This handbook is currently in development, with individual articles publishing online in advance of print publication. At this time, we cannot add information about unpublished articles in this handbook, however the table of contents will continue to grow as additional articles pass through the review process and are added to the site. Please note that the online publication date for this handbook is the date that the first article in the title was published online. For more information, please read the (...) site FAQs. (shrink)
The language of ethics expertise has become particularly important in bioethics in light of efforts to establish the value of the clinical ethics consultation, to specify who is qualified to function as a clinical ethics consultant, and to characterize how one should evaluate whether or not a person is so qualified. Supporters and skeptics about the possibility of ethics expertise use the language of ethics expertise in ways that reflect competing views about what ethics expertise entails. We argue for clarity (...) in understanding the nature of expertise and ethics expertise. To be an ethics expert, we argue, is to be an expert in knowing what ought to be done. Any attempt to articulate expertise with respect to knowing what ought to be done must include an account of ethics that specifies the nature of moral truth and the means by which we access this truth or a theoretical account of ethics such that expertise in another domain is linked to knowing or being better at judging what ought to be done and the standards by which this “knowing” or “being better at judging” is determined. We conclude with a discussion of the implications of our analysis for the literature on ethics expertise in CEC. We do think that there are clear domains in which a clinical ethics consultant might be expert but we are skeptical about the possibility that this includes ethics expertise. Clinical ethics consultants should not be referred to as ethics experts. (shrink)
I argue that valid informed consent is ethically required for organ donation from individuals declared dead using neurological criteria. Current policies in the U.S. do not require this and, not surprisingly, current practices inhibit the possibility of informed consent. Relevant information is withheld, opportunities to ensure understanding and appreciation are extremely limited, and the ability to make and communicate a free and voluntary decision is hindered by incomplete disclosure and other practices. Current practices should be revised to facilitate valid informed (...) consent for organ donation. (shrink)
The nature, possibility, and implications of ethics expertise in general and of bioethics expertise in particular has been the focus of extensive debate for over thirty years. What is ethics expertise and what does it enable experts to do? Knowing what ethics expertise is can help answer another important question: What, if anything, makes a claim of expertise legitimate? In other words, how does someone earn the appellation “ethics expert?” There remains deep disagreement on whether ethics expertise is possible, and (...) if so, what constitutes such expertise and what it entails and legitimates. Discussion of bioethics expertise has become particularly important given the growing presence of bioethicists in the clinical setting as well as efforts to professionalize bioethics through codes of ethics and certification efforts. Unlike in the law or in engineering, where there may be a body of knowledge that professional organizations or others have articulated as important for education and training of experts, ethics expertise admits of no such body of knowledge or required experience. Nor is there an entity seen as having the authority to articulate the necessary scope of knowledge. Questions about whether there is such a body of knowledge for particular areas within bioethics have emerged and played a central role in professionalization efforts in recent years, especially in the area of clinical ethics. (shrink)
Decisions regarding clinical procedures or research participation typically require the informed consent of individuals. When individuals are unable to give consent, the informed permission of a legally authorized representative or surrogate is required. Although many proposed procedures are aimed primarily at benefiting the individual, some are not. I argue that, particularly when individuals are asked to assume risks primarily or exclusively for the benefit of others, family members ought to be engaged in the informed consent process. Examples of procedures in (...) which individuals are asked to assume risks primarily or exclusively for the benefit of others include living organ donation and research participation. (shrink)
In most, if not all, jurisdictions with active organ transplantation programs, there is a persistent desire to increase donation rates because the demand for transplantable organs exceeds the supply. China, in particular, faces an extraordinary gap between the number of organs donated by deceased donors and the number of people seeking one or more transplants. China might look to Western countries with higher donation rates to determine how best to introduce Western practices into the Chinese system. In attempting to increase (...) its organ donation rate, China must not only ensure that its organ donation system reflects different Chinese cultural values, but also that it avoids the ethical problems of the United States and of other Western systems. This article examines four such problems. They concern the family, obtaining permission for organ donation, the definition and diagnosis of “brain death,” and trust. Revisions to the Chinese system should involve a careful look to China and Chinese cultural resources rather than to Western models. (shrink)
