Drug companies are moving their research from academic medical centers to physicians’ private offices. The shift brings in more subjects, and could mean faster and better results. It also changes the physician's relationship to patients, dangles monetary lures in front of physicians, and could produce subjects who don't understand what they're participating in and results that are unreliable.

The recently revised Common Rule requires that donors of biospecimens for research be informed if their specimens might be used for commercial profit. The Common Rule, however, does not apply to sharing or selling de-identified biospecimens that are “leftover” from clinical uses. As a result, many medical researchers remain uncertain of their legal and ethical obligations when a commercial entity expresses interest in these specimens.

A subcategory of medical tourism, reproductive tourism has been the subject of much public and policy debate in recent years. Specific concerns include: the exploitation of individuals and communities, access to needed health care services, fair allocation of limited resources, and the quality and safety of services provided by private clinics. To date, the focus of attention has been on the thriving medical and reproductive tourism sectors in Asia and Eastern Europe; there has been much less consideration given (...) to more recent ‘players’ in Latin America, notably fertility clinics in Chile, Brazil, Mexico and Argentina. In this paper, we examine the context-specific ethical and policy implications of private Argentinean fertility clinics that market reproductive services via the internet. Whether or not one agrees that reproductive services should be made available as consumer goods, the fact is that they are provided as such by private clinics around the world. We argue that basic national regulatory mechanisms are required in countries such as Argentina that are marketing fertility services to local and international publics. Specifically, regular oversight of all fertility clinics is essential to ensure that consumer information is accurate and that marketed services are safe and effective. It is in the best interests of consumers, health professionals and policy makers that the reproductive tourism industry adopts safe and responsible medical practices. (shrink)

Clinical ethics consultants occasionally encounter unethical and/or unprofessional behavior as part of their normal job functions. In this article, we explore whether resigning (i.e., threatening resignation or resigning) and whistleblowing are acceptable methods ethics consultants can use to address these situations. Per our analysis, whether one considers ethics consultants private or public employees, loyal to their employer or to patients, families, and the public, resigning and whistleblowing are all acceptable, if not obligatory, actions of ethics consultants in certain circumstances. (...) In this article, we analyze salient characteristics of ethics consultation as a profession as they pertain to resignation and whistleblowing in the context of ethics consultation. We also present tentative criteria for when ethics consultants are justified, if not obligated, to resign or blow the whistle. (shrink)

Clinical ethics consultants occasionally encounter unethical and/or unprofessional behavior as part of their normal job functions. In this article, we explore whether resigning (i.e., threatening resignation or resigning) and whistleblowing are acceptable methods ethics consultants can use to address these situations. Per our analysis, whether one considers ethics consultants private or public employees, loyal to their employer or to patients, families, and the public, resigning and whistleblowing are all acceptable, if not obligatory, actions of ethics consultants in certain circumstances. (...) In this article, we analyze salient characteristics of ethics consultation as a profession as they pertain to resignation and whistleblowing in the context of ethics consultation. We also present tentative criteria for when ethics consultants are justified, if not obligated, to resign or blow the whistle. (shrink)

Clinical next generation sequencing is a term that refers to a variety of technologies that permit rapid sequencing of large numbers of DNA segments, up to and including entire genomes. As an approach that is playing an increasingly important role in obtaining genetic information from patients, it may be viewed by public and private payers either positively, as an enabler of the promised benefits of personalized medicine, or as “the perfect storm” resulting from the confluence of high market demand, (...) an uproven technology, and an unprepared delivery system. A number of recent studies have noted that coverage and reimbursement will be critical for clinical integration of NGS, yet the evidentiary pathway for payer decision-making is unclear. Although there are multiple reasons for this uncertain reimbursement environment, the situation stems in large part from a long-standing lack of alignment between the information needs of regulators and post-regulatory decision-makers such as payers. (shrink)

Starting out : ethics issues in beginning a practice -- Clinical practice -- Documentation and record keeping -- Dealing with third parties and protecting confidentiality -- Financial decisions -- Staff training and office policies -- Advertising and marketing -- Continuing professional development -- Leaving a practice -- Closing thoughts.

In 2006, the Chief Medical Officer for England published the report Good Doctors, Safer Patients in a call for strengthened regulation of the medical profession. The changing relationship between patients and doctors in the United Kingdom arises from the interplay between societal expectation and clinical governance, personal formation and professional practice, private being and public doing. The wisdom of professional practice is in the habits of professionals, a practical wisdom that is the reflex of professional identity. Socialization into a (...) profession is the formation of such identity through the legitimate peripheral participation of the apprentice, oriented towards the contingent granting of admission to the community of practice. The conditional nature of continued insider status, permitting members to interact with clients across the professional boundary, is essential to the contract through which the profession enjoys the privileges conferred by society. The governance of the profession is therefore also necessarily circumscribed, a political reality that is currently evidenced in the regulation of medical practice in the United Kingdom. (shrink)

Chasing Medical Miracles" is the first book to give readers a behind-the-scenes look at the complicated world of clinical trials, revealing how a multibillion-dollar industry of private companies conducting them with little oversight has taken root and quietly become a major part of the American medical establishment.

