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)

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)

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 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 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 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.

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.

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)