recommendations for the target population follow a common inductive pattern: statistical generalization from randomized controlled trial (RCT) and meta-analysis evidence. Two of the CPGs also argue their treatment recommendations for older patients in this style, while three fail to justify pharmacotherapy specifically for the older population. Discussion: The arguments analysed lack the auxiliary assumptions that would warrant making a generalization about the clinical effectiveness of medications for the older population. Guidelines reason using simple induction, while ignoring important inferential gaps. Future guidelines should aspire to be well-reasoned rather than simply evidence-based; argue from a plurality of evidence; be wary of hasty inductions; appropriately limit the scope of their recommendations; and avoid making law-like, prescriptive generalizations. (shrink)

Clinical trials and other forms of evaluation of medical treatment are held to give an objective assessment of the ‘clinical effectiveness’ of the medical treatments under evaluation. This kind of evaluation is central to the evidence-based medicine movement, as it provides a basis for the rational selection of treatment. The ethical status of randomised clinical trials is widely agreed to depend crucially upon the state of equipoise regarding which of two (or more) treatments is more (or most) (...) effective in a defined population. However, the meaning and nature of ‘clinical effectiveness’ are unclear. in this paper, I discuss the proposals to define clinical effectiveness as a relational property and as an intrinsic property, and the way effectiveness may supervene upon more fundamental physical properties of treatments. I discuss whether effectiveness is a single property or a family of properties; the types of outcome which can be explained by effectiveness properties; and the relationship between ‘objective’ and ‘preference’ outcomes. This paper suggests that while it may be possible to put clinical effectiveness on a proper metaphysical footing, in practice the language of clinical effectiveness is more properly a topic of the human sciences than of the natural sciences. (shrink)

The development of genomics has dramatically expanded the scope of genetic research, and collections of genetic biosamples have proliferated in countries with active genomics research programs. In this essay, we consider a particular kind of collection, national biobanks. National biobanks are often presented by advocates as an economic ‘‘resource’’ that will be used by both basic researchers and academic biologists, as well as by pharmaceutical diagnostic and clinical genomics companies. Although national biobanks have been the subject of intense interest (...) in recent social science literature, most prior work on this topic focuses either on bioethical issues related to biobanks, such as the question of informed consent, or on the possibilities for scientific citizenship that they make possible. We emphasize, by contrast, the economic aspect of biobanks, focusing specifically on the way in which national biobanks create biovalue. Our emphasis on the economic aspect of biobanks allows us to recognize the importance of what we call clinical labor—that is, the regularized, embodied work that members of the national population are expected to perform in their role as biobank participants—in the creation of biovalue through biobanks. Moreover, it allows us to understand how the technical way in which national biobanks link clinical labor to databases alters both medical and popular understandings of risk for common diseases and conditions. (shrink)

This systematic review identifies and critically evaluates instruments that have been developed to measure clinical trial informed consent comprehension in non-cognitively-impaired adults.Literature searches were carried out on Medline (Ovid), PsycInfo, CINHAL, ERIC, ScienceDirect, and Cochrane Library for English language articles published between January 1980 and September 2008. Instruments were excluded if they focused on consent onto paediatric trials, the construct under study was primarily capacity or competency, or the instrument was developed specifically for psychiatric or cognitively-impaired populations. Instruments (...) selected for review were evaluated against the following criteria: (1) method of item generation; (2) type and format of test items; (3) administration and interpretation of test results; and (4) psychometric properties.Three instruments met our defined inclusion criteria: the Deaconess Informed Consent Comprehension Test (DICCT), the Quality of Informed Consent (QuIC) questionnaire and the Brief Informed Consent Protocol (BICEP). Each instrument varied in terms of content measured. Significantly, these are the first standardized instruments developed to assess comprehension in non-cognitively-impaired adults. Yet, each instrument had its own set of limitations such as the lack of generalizability and the absence of details pertaining to how test results should be used to guide clinical decision-making.Standardized clinical trial informed consent comprehension assessments have been developed to identify gaps in research participants' understanding and ensure that respect for patient autonomy is satisfied. (shrink)