Informed consent documents are central to the informed consent process and are required for participation in clinical trials in the U.S. The primary purpose of the document is “to assist a prospect...

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that (...) now are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that (...) now are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)

This is the first description of the questions that clinicians ask a department of clinical law, relating to the legal rules applicable to the care of their patients.ObjectivesTo describe in detail the demography of clinical legal enquiries made by clinicians of all professions concerning the care of their patients. To collate and categorise the varieties of enquiry, to identify phenotypic patterns. To provide colleges, regulators, commissioners, educators and the NHS with an insight into hitherto undescribed subject matter, better to understand (...) and respond to this aspect of clinical practice.DesignProspective collection of all clinical legal referrals recorded in writing over 12 years by a department of clinical law.SettingAn English Tertiary Hospital NHS Trust.ParticipantsClinical staff of the regulated professions, all seeking to have their clinical legal enquiries answered.Main outcome measuresThe description of the demography of clinical law.Results1251 written records were identified and reviewed. These were divided into nine broad clinical legal subject areas (domains): mental disorders, parents and children, incapacity, consent for treatment, disclosure of private information, other statutory, regulated practice, professional practice, clinical practice. Within these, 149 clinical legal phenotypes were identified to which each case could be assigned.ConclusionsAmong a broad range of enquiries, recognisable clinical legal phenotypes exist and have for the first time been described and categorised. These are clinical situations which clinicians need to be able to recognise and equipped to deal with. Doing so will likely facilitate timely and better treatment. (shrink)

In May 2011, the clinical ethics group of the Center for Ethics at Washington Hospital Center launched a 40-hour, three and one-half day Clinical Ethics Immersion Course. Created to address gaps in training in the practice of clinical ethics, the course is for those who now practice clinical ethics and for those who teach bioethics but who do not, or who rarely, have the opportunity to be in a clinical setting. “Immersion” refers to a high-intensity clinical ethics experience in a (...) busy, urban, acute care hospital. During the Immersion Course, participants join clinical ethicists on working rounds in intensive care units and trauma service. Participants engage in a videotaped role-play conversation with an actor. Each simulated session reflects a practical, realistic clinical ethics case consultation scenario. Participants also review patients’ charts, and have small group discussions on selected clinical ethics topics. As ethics consultation requests come into the center, Immersion Course participants accompany clinical ethicists on consultations. Specific to this pilot, because participants’ evaluations and course faculty impressions were positive, the Center for Ethics will conduct the course twice each year. We look forward to improving the pilot and establishing the Immersion Course as one step towards addressing the gap in training opportunities in clinical ethics. (shrink)

Our society has long sanctioned, at least tacitly, a degree of conflict of interest in medical practice and clinical research as an unavoidable consequence of the different interests of the physician or clinical investigator, the patient or clinical research subject, third party payers or research sponsors, the government, and society as a whole, to name a few. In the past, resolution of these conflicts has been left to the conscience of the individual physician or clinical investigator and to professional organizations. (...) The public is no longer willing to allow health care providers to wholly govern their own conflicts of interest for several reasons. These include: new forms of health care financing and delivery that provide innovative and lucrative opportunities for physician or insurer enrichment at patient expense; the increased importance of commercial research support as peer-reviewed governmental research support has decreased; evidence that physicians and clinical investigators too frequently resolve conflicts of interest in their own favor; and a general societal mistrust of authority. This volume represents a multidisciplinary effort, drawing from philosophy, medicine, law, economics and public policy to identify and categorize conflicts of interest in medical practice and clinical research, and, where possible, to offer a mechanism for resolving them. Part I addresses conflicts of interest from a theoretical perspective, offering basic concepts and analytical frameworks. The second part discusses two topics prominent in current health care policy debates--self-referral and financial incentives to limit care. Part III examines conflicts of interest generated by pharmaceutical industry involvement in clinical practice and research. The final section deals with conflicts of interest in clinical research in several contexts, including institutional reviews boards, clinical trials, Cooperative Research and Development Agreements between government and private researchers, brokerage of research subjects by Contract Research Organizations, and cost-effectiveness studies. (shrink)

Brummett and Salter propose a useful and timely taxonomy of clinical ethics expertise (2019). As the field becomes further “professionalized” this taxonomy is important, and the core of it is right. It needs some refinement around the edges, however. In their conclusion, Brummett and Salter rightly point out that there is a significant difference between the ethicist whose recommendations are procedure- and process-heavy, consensus-driven, and dialogical and the authoritarian ethicist whose recommendations flow from “private moral views” (Brummett and Salter, (...) 2019). This admission doesn’t go far enough. Brummett and Salter’s taxonomy fails to capture the notion that offering recommendations whose normative force is moral is different in kind from recommendations whose normative force is non-moral, such as those recommendations that are free of moral content or justified by convention. The difference is in kind, not scale. I argue further that clinical ethics expertise, if possible, consists at least in offering recommendations whose normative force is moral. These two claims imply that the taxonomy fails to cut clinical ethics expertise at the joints: the ethicist who offers justified non-moral normative recommendations is a different kind of ethicist from the one who offers justified moral normative recommendations, yet both are categorized as clinical ethics experts. I finish by offering a refinement of the taxonomy that more precisely categorizes clinical ethicists. (shrink)

