In response to a sharp rise in opioid-involved overdose deaths in the USA, states have deployed increasingly aggressive strategies to limit the loss of life, including civil commitment—the forcible detention of individuals whose opioid use presents a clear and convincing danger to themselves or others. While civil commitment often succeeds in providing short-term protection from overdose, emerging evidence suggests that it may be associated with long-term harms, including heightened risk of severe withdrawal, relapse and opioid-involved mortality. To better assess and (...) mitigate these harms, states should collect more robust data on long-term health outcomes, decriminalise proceedings and stays, provide access to medications for opioid use disorder and strengthen post-release coordination of community-based treatment. (shrink)

In this article, Harvey notes the initial confusion about the statement made by the pope concerning artificial nutrition and hydration on patients suffering persistent vegetative states (PVS) due to misunderstanding through the translation of the pope's words. He clarifies and assesses what was meant by the statement. He also discusses the problems of terminology concerned with the subject of PVS. Harvey concludes that the papal allocution was in line with traditional Catholic bioethics, and that while maintaining the life of a (...) patient is favorable, in particular cases this presumption wanes when it is clear that this treatment modality would be futile or very burdensome. (shrink)

Several lines of evidence suggest that children born via Cesarean section are at greater risk for adverse health outcomes including allergies, asthma and obesity. Vaginal seeding is a medical procedure in which infants born by C-section are swabbed immediately after birth with vaginal secretions from the mother. This procedure has been proposed as a way to transfer the mother's vaginal microbiome to the child, thereby restoring the natural exposure that occurs during vaginal birth that is interrupted in the case (...) of babies born via C-section. Preliminary evidence indicates partial restoration of microbes. However, there is insufficient evidence to determine the health benefits of the procedure. Several studies, including trial, are currently underway. At the same time, in the clinic setting, doctors are increasingly being asked to by expectant mothers to have their babies seeded. This article reports on the current research on this procedure and the issues it raises for regulators, researchers, physicians, and patients. (shrink)

This paper argues that there exists a collective epistemic state of ‘Broad Medical Uncertainty’ regarding the effectiveness of many medical interventions. We outline the features of BMU, and describe some of the main contributing factors. These include flaws in medical research methodologies, bias in publication practices, financial and other conflicts of interest, and features of how evidence is translated into practice. These result in a significant degree of uncertainty regarding the effectiveness of many medical treatments and (...) unduly optimistic beliefs about the benefit/harm profiles of such treatments. We argue for an ethical presumption in favour of openness regarding BMU as part of a ‘Corrective Response’. We then consider some objections to this position, including concerns that public honesty about flaws in medical research could undermine trust in healthcare institutions. We suggest that, as it stands, the Anti-Corrective Response is unconvincing. (shrink)

Medical practitioners are duty-bound to tell their patients the truth about their medical conditions, along with the risks and benefits of proposed treatments. Some patients, however, would rather not receive medical information. A recent response to this tension has been to argue that that the disclosure of medical information is not optional. As such, patients do not have permission to refuse medical information. In this paper I argue that, depending on the context, the disclosure of (...) medical information can undermine the patient’s ability to exercise her autonomy or have therapeutically detrimental effects. In the light of these insights I go on to develop a context-sensitive approach to medical disclosure. The advantage of this account is that it addresses concerns on both sides of the debate; whilst it acknowledges that patients do not have an exercisable ‘right not to know,’ it allows that in some cases medical information ought to be withheld. (shrink)

Research Ethics, Volume 18, Issue 2, Page 132-150, April 2022. Limited research has been done among pregnant people participating in investigational drug trials. To enhance the ethical understanding of pregnant people’s perspectives on research participation, we sought to describe motives and risk perceptions of participants in a phase 1 trial of ledipasvir/sofosbuvir treatment for chronic Hepatitis C virus during pregnancy. Pregnant people with chronic HCV infection enrolled in an open-label, phase 1 study of LDV/SOF participated in semi-structured, in-depth interviews to (...) explore their reasons for participation and experiences within the study. Pregnant people took 12 weeks of LDV/SOF and were interviewed at enrollment and at the end of study. We recorded the interviews, transcribed them verbatim, coded them using NVivo software, and performed inductive thematic analysis. Nine women completed the study yielding 18 interview transcripts. We identified two themes regarding motives and one regarding risk perception. Motives— Women conceptualized study participation as part of the caregiving role they associate with motherhood; participating was viewed as an act of caregiving for their infants, their families, themselves, and other pregnant women with chronic HCV. Women also noted that they faced multiple barriers to treatment prior to pregnancy that created a desire to receive therapy through trial participation. Risk perception— Women acknowledged personal and fetal risk associated with participation. Acceptance of risk was influenced by women’s concepts of motherhood, preexisting knowledge of HCV and medical research, family members, intimate partners, or by the study design. Women enrolled in a phase 1 trial for chronic HCV therapy during pregnancy acknowledged risks of participation and were motivated by hopes for fetal and personal benefit and by lack of prenatal access to treatment. Ethical inclusion of pregnant people in research should acknowledge structural factors that contribute to vulnerability and data deficiencies for treatment in pregnancy. (shrink)

Although it is commonly believed that the concept of brain death was developed to benefit organ transplants, it evolved independently. Transplantation owed its development to advances in surgery and immunosuppressive treatment; BD owed its origin to the development of intensive care. The first autotransplant was achieved in the early 1900s, when studies of increased intracranial pressure causing respiratory arrest with preserved heartbeat were reported. Between 1902 and 1950, the BD concept was supported by the discovery of EEG, Crile’s definition (...) of death, the use of EEG to demonstrate abolition of brain potentials after ischaemia, and Crafoord’s statement that death was due to cessation of blood flow. Transplantation saw the first xenotransplant in humans and the first unsuccessful kidney transplant from a cadaver. In the 1950s, circulatory arrest in coma was identified by angiography, and the death of the nervous system and coma dépassé were described. Murray performed the first successful kidney transplant. In the 1960s, the BD concept and organ transplants were instantly linked when the first kidney transplant using a brain-dead donor was performed; Schwab proposed to use EEG in BD; the Harvard Committee report and the Sydney Declaration appeared; the first successful kidney, lung and pancreas transplants using cadaveric donors were achieved; Barnard performed the first human heart transplant. This historical review demonstrates that the BD concept and organ transplantation arose separately and advanced in parallel, and only began to progress together in the late 1960s. Therefore, the BD concept did not evolve to benefit transplantation. (shrink)