The Islamic government of Iran recently passed and announced a new law titled “Rejuvenation of the Population and Protection of the Family.” This legislation is a noteworthy example of biopolitics‐influenced biolaw. In terms of abortion, contraception, prenatal screening, and population control, this law clearly contrasts with women's fundamental rights and freedoms and has significant health‐related consequences for different sectors of the population. A historical review of the population policies of the Islamic Republic of Iran shows the occurrence of multiple abrupt (...) and radical changes in such policies over the past four decades. This new law, promoted by religious biopolitics, is the most recent example, and places stringent limits on abortion. According to it, all decisions concerning abortion must be made in courts rather than in health clinics. Such courts are typically presided over by male religious scholars. This law also limits prenatal screening to the degree that will increase the rate of genetic defects, especially in the population's lower socioeconomic strata. By strictly limiting access to contraception, this law will increase the rate of unwanted pregnancies and sexually transmitted diseases. This paper argues that such an influence of biopolitics on biolaw contrasts with the principles of bioethics. Still, Iran's current institution of bioethics cannot address it effectively. Therefore, a new model of interaction between bioethics, biopolitics, and biolaw is needed to prevent the detrimental consequences of such pieces of legislation. Such a paradigm shift is demanded by the current “Woman, Life, Freedom” movement of the Iranian people. (shrink)

The prevalence and negative impact of brain disorders are increasing. Clinical Neuropsychology is a specialty dedicated to understanding brain-behavior relationships, applying such knowledge to the assessment of cognitive, affective, and behavioral functioning associated with brain disorders, and designing and implementing effective treatments. The need for services goes beyond neurological diseases and has increased in areas of neurodevelopmental and psychiatric conditions, among others. In Europe, a great deal of variability exists in the education and training of Clinical Neuropsychologists. Training (...) models include master’s programs, continuing education courses, doctoral programs, and/or post-doctoral specialization depending on the country, with no common framework of requirements, although patients’ needs demand equal competencies across Europe. In the past five years, the Standing Committee on Clinical Neuropsychology of the European Federation of Psychologists’ Association has conducted a series of surveys and interviews with experts in the field representing 30 European countries. The information, along with information from the existing literature, is used in presenting an overview of current and relevant topics related to policy and guidelines in the training and competencies in Clinical Neuropsychology. An option for the way forward is the EuroPsy Specialist Certificate which is currently offered in Work- and Organizational psychology and Psychotherapy. It builds upon the Basic Certificate and complements national standards without overriding them. General principles can be found that can set the basis for a common, solid, and comprehensive specialty education/training, sharpening the Neuropsychologists’ competencies across Europe. The requirements in Clinical Neuropsychology should be comparable to those for the existing specialty areas in the EuroPsy model. Despite the perceived challenges, developing a Specialist Certificate appears a step forward for the development of Clinical Neuropsychology. Recommendations are proposed towards a shared framework of competencies by the means of a common level of education/training for the professionals in Europe. Benchmarking training standards and competencies across Europe has the potential of providing protection against unqualified and ethically questionable practice, creating transparency, raising the general European standard, and promoting mobility of both Clinical Neuropsychologists and patients in Europe, for the benefit of the professional field and the population. (shrink)

Starting research -- Enrolling research participants -- Protecting research participants -- Conducting research with vulnerable populations -- Balancing clinical research and clinical care -- Navigating interpersonal difficulties -- Ending research.

It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for participants. There is evidence that such a competition is a predictor of low study accrual, with increased competition tied to increased recruitment shortfalls. But there is no consensus on what steps, if any, institutions should take to approach this issue. In this article, we (...) argue that an institutional policy that prioritises some trials for recruitment ahead of others is ethically permissible and indeed prima facie preferable to alternative means of addressing recruitment competition. We motivate this view by appeal to the ethical importance of minimising the number of studies that begin but do not complete, thereby exposing their participants to unnecessary risks and burdens in the process. We then argue that a policy of prioritisation can be fair to relevant stakeholders, including participants, investigators and funders. Finally, by way of encouraging and helping to frame future debate, we propose some questions that would need to be addressed when identifying substantive ethical criteria for prioritising between studies. (shrink)

Background The enhancement of nursing care quality is closely related to the clinical competence of nurses, making it a crucial component within health systems. Objective The present study investigated the relationship between nurses’ clinical competence, moral identity, and moral injury during the COVID-19 outbreak. Research design This cross-sectional study was carried out among frontline nurses, using the Moral Identity Questionnaire (MIQ), the Moral Injury Symptom Scale-Healthcare Professionals version (MISS-HP), and the Competency Inventory for Registered Nurse (CIRN) as data (...) collection tools. Participants and research context: The research population for this study consisted of all frontline nurses ( n = 251) employed in a hospital in southern Iran. Sampling was conducted between May 1, 2021 and September 30, 2021, during the COVID-19 outbreak. Ethical considerations The present study received approval from the research ethics committee of Rafsanjan University of Medical Sciences, with project No. 99267 and code of ethics ID No. IR. RUMS.REC.1399.262, dated 15.02.2021. Results According to the study findings, 42.2% of the nurses demonstrated high clinical competence, while 51.4% exhibited moderate clinical competence. The results indicated a positive correlation between moral identity and clinical competence but a negative correlation between moral injury and clinical competence. Furthermore, the variables of moral identity and moral injury were found to predict 10% of the variance in clinical competence. Conclusion According to the results, moral identity and moral injury had an impact on the clinical competence of nurses. Therefore, implementing a program aimed at enhancing moral identity and providing training strategies to address moral injury during crises like the COVID-19 pandemic can lead to improvements in nurses’ clinical competence and the overall quality of care they provide. (shrink)

