Despite increasing interests and urgent needs for quality end-of-life care, there is no exact definition of what is the interval referred to as end of life or what end-of-life care is. The purpose of this article is to report our examination of terms related to end-of-life care and define end-of-life care from nursing ethics perspectives. Current terms related to end-of-life care, such as terminal care, hospice care, and palliative care, are based on a medical model and are restrictive in (...) terms of diagnosis and prognosis. Using codes of ethics for nurses as a framework, we attempt to identify people to whom nurses are responsible to provide end-of-life care and develop a definition of end-of-life care that is more inclusive and applicable to a broader range of people who would benefit from end-of-life care by nurses and other health-care providers. (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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

Human experimentation can have different meanings: indeed, with the development of medical research, therapeutic acts have to be distinguished from acts of cognitive values. For each kind of acts, specific conditions of acceptability and specific protections of human beings have to be defined.Human experimentation must be envisaged at different levels to evaluate ethical aspects: its scientific value, the risks, benefits envisaged, the populations implicated, etc…The individual consent must be present too in the relationship between the subject and the doctors. (...) In fact, is a real consent possible?Instead to insist on problems in terms of medical research, one would have to insist perhaps more on the fact that the medical practice in general would have to answer more to ethical grounds and to scientific rules. It is the non scientific medicine which is immoral and dangerous, as well the medicine with financial interests, or also the medecine without experimentation.The main arguments must remain at the level of the dignity of the persons, autonomy and freedom of choice must remain the fundamental values. (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)

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)

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)

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)

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)

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)

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)

In 1986, philosopher-bioethicist Samuel Gorovitz published an essay entitled “Baiting Bioethics,” in which he reported on various criticisms of bioethics that were “in print, or voiced in and around … the field” at that time, and set forth his assessment of their legitimacy. He gave detailed attention to what he judged to be the particularly fierce and “irresponsible attacks” on “the moral integrity” and soundness of bioethics contained in two papers: “Getting Ethics” by philosopher William Bennett and “Medical Morality (...) Is Not Bioethics,” coauthored by us. Gorovitz attributed some of the criticisms that bioethics was eliciting to the fact that this new, rapidly rising, and increasingly visible field had brought “scholars and practitioners together who otherwise would have little exposure to one another's disciplines. Their interactions are mutually enriching at times,” he declared, “but mutually baffling and even infuriating at other times.” In this latter regard, he suggested that “perhaps” Fox and Swazey's characterization of bioethics in the article he dissected “reflects a general revulsion at endeavors they see as inadequately like the social sciences or insufficiently respectful of them.” He went on to say that despite his objections to our “complaints” about bioethics—especially to our claim that “autonomy [had] been an unduly emphasized value” in the field—he had “a lingering sense” that there might be “a grain of truth” in them. Gorovitz ended his essay with an affirmation about the “benefit” that bioethics can derive from “responsible” and even from “irresponsible” criticism. “The unexamined discipline invites the philosopher's critical scrutiny no less than the unexamined life,” he aphoristically concluded. a. (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)