It is widely agreed that medical researchers who conduct studies in low- and middle-income countries (LMICs) are morally required to ensure that their research benefits the broader host community, not only the subjects. The justification for this moral requirement has not been adequately examined. Most attempts to justify this requirement focus on researchers' interaction with the community as a whole, not on their relationship with their subjects. This paper argues that in some cases, research must benefit the broader (...) host community for researchers to treat subjects and prospective subjects ethically. If research presents substantial net risks to subjects, researchers can ethically ask LMIC citizens to participate only if people in LMICs, normally including people in the host community, stand to benefit. (shrink)

Self-medication behaviour is the use of natural materials or chemical substances to manipulate behaviour or alter the body’s response to parasites or pathogens. Self-medication can be preventive, performed before an individual becomes infected or diseased, and/or therapeutic, performed after an individual becomes infected or diseased. We summarized all available reports of self-medication in mammals and reconstructed its evolution. We found that reports of self-medication were restricted to eutherian mammals and evolved at least four times independently. Self-medication was most commonly reported (...) in primates. Detailed analyses of primates suggest that self-medication is a life-history trait associated with body size, absolute brain size and longevity, but we found no support for the hypothesis that self-medication evolved to reduce the costs of social living. Large, longer-lived species might thus benefit uniquely from self-medication. (shrink)

Objectives: To explore how subjects in a placebo-controlled vitamin A supplementation trial among Ghanaian women aged 15–45 years perceive the trial and whether they know that not all trial capsules are the same, and to identify factors associated with this knowledge.Methods: 60 semistructured interviews and 12 focus groups were conducted to explore subjects’ perceptions of the trial. Steps were taken to address areas of low comprehension, including retraining fieldworkers. 1971 trial subjects were randomly selected for a survey measuring their knowledge (...) that not all trial capsules are the same. The subjects’ fieldworkers were also interviewed about their characteristics and trial knowledge. Factors associated with knowledge were explored using multi-level modeling.Results: Although subjects knew they were taking part in research, most thought they were receiving an active and beneficial medication. Variables associated with knowledge were education and district of residence. Radio broadcasts benefited those with some schooling. Fieldworkers’ characteristics were not associated with subjects’ knowledge.Conclusions: Research and debate on new or improved consent procedures are urgently required, particularly for subjects with little education. (shrink)

Boxers and healthcare workers alike should be able to exercise their rightsAlthough there are calls elsewhere to ban boxing, the Australian Medical Association advocates a less restrictive rule. Professional boxers would submit to brain scans and MRIs—but what to do with the results of such tests? Critics say that boxers should decide which risks they take, but boxers are not the only ones in the debate. Healthcare workers understandably want some say in which risks people take, because the hospital (...) is where boxers go when injuries occur . These issues of ethics and obligation are not made easier to resolve by the many disputed comparisons in this debate. Is boxing like other risk taking behaviour? Are physicians like other public employees? Until such questions are answered, a compromise would have check ups made mandatory, without forcing boxers to act on any knowledge gained.There is no shortage of comparisons in the debate over boxing. Boxing, we hear, is like fast food: dangerous yes, but it does offer some benefits. No, the opposing side contends, boxing is like a pistol duel: once considered sophisticated, it is now just a ritualistic violence. Perhaps boxing is like smoking: inform boxers of the risks and let them at it. Then again, if boxing is like smoking, people who do not realise how dangerous it is need protection from it. Depending on who you listen to, boxing is an expression of individualism and personal sacrifice—the next best thing to running your own country—or it illustrates the danger in letting concern for autonomy overstretch the social fabric. And so the comparisons continue, without really convincing anyone. Not surprisingly, reformist proposals that could include mandatory brain scans for boxers are viewed as intrusive …. (shrink)

Wakefield’s harmful dysfunction analysis asserts that the concept of medical disorder includes a naturalistic component of dysfunction and a value component, both of which are required for disorder attributions. Muckler and Taylor, defending a purely naturalist, value-free understanding of disorder, argue that harm is not necessary for disorder. They provide three examples of dysfunctions that, they claim, are considered disorders but are entirely harmless: mild mononucleosis, cowpox that prevents smallpox, and minor perceptual deficits. They also reject the proposal that (...) dysfunctions need only be typically harmful to qualify as disorders. We argue that the proposed counterexamples are, in fact, considered harmful; thus, they fail to disconfirm the harm requirement: incapacity for exertion is inherently harmful, whether or not exertion occurs, cowpox is directly harmful irrespective of indirect benefits, and colorblindness and anosmia are considered harmful by those who consider them disorders. We also defend the typicality qualifier as viably addressing some apparently harmless disorders and argue that a dysfunction’s harmfulness is best understood in dispositional terms. (shrink)

Our increasingly sophisticated medical technological interventions yield numerous benefits. At the same time, there are dangerous trade-offs, particularly in the domain of digitized health communication and electronic medical records. These have become the rule of thumb, the default posture, in place of interpersonal, embodied, face-to-face interaction. This foremost stumbling block in our healthcare system generates an urgent moral imperative to resuscitate embodied presence in healthcare. Through applying a phenomenological lens, focusing particularly on insights from Emmanuel Levinas, this essay (...) examines his metaphysic of ethics that occurs through encountering the face of the Other, le visage. This encounter evokes an epiphany, a “rupture of being,” that constitutes a moral invitation, a beckoning that offers further ground for an ethics of embodied presence as a path to re-establish genuine communication with our patients. (shrink)

