There are competing ethical concerns when it comes to designing any clinical research study. Clinical trials of possible treatments for Ebola virus are no exception. If anything, the competing ethical concerns are exacerbated in trying to find answers to a deadly, rapidly spreading, infectious disease. The primary goal of current research is to identify experimental therapies that can cure Ebola or cure it with reasonable probability in infected individuals. Pursuit of that goal must be methodologically sound, practical and consistent with (...) prevailing norms governing human subjects research. Some maintain that only randomized controlled trials with a placebo or standard-of-care arm can meet these conditions. We maintain that there are alternative trial designs that can do so as well and that sometimes these are preferable to RCTs. (shrink)
This article reflects on the relevance and applicability of the Belmont Report nearly four decades after its original publication. In an exploration of criticisms that have been raised in response to the report and of significant changes that have occurred within the context of biomedical research, five primary themes arise. These themes include the increasingly vague boundary between research and practice, unique harms to communities that are not addressed by the principle of respect for persons, and how growing complexity and (...) commodification in research have shed light on the importance of transparency. The repercussions of Belmont's emphasis on the protection of vulnerable populations is also explored, as is the relationship between the report's ethical principles and their applications. It is concluded that while the Belmont Report was an impressive response to the ethical issues of its day, the field of research ethics involving human subjects may have outgrown it. (shrink)
Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. (...) Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated. (shrink)
Conceived as a solution to clinical dilemmas, and now required by organizations for hospital accreditation, ethics committees have been subject only to small-scale studies. The wide use of ethics committees and the diverse roles they play compel study. In 1999 the University of Pennsylvania Ethics Committee Research Group (ECRG) completed the first national survey of the presence, composition, and activities of U.S. healthcare ethics committees (HECs). Ethics committees are relatively young, on average seven years in operation. Eighty-six percent of ethics (...) committees report that they play a role in ongoing clinical decision making through clinical ethics consultation. All are engaged in developing institutional clinical policy. Although 4.5% of HECs write policy on managed care, 50% of HEC chairs feel inadequately prepared to address managed care. The power and activity of ethics committees parallels the composition of those committees and the relationship of members to their institutions. The role of ethics committees across the nation in making policies about clinical care is greater than was known, and ethics committees will likely continue to play an important role in the debate and resolution of clinical cases and clinical policies. (shrink)
Although a safe, effective, and licensed coronavirus vaccine does not yet exist, there is already controversy over how it ought to be allocated. Justice is clearly at stake, but it is unclear what justice requires in the international distribution of a scarce vaccine during a pandemic. Many are condemning ‘vaccine nationalism’ as an obstacle to equitable global distribution. We argue that limited national partiality in allocating vaccines will be a component of justice rather than an obstacle to it. For there (...) are role-based and community-embedded responsibilities to take care of one’s own, which constitute legitimate moral reasons for some identity-related prioritisation. Furthermore, a good form of vaccine nationalism prioritises one’s own without denying or ignoring duties derived from a principle of equal worth, according to which all persons, regardless of citizenship or identity, equally deserve vaccine-induced protection from COVID-19. Rather than dismissing nationalism as a tragic obstacle, it is necessary to acknowledge that a limited form of it is valuable and expresses moral commitments. Only then can one understand our world of competing obligations, a world where cosmopolitan duties of benevolence sometimes conflict with special obligations of community membership. Once these competing obligations are recognised as such, we can begin the work of designing sound ethical frameworks for achieving justice in the global distribution of a coronavirus vaccine and developing practical strategies for avoiding, mitigating or resolving conflicts of duty. (shrink)
Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms (...) enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients’ best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee. Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice. (shrink)
Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. (...) Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated. (shrink)
In 1992, the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) passed a mandate that all its approved hospitals put in place a means for addressing ethical concerns.Although the particular process the hospital uses to address such concernsmay vary, the hospital or healthcare ethics committee (HEC) is used most often. In a companion study to that reported here, we found that in 1998 over 90% of U.S. hospitals had ethics committees, compared to just 1% in 1983, and that many (...) have some and a few have sweeping clinical powers in hospitals. (shrink)
Richard Thaler and Cass Sunstein (2008) contend that mandated choice is the most practical nudge for increasing organ donation. We argue that they are wrong, and their mistake results from failing to appreciate how perceptions of meaning can influence people's responses to nudges. We favor a policy of default to donation that is subject to immediate family veto power, includes options for people to opt out (and be educated on how to do so), and emphasizes the role of organ procurement (...) organizations and in-house transplant donation coordinators creating better environments for increasing the supply of organs and tissues obtained from cadavers. This policy will provide better opportunities for offering nudges in contexts where in-house coordinators work with families. We conclude by arguing that nudges can be introduced ethically and effectively into these contexts only if nudge designers collaborate with in-house coordinators and stakeholders. (shrink)
For decades The People’s Republic of China has been expanding its capacity to perform organ transplants, primarily kidneys and livers but also hearts, lungs and multiorgan transplants. The annual number of organ transplants performed is estimated to be over 30 000. The number is expected to grow with a projected market for immunosuppressants expected to be over ¥30 billion/$4.3 billion by 2024.1 China is second only to the USA and is expected to become the country with the largest number of (...) organ transplants by 2021 or 2022. Many transplants are performed on Chinese citizens but an active market in transplants for ‘tourists’ is ongoing.2 The source of the supply of organs to fuel this rapid growth has long been suspect.3 China had no system for obtaining organs for many years from cadaver sources making it impossible to credit claims that gifts from the newly dead were the sole or even majority source of transplantable organs. Critics, including myself, have long alleged that the only possible source of organs for both Chinese citizens and transplant tourists are executed prisoners. Many accounts, commissions and investigations have confirmed an immoral reliance on this vulnerable …. (shrink)
Some argue that to be effective in healthcare settings autonomy needs to be strengthened. The author thinks autonomy is fundamentally inadequate in healthcare settings and requires supplementation by experience-based paternalism on the part of doctors and healthcare providers.