The paper argues that pain is not a good counter-example to the privation theory of evil. Objectors to the privation thesis see pain as too real to be accounted for in privative terms. However, the properties for which pain is intuitively thought of as real, i.e. its localised nature, intensity, and quality are features of the senso-somatic aspect of pain. This is a problem for the objectors because, as findings of modern science clearly demonstrate, the senso-somatic aspect of pain is (...) neurologically and clinically separate from the emotional-psychological aspect of suffering. The intuition that what seems so real in pain is also the source of pain’s negative value thus falls apart. As far as the affective aspect of pain, i.e. ”painfulness’ is concerned, it cannot refute the privation thesis either. For even if this is indeed the source of pain’s badness, the affective aspect is best accounted for in privative terms of loss and negation. The same holds for the effect of pain on the aching person. (shrink)

HIV infection and AIDS create many dilemmas in Chinese AIDS/HIV prevention policy. A strategy of clinical tolerance is proposed to address these dilemmas. The immediate purpose of the strategy of clinical tolerance is to win the cooperation of members of stigmatized groups at high risk for contracting HIV infection and AIDS, which occurs as a result of acts done in private and thus beyond the reach of regulation. The strategy of clinical tolerance differs from both tolerance as liberal tolerance (...) and tolerance as a moral ideal of tolerance. A strategy of clinical tolerance does not ask the government, health worker, health official or the public to change either laws or the disapproval of prostitution, homosexuality and drug use. A strategy of clinical tolerance asks, instead, that we weigh what we may regard as the wrong involved in prostitution, homosexuality, and drug use against the greater evil of an HIV/AIDS epidemic. A strategy of clinical tolerance offers the most effective and practical way to confront a growing and significant public health problem in China. (shrink)

Drug repurposing is a strategy of identifying new potential uses for already existing drugs. Many researchers adopted this method to identify treatment or prevention during the COVID-19 pandemic. However, despite the considerable number of repurposed drugs that were evaluated, only some of them were labeled for new indications. In this article, we present the case of amantadine, a drug commonly used in neurology that attracted new attention during the COVID-19 outbreak. This example illustrates some of the ethical challenges associated with (...) the launch of clinical trials to evaluate already approved drugs. In our discussion, we follow the ethics framework for prioritization of COVID-19 clinical trials proposed by Michelle N Meyer and colleagues (2021). We focus on four criteria: social value, scientific validity, feasibility, and consolidation/collaboration. We claim that launching amantadine trials was ethically justified. Although the scientific value was anticipated to be low, unusually, the social value was expected to be high. This was because of significant social interest in the drug. In our view, this strongly supports the need for evidence to justify why the drug should not be prescribed or privately accessed by interested parties. Otherwise, a lack of evidence-based argument could enhance its uncontrolled use. With this paper, we join the discussion on the lessons learned from the pandemic. Our findings will help to improve future efforts to decide on the launch of clinical trials on approved drugs when dealing with the widespread off-label use of the drug. (shrink)

An ethical issue that has largely been overlooked and neglected is the potential conflict of interests faced by medical professionals in the recruitment, counselling and reimbursement of egg donors. It must be noted that fertility treatment in private practice is an overwhelmingly profit-driven enterprise. To attract more patients and generate more income, there is a strong incentive for fertility clinics and doctors to actively and aggressively recruit women for their egg donation programme. In some countries where substantial financial (...) remuneration for egg donation is permitted—for example, the United States,1 2 fertility doctors and clinical embryologists often act as the “middleman” or broker to facilitate the transaction of eggs between donor and recipient. Very often, the usual practice is for fertility clinics to charge patients a commission for sourcing egg donors, which is an additional profit on top of substantial medical fees that would be earned from provision of fertility treatment to the same patient. This is ethically contentious; because the money earned is not directly related to medical services rendered to the patient, but is instead attributed to the brokerage and transaction of donated human material.There is a risk that the welfare of the …. (shrink)

This paper explores the experiences of infertile women who occupy a liminal space in society, and argues that the fertility clinic served as a space to tolerate women's experiences of liminality. It provided not only rituals aimed at transition to pregnancy, but also a space where women's liminal experiences, which are caused by the existential chaos of infertility, could be tolerated. The British experience seemed to differ from the American one identified in the literature, where self‐management and peer group support (...) are described as strategies used by infertile women to manage infertility. The British women in this study did not appear to draw so much on self‐management or peer group support to deal with their experiences of infertility. They appeared to be isolated in their experience. The clinic thus provided a space in which recognition was given to their intensely private experiences of difference from those in the outside fertile world and allowed them to manage these socially unacceptable, culturally taboo and invisible experiences. However, because of its very limited success rate in enabling women to become pregnant, rather than facilitating the transition of status from infertile to fertile woman, the clinic also served to reinforce the liminal experiences of those women who remained infertile. Inadvertently, the clinic offered a way of being in limbo while at the same time reinforcing the liminal experiences of women. (shrink)