Many ethicists maintain that medical research on human subjects that presents no prospect of direct medical benefit must have a prospect of social benefit to be ethical. Payment is not the sort of benefit that justifies exposing subjects to risk. Alan Wertheimer has raised a serious challenge to this view, pointing out that in industry, social value is not considered necessary to make dangerous jobs ethical. This article argues that Wertheimer was correct to think that (...) the ethics of hazard pay should be the same in medical research and in business. Nevertheless, a qualified social benefit requirement should apply in both fields. For a study or a job with significant net physical risk to be ethical, it must have social value beyond the satisfaction of ordinary preferences, including the preference for money. The requirement derives from a non-absolutist version of the doctrine of double effect. If a risky study or a dangerous job has no distinctive social value, and hazard pay is subjects' or workers’ only reason to undergo risks, the very fact that they undergo risk is intended as a means to a financial end. Inviting people to enrol in such a study or to take such a job wrongfully treats people as mere means. By contrast, if a study or a job has social value, people can participate with a primary end other than money, even if they accept compensation. Researchers or employers do not intend but merely foresee risks to subjects or workers. (shrink)

A commentary on “SUPPORT and the Ethics of Study Implementation: Lessons for Comparative Effectiveness Research from the Trial of Oxygen Therapy for Premature Babies,” by John D. Lantos and Chris Feudtner, in the January‐February 2015 issue.

BackgroundResearch using data from medical care promises to advance medical science and improve healthcare. Academia is not the only sector that expects such research to be of great benefit. The research-based health industry is also interested in so-called ‘real-world’ health data to develop new drugs, medical technologies or data-based health applications. While access to medical data is handled very differently in different countries, and some empirical data suggest people are uncomfortable with the idea of companies (...) accessing health information, this paper aims to advance the ethical debate about secondary use of medical data generated in the public healthcare sector by for-profit companies for medical research (ReuseForPro).MethodsWe first clarify some basic concepts and our ethical-normative approach, then discuss and ethically evaluate potential claims and interests of relevant stakeholders: patients as data subjects in the public healthcare system, for-profit companies, the public, and physicians and their healthcare institutions. Finally, we address the tensions between legitimate claims of different stakeholders in order to suggest conditions that might ensure ethically sound ReuseForPro.ResultsWe conclude that there are good reasons to grant for-profit companies access to medical data if they meet certain conditions: among others they need to respect patients’ informational rights and their actions need to be compatible with the public’s interest in health benefit from ReuseForPro. (shrink)

David KC Cooper,1 David Ayares21Thomas E Starzl Transplantation Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; 2Revivicor, Blacksburg, VA, USA: The transplantation of organs and cells from pigs into humans could overcome the critical and continuing problem of the lack of availability of deceased human organs and cells for clinical transplantation. Developments in the genetic engineering of pigs have enabled considerable progress to be made in the experimental laboratory in overcoming the immune barriers to successful xenotransplantation. With regard (...) to pig organ xenotransplantation, antibody- and cell-mediated rejection have largely been overcome, and the current major barrier is the development of coagulation dysregulation. This is believed to be due to a combination of immune activation of the vascular endothelial cells of the graft and molecular incompatibilities between the pig and primate coagulation–anticoagulation systems. Pigs with new genetic modifications specifically directed to this problem are now becoming available. With regard to less complex tissues, such as islets, neuronal cells, and corneas, the remaining barriers are less problematic, and graft survival in nonhuman primate models extends for >1 year in all three cases. In planning the initial clinical trials, consideration will be concentrated on the risk–benefit ratio, based to a large extent on the results of preclinical studies in nonhuman primates. If the benefit to the patient is anticipated to be high, eg, insulin-independent control of glycemia, and the potential risks low, eg, minimal risk of transfer of a porcine infectious agent, then a clinical trial would be justified.Keywords: infection, pigs, genetically-engineered, xenotransplantation, islets, xenotransplantation, organs. (shrink)

What ethically justifies the provision of invasive and irreversible treatments to minors? In this commentary, I examine this question in response to Moti Gorin's article “What Is the Aim of Pediatric ‘Gender‐Affirming’ Care?,” which critiques autonomy‐based arguments for justification of gender‐affirming care in minors. Minors generally lack sufficient autonomy to make significant medical decisions or major life decisions. For this reason, parents are generally their decision‐makers, working with medical professionals to choose treatments that serve the best interests of (...) the minor. Medical care in minors is justified by beneficence, not autonomy, and this should be no different for gender‐affirming care. This severely undermines autonomy‐based arguments for provision of gender‐affirming care to minors. Given the lack of conclusive evidence for benefit, the nature of the treatment, and the fact that gender dysphoria in minors resolves spontaneously in most cases, there is presently insufficient justification for provision of such care to minors. (shrink)

Currently, many women who are expecting to give birth have no option but to attempt vaginal delivery, since access to elective planned caesarean sections (PCS) in the absence of what is deemed to constitute ‘clinical need’ is variable. In this paper, we argue that PCS should be routinely offered to women who are expecting to give birth, and that the risks and benefits of PCS as compared with planned vaginal delivery should be discussed with them. Currently, discussions of elective PCS (...) arise in the context of what are called ‘Maternal Request Caesarean Sections’ (MRCS) and there is a good deal of support for the position that women who request PCS without clinical indication should be provided with them. Our argument goes further than support for acceding to requests for MRCS: we submit that healthcare practitioners caring for women with uncomplicated pregnancies have a positive duty to inform them of the option of PCS as opposed to assuming vaginal delivery as a default, and to provide (or arrange for the provision of) PCS if that is the woman's preferred manner of delivery. (shrink)

BackgroundHealthcare professionals are exposed to advertisements for prescription drugs in medical journals. Such advertisements may increase prescriptions of new drugs at the expense of older treatments even when they have no added benefits, are more harmful, and are more expensive. The publication of medical advertisements therefore raises ethical questions related to editorial integrity.MethodsWe conducted a descriptive cross-sectional study of all medical advertisements published in the Journal of the Danish Medical Association in 2015. Drugs advertised 6 times (...) or more were compared with older comparators: comparative evidence of added benefit; Defined Daily Dose cost; regulatory safety announcements; and completed and ongoing post-marketing studies 3 years after advertising.ResultsWe found 158 medical advertisements for 35 prescription drugs published in 24 issues during 2015, with a median of 7 advertisements per issue. Four drug groups and 5 single drugs were advertised 6 times or more, for a total of 10 indications, and we made 14 comparisons with older treatments. We found: ‘no added benefit’ in 4 of 14 comparisons, ‘uncertain benefits’ in 7, and ‘no evidence’ in 3 comparisons. In no comparison did we find evidence of ‘substantial added benefit’ for the new drug; advertised drugs were 2 to 196 times more expensive per Defined Daily Dose; 11 safety announcements for five advertised drugs were issued compared to one announcement for one comparator drug; 20 post-marketing studies were requested for the advertised drugs versus 10 studies for the comparator drugs, and 7 studies assessed both an advertised and a comparator drug at 3 year follow-up.Conclusions and relevanceIn this cross-sectional study of medical advertisements published in the Journal of the Danish Medical Association during 2015, the most advertised drugs did not have documented substantial added benefits over older treatments, whereas they were substantially more expensive. From January 2021, the Journal of the Danish Medical Association no longer publishes medical advertisements. (shrink)

