After witnessing extraordinary scientific and regulatory efforts to speed development of and access to new COVID-19 interventions, patients facing other serious diseases have begun to ask “where’s...

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)

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)

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)

This collection of essays examines the ways in which disputes and controversies about the application of scientific knowledge are resolved. Four concrete examples of public controversy are considered in detail: the efficacy of Laetrile, the classification of homosexuality as a disease, the setting of safety standards in the workplace, and the utility of nuclear energy as a source of power. The essays in this volume show that debates about these cases are not confined to matters of empirical fact. Rather, as (...) is seen with most scientific and technical controversies, they focus on and are structured by complex ethical, economic, and political interests. Drs. Engelhardt and Caplan have brought together a distinguished group of scholars from the sciences and humanities, who sketch a theory of scientific controversy and attempt to provide recommendations about the ways in which both scientists and the public ought to seek more informed resolutions of highly contentious issues in science and technology. Scientific Controversies is offered as a contribution to the better understanding of the roles of both science and nonscientific interests in disputes and controversies pertaining to science and technology. (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)

The concepts of health and disease play pivotal roles in medicine and the health professions This volume brings together the requisite literature for understanding current discussions and debates these concepts. The selections in the volume attempt to present a wide range of views concerning the nature of the concepts of health and issues using both historical and contemporary sources -- Back cover.

Researchers are developing a fertility preservation technique?testicular tissue cryopreservation (TTCP)?for prepubescent boys who may become infertile as a result of their cancer treatment. Although this technique is still in development, some researchers are calling for its widespread use. They argue that if boys do not bank their tissue now, they will be unable to benefit from any therapies that might be developed in the future. There are, however, risks involved with increasing access to an investigational procedure. This article examines four (...) methods of expanding access to TTCP: (1) expansion of institutional review board (IRB)-approved research trials; (2) offering TTCP as an innovative procedure in hospitals; (3) offering TTCP as a standard practice in hospitals; and (4) commercialization of TTCP. The ethical and practical implications of each are evaluated through a comparison with umbilical cord blood banking (UCBB), a technology that has achieved widespread use based on similar claims of future benefit. (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)

Clinical bioethics is big business. There are now hundreds of people who bioethics in community and university hospitals, nursing homes, rehabilitation and home care settings, and some who play the role of clinical ethics consultant to transplant teams, managed care companies, and genetic testing firms. Still, there is as much speculation about what clinically active bioethicists actually do as there was ten years ago. Various commentators have pondered the need for training standards, credentials, exams, and malpractice insurance for ethicists engaged (...) in clinical consultation. Much of the discussion seems to accept an implicit presumption that all clinical ethics consultation practices look pretty much alike. But is this accurate? What do clinical ethicists do, how and where do they do it, and what kind of clinical ethics is useful in the hospital and in other settings? (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)

The movement to try to close the ever-widening gap between demand and supply of organs has recently arrived at the prison gate. While there is enthusiasm for using executed prisoners as sources of organs, there are both practical barriers and moral concerns that make it unlikely that proposals to use prisoners will or should gain traction. Prisoners are generally not healthy enough to be a safe source of organs, execution makes the procurement of viable organs difficult, and organ donation post-execution (...) ties the medical profession too closely to the act of execution. (shrink)

Over 90% of the organs transplanted in China before 2010 were procured from prisoners. Although Chinese officials announced in December 2014 that the country would completely cease using organs harvested from prisoners, no regulatory adjustments or changes in China’s organ donation laws followed. As a result, the use of prisoner organs remains legal in China if consent is obtained. We have collected and analysed available evidence on human rights violations in the organ procurement practice in China. We demonstrate that the (...) practice not only violates international ethics standards, it is also associated with a large scale neglect of fundamental human rights. This includes organ procurement without consent from prisoners or their families as well as procurement of organs from incompletely executed, still-living prisoners. The human rights critique of these practices will also address the specific situatedness of prisoners, often conditioned and traumatized by a cascade of human rights abuses in judicial structures. To end the unethical practice and the abuse associated with it, we suggest to inextricably bind the use of human organs procured in the Chinese transplant system to enacting Chinese legislation prohibiting the use of organs from executed prisoners and making explicit rules for law enforcement. Other than that, the international community must cease to abet the continuation of the present system by demanding an authoritative ban on the use of organs from executed Chinese prisoners. (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)

In 1968, the definition of death in the United States was expanded to include not just death by cardiopulmonary criteria, but also death by neurologic criteria. We explore the way the definition has been modified by the medical and legal communities over the past 50 years and address the medical, legal and ethical controversies associated with the definition at present, with a particular highlight on the Supreme Court of Nevada Case of Aden Hailu.