Moral and legal notions engaged in clinical ethics should not only possess analytic clarity but a sound basis in empirical findings. The latter condition brings into question the expansion of the mature minor exception. The mature minor exception in the healthcare law of the United States has served to enable those under the legal age to consent to medical treatment. Although originally developed primarily for minors in emergency or quasi-emergency need for health care, it was expanded especially from the (...) 1970s in order to cover unemancipated minors older than 14 years. This expansion initially appeared plausible, given psychological data that showed the intellectual capacity of minors over 14 to recognize the causal connection between their choices and the consequences of their choices. However, subsequent psychological studies have shown that minors generally fail to have realistic affective and evaluative appreciations of the consequences of their decisions, because they tend to over-emphasize short-term benefits and underestimate long-term risks. Also, unlike most decisionmakers over 21, the decisions of minors are more often marked by the lack of adequate impulse control, all of which is reflected in the far higher involvement of adolescents in acts of violence, intentional injury, and serious automobile accidents. These effects are more evident in circumstances that elicit elevated affective responses. The advent of brain imaging has allowed the actual visualization of qualitative differences between how minors versus persons over the age of 21 generally assess risks and benefits and make decisions. In the case of most under the age of 21, subcortical systems fail adequately to be checked by the prefrontal systems that are involved in adult executive decisions. The neuroanatomical and psychological model developed by Casey, Jones, and Summerville offers an empirical insight into the qualitative differences in the neuroanatomical and neuropsychological bases of adolescent versus adult decision making. These and other data, as well as developing law bearing on the culpability of juvenile criminal offenders, argue for critically re-evaluating the expansion of the mature minor exception with regard to medical decision making, as well as in support of a rebuttable presumption in favor of treating minors as immature decisionmakers. The clinical ethics of adolescent medical decision making will need foundationally to be reconsidered. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Anorexia and the MacCAT-T Test for Mental Competence:Validity, Value, and EmotionLouis C. Charland (bio)Keywordsmental competence, decisional capacity, anorexia, value, emotionValidity of the MacCAT-THow does one scientifically verify a psychometric instrument designed to assess the mental competence of medical patients who are asked to consent to medical treatment? Aside from satisfying technical requirements like statistical reliability, results yielded by such a test must conform to at least some (...) accepted pretheoretical desiderata; for example, determinations of competence, as measured by the test, must capture a minimal core of accepted basic intuitions about what competence means and what a theory of competence is supposed to do. The concepts of "face validity" and "content validity" are both important here. Face validity "indicates that an instrument appears to test what it is supposed to and that it is a plausible method for doing so" (Portney and Watkins 2000, 82). Content validity "means that the test contains all the elements that reflect the variable being studied" (Portney and Watkins 2000, 83). An adequate instrument for measuring mental competence must at minimum satisfy both of these requirements.What Tan and her colleagues (2006) have shown is that the MacArthur Competence Assessment Tool—Treatment (MacCAT-T) test for mental competence may not be an empirically valid measure of mental competence for some cases of anorexia. The data they report show that "competence," as measured by the MacCAT-T, does not conform sufficiently well with what is wanted of a clinical medical theory of competence. More specifically, the MacCAT-T is deficient in both face and content validity. This result is extremely significant; previous challenges to the validity of the MacCAT-T have often been largely theoretical in nature. My own objection that the MacCAT is inadequate because it omits the influence of emotion is based on a combination of empirical theory (Charland 1998a) and philosophical argument (Charland 1998b). However, it is entirely theoretical in nature. So is my argument that in ignoring emotion the MacCAT misses a crucial contributing ingredient in competence, namely, value (Charland 2001, see especially 136 note 2). Tan's study provides valuable empirical evidence for the second of these challenges, which deals more specifically with value. On the one hand, the study clearly demonstrates that patients sometimes do [End Page 283] base their treatment decisions on reasons derived from values. And on the other hand, it also nicely illustrates the centrality of values—"utilities" or "preferences"—in the decision-making process generally; a basic assumption of standard decision theory for which, paradoxically, there appears to be no satisfactory counterpart in the MacCAT-T model of reasoning and decision making.Thus, values figure among the reasons that patients actually use in reasoning when they weigh the risks and benefits of proposed treatment options. The MacCAT-T must be amended to incorporate this fact if it is to be a satisfactory clinical medical tool. Without such a correction, the concept of mental competence it measures is empirically invalid. At the root of the problem is a clash of intuitions. Tan's data provide convincing evidence that some of the patients who are deemed to be mentally competent by MacCAT-T standards should not in fact be considered competent. Note that the language in which this clash is expressed—"should not in fact"—involves a combination of descriptive and prescriptive elements, reminding us that the concept of competence is dual in nature: it is both prescriptive and descriptive (Freedman 1981). These problems underscore the need for greater clarity about what pretheoretically we want a clinical theory and test of competence to capture. It is of course reasonable to say that such a test must be consistent with major tenets of the relevant case law (Appelbaum 1998). But a legally valid concept of competence of this sort is too thin and arbitrary a foundation on which to build a clinical medical theory of competence. An empirically valid theory and test of the latter sort must incorporate the role of values if it is be truly helpful in medical practice.Value and the MacCAT-TI agree with Tan and her colleagues that some notion of "pathological value" needs to be... (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)