In bioethics and health policy, we often discuss the appropriate boundaries of public funding; how the interface of public and private purchasers and providers should be organized and regulated receives less attention. In this paper, I discuss ethical and regulatory issues raised at this interface by three medical practice models in which physicians provide insured services while requiring or requesting that patients pay for services or for the non-insured services of the physicians themselves or their associates. This choice for (...) such practice models is different from the decision to design an insurance plan to include or exclude user fees, co-payments and deductibles. I analyze the issues raised with regards to familiar health care values of equity and efficiency, while highlighting additional concerns about fair terms of access, provider integrity, and fair competition. I then analyze the common Canadian regulatory response to block fee models, considering their extension to wellness clinics, with regards to fiduciary standards governing the physician–patient relationship and the role of informed consent. I close by highlighting briefly issues that are of common concern across different fundamental normative frameworks for health policy. (shrink)

In the United States, single individuals and LGBTQ couples who wish to conceive biological children are considered to be “socially infertile” due to their relationship status. Due to the high cost of infertility treatments and inadequate insurance coverage, the socially infertile has minimal access to assisted reproductive technology. Under the current medical definitions of infertility, even in states with infertility insurance mandates, only heterosexual couples with physiological infertility are covered for ART. It is well documented that infertility interferes with many (...) aspects of the human experience and reduces the quality of life for involuntarily childless individuals regardless of whether the infertility is physiologically or socially based. Physiological infertility was initially considered to be a private issue before being recognized as a medical diagnosis and has since legitimized heterosexual couples’ access to ARTs. The medical diagnosis of infertility not only affirms that their intention to conceive biological children is justifiable but also confirms that it is a condition that can and should be treated with current medical interventions. Expanding the current definition of infertility to include social infertility will elevate it to a treatable medical condition, justifying the use of ART for such individuals and potentially alleviating the negative impacts of infertility. Thus, states with infertility insurance mandates should provide the same infertility coverage to socially infertile individuals as physiologically infertile heterosexual couples. (shrink)

The concept of ‘ownership’ is increasingly central to debates, in the media, health policy and bioethics, about the appropriate management of clinical data. I argue that the language of ownership acts as a metaphor and reflects multiple concerns about current data use and the disenfranchisement of citizens and collectives in the existing data ecosystem. But exactly which core interests and concerns ownership claims allude to remains opaque. Too often, we jump straight from ‘ownership’ to ‘private property’ and conclude ‘the (...) data belongs to the patient’. I will argue here that private property is only one type of relevant relationship between people, communities and data. There are several reasons to doubt that conceptualising data as private property presents a compelling response to concerns about clinical data ownership. In particular I argue that clinical data are co-constructed, so a property account would fail to confer exclusive rights to the patient. A non-property account of ownership acknowledges that the data are ‘about the patient’, and therefore the patient has relevant interests, without jumping to the conclusion that the data ‘belongs to the patient’. On this broader account of ownership, the relevant harm is the severing of the connection between the patient and their data, and the solution is to re-engage and re-connect patients to the data research enterprise. (shrink)

Private cord blood banking is the practice of paying to save cord blood for potential future use. Informed by the literature on corporeal commodification and feminist theories, this article analyses women’s work in banking cord blood. This article is based on in-depth interviews with 13 women who banked in a private bank in Canada. From learning about cord blood banking to collecting cord blood and transporting it to the private bank’s laboratory, women labour to ensure that cord (...) blood is successfully banked. Private cord blood banking involves the overlap or insertion of commercial practices, and relations with clinical practices and relations that may cause tensions and confusion for women and clinical practitioners. Moreover, private banking reinforces and is reinforced by an ‘intensive mothering’ ideology. This article shows that corporeal commodification is not confined to a laboratory and the work of experts but extends into women’s everyday lives. (shrink)

Clinical practices are considered one of the cornerstones in nurses' education. This study provides a framework to determine how factors in the academic environment, influence nursing student's satisfaction with their practices. A cross-sectional analytical study was conducted in a convenience sample of 574 nursing students at a private university in Valencia, during the 2016/2017 academic year, 79% were women. Two statistical methodologies were used for data analysis: hierarchical regression models and fuzzy sets qualitative comparative analysis. The HRM indicate that (...) the students' mean score influences all dimensions of satisfaction. Furthermore, in the fsQCA, the type of service and center, as well as the type of management, the preference in the choice of the practice center and the number of students per period per clinical educator influence satisfaction with clinical practices. These results could be used to understand how academic factors influence nursing students' satisfaction with their clinical practices and to create intervention programmes that improve it. This will help prepare students to be the future nursing workforce. (shrink)