Background In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reached the deliberation processes. (...) Methods To gather data, we used the Dutch Medicines Evaluation Board database and first searched for the inspections, and their accompanying site inspection reports and integrated inspection reports, related to central marketing authorization applications of drugs submitted to the European Medicines Agency from 2011 to 2015. We then extracted inspection findings that were purely of ethical nature, i.e., those that did not affect the benefit/risk balance of the study. Only findings graded at least major by the inspectorate were included. Lastly, to identify how many of the ethically relevant findings reach the application deliberation processes, we extracted the relevant joint response assessment reports and reviewed the sections that discussed inspection findings. Results From 2011 to 2015, there were 390 processed applications, of which 65 had inspection reports and integrated inspection reports accessible via the database of the Dutch Medicines Evaluation Board. Of the 65, we found ERFs in 37. The majority of the ERFs were graded as major and half of the time it was informed-consent related. A third of these findings were related to research ethics committee processes and requirements. Of the 37 inspections with ERFs, 30 were endorsed in the integrated inspection reports as generally GCP compliant. Day 150 joint response assessment reports and Day 180 list of outstanding issues were reviewed for all 37 inspections, and none of the ERFs were carried over in any of the assessment reports or list of outstanding issues. Conclusion None of the ethically relevant findings, all of which were graded as major or critical in integrated inspection reports, were explicitly carried over to the joint assessment reports. This calls for more transparency in EMA application deliberations on how ERFs are considered, if at all, in the decision-making processes. (shrink)

Reality medical television, an increasingly popular genre, depicts private medical moments between patients and healthcare providers. Journalists aim to educate and inform the public, while the participants in their documentaries—providers and patients—seek to heal and be healed. When journalists and healthcare providers work together at the bedside, moral problems precipitate. During the summer of 2010, ABC aired a documentary, Boston Med, featuring several Boston hospitals. We examine the ethical issues that arise when journalism and medicine intersect. We provide (...) a framework for evaluating the potential benefits and harms of reality medical television, highlighting critical issues such as informed consent, confidentiality, and privacy. (shrink)

The Healer's Art curriculum is one of the best-known educational strategies to support medical student professional identity formation. HART has been widely used as an elective curriculum. We evaluated students’ experience with HART when the curriculum was required. All one hundred eleven members of the class of 2019 University of New Mexico School of Medicine students were required to enroll in HART. We surveyed the students before and after the course to assess its self-reported impact on key elements of (...) professional identity formation such as empathy towards patients and peers, commitment to service, and burnout. A majority of students reported positive effects of the course on their empathy towards other students. This finding was significantly associated with self-reported willingness to have elected the course had it not been required. One-half of respondents reported positive effects on their empathy towards future patients. At least one-quarter to one-third of respondents reported positive influences on commitment to service, conceptions about being a physician, and self-perceived burnout. Students report benefits on their professional identity formation after participating in a required course on humanism. Empathy-building among peers is one valuable outcome of such curricula. (shrink)

In the light of increasing public mistrust, there is an urgent need to clarify the moral status of the medical profession and of the relationship of the clinician to his/her patients. In addressing this question, I first establish the coherence, within moral philosophy generally, of the concept of supererogation . I adopt the notion of an act of “unqualified” supererogation as one that is non-derivatively good, praiseworthy, and freely undertaken for others' benefit at the risk of some cost (...) to the agent. I then argue that committing oneself to the profession of clinical medicine is an act of this kind. This is the case, not because the aim of medicine is to help patients, but because of the open ended commitment of time and the vulnerability to the consequences of failure that the clinician must accept. (shrink)

Ben Rich’s stated aim in this book is to prove that the legal system has had a positive rather than a negative impact on medical practice and research. When lawyers are often attacked (by the medical professions and governments alike) for their role in medical litigation this conclusion seems to be at odds with our experience. Rich’s text is a timely and scholarly contribution to the debate about the role of the legal system in medicine. While it (...) may not prove to be completely convincing, the work offers penetrating insights into how the American legal system has influenced bioethics, primarily because of the way that it provides an ultimate forum for the resolution of ethical disputes. Rich’s initial chapters serve as an introduction to schools of medical ethics and jurisprudence. Chapters two and three will be of real benefit to the new student of bioethics as Rich provides very clear and concise summaries of the major schools of ethics …. (shrink)

In this response to Jonny Anomaly’s ‘Is Obesity a Public Health Problem?’ I argue, contra the author that public health actually increases individuals’ abilities to choose actions that further their health goals, specifically in the case of obesity. The intractability of obesity as an individual medical problem combined with the health benefits of modest (5–10 per cent of body weight) weight loss suggest that public health measures helping people make small changes in eating habits improve population health. I argue (...) that such measures are available to public health via behavioral economic research and policy proposals from libertarian paternalists. I respond to author’s claim that obesity does not constitute a public health problem because: (i) it is not an epidemic and (ii) obesity reduction is not a public good. I argue that epidemic status is not required for classification as a public health problem, but that obesity does have the status of an epidemic. I also point out flaws in author’s reasoning about obesity, public health and social costs. I conclude by suggesting that public health, in partnership with stakeholders and other areas of government, is poised to help create conditions for modest weight loss and increased population health overall. (shrink)

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)