Over 115 000 people are waiting for life-saving organ transplants, of whom a small fraction will receive transplants and many others will die while waiting. Existing efforts to expand the number of available organs, including increasing the number of registered donors and procuring organs in uncontrolled environments, are crucial but unlikely to address the shortage in the near future and will not improve donor/recipient compatibility or organ quality. If successful, organ bioengineering can solve the shortage and improve functional outcomes. Studying (...) manufactured organs in animal models has produced valuable data, but is not sufficient to understand viability in humans. Before risking manufactured organ experimentation in living humans, study of bioengineered organs in recently deceased humans would facilitate evaluation of the function of engineered tissues and the complex interactions between the host and the transplanted tissue. Although such studies do not pose risk to human subjects, they pose unique ethical challenges concerning the previous wishes of the deceased, rights of surviving family members, effective operation and fair distribution of medical services, and public transparency. This article investigates the ethical, legal and social considerations in performing engineered organ research on the recently deceased. (shrink)
:Facial transplantation is emerging as a therapeutic option for self-inflicted gunshot wounds. The self-inflicted nature of this injury raises questions about the appropriate role of self-harm in determining patient eligibility. Potential candidates for facial transplantation undergo extensive psychosocial screening. The presence of a self-inflicted gunshot wound warrants special attention to ensure that a patient is prepared to undergo a demanding procedure that poses significant risk, as well as stringent lifelong management. Herein, we explore the ethics of considering mechanism of injury (...) in the patient selection process, referring to the precedent set forth in solid organ transplantation. We also consider the available evidence regarding outcomes of individuals transplanted for self-inflicted mechanisms of injury in both solid organ and facial transplantation. We conclude that while the presence of a self-inflicted gunshot wound is significant in the overall evaluation of the candidate, it does not on its own warrant exclusion from consideration for a facial transplantation. (shrink)
In the U.S., there is no requirement for research sponsors to compensate human research subjects who experience injuries as a result of their participation. In this article, we review the moral justifications that compel the establishment of a better research-related injury compensation system. We explore how other countries and certain institutions within the U.S. have adopted various systems of compensation. The existence of these systems demonstrates both that the U.S. lags behind other nations in its protection of human research subjects (...) and that the establishment of a compensation system is both practical and feasible. We then examine factors which have prevented the U.S. from establishing its own compensation system. We consider possible alternatives for the U.S. by examining the advantages and disadvantages of both established and proposed systems. We offer a new proposal that addresses the justice concerns which compel the establishment of a national compensation system, distributes the burdens of such a system on multiple stakeholders that benefit from research, and has the additional advantage of minimizing the administrative and logistical challenges associated with initiating such a system. (shrink)
Debates over vaccine mandates raise intense emotions, as reflected in the current controversy over whether to mandate the vaccine against human papilloma virus (HPV), the virus that can cause cervical cancer. Public health ethics so far has failed to facilitate meaningful dialogue between the opposing sides. When stripped of its emotional charge, the debate can be framed as a contest between competing ethical values. This framework can be conceptualized graphically as a conflict between autonomy on the one hand, which militates (...) against government intrusion, and beneficence, utilitarianism, justice, and nonmaleficence on the other, which may lend support to intervention. When applied to the HPV vaccine, this framework would support a mandate based on utilitarianism, if certain conditions are met and if herd immunity is a realistic objective. (shrink)
The field of medical rehabilitation is relatively new.... Until recently, the ethical problems of this new field were neglected. There seemed to be more pressing concerns as rehabilitation medicine struggled to establish itself, sometimes in the face of considerable skepticism or hostility. There also seemed no pressing moral questions of the kind and intensity to be encountered, say, in high-technology acute care medicine or genetic engineering.... Those in biomedical ethics could and did easily overlook the quiet, less obtrusive issues of (...) rehabilitation.... The Hastings Center set out in 1985 to rectify that situation.... To explore the issues, the Center assembled a group of practitioners in the field, Hastings Center staff members, and individuals experienced in other areas of medical ethics.... The report that follows was written by Arthur Caplan and Daniel Callahan, assisted by Dr. Janet Haas of the Moss Rehabilitation Hospital in Philadelphia... (shrink)