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)

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)

The success of deep brain stimulation (DBS) for movement disorders and the improved understanding of the neurobiologic and neuroanatomic bases of psychiatric diseases have led to proposals to expand current DBS applications. Recent preclinical and clinical work with Alzheimer's disease and obsessive-compulsive disorder, for example, supports the safety of stimulating regions in the hypothalamus and nucleus accumbens in humans. These regions are known to be involved in addiction and overeating associated with obesity. However, the use of DBS targeting these areas (...) as a treatment modality raises common ethical considerations, which include informed consent, coercion, enhancement, threat to personhood, and manipulation of the reward center. Pilot studies for both of these conditions are currently investigational. If these studies show promise, then there is a need to address the ethical concerns related to the initiation of clinical trials including the reliability of preclinical evidence, patient selection, study design, compensation for participation and injury, cost-effectiveness, and the need for long-term follow-up. Multidisciplinary teams are necessary for the ethical execution of such studies. In addition to establishing safety and efficacy, the consideration of these ethical issues is vital to the adoption of DBS as a treatment for these conditions. We offer suggestions about the pursuit of future clinical trials of DBS for the treatment of addiction and overeating associated with obesity and provide a framework for addressing ethical concerns related to treatment. (shrink)

Health, Disease, and Illness brings together a sterling list of classic and contemporary thinkers to examine the history, state, and future of ever-changing "concepts" in medicine.

Biomedical science suffered a loss of trust during the Covid‐19 pandemic. Why? One reason is a crisis fueled by confusion over the epistemology of science. Attacks on biomedical expertise rest on a mistaken view of what the justification is for crediting scientific information. The ideas that science is characterized by universal agreement and that any evolution or change of beliefs about facts and theories undermines trustworthiness in science are simply false. Biomedical science is trustworthy precisely because it is fallible, admits (...) error, adjusts to new information, and, most importantly, is practical. Successful diagnosis and cure demarcate the boundaries of warranted knowledge. The other reason is sociological. As the pandemic made all too clear, the loss of faith in scientific experts was due to the failure of most of them to engage in regular public dialogue, reflecting a failure to recognize the obligation that science has to bolster trust in its work and findings by concerted public engagement. (shrink)

Whistleblowers remain essential as complainants in allegations of research misconduct. Frequently internal to the research team, they are poorly protected from acts of retribution, which may deter the reporting of misconduct. In order to perform their important role, whistleblowers must be treated fairly. Draft regulations for whistleblower protection were published for public comment almost a decade ago but never issued. In the face of the growing challenge of research fraud, we suggest vigorous steps, to include: organizational responsibility to certify the (...) accuracy of research including audit, required whistleblower action in the face of imminent or grave harm to subjects, strengthened legal protections against retaliation including prompt enactment of Federal whistleblower protections and consideration of criminalizing the most egregious cases of research misconduct. (shrink)

Volume 20, Issue 7, July 2020, Page 160-162.

The need for organs to transplant is clear. Due to the lack of transplants, people suffer, they die, and the cost of taking care of them until they die is huge. There is general agreement that it would be good to increase the supply of organs in order to meet the demand for organ transplantation.

Myriad Genetics holds a patent on testing for the hereditary breast and ovarian cancer genes, BRCA1 and BRCA2, and therefore has a forced monopoly on this critical genetic test. Myriad launched a Direct-to-Consumer (DTC) marketing campaign in the Northeast United States in September 2007 and plans to expand that campaign to Florida and Texas in 2008. The ethics of Myriad's patent, forced monopoly and DTC campaign will be reviewed, as well as the impact of this situation on patient access and (...) care, physician liability, and the future of DTC campaigns for genetic testing. (shrink)