Health promotion involves social and environmental interventions designed to benefit and protect health. It often harmfully impacts the environment through air and water pollution, medical waste, g...

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)

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)

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)

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)

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)

There has been a move in medicine towards patient-centred care, leading to more demands from patients for particular therapies and treatments, and for wish-fulfilling medicine: the use of medical services according to the patient's wishes to enhance their subjective functioning, appearance or health. In contrast to conventional medicine, this use of medical services is not needed from a medical point of view. Boundaries in wish-fulfilling medicine are partly set by a physician's decision to fulfil or decline a (...) patient's wish in practice. In order to develop a better understanding of how wish-fulfilling medicine occurs in practice in The Netherlands, a qualitative study (15 semistructured interviews and 1 focus group) was undertaken. The aim was to investigate the range and kind of arguments used by general practitioners and plastic surgeons in wish-fulfilling medicine. These groups represent the public funded realm of medicine as well as privately paid for services. Moreover, GPs and plastic surgeons can both be approached directly by patients in The Netherlands. The physicians studied raised many arguments that were expected: they used patient autonomy, risks and benefits, normality and justice to limit wish-fulfilling medicine. In addition, arguments new to this debate were uncovered, which were frequently used to justify compliance with a patient's request. Such arguments seem familiar from conventional medicine, including empathy, the patient–doctor relationship and reassurance. Moreover, certain arguments that play a significant role in the literature on wish-fulfilling medicine and enhancement were not mentioned, such as concepts of disease and the enhancement–treatment dichotomy and ‘suspect norms’. (shrink)

Background When anti-cancer treatments have been given market authorization, but are not (yet) reimbursed within a healthcare system, physicians are confronted with ethical dilemmas. Arranging access through other channels, e.g., hospital budgets or out-of-pocket payments by patients, may benefit patients, but leads to unequal access. Until now, little is known about the perspectives of physicians on access to non-reimbursed treatments. This interview study maps the experiences and moral views of Dutch oncologists and hematologists.Methods A diverse sample of oncologists and (...) hematologists (n = 22) were interviewed. Interviews were analyzed thematically using Nvivo 12 qualitative data software.Results This study reveals stark differences between physicians’ experiences and moral views on access to anti-cancer treatments that are not (yet) reimbursed: some physicians try to arrange other ways of access and some physicians do not. Some physicians inform patients about anti-cancer treatments that are not yet reimbursed, while others wait for reimbursement. Some physicians have principled moral objections to out-of-pocket payment, while others do not.Conclusion Oncologists and hematologists in the Netherlands differ greatly in their perspectives on access to expensive anti-cancer treatments that are not (yet) reimbursed. As a result, they may act differently when confronted with dilemmas in the consultation room. Physicians working in different healthcare systems may face similar dilemmas. (shrink)