BackgroundMachine learning-based clinical decision support systems (ML_CDSS) are increasingly employed in various sectors of health care aiming at supporting clinicians’ practice by matching the characteristics of individual patients with a computerised clinical knowledge base. Some studies even indicate that ML_CDSS may surpass physicians’ competencies regarding specific isolated tasks. From an ethical perspective, however, the usage of ML_CDSS in medical practice touches on a range of fundamental normative issues. This article aims to add to the ethical discussion by using professionalisation theory (...) as an analytical lens for investigating how medical action at the micro level and the physician–patient relationship might be affected by the employment of ML_CDSS.Main textProfessionalisation theory, as a distinct sociological framework, provides an elaborated account of what constitutes client-related professional action, such as medical action, at its core and why it is more than pure expertise-based action. Professionalisation theory is introduced by presenting five general structural features of professionalised medical practice: (i) the patient has a concern; (ii) the physician deals with the patient’s concern; (iii) s/he gives assistance without patronising; (iv) s/he regards the patient in a holistic manner without building up a private relationship; and (v) s/he applies her/his general expertise to the particularities of the individual case. Each of these five key aspects are then analysed regarding the usage of ML_CDSS, thereby integrating the perspectives of professionalisation theory and medical ethics.ConclusionsUsing ML_CDSS in medical practice requires the physician to pay special attention to those facts of the individual case that cannot be comprehensively considered by ML_CDSS, for example, the patient’s personality, life situation or cultural background. Moreover, the more routinized the use of ML_CDSS becomes in clinical practice, the more that physicians need to focus on the patient’s concern and strengthen patient autonomy, for instance, by adequately integrating digital decision support in shared decision-making. (shrink)

Immunology researchers are beginning to explore the possibilities of reproducibility, reuse and secondary analyses of immunology data. Open-access datasets are being applied in the validation of the methods used in the original studies, leveraging studies for meta-analysis, or generating new hypotheses. To promote these goals, the ImmPort data repository was created for the broader research community to explore the wide spectrum of clinical and basic research data and associated findings. The ImmPort ecosystem consists of four components–Private Data, Shared Data, (...) Data Analysis, and Resources—for data archiving, dissemination, analyses, and reuse. To date, more than 300 studies have been made freely available through the ImmPort Shared Data portal , which allows research data to be repurposed to accelerate the translation of new insights into discoveries. (shrink)

Originally published in 1970 this title commemorates the men and ideas that started, inspired and established a pioneer institution in British psychiatry. Based on the impetus of Freudian and related innovations after the First World War, the Tavistock Clinic offered treatment, training and research facilities in the field of neurosis, child guidance and later on group relations. Dr Dicks, who had been associated for nearly forty years with the work and personalities that helped to develop the Tavistock venture, describes the (...) struggles and capacity for survival of the clinic. He shows how, belonging neither to the older classical psychiatry nor to orthodox psychoanalysis, and suspect to both, the Clinic nevertheless became increasingly used by the rest of the profession as a psychotherapeutic resource. Dr Dicks describes the influence of the Tavistock on the medical, psychological and social work scene both before and after the Second World War, and assesses its achievements as a centre of psycho- and socio-dynamic thinking. The Tavistock is shown as a pioneer _sui generis_, launching psychosomatic research and initiating the exciting ventures in social psychiatry associated with the Army in the Second World War. As the Tavistock was the outcome of work with shell-shock victims in the first war, so its offspring, the Institute of Human Relations, was the natural continuation of the military effort in man-management, morale and group dynamic studies. The book includes an account of the inter-relationship between the Clinic, now part of the National Health Service, and the Institute, a private corporation. Still going strong as part of the Tavistock and Portman NHS Foundation Trust today this is an opportunity to revisit its early history. (shrink)

This article describes and rejects three standard views of reason in secular clinical ethics. The first, instrumental reason view, affirms that reason may be used to draw conceptual distinctions, map moral geography, and identify invalid forms of argumentation, but prohibits recommendations because reason cannot justify any content-full moral or metaphysical commitments. The second, public reason view, affirms instrumental reason, and claims ethicists may make recommendations grounded in the moral and metaphysical commitments of bioethical consensus. The third, comprehensive reason view, also (...) affirms instrumental reason, but encourages ethicists to make recommendations grounded in the moral and metaphysical commitments of their private worldviews. A compatibilist view of public reason is then defended, which holds that each standard view captures an important role for reason in different aspects of secular clinical ethics. The article ends by identifying three implications for enduring theoretical debates in clinical ethics. (shrink)

Moral concerns about the authority, power, and trustworthiness of physicians have become important topics in clinical ethics during the past three decades. These concerns have come to greater prominence with the increasing involvement of large-scale private institutions in the organization and delivery of medical services, especially managed care organizations, and with the increasing involvement of government in the payment for and organization and delivery of medical services. When physicians act as the agents of large institutions or governments, the power (...) of physicians over their patients increases. The purposes of this article are (1) to reflect briefly on the historical origins of the moral problem of physicians' power in medicine, and (2) to introduce the articles in the 1999 annual number of the Journal of Medicine and Philosophy on topics in clinical ethics. (shrink)