Research misconduct remains an important problem in health research despite decades of local, national, regional, and international efforts to eliminate it. The ultimate goal of every health research project, irrespective of setting, is to produce trustworthy findings to address local as well as global health issues. To be able to lead or participate meaningfully in international research collaborations, individual and institutional capacities for research integrity are paramount. Accordingly, this paper concerns itself not only with individuals’ research skills but also with (...) institutional and national policies and governance. Such policies and governance provide an ethical scaffold for the production of knowledge and structure incentives. This paper’s operational definition of research therefore draws from Institute of Medicine’s articulation of health research as an inquiry that aims to produce knowledge about the structure, processes, or effects of personal health services; and from an existing health systems framework. The paper reviews the research regulatory environment and the ethics apparatus in Ghana, and describes a project jointly undertaken by Ghanaian researchers in collaboration with New York University to assess the perceived adequacy of current institutional practices, opportunities, and incentives for promoting RI. (shrink)

BackgroundIn December 2014, China announced that only voluntarily donated organs from citizens would be used for transplantation after January 1, 2015. Many medical professionals worldwide believe that China has stopped using organs from death-row prisoners.DiscussionIn the present article, we briefly review the historical development of organ procurement from death-row prisoners in China and comprehensively analyze the social-political background and the legal basis of the announcement. The announcement was not accompanied by any change in organ sourcing legislations or regulations. As a (...) fact, the use of prisoner organs remains legal in China. Even after January 2015, key Chinese transplant officials have repeatedly stated that death-row prisoners have the same right as regular citizens to “voluntarily donate” organs. This perpetuates an unethical organ procurement system in ongoing violation of international standards.ConclusionsOrgan sourcing from death-row prisoners has not stopped in China. The 2014 announcement refers to the intention to stop the use of organs illegally harvested without the consent of the prisoners. Prisoner organs procured with “consent” are now simply labelled as “voluntarily donations from citizens”. The semantic switch may whitewash sourcing from both death-row prisoners and prisoners of conscience. China can gain credibility only by enacting new legislation prohibiting use of prisoner organs and by making its organ sourcing system open to international inspections. Until international ethical standards are transparently met, sanctions should remain. (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.

Experts discuss the economic, legal, and social issues surrounding the use of genetic testing in determining eligibility for life insurance. Insurance companies routinely use an individual's medical history and family medical history in determining eligibility for life insurance; this is part of the process of medical underwriting. Insurers have also long used genetic information, often derived from family history, in underwriting. But rapid advances in gene identification and genetic testing are changing the way we look at genetic information. Should the (...) results of genetic testing (which might identify a predisposition toward disease not related to medical history) be available to life insurance medical underwriters? Few if any life insurers currently require genetic testing, but there are no laws or regulations prohibiting its use. Genetics and Life Insurance examines the complex economic, legal, and social issues surrounding the use of genetic information in life insurance underwriting. The contributors are legal scholars, representatives of the life insurance industry (including an actuary and an insurance physician), a geneticist, a genetic counselor, a philosopher, and a consumer advocate. They explore all aspects of an issue that has only recently drawn the attention of policymakers and the public. The book opens with a report on the results of a public opinion poll on genetics and life insurance. Succeeding chapters present the insurer perspective, a discussion of the economics of risk selection in life insurance, background information on the process of underwriting, a scientific analysis of genetic risks and mortality rates, a philosophical discussion of fairness and genetic underwriting, the viewpoints of consumers and genetics counselors, a comparison of different international policy approaches to the issue, and a legal analysis of antitrust implications when insurers collaborate in setting standards for medical underwriting. In the final chapter the editor addresses various policy options, examining the pros and cons of each one and assessing their political feasibility. (shrink)

A former Prime Minister of Israel is alleged to have said that her country would never ascend to the status of authentic statehood until it possessed certain well-known social attributes — organized crime, prostitution, and corruption. These features, while obviously undesirable, were she felt, reliable indices of societal maturation. This anecdote is suggestive in understanding current events pertaining to the field of applied ethics.Philosophers have produced a massive body of opinion and argument on a diverse range of subjects under the (...) rubric of applied ethics. Moreover, they have assumed positions on various panels, commissions, governmental bodies and committees in the hope of making an informed contribution to the formulation of institutional and public policy. These accomplishments have begun to elicit the kinds of attributes commonly associated with philosophical maturation — exposées, debunkings, refutations, and ideologically informed critiques. (shrink)