Advances in DNA sequencing technology open new possibilities for public health genomics, especially in the form of general population preventive genomic sequencing. Such screening programs would sit at the intersection of public health and preventive health care, and thereby at once invite and resist the use of clinical ethics and public health ethics frameworks. Despite their differences, these ethics frameworks traditionally share a central concern for individual rights. We examine two putative individual rights—the right not to know, and the (...) child’s right to an open future—frequently invoked in discussions of predictive genetic testing, in order to explore their potential contribution to evaluating this new practice. Ultimately, we conclude that traditional clinical and public health ethics frameworks, and these two rights in particular, should be complemented by a social justice perspective in order adequately to characterize the ethical dimensions of general population PGS programs. (shrink)

The 21st century has been revolutionary for the field of clinical genomics, with major advancements and breakthroughs over the years. It is now considered an instrumental tool in clinical and preventive medicine and has been used on a day-to-day basis to complement current clinical practice. However, with advancements in genomics comes greater bioethical concerns, which becomes increasingly complex with more cutting-edge technology. Some of the major ethical concerns include obtaining informed consent, possibility for genetic enhancements and eugenics, (...) genomic equity and potential discrimination and cloning. It is imperative that we appreciate the benefits of genomic medicine in complementing traditional practices, identify and address the ethical concerns with relation to the practice of genomic medicine, and to ensure a common goal of improving human lives. With these in mind, the practice of genomics can have maximum impact in the collective health of the population, with greater benefit to all. (shrink)

Leading paradigms of clinical ethics consultation closely follow a biomedical model of care. In this paper, we present a theoretical reflection on the underlying biomedical model of disease, how it shaped clinical practices and patterns of ethical deliberation within these practices, and the repercussions it has on clinical ethics consultations for patients with chronic illness. We contend that this model, despite its important contribution to capturing the ethical issues of day-to-day clinical ethics deliberation, might not be (...) sufficient for patients presenting with chronic illnesses and navigating as “lay experts” of their medical condition(s) through the health care system. Not fully considering the sources of personal knowledge and expertise may lead to epistemic injustice within an ethical deliberation logic narrowly relying on a biomedical model of disease. In caring “for” and collaboratively “with” this patient population, we answer the threat of epistemic injustice with epistemic modesty and humility. We will propose ideas about how clinical ethics could contribute to an expansion of the biomedical model of care, so that important aspects of chronic illness experience would flow into clinical-ethical decision-making. (shrink)

Background: The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective: Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods: To gain an understanding of how clinicians (...) view clinical studies in the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results: Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion: Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies. (shrink)

BackgroundHumanitarian crises and emergencies, events often marked by high mortality, have until recently excluded palliative care—a specialty focusing on supporting people with serious or terminal illness or those nearing death. In the COVID-19 pandemic, palliative care has received unprecedented levels of societal attention. Unfortunately, this has not been enough to prevent patients dying alone, relatives not being able to say goodbye and palliative care being used instead of intensive care due to resource limitations. Yet global guidance was available. In 2018, (...) the WHO released a guide on‘Integrating palliative care and symptom relief into the response to humanitarian emergencies and crises’—the first guidance on the topic by an international body.AimsThis paper argues that while a landmark document, the WHO guide took a narrowly clinical bioethics perspective and missed crucial moral dilemmas. We argue for adding a population-level bioethics lens, which draws forth complex moral dilemmas arising from the fact that groups having differential innate and acquired resources in the context of social and historical determinants of health. We discuss dilemmas concerning: limitations of material and human resources; patient prioritisation; euthanasia; and legacy inequalities, discrimination and power imbalances.ImplicationsIn parts of the world where opportunity for preparation still exists, and as countries emerge from COVID-19, planners must consider care for the dying. Immediate steps to support better resolutions to ethical dilemmas of the provision of palliative care in humanitarian and emergency contexts will require honest debate; concerted research effort; and international, national and local ethical guidance. (shrink)