Increasing ethical attention and debate is focusing on whether individuals who take part in clinical trials should be given access to post-trial care. However, the main focus of this debate has been upon drug trials undertaken in low-income settings. To broaden this debate, we report findings from interviews with individuals (n = 24) who participated in a clinical trial of a closed-loop system, which is a medical device under development for people with type 1 diabetes that automatically adjusts blood (...) glucose to help keep it within clinically recommended ranges. Individuals were recruited from UK sites and interviewed following trial close-out, at which point the closed-loop had been withdrawn. While individuals were stoical and accepting of the requirement to return the closed-loop, they also conveyed varying degrees of distress. Many described having relaxed diabetes management practices while using the closed-loop and having become deskilled as a consequence, which made reverting back to pre-trial regimens challenging. Participants also described unanticipated consequences arising from using a closed-loop. As well as deskilling, these included experiencing psychological and emotional benefits that could not be sustained after the closed-loop had been withdrawn and participants reevaluating their pre- and post-trial life in light of having used a closed-loop and now perceiving this life much more negatively. Participants also voiced frustrations about experiencing better blood glucose control using a closed-loop and then having to revert to using what they now saw as antiquated and imprecise self-management tools. We use these findings to argue that ethical debates about post-trial provisioning need to be broadened to consider potential psychological and emotional harms, and not just clinical harms, that may result from withdrawal of investigated treatments. We also suggest that individuals may benefit from information about potential nonclinical harms to help make informed decisions about trial participation. (shrink)

BackgroundResearch ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all (...) the risk-benefit tasks; instead, RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision.ConclusionAs such, research ethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs’ risk-benefit task. (shrink)

Background Scientific and technological advancements in mapping and understanding the interrelated pathways through which biological and environmental exposures affect disease development create new possibilities for detecting disease risk factors. Early detection of such risk factors may help prevent disease onset or moderate the disease course, thereby decreasing associated disease burden, morbidity, and mortality. However, the ethical implications of screening for disease risk factors are unclear and the current literature provides a fragmented and case-by-case picture. Methods To identify key ethical considerations (...) arising from the early detection of disease risk factors, we performed a systematic scoping review. The Scopus, Embase, and Philosopher’s Index databases were searched for peer-reviewed, academic records, which were included if they were written in English or Dutch and concerned the ethics of (1) early detection of (2) disease risk factors for (3) disease caused by environmental factors or gene-environment interactions. All records were reviewed independently by at least two researchers. Results After screening 2034 titles and abstracts, and 112 full papers, 55 articles were included in the thematic synthesis of the results. We identified eight common ethical themes: (1) Reliability and uncertainty in early detection, (2) autonomy, (3) privacy, (4) beneficence and non-maleficence, (5) downstream burdens on others, (6) responsibility, (7) justice, and (8) medicalization and conceptual disruption. We identified several gaps in the literature, including a relative scarcity of research on ethical considerations associated with environmental preventive health interventions, a dearth of practical suggestions on how to address expressed concerns about overestimating health capacities, and a lack of insights into preventing undue attribution of health responsibility to individuals. Conclusions The ethical concerns arising with the early detection of risk factors are often interrelated and complex. Comprehensive ethical analyses are needed that are better embedded in normative frameworks and also assess and weigh the expected benefits of early risk factor detection. Such research is necessary for developing and implementing responsible and fair preventive health policies. (shrink)

Benefiting from a widely recognised experience of the field of bioethics, the Council of Europe which represents all the democratic countries of Europe, has embarked on the ambitious task of drafting a European Convention on bioethics. The purpose of this text is to set out fundamental values, such as respect for human dignity, free informed consent and non-commercialisation of the human body. In addition to this task, protocols will provide specific standards for the different fields concerned with the application of (...) biomedical sciences. The convention and the first two protocols (human experiments and organ transplants) are due to be ready for signature by mid 1994. (shrink)

Although deceptive psychology experiments receive less attention than some forms of medical research, they pose similar moral challenges. These challenges mainly concern the use of human subjects and intentional deception. Psychologists provide an argument to justify this deception. But what is an essentially utilitarian argument too often includes faulty comparisons and dubious accounts of risks and benefits. Commentators in other areas of humansubject research might examine this argument and the assumptions behind it. Bioethics commentators seem especially well-positioned for this (...) task. (shrink)

The legacy of colonial rule has permeated into all aspects of life and contributed to healthcare inequity. In response to the increased interest in social justice, medical educators are thinking of ways to decolonise education and produce doctors who can meet the complex needs of diverse populations. This paper aims to explore decolonising ideas of healing within medical education following recent events including the University College London Medical School’s Decolonising the Medical Curriculum public engagement event, the (...) Wellcome Collection ’s Ayurvedic Man: Encounters with Indian Medicine exhibition and its symposium on Decolonising Health, SOAS University of London’s Applying a Decolonial Lens to Research Structures, Norms and Practices in Higher Education Institutions and University College London Anthropology Department’s Flourishing Diversity Series. We investigate implications of ‘recentring’ displaced indigenous healing systems, medical pluralism and highlight the concept of cultural humility in medical training, which while challenging, may benefit patients. From a global health perspective, climate change debates and associated civil protests around the issues resonate with indigenous ideas of planetary health, which focus on the harmonious interconnection of the planet, the environment and human beings. Finally, we look further at its implications in clinical practice, addressing the background of inequality in healthcare among the BAME populations, intersectionality and an increasing recognition of the role of inter-generational trauma originating from the legacy of slavery. By analysing these theories and conversations that challenge the biomedical view of health, we conclude that encouraging healthcare educators and professionals to adopt a ‘ decolonising attitude ’ can address the complex power imbalances in health and further improve person-centred care. (shrink)