Objectives: To report the attitudes and opinions of subjects in US clinical trials about whether or not, and why, they should receive post-trial access (PTA) to the trial drug, care and information. Design: Focus groups, short self-administered questionnaires. Setting: Boston, Dallas, Detroit, Oklahoma City. Participants: Current and recent subjects in clinical trials, primarily for chronic diseases. Results: 93 individuals participated in 10 focus groups. Many thought researchers, sponsors, health insurers and others share obligations to facilitate PTA to the trial drug, (...) if it benefited the subject, or to a therapeutic equivalent. Some thought PTA obligations include providing transition care (referrals to non-trial physicians or other trials, limited follow-up, short-term drug supply) or care for long-term adverse events. Others held, in contrast, that there are no PTA obligations regarding drugs or care. However, there was agreement that former subjects should receive information (drug name, dosage received, market approval date, long-term adverse effects, trial results). Participants frequently appealed to health need, cost, relationships, reciprocity, free choice and sponsor self-interest to support their views. Many of their reasons overlapped with those commonly discussed by bioethicists. Conclusion: Many participants in US trials for chronic conditions thought there are obligations to facilitate PTA to the trial drug at a “fair” price; these views were less demanding than those of non-US subjects in other studies. However, our participants’ views about informational obligations were broader than those of other subjects and many bioethicists. Our results suggest that the PTA debate should expand beyond the trial drug and aggregate results. (shrink)

Contrary to the widespread concern about over-treatment at the end of life, today, patient preferences for palliative care at the end of life are frequently respected. However, ethically challenging situations in the current healthcare climate are, instead, situations in which a competent patient requests active treatment with the goal of life-prolongation while the physician suggests best supportive care only. The argument of futility has often been used to justify unilateral decisions made by physicians to withhold or withdraw life-sustaining treatment. However, (...) we argue that neither the concept of futility nor that of patient autonomy alone is apt for resolving situations in which physicians are confronted with patients' requests for active treatment. Instead, we integrate the relevant arguments that have been put forward in the academic discussion about ‘futile’ treatment into an ethical algorithm with five guiding questions: (1) Is there a chance that medical intervention will be effective in achieving the patient's treatment goal? (2) How does the physician evaluate the expected benefit and the potential harm of the treatment? (3) Does the patient understand his or her medical situation? (4) Does the patient prefer receiving treatment after evaluating the benefit-harm ratio and the costs? (5) Does the treatment require many resources? This algorithm shall facilitate approaching patients' requests for treatments deemed futile by the physician in a systematic way, and responding to these requests in an ethically appropriate manner. It thereby adds substantive considerations to the current procedural approaches of conflict resolution in order to improve decision making among physicians, patients and families. (shrink)

Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called morally imperative, and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.United States research regulations are derived largely from the deliberations and report of the National Commission for the Protection of Human Subjects of (...) Biomedical and Behavioral Research. The authors of this report specifically designated children as a vulnerable population and suggested additional protections, most of which became U.S. law. One of the more contested sets of regulations surrounds non-therapeutic research, e.g., research that does not offer the potential for direct benefit to participants. Federal regulations allow local Institutional Review Boards to approve non-therapeutic research posing a minor increase above minimal risk when it involves children who have the disease or medical condition that the research addresses. (shrink)

BackgroundECMO is a particularly scarce resource during the COVID-19 pandemic. Its allocation involves ethical considerations that may be different to usual times. There is limited pre-pandemic literature on the ethical factors that ECMO physicians consider during ECMO allocation. During the pandemic, there has been relatively little professional guidance specifically relating to ethics and ECMO allocation; although there has been active ethical debate about allocation of other critical care resources. We report the results of a small international exploratory survey of ECMO (...) clinicians’ views on different patient factors in ECMO decision-making prior to and during the COVID-19 pandemic. We then outline current ethical decision procedures and recommendations for rationing life-sustaining treatment during the COVID-19 pandemic, and examine the extent to which current guidelines for ECMO allocation (and reported practice) adhere to these ethical guidelines and recommendations.MethodsAn online survey was performed with responses recorded between mid May and mid August 2020. Participants (n = 48) were sourced from the ECMOCard study group—an international group of experts (n = 120) taking part in a prospective international study of ECMO and intensive care for patients during the COVID-19 pandemic. The survey compared the extent to which certain ethical factors involved in ECMO resource allocation were considered prior to and during the pandemic.ResultsWhen initiating ECMO during the pandemic, compared to usual times, participants reported giving more ethical weight to the benefit of ECMO to other patients not yet admitted as opposed to those already receiving ECMO, (p < 0.001). If a full unit were referred a good candidate for ECMO, participants were more likely during the pandemic to consider discontinuing ECMO from a current patient with low chance of survival (53% during pandemic vs. 33% prior p = 0.002). If the clinical team recommends that ECMO should cease, but family do not agree, the majority of participants indicated that they would continue treatment, both in usual circumstances (67%) and during the pandemic (56%).ConclusionsWe found differences during the COVID-19 pandemic in prioritisation of several ethical factors in the context of ECMO allocation. The ethical principles prioritised by survey participants were largely consistent with ECMO allocation guidelines, current ethical decision procedures and recommendations for allocation of life-sustaining treatment during the COVID-19 pandemic. (shrink)