The term ‘culture wars’ has been used to describe deep, apparently intractable, disagreements between groups for many years. In contemporary discourse, it refers to disputes regarding significant moral matters carried out in the public square and for which there appears to be no way to achieve consensus or compromise. One set of battle lines is drawn between those who hold traditional Christian commitments and those who do not. Christian bioethics is nested in a set of moral and metaphysical understandings that (...) collide with those of the dominant secular culture. The result is a gulf between a moral life and an approach to bioethics framed in the face of a transcendent God and a final judgment versus a moral life and an approach to bioethics framed as if the world were without ultimate meaning and as if death were the end of personal existence. These approaches are separated by a moral and metaphysical gulf that sustains incompatible life worlds and incompatible understandings of bioethics. Attempts to bridge the gulf with secular reason are ineffective because there is no shared conception of reason or standard of evidence. Efforts to use the state to enforce a particular set of metaphysical and moral commitments, whether secular or religious, lead to public disputes with a war-like character. (shrink)
Recent work calls for excluding clinical ethics consultants’ religious ethical commitments from formulating recommendations about particular cases and communicating those recommendations. I demonstrate that three arguments that call for excluding religious ethical commitments from this work logically imply that consultants may not use their secular ethical commitments in their work. The call to sever clinical ethics consultation from the ethical commitments of clinical ethics consultants has implications for the scope of work consultants may do and for the competencies required for (...) such work. (shrink)
Roman Catholic healthcare institutions in the United States face a number of threats to the integrity of their missions, including the increasing religious and moral pluralism of society and the financial crisis many organizations face. These organizations in the United States often have fought fervently to avoid being obligated to provide interventions they deem intrinsically immoral, such as abortion. Such institutions no doubt have made numerous accommodations and changes in how they operate in response to the growing pluralism of our (...) society, but they have resisted crossing certain lines and providing particular interventions deemed objectively wrong. Catholic hospitals in Belgium have responded differently to pluralism. In response to a growing diversity of moral views and to the Belgian Act of Euthanasia of 2002, Catholic hospitals in Belgium now engage in euthanasia. This essay examines a defense that has been offered of this practice of euthanasia in Catholic hospitals and argues that it is misguided. (shrink)
Contemporary bioethics is, at least in part, the product of biomedical and sociopolitical changes in the middle to latter part of the 20th century. These changes prompted reflection on deep moral questions at a time when traditional sources of moral guidance no longer were widely respected and, in some cases, were being rejected. In light of this, scholars, policy makers, and clinicians sought to identify a common morality that could be used among persons with different moral commitments to resolve disputes (...) and guide clinical practice and health policy. The concept of the common morality remains important in bioethics. This essay considers the common morality in light of the work of H. Tristram Engelhardt, Jr. (shrink)
What the Doctor Didn’t Say, by Jerry Menikoff and Edward P. Richards, is a courageous and well-written volume that examines some of the fundamental debates pertaining to the ethics of clinical research. The volume deserves a careful reading by anyone with a potential role in clinical research: clinicians who might serve as investigators or refer patients to clinical trials; research staff; Institutional Review Board members and administrators; sponsors who design clinical trials; and the book’s intended audience, namely, potential research participants (...) and their families. A cursory reading of this volume might lead one to think that Menikoff and Richards have declared war on clinical research. They have not. Instead, they offer an in-depth study of the conduct and oversight of clinical research through the lens of law and ethics. They shed light on old issues and initiate discussion of new questions, challenging readers to think critically about the relationship between medical ethics, research ethics, the law, and the conduct of clinical research. (shrink)
An Institute of Medicine panel charged with reviewing the system for overseeing research involving children concluded in 2004 that Institutional Review Boards, institutions engaged in research, and study sponsors should “adopt explicit written policies on acceptable and unacceptable types and amounts of payments related to [children’s] research participation.” We previously reported data on practices and policies in the U.S. regarding payments to children who participate in research and their parents. Here, we report additional results from our study and identify some (...) of the decisions that must be made in developing payment plans and on which payment policies will be expected to offer guidance. We conclude that further conceptual analysis and empirical research are necessary before IRBs, institutions, and sponsors can develop specific rules on numerous aspects of payment. Nevertheless, payment policies that promote the ethical treatment of children in research and their parents can be developed. We propose a structure for such policies. (shrink)