COVID-19 vaccine requirements have generated significant debate. Here, we argue that, on the evidence available, such policies should have recognised proof of natural immunity as a sufficient basis for exemption to vaccination requirements. We begin by distinguishing our argument from two implausible claims about natural immunity: natural immunity is superior to ‘artificial’ vaccine-induced immunity simply because it is ‘natural’ and it is better to acquire immunity through natural infection than via vaccination. We then briefly survey the evidence base for the (...) comparison between naturally acquired immunity and vaccine-induced immunity. While we clearly cannot settle the scientific debates on this point, we suggest that we lack clear and convincing scientific evidence that vaccine-induced immunity has a significantly higher protective effect than natural immunity. Since vaccine requirements represent a substantial infringement of individual liberty, as well as imposing other significant costs, they can only be justified if they are necessary for achieving a proportionate public health benefit. Without compelling evidence for the superiority of vaccine-induced immunity, it cannot be deemed necessary to require vaccination for those with natural immunity. Subjecting them to vaccine mandates is therefore not justified. We conclude by defending the standard of proof that this argument from necessity invokes, and address other pragmatic and practical considerations that may speak against natural immunity exemptions. There are no data in this work. (shrink)

Current UK legislation is impacting upon the feasibility and cost-effectiveness of medical record-based research aimed at benefiting the NHS and the public heath. Whereas previous commentators have focused on the Data Protection Act 1998, the Health and Social Care Act 2001 is the key legislation for public health researchers wishing to access medical records without written consent. The Act requires researchers to apply to the Patient Information Advisory Group for permission to access medical records without written permission. (...) We present a case study of the work required to obtain the necessary permissions from PIAG in order to conduct a large scale public health research project. In our experience it took eight months to receive permission to access basic identifying information on individuals registered at general practices, and a decision on whether we could access clinical information in medical records without consent took 18 months. Such delays pose near insurmountable difficulties to grant funded research, and in our case £560 000 of public and charitable money was spent on research staff while a large part of their work was prohibited until the third year of a three year grant. We conclude by arguing that many of the current problems could be avoided by returning PIAG’s responsibilities to research ethics committees, and by allowing “opt-out” consent for many public health research projects. (shrink)

To an increasing extent ethical controversies affect and sometimes obstruct public health work and epidemiological research. In order to improve communication between the concerned parties a model for identification and analysis of ethical conflicts in individual-based research has been worked out in co-operation between epidemiologists and moral philosophers. The model has two dimensions. One dimension specifies relevant ethical principles (as beneficence, non-maleficence, autonomy and justice). The other dimension specifies the groups of persons involved in the conflict under consideration (for example: (...) the study-population, individuals who may benefit from the results, the researchers and their personnel, the community at large). The model has been applied to the problem of legitimacy of case-register research and to problems in psychiatric health services research as well as epidemiological research. (shrink)

Research is increasingly recognised as a key component of medical curricula, offering a range of benefits including development of skills in evidence-based medicine. The literature indicates that experienced academic supervision or mentoring is important in any research activity and positively influences research output. The aim of this project was to investigate the human research ethics experiences and knowledge of three groups: medical students, and university academic staff and clinicians eligible to supervise medical student research projects; at two (...) Australian universities. Training in research ethics was low amongst academic staff and clinicians eligible to supervise medical student research. Only two-thirds of academic staff and students and less than half of clinicians surveyed indicated that specific patient consent was required for a doctor to include patient medical records within a research publication. There was limited awareness of requirements for participant information and consent forms amongst all groups. In the case of clinical trials, fewer clinicians and students than academics indicated there was a requirement to obtain consent. Awareness of the ethics committee focus on respect was low across all groups. This project has identified significant gaps in human research ethics understanding among medical students, and university academic staff and clinicians. The incorporation of research within medical curricula provides the impetus for medical schools and their institutions to ensure that academic staff and clinicians who are eligible and qualified to supervise students’ research projects are appropriately trained in human research ethics. (shrink)

Background: Funding organisations and research ethics committees should play a part in strengthening attention to gender equality in clinical research. In the research policy of European Union , funding measures have been taken to realise this, but such measures are lacking in the EU policy regarding RECs.Objective: To explore how RECs in Austria, Germany, Ireland, The Netherlands and Sweden deal with gender equality issues by asking two questions: Do existing procedures promote representation of women and gender expertise in the committee? (...) How are sex and gender issues dealt with in protocol evaluation?Methods: Two RECs were selected from each country. Data were obtained through interviews with key informants and content analysis of relevant documents .Results: All countries have rules to ensure the presence of women on RECs; gender expertise is not required. Drug study protocols are carefully evaluated, sometimes on a formal basis, as regards the inclusion of women of childbearing age. The reason for excluding either one of the sexes or including specific groups of women or making a gender-specific risk–benefit analysis are investigated by some RECs. Such measures are, however, neither defined in the regulations nor integrated in review tools.Conclusions: The RECs investigated in five European member states are found to pay limited attention to gender equality in their working methods and, in particular in protocol evaluation. Policy and regulations of EU are needed to strengthen attention to gender equality in the work of RECs. (shrink)

In addition to preparing students for graduate school or emphasizing transferable skills that are useful in any career, philosophy departments ought to give majors the education and work experience that will train them to become ethics officers outside of academia. This is a growing field that allows students to engage non-philosophers in setting corporate policies and addressing morally significant social issues. Using a course in medical ethics as an example, I show how incorporating service-learning into philosophy classes benefits students (...) both academically and professionally, and also demonstrates the value of philosophy to the community and to academic administrators. (shrink)

Background: Treating medication-refractory freezing of gait in Parkinson’s disease remains challenging despite several trials reporting improvements in motor symptoms using subthalamic nucleus or globus pallidus internus deep brain stimulation. Pedunculopontine nucleus region DBS has been used for medication-refractory FoG, with mixed findings. FoG, as a paroxysmal phenomenon, provides an ideal framework for the possibility of closed-loop DBS.Methods: In this clinical trial, five subjects with medication-refractory FoG underwent bilateral GPi DBS implantation to address levodopa-responsive PD symptoms with open-loop stimulation. Additionally, PPN (...) DBS leads were implanted for CL-DBS to treat FoG. The primary outcome of the study was a 40% improvement in medication-refractory FoG in 60% of subjects at 6 months when “on” PPN CL-DBS. Secondary outcomes included device feasibility to gauge the recruitment potential of this four-lead DBS approach for a potentially larger clinical trial. Safety was judged based on adverse events and explantation rate.Findings: The feasibility of this approach was demonstrated as we recruited five subjects with both “on” and “off” medication freezing. The safety for this population of patients receiving four DBS leads was suboptimal and associated with a high explantation rate of 40%. The primary clinical outcome in three of the five subjects was achieved at 6 months. However, the group analysis of the primary clinical outcome did not reveal any benefit.Interpretation: This study of a human PPN CL-DBS trial in medication-refractory FoG showed feasibility in recruitment, suboptimal safety, and a heterogeneous clinical effect in FoG outcomes. (shrink)

