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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
: Pluripotent human stem cell research may offer new treatments for hundreds of diseases, but opponents of this research argue that such therapy comes attached to a Faustian bargain: cures at the cost of the destruction of many frozen embryos. The National Bioethics Advisory Commission (NBAC), government officials, and many scholars of bioethics, including, in these pages, John Robertson, have not offered an adequate response to ethical objections to stem cell research. Instead of examining the ethical issues involved in sacrificing (...) human embryos for the goal of curing fatal and disabling diseases, they seek to either dismiss the moral concerns of those with objections or to find an "accommodation" with those opposed to stem cell research. An ethical argument can be made that it is justifiable to modify or destroy certain human embryos in the pursuit of cures for dread and lethal diseases. Until this argument is made, the case for stem cell research will rest on political foundations rather than on the ethical foundations that the funding of stem cell research requires. (shrink)
The contributions that the philosophy of medicine can make to both the philosophy of science and the practice of science have been obscured in recent years by an overemphasis on personalities rather than critical themes. Two themes have dominated general discussion within contemporary philosophy of science: methodological essentialism and dynamic gradualism. These themes are defined and considered in light of Kenneth Schaffner's argument that theories in biomedicine have a structure and logic unlike that found in theories of the natural sciences. (...) Schaffner's arguments are suggestive but not definitive as a refutation of methodological essentialism. I argue that a primary reason for differences in the logic and structure of theories in biomedicine is not, as some philosophers have suggested, a product of ontological differences, but rather a product of the practical and pragmatic concerns of scientific theorizing in many areas of science, such as medicine. Keywords: philosophy of medicine, philosophy of science, logic of medicine, medical theory, methodological essentialism, dynamic gradualism CiteULike Connotea Del.icio.us What's this? (shrink)