Regulating clinical trials for testing new drugs is fraught with risk. Misregulation can slow development of innovative and useful new drugs, but in other ways misregulation can foster trials that are inefficient and unethical, driven by commercial rather than scientific ends, and that can harm patients. In this paper, we argue not for more but for better regulation, based on the goal of rapidly producing innovative and safe products that represent significant advances in medical care. Data on industry-funded, late-stage clinical (...) trials demonstrate an urgent need for dramatic changes in how these trials are designed, conducted, and analyzed. On the one hand, current patent rules can dissuade development of innovative new products with smaller markets and press trial designers to create positive results too rapidly. But at the same time, numerous studies show that when the pharmaceutical industry sponsors clinical trials, the results are systematically biased in favor of the sponsor's product, often to the detriment of patients and the public. The reasons for this bias are both complex and unavoidable, and the ways in which clinical trial design, conduct, and reporting can be inappropriately influenced are so varied and nuanced, that efforts to manage this conflict of interest and prevent harms are inevitably unsuccessful. Instead, we conclude such conflict should be avoided and a strong firewall should exist between drug developers and the final stages of clinical testing in humans. All financial support for phase III clinical trials should pass through a public-private partnership organization — perhaps tied to a broader clinical effectiveness research enterprise — which would be charged with designing, funding, and monitoring late-stage human clinical trials of new pharmaceutical products. (shrink)

Originally published in 1970 this title commemorates the men and ideas that started, inspired and established a pioneer institution in British psychiatry. Based on the impetus of Freudian and related innovations after the First World War, the Tavistock Clinic offered treatment, training and research facilities in the field of neurosis, child guidance and later on group relations. Dr Dicks, who had been associated for nearly forty years with the work and personalities that helped to develop the Tavistock venture, describes the (...) struggles and capacity for survival of the clinic. He shows how, belonging neither to the older classical psychiatry nor to orthodox psychoanalysis, and suspect to both, the Clinic nevertheless became increasingly used by the rest of the profession as a psychotherapeutic resource. Dr Dicks describes the influence of the Tavistock on the medical, psychological and social work scene both before and after the Second World War, and assesses its achievements as a centre of psycho- and socio-dynamic thinking. The Tavistock is shown as a pioneer _sui generis_, launching psychosomatic research and initiating the exciting ventures in social psychiatry associated with the Army in the Second World War. As the Tavistock was the outcome of work with shell-shock victims in the first war, so its offspring, the Institute of Human Relations, was the natural continuation of the military effort in man-management, morale and group dynamic studies. The book includes an account of the inter-relationship between the Clinic, now part of the National Health Service, and the Institute, a private corporation. Still going strong as part of the Tavistock and Portman NHS Foundation Trust today this is an opportunity to revisit its early history. (shrink)

Suppose that there are good or morally defensible reasons for not responding truthfully to a question or request for information. Is a lie or a deception better as a means to avoid telling the truth? There are many situations in public and private life in which the answer to this question would serve as a useful moral guide, for instance, clinical situations involving dying patients, educational situations involving young children and personal situations involving close friends. Intuitively, we feel that (...) there is a moral asymmetry in favor of deceiving over lying. However, doubts have been cast on such intuition. The aim of this paper is to bolster this intuition. It will be argued that the claim of moral asymmetry in favor of deception can be supported on a consideration of the different degrees of expectation involved in communicative ethics. Two other objections to the claim of asymmetry will also be considered. (shrink)

BackgroundPrivate umbilical cord blood banking is a for-profit industry in which parents pay to store blood for potential future use. Governments have noted the tendency for private banks to oversell the potential for cord blood use, especially in relation to speculative cell therapies not yet supported by clinical evidence. We assessed the regulatory landscape governing private cord bank marketing in Canada.Main bodyBecause the problematic marketing of private cord blood banking for future use often relates to speculative future (...) cell therapies that do not exist and are not being advertised for current clinical use, most private blood bank marketing seems to fall outside Health Canada’s regulatory scope. However, this problematic marketing is regulated by the Competition Bureau pursuant to the Competition Act. While representations relating to future hypothetical treatments may not always be subject to the legal requirement for claim substantiation, the law also prohibits individuals and companies from knowingly or recklessly making representations that are “false or misleading in a material respect.” A representation is materially false or misleading when it could “influence a consumer’s behavior or purchasing decisions,” and consumers are likely to be considered to be “credulous and inexperienced” for the purposes of assessing an advertisement’s general impression. Because all of the potential benefit of the banking is derived from the potential future use of the biological material for health interventions directed toward the customers and their relatives, and because we know the best available medical evidence indicates a very low probability of utility in this context, we can say with confidence that some private cord blood banking claims are materially misleading. Moreover, to the extent that medical professionals are involved in private bank interactions with customers or hold ownership stakes in private banks, they are subject to professional codes, standards of practice, and potentially fiduciary obligations that further prohibit misleading marketing.ConclusionsPrivate cord blood bank marketing that advertises hypothetical future treatments can be misleading and may influence consumer behaviour. This marketing may breach existing advertising law. Regulatory bodies should enforce the law in order to help prevent public health and personal financial harm. (shrink)

