The Office for Human Research Protections was correct in determining that the consent forms for the National Institutes of Health -sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: how risks and benefits should be described in informed consent documents; the meaning and application of the concept of “standard of care” in the context of research; and the proper role of OHRP. Examination of the consent forms (...) reveals that they failed to disclose the reasonably foreseeable risks of the experimental interventions in the study, as well as the potential for differences in the degree of risk between these interventions. Although the concept of “standard of care” may be helpful in determining the ethical acceptability of other aspects of research, such as clinical equipoise, it is not helpful in discussing consent requirements. (shrink)

Embedded pragmatic clinical trials (PCTs), like other types of randomized comparative-effectiveness research (CER) studies, are sometimes conducted without informed consent. Indeed, authors of both...

Policies promoted and adopted for allocating ventilators during the COVID-19 pandemic have often prioritised healthcare workers or other essential workers. While the need for such policies has so far been largely averted, renewed stress on health systems from continuing surges, as well as the experience of allocating another scarce resource—vaccination—counsel revisiting the justifications for such prioritisation. Prioritising healthcare workers may have intuitive appeal, but the ethical justifications for doing so and the potential harms that could follow require careful analysis. Ethical (...) justifications commonly offered for healthcare worker prioritisation for ventilators rest on two social value criteria: instrumental value, also known as the ‘multiplier effect’, which may preserve the ability of healthcare workers to help others, and reciprocity, which rewards past usefulness or sacrifice. We argue that these justifications are insufficient to over-ride the common moral commitment to value each person’s life equally. Institutional policies prioritising healthcare workers over other patients also violate other ethical norms of the healthcare professions, including the commitment to put patients first. Furthermore, policy decisions to prioritise healthcare workers for ventilators could engender or deepen existing distrust of the clinicians, hospitals and health systems where those policies exist, even if they are never invoked. (shrink)

This paper evaluates four recent randomized clinical trials in which the informed consent of participants was either not sought at all, or else was conducted with critical information missing from the consent documents. As these studies have been taking place, various proposals to conduct randomized clinical trials without consent have been appearing in the medical literature. Some of the explanations offered for why it is appropriate to bypass consent or disclosure requirements appear to represent a fundamental misunderstanding of applicable government (...) regulations and even the research enterprise. Others are the result of conceptual disagreements about the importance and application of traditional research ethics norms to ‘comparative effectiveness research’ and modern research environments. Common among these explanations, however, is a failure to appreciate when a research intervention, rather than merely an observation or review of data, is taking place. Review committees and investigators are failing to see, or choosing to ignore, interventions in the lives of research subjects. When these studies have come to light, government agencies with oversight authority have done little or backed down. Prestigious medical journals have published research results knowing that the required consent was not obtained, or they have stood by the published studies even after the inadequacy of consent is discovered. This article critically examines this erosion of consent in theory and practice and calls for restoring the requirement of informed consent to its proper place as a priority in human subjects research. (shrink)

Many current abortion regulations represent an over-medicalization of abortion or a corruption of abortion's true medical nature, with disproportionate consequences to women with lower incomes and lesser means. This article explores the effects of unnecessary and harmful abortion restrictions on women living in poverty. A brief summary of the major abortion rights cases explains how the Constitution, as currently interpreted, vests the government and sometimes the medical profession with the power to protect women's health, rather than granting this power to (...) women themselves. The article then argues for a new approach for protecting women's health and respecting their dignity by reframing reproductive rights as health rights that women themselves can assert. (shrink)

The Russian philosopher and cultural theorist Mikhail Bakhtin has traditionally been seen as the leading figure in the group of intellectuals known as the Bakhtin Circle. The writings of other members of the Circle are considered much less important than his work, while Bakhtin's achievement has been exaggerated in proportion to the downgrading of the thinkers with whom he associated in the 1920s. This volume, which includes new translations and studies of the work of the most important members of the (...) Circle, sets out to correct the distortions in the established representations of its activity. The original contributions to literary and linguistic theory made by Valentin Voloshinov and Pavel Medvedev (but frequently credited to Bakhtin) are assessed, and the distinctiveness of their approaches is highlighted. (shrink)

The physician-researcher conflict of interest has thus far eluded satisfactory solution. Most attempts to deal with it focus on improving informed consent. But those attempts are not successful and may even make things worse. Research subjects are already voluntarily undertaking the risks of research — we should not ask them to go it alone — to undergo medical “treatment” without medical “care.” The only effective solution is that in much clinical research, each research subject should have a doctor independent from (...) the research study. (shrink)

The physician-researcher conflict of interest, a long-standing and widely recognized ethical challenge of clinical research, has thus far eluded satisfactory solution. The conflict is fairly straightforward. Medical research and medical therapy are distinct pursuits; the former is aimed at producing generalizable knowledge for the benefit of future patients, whereas the latter is aimed at addressing the individualized medical needs of a particular patient. When the physician-researcher combines these pursuits, he or she serves two masters and cannot — no matter how (...) well-intentioned — avoid the risk of compromising the duties owed in one of the professional roles assumed. Because of the necessary rigidity of a research protocol, the more demanding of the two masters is frequently the research.The problem of the physician-researcher conflict has been evident since the first attempts to regulate human research in the United States. Otto E. Guttentag, a physician at the University of California School of Medicine in San Francisco, addressed the conflict in a 1953Sciencemagazine article. (shrink)

The medical profession has a tradition of presenting itself as exceptionally altruistic. This article challenges the idea that physicians are, or should be, more altruistic than other professionals or other people, and goes so far as to posit that even a professional aspiration of altruism can have negative consequences.