Kerridge et al recently published a paper in the journal about organ transplantation and the diagnosis of death.1 Although I appreciate the authors’ efforts to present their arguments about such a controversial issue, I found some inconsistencies in this article that I would like to discussWhen Kerridge and his collaborators discussed the origins of the concept of brain death , they emphasised that after the report of the medical consultants on the diagnosis of death to the US President’s Commission (...) was published in 1981,2 clinicians equated the concept of BD with brainstem death. In fact, the brainstem criterion was first proposed by Mohandas and Chou in Minnesota, in 1971.3 The Minnesota criteria inspired the UK code, which was mainly adopted in UK commonwealth countries.4 This view was afterwards powerfully defended by Christopher Pallis.5 After the US President’s Commission report,2 a lot of countries, and most US states, accepted the whole brain, and not the brainstem, criterion.6Regarding the “dead donor rule”, with the advent of transplant surgery, interest in definitions and diagnosis of death based on brain formulations really acquired a new urgency. None the less, it is important to point out that the concept of BD as death of the individual, did not appear to benefit organ transplantation, but was a consequence of the development of intensive care. As Pallis emphasised, if organ transplant techniques had never been developed, intensive care procedures would have provided the possibility of supplying life support to those cases with destroyed brains and preserved heart function, and physicians would need to face the clinical syndrome called BD.5 When French neurophysiologists and neurologists described the death of the nervous system and coma dépassé, organ transplant techniques were only in the very early stages of development. …. (shrink)

Kerridge et al recently published a paper in the journal about organ transplantation and the diagnosis of death.1 Although I appreciate the authors’ efforts to present their arguments about such a controversial issue, I found some inconsistencies in this article that I would like to discuss When Kerridge and his collaborators discussed the origins of the concept of brain death (BD), they emphasised that after the report of the medical consultants on the diagnosis of death to the US President’s (...) Commission was published in 1981,2 clinicians equated the concept of BD with brainstem death. In fact, the brainstem criterion was first proposed by Mohandas and Chou in Minnesota, in 1971.3 The Minnesota criteria inspired the UK code, which was mainly adopted in UK commonwealth countries.4 This view was afterwards powerfully defended by Christopher Pallis.5 After the US President’s Commission report,2 a lot of countries, and most US states, accepted the whole brain, and not the brainstem, criterion.6 Regarding the “dead donor rule”, with the advent of transplant surgery, interest in definitions and diagnosis of death based on brain formulations really acquired a new urgency. None the less, it is important to point out that the concept of BD as death of the individual, did not appear to benefit organ transplantation, but was a consequence of the development of intensive care. As Pallis emphasised, if organ transplant techniques had never been developed, intensive care procedures would have provided the possibility of supplying life support to those cases with destroyed brains and preserved heart function, and physicians would need to face the clinical syndrome called BD.5 When French neurophysiologists and neurologists described the death of the nervous system and coma dépassé, organ transplant techniques were only in the very early stages of development. …. (shrink)

Current UK legislation is impacting upon the feasibility and cost-effectiveness of medical record-based research aimed at benefiting the NHS and the public heath. Whereas previous commentators have focused on the Data Protection Act 1998, the Health and Social Care Act 2001 is the key legislation for public health researchers wishing to access medical records without written consent. The Act requires researchers to apply to the Patient Information Advisory Group for permission to access medical records without written permission. (...) We present a case study of the work required to obtain the necessary permissions from PIAG in order to conduct a large scale public health research project. In our experience it took eight months to receive permission to access basic identifying information on individuals registered at general practices, and a decision on whether we could access clinical information in medical records without consent took 18 months. Such delays pose near insurmountable difficulties to grant funded research, and in our case £560 000 of public and charitable money was spent on research staff while a large part of their work was prohibited until the third year of a three year grant. We conclude by arguing that many of the current problems could be avoided by returning PIAG’s responsibilities to research ethics committees, and by allowing “opt-out” consent for many public health research projects. (shrink)

Secondary findings for adult-onset diseases in pediatric clinical sequencing can benefit parents or other family members. In the absence of data showing harm, it is ethically reasonable for parents to request such information, because in other types of medical decision-making, they are often given discretion unless their decisions clearly harm the child. Some parents might not want this information because it could distract them from focusing on the child's underlying condition that prompted sequencing. Collecting family impact data may (...) improve future policy determinations. (shrink)

Ethical controversy over transplantation of human fetal tissue has arisen because the source of tissue is induced abortions. Opposition to such transplants has been based on various arguments, including the following: rightful informed consent cannot be obtained for use of fetal tissue from induced abortions, and fetal tissue transplantation might result in an increase in the number of abortions. These arguments were not accepted by the National Institutes of Health (NIH) Human Fetal Tissue Transplantation Research Panel. The majority opinion of (...) the panel stated that abortion and fetal tissue use are entirely separate issues, and that tissue use is ethically acceptable because it can be morally insulated from the issue of abortion. In support of this view, panel members and others have replied to the arguments put forward by opponents of fetal tissue use. However, replies to the two arguments mentioned above have been unsatisfactory, and the shortcomings of those replies are identified herein. Examination of the arguments pro and con suggests that fetal tissue use cannot be completely insulated from the issue of abortion. Thus, in seeking an ethical justification for fetal tissue transplantation we must consider reasons other than those put forward by the NIH panel. In this paper it is argued that whatever wrong is involved in using fetal tissue from induced abortions must be balanced against the benefits for patients, and it is on this basis that fetal tissue transplantation can be ethically justified. (shrink)