Conflicts in the clinical setting can spiral downward with remarkable speed, as parties become ever more incensed and entrenched in their positions. Productive conversations seem unlikely at best. Nevertheless, such situations can sometimes be turned into collaborative problem solving with equally remarkable speed. For this to happen, those providing conflict-resolution services such as mediation need to bring, not just a set of skills, but also some key norms: the process must be voluntary for all; the mediator must abjure giving advice (...) or taking sides, and must honor the privacy of privately offered thoughts. This article describes a conflict that had reached the point of a hospital’s requesting judicial coercion. However, a conflict-resolution process was then initiated that, in the end, led to amicable resolution and mended relationships, obviating the need for court orders. This article describes that conflict and the resolution process in detail, along the way annotating specific strategies that are often highly effective. (shrink)

The exportation of unethical practices to low- and middle-income countries has been conceived as a prevalent practice which needs to be examined more closely. Such a practice might point towards the exploitation of vulnerable population groups. We conducted a survey among Mexican research ethics committee members to explore the issue of ethics dumping in Mexico by understanding how its existence and contributing factors and norms are perceived by these ethics committee members. We designed an exploratory survey based on a five-point (...) Likert scale, following an established, validated and published methodology. The questionnaire included both open close-ended questions. The aspects covered in the questionnaire were introductory questions on the existence of ethical issues; general perception on ethics dumping in Mexico; lack of voluntariness, undue inducement, and therapeutic misconception as exploitation risks; existence of exploitative practices; norms facilitating ethics dumping; acceptable levels of benefit to Mexico; boundaries of ethics dumping. The survey was administered to a sample of research ethics committee members from public and private Mexican hospitals in 2016. Most of the ethics committee members believed clinical trials are generally ethically sound, though almost a majority think that ethics dumping is a common occurrence and that it is a serious issue. Most agree that ethics dumping needs to be addressed. They also identified other issues such as ethical issues related to patient participation and ethics committees. Further, most committee members agree that undue inducement and therapeutic misconception affect voluntariness, and that both individuals and communities receive appropriate benefits. From the perspective of Mexican research ethics committee members, ethics dumping commonly exists in Mexican clinical trials, as well as several related issues such as ethical issues on patient participation and ethics committees, as well as voluntariness issues. Further, most members believed these issues need to be addressed. However, most were also of the opinion that clinical trials are generally ethically compliant. This points to the need for further studies on the reasons for these perspectives. (shrink)

Mental disorders in university students are very frequent, therefore higher education institutions have established in-campus mental healthcare centres. These clinics have particular characteristics that differ from other mental health centres, as they report to and represent an educational institution, while at the same time looking after the interests and well-being of patients requesting assistance, thus generating unique bioethical conflicts. Ethics Committees are useful tools to offer support to mental health professionals in making ethical decisions. In order to respond to (...) these issues, it was decided that an Ethics Committee would be created in the mental health clinic of a private university in Mexico City. This article describes the implementation process for this Committee, its duties and scope, as well as the case work and review methodology. A list of the most frequent ethical conflicts is attached, jointly with the ethical analysis of the cases treated throughout the year and a half or work by the Committee. (shrink)

Data gathered by investigators are used to test the validity of a specific scientific hypothesis. When the hypothesis relates to the biology of a disease or its treatment, then data sets may contain specific and identifiable medical information. Since the information in a clinical data set was gathered to test a specific hypothesis and there is usually a sponsor interested in the outcome, the issue of who owns the data is a critical one. In my opinion, data from both publicly (...) and privately funded research should be made available, in a format that protects confidentiality and intellectual property rights, to interested and responsible parties within a reasonable period of time after publication. (shrink)

BackgroundThe COVID-19 pandemic has magnified pre-existing challenges in healthcare in Africa. Long-standing health inequities, embedded in the continent over centuries, have been laid bare and have raised complex ethical dilemmas. While there are very few clinical ethics committees (CECs) in Africa, the demand for such services exists and has increased during the COVID-19 pandemic. The views of African healthcare professionals or bioethicists on the role of CECs in Africa have not been explored or documented previously. In this study, we aim (...) to explore such perspectives, as well as the challenges preventing the establishment of CECs in Africa.MethodsTwenty healthcare professionals and bioethicists from Africa participated in this qualitative study that utilized in-depth semi-structured interviews with open-ended questions. Themes were identified through thematic analysis of interviews and open-ended responses.ResultsKenya and South Africa are the only countries on the continent with formal established CECs. The following themes emerged from this qualitative study: (1) Lack of formal CECs and resolution of ethical dilemmas; (2) Role of CECs during COVID-19; (3) Ethical dilemmas presented to CECs pre-COVID-19; (4) Lack of awareness of CECs; (5) Lack of qualified bioethicists or clinical ethicists; (6) Limited resources to establish CECs; (7) Creating interest in CECs and networking.ConclusionsThis study illustrates the importance of clinical ethics education among African HCPs and bioethicists, more so now when COVID-19 has posed a host of clinical and ethical challenges to public and private healthcare systems. The challenges and barriers identified will inform the establishment of CECs or clinical ethics consultation services (CESs) in the region. The study results have triggered an idea for the creation of a network of African CECs. (shrink)