On Monday, June 25, 2018, H. Tristram Engelhardt, Jr., PhD, MD, co-founder of The Journal of Medicine and Philosophy, was laid to rest in the beautiful Hill Country of Texas near Comal County. Professor Engelhardt co-founded The Journal of Medicine and Philosophy in 1976 with Dr. Edmund Pellegrino. Engelhardt first served as Associate Editor, and then Editor and Senior Editor from 1976 until 2018. The Journal thrived for more than four decades through his energy, vision, and dedication. One of the (...) intellectual founders of the fields that would become known as bioethics and the philosophy of medicine, Engelhardt’s seminal scholarship has framed the philosophical debates surrounding healthcare policy and medical practice throughout the world. The Journal of Medicine and Philosophy mourns his passing. (shrink)
Much of the human research conducted in the United States or by U.S. researchers is regulated by the Common Rule. The Common Rule reflects the decision of 17 federal agencies, including the Department of Health and Human Services, to require that investigators follow the same rules for conducting human research., though there is significant overlap with the Common Rule.) Many of the obligations delineated in the Common Rule can be traced back to the work of the National Commission for the (...) Protection of Human Subjects of Biomedical and Behavioral Research. The National Commission was appointed in 1974 as part of the National Research Act in response to revelations about serious abuses involving human subjects, most notably the Tuskegee/United States Public Health Service Syphilis Study. (shrink)
This essay examines conceptual difficulties with one of the ways in which justice has been understood and applied the ethical and regulatory review of human research. Justice requires the fair distribution of the benefits and burdens of research. Class membership is seen as justifying inclusion in higher hazard-no benefit research from which members of potentially vulnerable classes, such as children, typically would be excluded. I argue that class membership does not do the justificatory work it is thought to do and (...) that the use of class membership to justify inclusion in higher hazard-no benefit research leads to unjustified discrimination of sick children and offers special protections to healthy children. (shrink)
IntroductionThe bioethics literature reflects significant interest in and concern with the use of genetic and genomic information in various settings. Because psychiatric treatment and research raises unique ethical, legal, and social issues, we conducted a scoping review of the biomedical, bioethics, and psychology literature regarding the application of genetic and genomic tools to psychiatric disorders and two associated behaviors or symptoms to provide a more detailed overview of the state of the field.ObjectivesThe primary objective was to examine the available bioethics, (...) biomedical, and psychology literature on applying genetic and genomic tools to psychiatric disorders and two behaviors or symptoms sometimes associated with them to identify the disorders to which these tools have been applied, the contexts in or purposes for which they have been applied, the ethical, legal, or social concerns associated with those uses, and proposed recommendations for mitigating those concerns.MethodsWe used Arksey and O’Malley’s scoping review framework: identify the research question; identify relevant studies; select studies; chart the data; and collate, summarize, and report results. We relied on Levac et al. to inform our application of the framework. The PRISMA extension for scoping reviews checklist informed our reporting. We searched three electronic databases MEDLINE, Embase, and PsycInfo for peer-reviewed journal articles in English to identify relevant literature. One author screened the initial results and additional screening was done in consultation with other authors. A data extraction form using DSM-5 diagnostic categories was developed and two authors independently each reviewed approximately half of the articles. Inter-rater reliability was ensured by double-coding approximately 10% of the papers. An additional author independently coded 10% of the articles to audit the data.ResultsIn 365 coded publications, we identified 15 DSM-5 diagnostic categories in addition to the two pre-selected behaviors or symptoms to which genetic or genomic tools have been applied. We identified 11 settings in or purposes for which these tools were applied. Twenty-two types of ethical, legal, or social concerns associated with the application of genetic or genomic tools to these disorders or behaviors/symptoms were identified along with 13 practices or policies that could mitigate these concerns.ConclusionGenetic and genomic tools have been applied to a wide range of psychiatric disorders. These raise a range of ethical, legal, and social concerns. Additional research is warranted to better understand the concerns and effective ways to address them. Advancing the literature to identify relevant ethical, legal, or social concerns and solutions to those problems likely requires greater attention to specific applications of genetic or genomic tools to particular psychiatric disorders and associated behaviors/symptoms as well as broad stakeholder engagement. (shrink)
What the Doctor Didn’t Say, by Jerry Menikoff and Edward P. Richards, is a courageous and well-written volume that examines some of the fundamental debates pertaining to the ethics of clinical research. The volume deserves a careful reading by anyone with a potential role in clinical research: clinicians who might serve as investigators or refer patients to clinical trials; research staff; Institutional Review Board members and administrators; sponsors who design clinical trials; and the book’s intended audience, namely, potential research participants (...) and their families. A cursory reading of this volume might lead one to think that Menikoff and Richards have declared war on clinical research. They have not. Instead, they offer an in-depth study of the conduct and oversight of clinical research through the lens of law and ethics. They shed light on old issues and initiate discussion of new questions, challenging readers to think critically about the relationship between medical ethics, research ethics, the law, and the conduct of clinical research. (shrink)