Although it is commonly believed that the concept of brain death was developed to benefit organ transplants, it evolved independently. Transplantation owed its development to advances in surgery and immunosuppressive treatment; BD owed its origin to the development of intensive care. The first autotransplant was achieved in the early 1900s, when studies of increased intracranial pressure causing respiratory arrest with preserved heartbeat were reported. Between 1902 and 1950, the BD concept was supported by the discovery of EEG, Crile’s definition (...) of death, the use of EEG to demonstrate abolition of brain potentials after ischaemia, and Crafoord’s statement that death was due to cessation of blood flow. Transplantation saw the first xenotransplant in humans and the first unsuccessful kidney transplant from a cadaver. In the 1950s, circulatory arrest in coma was identified by angiography, and the death of the nervous system and coma dépassé were described. Murray performed the first successful kidney transplant. In the 1960s, the BD concept and organ transplants were instantly linked when the first kidney transplant using a brain-dead donor was performed; Schwab proposed to use EEG in BD; the Harvard Committee report and the Sydney Declaration appeared; the first successful kidney, lung and pancreas transplants using cadaveric donors were achieved; Barnard performed the first human heart transplant. This historical review demonstrates that the BD concept and organ transplantation arose separately and advanced in parallel, and only began to progress together in the late 1960s. Therefore, the BD concept did not evolve to benefit transplantation. (shrink)

Most ethics guidelines for distributing scarce medical resources during the coronavirus pandemic seek to save the most lives and the most life‐years. A patient’s prognosis is determined using a SOFA or MSOFA score to measure likelihood of survival to discharge, as well as a consideration of relevant comorbidities and their effects on likelihood of survival up to one or five years. Although some guidelines use age as a tiebreaker when two patients’ prognoses are identical, others refuse to consider age (...) for fear of discriminating against the elderly. In this paper, I argue that age is directly relevant for maximizing health benefits, so current ethics guidelines are wrongly excluding or deemphasizing life‐stage in their triage algorithms. Research on COVID‐19 has shown that age is a risk factor in adverse outcomes, independent of comorbidities. And limiting a consideration of life‐years to only one or five years past discharge does not maximize health benefits. Therefore, based on their own stated values, triage algorithms for coronavirus patients ought to include life‐stage as a primary consideration, along with the SOFA score and comorbidities, rather than excluding it or using it merely as a tiebreaker. This is not discriminatory because patients ought to have equal opportunity to experience life‐stages. The equitable enforcement of that right justifies unequal treatment based on age in cases when there is a scarcity of life‐saving resources. A consideration of life‐stage would thus allow healthcare workers to responsibly steward public resources in order to maximize lives and life‐years saved. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.4 (2004) 411-425 [Access article in PDF] Vulnerability, Vulnerable Populations, and Policy Mary C. Ruof "Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are selected, the means of protecting their rights and welfare must be strictly applied."Guideline 13: Research Involving Vulnerable Persons International Ethical Guidelines for Biomedical Research Involving Human Subjects Council for International Organizations of (...) Medical Sciences (CIOMS) and World Health Organization (WHO) Geneva, Switzerland, 2002 Within medical research and healthcare certain groups are afforded special protections and services because of their designation as vulnerable. The vulnerable require special justification to participate in human subject research in order to eliminate potential human rights abuses. The Nuremberg Code of 1947 was written in response to the extreme human subject abuses that occurred under the Nazi regime, and, although the intent of the 1947 Code was to protect human rights, rigid voluntary consent requirements deprived some individuals of the right to participate in clinical trials. Recent human research guidelines, such as the CIOMS/WHO guidelines referenced above and the guidelines referenced in Section V of this Scope Note, attempt to balance both protection from abuse in research and access to new, experimental treatments for the vulnerable.Although various protective guidelines stipulate special protections for vulnerable populations, the concept of vulnerability and consequently the criteria designating vulnerable populations remain vague. Precisely who are the vulnerable? The word "vulnerability" stems from the Latin vulnerare, "to wound." (Oxford Encyclopedic English Dictionary 1995). In clinical research, the term [End Page 411] vulnerable generally is applied to individuals who are unable to give informed consent or who are susceptible to coercion. The Common Rule (45 CFR 46, Subpart A) includes as vulnerable research subjects: children, prisoners, pregnant women, and persons who are handicapped, mentally disabled, economically disadvantaged, or educationally disadvantaged. Although the Common Rule specifies certain vulnerable categories, the guidelines were not intended to be exclusive, leaving open the interpretation of vulnerability.In medical research and health policy, vulnerability is an abstract concept that has concrete effects both for those labeled vulnerable and for those not. Clinical researchers, healthcare workers, ethical reviewers, and policymakers must be able to identify vulnerable subjects to establish how healthcare resources will be allocated and who will qualify for special protections and socialized benefits. Attempts to quantify vulnerability in clear, measurable ways have met little if any consensus. As Alexander Morawa (II, 2003, p. 150) states, "There is no single approach to definition of vulnerability. In fact, there is no purposeful categorisation at all."Difficulties in defining vulnerability have prompted discourse surrounding its utility as a qualifying factor in the allocation of health resources and its appropriateness as a guiding principle in bioethics. Some of the authors cited in this Scope Note argue against the labeling and categorization of vulnerable individuals and populations. "Labeling individuals as 'vulnerable' risks viewing vulnerable individuals as 'others' worthy of pity, a view rarely appreciated" (III, Danis and Patrick 2002, p. 320). The categories of vulnerable groups listed under the Common Rule have been the source of controversy, "for example, many find the suggestion that pregnant women are vulnerable to be quite sexist" (IV, DeBruin 2001, p. 7). Instead of creating categories of vulnerable populations, would it not be better to derive an account of just treatment from a just social policy at large that encompasses human vulnerabilities (II, Brock 2002, p. 283).For some of the authors listed here, the concept of vulnerability is essential to bioethics. Robert Goodin (I, 1985, p. 107) writes that the vulnerability of other human beings is the source of our special responsibilities to them. In contrast to the four American principles of biomedical ethics—autonomy, nonmaleficence, beneficence, and justice—the four principles of European bioethics and biolaw include vulnerability along with autonomy, dignity, and integrity. According to, Jacob Dahl Rendtorff and Peter Kemp (I, 2000, p. 274) "the principle of vulnerability is ontologically prior to the other [European] principles, it expresses better than all of the other ethical principles... the finitude of the human condition."Some of the... (shrink)