A sudden paradigm shift has resulted in governmental measures that greatly impact the scope in which the ethics committees in Germany can perform their task of providing expert opinions for clinical research. The so-called “revaluation” of the Medical Device Law Deutsches Medizinproduktegesetz—MPG) is, in our opinion, not based on sound political and professional judgment. In accordance with the changed regulations, ethics committees are now seen as being sub-organs of the state medical associations or the medical faculties and are therefore official (...) authorities. It follows that the votes of ethics committees are then “sovereign acts” or authoritative measures! However, equality and justice speak against this misleading conclusion and its resulting consequence that an ethics committee’s vote is a sovereign act. This has, in turn, resulted in the public ethics committees obtaining their long-sought goal of having a state-sanctioned monopoly. The private ethics committees are not recognized as being authoritative bodies, nor are they to be seen as such in the future (i.e. such a status has been denied the Freiburg Ethics Commission International (FEKI) in Baden-Württemberg). This political mistake must be corrected, otherwise, conducting clinical research will become increasingly difficult. (shrink)

ABSTRACT The aim of this study is to determine how stakeholder engagement can be adapted for the conduct of COVID‐19‐related clinical trials in sub‐Saharan Africa. Nine essential stakeholder engagement practices were reviewed: formative research; stakeholder engagement plan; communications and issues management plan; protocol development; informed consent process; standard of prevention for vaccine research and standard of care for treatment research; policies on trial‐related physical, psychological, financial, and/or social harms; trial accrual, follow‐up, exit trial closure and results dissemination; and post‐trial access (...) to trial products or procedures. The norms, values, and practices of collectivist societies in Sub‐Saharan Africa and the low research literacy pose challenges to the conduct of clinical trials. Civil‐society organizations, members of community advisory boards and ethics committees, young persons, COVID‐19 survivors, researchers, government, and the private sector are assets for the implementation and translation of COVID‐19 related clinical trials. Adapting ethics guidelines to the socio‐cultural context of the region can facilitate achieving the aim of stakeholder engagement. (shrink)

The ramifications of including genetic components in the clinical studies conducted in non-academic settings create unique ethical challenges. We used a qualitative research design consisting of semi-structured interviews that took place between October 2010 and September 2012. The sample consisted of 80 participants − 38 physicians and 42 coordinators − who worked across a number of different settings, including clinics, private practices, small hospitals, free standing research centers, and blended hospital-institutes in both rural and urban communities in 13 (...) states across the United States. The respondents primarily conducted industry sponsored trials and recruited their own patients as research participants. A majority of the respondents (65%) reported that most of the studies they conducted included an additional genetics component, and so participants were asked to donate specimens for genomics or biobanking. While genomics association studies were perceived as being of benefit, awareness of ethical implications associated with such studies was limited. The rapid advances in genetic technologies make it hard for clinicians and coordinators to help patients make informed decisions about participating in clinical research, and underscore the need to ensure that the regulations governing research on human subjects keep pace with the social and technological changes. It seems essential to discern legitimate ethical concerns and find ways to convey what is going on, what is possible and what might not be possible in terms of protecting privacy, anonymity, and confidentiality. (shrink)

Ideally, guidelines reflect an accepted position with respect to matters of concern, ranging from clinical practices to researcher behaviour. Upon close reading, authorship guidelines reserve authorship attribution to individuals fully or almost fully embedded in particular studies, including design or execution as well as significant involvement in the writing process. These requirements prescribe an organisation of scientific work in which this embedding is specifically enabled. Drawing from interviews with nutrition scientists at universities and in the food industry, we demonstrate that (...) the organisation of research labour can deviate significantly from such prescriptions. The organisation of labour, regardless of its content, then, has consequences for who qualifies as an author. The fact that fewer food industry employees qualify is actively used by the food industry to manage the credibility and ownership of their knowledge claims as allonymous science: the attribution of science assisted by authorship guidelines blind to all but one organisational frame. (shrink)

Private industry funds more than half of all medical research in the United States. While industry involvement in research has benefits, it can also create conflicts of interest. The most common policies adopted to address conflict of interest in medical research are focused primarily on the ways in which industry sponsorship may undermine a clinician’s judgment regarding patient care. Insufficient attention has been given to the ways in which industry sponsorship may undermine judgment relative to the goal of scientific (...) integrity in research. The most common conflict of interest policies do not adequately address this problem. Disclosure policies alone will not remove or ameliorate all conflicts. Further, severing or monitoring ties between clinicians and industries will not adequately address the problem, since in many cases it is not the clinicians who are making the relevant research judgments. In order to address the problem of conflict of interest inindustry-sponsored research, fundamental changes in strategy and practice must be adopted which either remove the power to make research decisions from industry employees, or increase the review of those decisions by independent investigators. (shrink)