There has been a great deal of discussion, in this journal and others, about obstacles hindering the evolution of the philosophy of medicine. Such discussions presuppose that there is widespread agreement about what it is that constitutes the philosophy of medicine.Despite the fact that there is, and has been for decades, a great deal of literature, teaching and professional activity carried out explicitly in the name of the philosophy of medicine, this is not enough to establish that consensus exists as (...) to the definition of the field. And even if consensus can be obtained as to what constitutes the philosophy of medicine, this does not mean that it exists as a field. (shrink)
An increasingly long line of high-profile scientific misconduct cases raises the question of whether regulatory policy ought to incorporate more rigorous sanctions for investigators and their institutions. Broad and Wade graphically describe these cases through the early 1980s. They continue to recent times with the cases of Evan Dreyer, Kimon Angelides and Robert Liburdy, Justin Radolf, and others. In addition, recent Congressional investigation into conflict of interest concerns surrounding consulting by National Institutes of Health scientists has raised further questions about (...) ethical standards. The record of continuing scandal suggests that current policy may not be optimal for controlling scientific misconduct. Would an alternative policy better minimize its incidence and associated costs?What should we expect of public policy governing misconduct by American scientists? Surely the public has a right to presume that its tax money is being spent wisely and that any economic rewards from taxpayer funded research are used prudently and in the public interest. (shrink)
The 11 original regions for organ allocation in the United States were determined by proximity between hospitals that provided deceased donors and transplant programs. As liver transplants became more successful and demand rose, livers became a scarce resource. A national system has been implemented to prioritize liver allocation according to disease severity, but the system still operates within the original procurement regions, some of which have significantly more deceased donor livers. Although each region prioritizes its sickest patients to be liver (...) transplant recipients, the sickest in less liver-scarce regions get transplants much sooner and are at far lower risk of death than the sickest in more liver-scarce regions. This has resulted in drastic and inequitable regional variation in preventable liver disease related death rate.A new region districting proposal – an eight district model – has been carefully designed to reduce geographic inequities, but is being fought by many transplant centers that face less scarcity under the current model. The arguments put forth against the new proposal, couched in terms of fairness and safety, will be examined to show that the new system is technologically feasible, will save more lives, and will not worsen socioeconomic disparity. While the new model is likely not perfect, it is a necessary step toward fair allocation. (shrink)
An increasingly long line of high-profile scientific misconduct cases raises the question of whether regulatory policy ought to incorporate more rigorous sanctions for investigators and their institutions. Broad and Wade graphically describe these cases through the early 1980s. They continue to recent times with the cases of Evan Dreyer, Kimon Angelides and Robert Liburdy, Justin Radolf, and others. In addition, recent Congressional investigation into conflict of interest concerns surrounding consulting by National Institutes of Health scientists has raised further questions about (...) ethical standards. The record of continuing scandal suggests that current policy may not be optimal for controlling scientific misconduct. Would an alternative policy better minimize its incidence and associated costs?What should we expect of public policy governing misconduct by American scientists? Surely the public has a right to presume that its tax money is being spent wisely and that any economic rewards from taxpayer funded research are used prudently and in the public interest. (shrink)
Consider this hypothetical scenario involving a choice not to vaccinate a child. Ms. S has a niece who is autistic. The girl's parents are suspicious that there is some relationship between her autism and her Measles Mumps and Rubella vaccination. They have shared their concerns with Ms. S. She then declines to have her own daughter, Jinny S., vaccinated with the MMR vaccine. To bypass the state's mandatory vaccination requirement, Ms. S claims a state-legislated philosophical exemption, whereby she simply attests (...) to the fact that she is opposed to vaccinating her daughter due to a conscientiously held belief. At the age of four, Jinny goes on a trip by airplane to Germany with her mother. After returning to the United States, she attends daycare despite having some mild cold symptoms. Subsequently, she develops a classic measles rash, at which point her mother brings her to a pediatrician and keeps her home from daycare. (shrink)