Mood disorders, including major depressive disorder and bipolar disorder, are highly prevalent, frequently disabling, and sometimes deadly. Additional research and more effective medications are desperately needed, but clinical trials research in mood disorders is fraught with ethical issues. Although many authors have discussed these issues, most do so from a theoretical viewpoint. This manuscript uses available empirical data to inform a discussion of the primary ethical issues raised in mood disorders research. These include issues of consent and decision-making capacity, including (...) patients’ motivations for participating in research. We also address drug withdrawals, placebo controls, and the overall safety of research. Finally, we examine the extant literature for studies discussing potential indirect benefits of clinical trials research to participants. Taken together, the evidence suggests that clinical trials research incorporating drug withdrawals and placebo controls can be conducted safely and ethically, even in patients with severe or treatment-resistant mood disorders. In fact, given the dearth of effective treatment options for this population, it is our opinion that a moral imperative exists to extend the offer of research participation to severely ill or treatment-resistant groups. (shrink)

Context The conduct of medical research led by Northern countries in developing countries raises ethical questions. The assessment of research protocols has to be twofold, with a first reading in the country of origin and a second one in the country where the research takes place. This reading should benefit from an independent local ethical review of protocols. Consequently, ethics committees for medical research are evolving in Africa. Objective To investigate the process of establishing ethics committees and (...) their independence. Method Descriptive study of 25 African countries and two North American countries. Data were recorded by questionnaire and interviews. Two visits of ethics committee meetings were conducted on the ground: over a period of 3 months in Kigali (Rwanda) and 2 months in Washington DC (USA). Results 22 countries participated in this study, 20 from Africa and two from North America. The response rate was 80%. 75% of local African committees developed into national ethics committees. During the last 5 years, these national committees have grown on a structural level. The circumstances of creation and the general context of underdevelopment remain the major challenges in Africa. Their independence could not be ensured without continuous training and efficient funding mechanisms. Institutional ethics committees are well established in USA and in Canada, whereas ethics committees in North America are weakened by the institutional affiliation of their members. Conclusion The process of establishing ethics committees could affect their functioning and compromise their independence in some African countries and in North America. (shrink)

As the HIV epidemic continues to grow worldwide, women are increasingly and disproportionally affected. With the introduction of anti-retroviral medications that have been found to effectively prevent perinatal transmission of HIV, the approach to HIV testing in pregnant women has grown increasingly more controversial. In recent years, the model of voluntary counseling and testing (VCT) has come into question with opt-out testing now advocated for by the Centers for Disease Control and occurring widely in pregnancy. The benefits of opt-out testing (...) are numerous and may justify its use in replacing the VCT that many have come to see as insufficient. An ethical analysis of opt-out testing suggests it may be at odds with true informed consent and involve a degree of coercion that would not be allowed outside the prenatal setting. If opt-out testing is going to remain the standard of care then the ethical issues it raises must be made transparent. Strategies need to be designed for ensuring that HIV counseling and testing in pregnancy is done in accordance with ethical and reproductive rights principles. (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)

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)