Global Health Needs and the Short-Term Medical Volunteer: Ethical Considerations Content Type Journal Article Pages 71-78 DOI 10.1007/s10730-011-9158-5 Authors Michele K. Langowski, Albert Gnaegi Center for Health Care Ethics, Salus Center, Saint Louis University, 3545 Lafayette, 5th Floor, St. Louis, MO 63104-1314, USA Ana S. Iltis, Department of Philosophy and Center for Bioethics, Health and Society, Wake Forest University, P.O. Box 7332, Winston-Salem, NC 27109, USA Journal HEC Forum Online ISSN 1572-8498 Print ISSN 0956-2737 Journal Volume Volume 23 Journal Issue (...) Volume 23, Number 2. (shrink)
What the Doctor Didn’t Say, by Jerry Menikoff and Edward P. Richards, is a courageous and well-written volume that examines some of the fundamental debates pertaining to the ethics of clinical research. The volume deserves a careful reading by anyone with a potential role in clinical research: clinicians who might serve as investigators or refer patients to clinical trials; research staff; Institutional Review Board members and administrators; sponsors who design clinical trials; and the book’s intended audience, namely, potential research participants (...) and their families. A cursory reading of this volume might lead one to think that Menikoff and Richards have declared war on clinical research. They have not. Instead, they offer an in-depth study of the conduct and oversight of clinical research through the lens of law and ethics. They shed light on old issues and initiate discussion of new questions, challenging readers to think critically about the relationship between medical ethics, research ethics, the law, and the conduct of clinical research. (shrink)
The bioethics literature has paid little attention to matters of informed reproductive decision-making among women of childbearing age who have chronic kidney disease, including women who are on dialysis or women who have had a kidney transplant. Women with CKD receive inconsistent and, sometimes, inadequate reproductive counseling, particularly with respect to information about pursuing pregnancy. We identify four factors that might contribute to inadequate and inconsistent reproductive counseling. We argue that women with CKD should receive comprehensive reproductive counseling, including information (...) about the possibility of pursuing pregnancy, and that more rigorous research on pregnancy in women with CKD, including women on dialysis or who have received a kidney transplant, is warranted to improve informed reproductive decision making in this population. (shrink)
In the absence of centralized human rights leadership in an increasingly fragmented global health policy landscape, regional health offices have stepped forward to advance the rights-based approach to health. Reviewing the efforts of the Pan American Health Organization, this article explores the evolution of human rights in PAHO policy, assesses efforts to mainstream human rights in the Pan American Sanitary Bureau, and analyzes the future of the rights-based approach through regional health governance, providing lessons for other regional health offices and (...) global health institutions. This article explores PAHO's 15-year effort to mainstream human rights through PASB technical units, national capacity-building, the Inter-American human rights system, and the PAHO Directing Council. Through documentary analysis of PAHO policies and semi-structured interviews with key PASB stakeholders, the authors analyze the understandings and actions of policymakers and technical officers in implementing human rights through PAHO governance. Analyzing the themes arising from this narrative, the authors examine the structural role of secretariat leadership, state support, legal expertise, and technical unit commitment in facilitating a rights-based approach to the health in the Americas. Human rights are increasingly framing PAHO efforts, and this analysis of the structures underlying PAHO's approach provides an understanding of the institutional determinants of the rights-based approach to health, highlighting generalizable themes for the mainstreaming of human rights through regional health governance. With this regional-level understanding of health governance, future national-level research can begin to understand the causal forces linking regional human rights work with national policy reforms and public health outcomes. (shrink)
In the development of a rights-based approach to global health governance, international organizations have looked to human rights under international law as a basis for public health. Operationalizing human rights law through global health policy, the World Health Organization has faced obstacles in efforts to mainstream human rights across the WHO Secretariat. Without centralized human rights leadership in an increasingly fragmented global health policy landscape, regional health offices have sought to advance human rights in health governance and support states in (...) realizing a rights-based approach to health. Examining the efforts of the Pan American Health Organization, this article explores the evolution of human rights in PAHO policy, assesses the mainstreaming of human rights in the Pan American Sanitary Bureau, and analyzes the future of the rights-based approach through regional health governance. (shrink)