The AHP Code of Ethics requires members to serve the best interests of their clients, be clear and honest with them, and keep their secrets confidential. Members pledge to represent their skills and qualifications honestly and to make appropriate referrals to others more qualified when out of their depth.AHP stands for “Associated Hair Professionals,” or hair stylists, but their Code of Ethics looks a lot like the Hippocratic Oath and the current Principles of Medical Ethics of the American Medical Association. (...) All of these ethics statements emphasize honesty, confidentiality, competence, serving patients’ best interests, and willingness to refer to other qualified professionals. But it’s not just doctors and hair professionals who have Codes of Ethics. The SPCP — Society of Permanent Cosmetic Professionals —requires its members to “maintain high professional standards consistent with sound practices,” “conduct business relationships in a manner that is fair to all,” and avoid false or misleading statements to the effect that the application of permanent makeup is not tattooing, not permanent, and not painful. (shrink)

This paper explains why informed consent for randomized comparative effectiveness research must include risks of standard care. Disclosures of such risks are both legally and ethically required and, for reasons discussed in the paper, should remain so.

Lantos and Feudtner argue that SUPPORT was an instance of CER and that CER differs from research involving unproven, experimental therapies because it exposes research subjects to the same risks patients regularly face in clinical practice. Like many defenders of SUPPORT, they formally acknowledge the study as research but want it to be thought of as clinical care. They develop an appealing argument, but it is misleading. Whatever doctors might have done in clinical practice, their choice of target range within (...) the study and for study participants was influenced by research aims. Just as in research involving unproven, experimental therapies, the care of patients in SUPPORT was altered for the goal of obtaining knowledge to help future patients. (shrink)

A recent legal case involving an ambiguous diagnosis in a woman with a severe disorder of consciousness raises pressing questions about treatment withdrawal in a time when much of what experts know about disorders of consciousness is undergoing revision and refinement. How much should diagnostic certainty about consciousness matter? For the judge who refused to allow withdrawal of artificial nutrition and hydration, it was dispositive. Rather than relying on substituted judgment or best interests to determine treatment decisions, he ruled that (...) withdrawal was categorically prohibited, even as he concluded that Hannah Capes was more likely than not in a permanent vegetative state. In many jurisdictions, his decision would likely be consistent with existing law. Evolving technological advances have demonstrated that biologically distinct diagnoses incorporated into state laws may be difficult to establish even under ideal conditions. We offer the Capes case for purposes of examining the consequences of enshrined legal distinctions between permanent vegetative state and other severe disorders of consciousness. Insistence on proof of the permanent absence of consciousness before treatment withdrawal is allowed fails to respect the rights of persons with disorders of consciousness. Even the well-established rights to treatment withdrawal for those in a permanent vegetative state may be in jeopardy if reform is not undertaken. (shrink)

The question, what makes a clinician a healer? may evoke the image of a devoted physician paying a critically important home visit at the end of a long day or the image of an astute nurse—steadfast, empathic, anticipating the patient's needs before they become apparent to others. But health care is no longer provided by lone doctors or nurses. In the modern health care system, multiple professionals must work together to provide safe and effective care. The moral nature of healing (...) has not changed. But what is required of clinicians to facilitate healing has. To be a healer today, a clinician must be a good team player. Medical students have opened our eyes to this new reality. Building on their observations, we articulate a view that, over and above the role of teamwork in providing technically appropriate care and preventing errors, health care requires teamwork to promote healing. Being a good team player is now a moral imperative because it makes an essential contribution to healing. (shrink)

Disorders of consciousness and the permanent vegetative state -- Legal and political wrangling over Terri's life -- In context--law and ethics -- Terri's wishes -- The limits of evidence -- The implications of surrogacy -- Qualities of life -- Feeding -- The preservation of life -- Respect and care : an alternative framework.

This article explores a gendered dimension of war and conflict analysis that has up until now received little attention at the intersection of gender studies and studies of global politics: queer bodies in, and genderqueer significations of, war and conflict. In doing so, the article introduces the concept of cisprivilege to International Relations as a discipline and security studies as a core sub-field. Cisprivilege is an important, but under-explored, element of the constitution of gender and conflict. Whether it be in (...) controversial reactions to the suggestion of United Nations Special Rapporteur Martin Scheinin that airport screenings for terrorists not discriminate against transgendered people, or in structural violence that is ever-present in the daily lives of many individuals seeking to navigate the heterosexist and cissexist power structures of social and political life, war and conflict is embodied and reifies cissexism. This article makes two inter-related arguments: first, that both the invisibility of genderqueer bodies in historical accounts of warfare and the visibility of genderqueer bodies in contemporary security strategy are forms of discursive violence; and second, that these violences have specific performative functions that can and should be interrogated. After constructing these core arguments, the article explores some of the potential benefits of an interdisciplinary research agenda that moves towards the theorisation of cisprivilege in security theory and practice. (shrink)

Fertility preservationFertility preservation is increasingly available to pediatric and adolescentAdolescents populations whose future fertility is threatened. These reproductive technologies raise questions about the interestsInterest of younger children in future fertility, parental interestsInterest and influences on adolescentsAdolescents, and the interestsInterest of persons no longer living. Ethical and legal analyses of specific case examples highlight key issues of parental permissionParental permission and minorMinorassentAssent, emerging adolescentAdolescentsautonomyAutonomy, and postmortemRetrieval, gametegamete retrievalGamete retrieval.