Decisions by industry sponsors to end clinical trials early for commercial reasons have been the subject of controversy. I argue that the principal consideration in assessing these decisions ought to be the way in which the termination would affect the trial’s risk–benefit relationship. If there is not yet sufficient benefit to be gained from the study to offset the risks to which participants were exposed and it is expected that important scientific information would be obtained if the trial were continued, (...) early termination constitutes an unethical alteration of the risk−benefit relationship. This violates the grounds on which permission is given to conduct human research, patients consent to participate, and investigators agree to conduct studies. These knowable and avoidable changes in risk–benefit relationship should generally be seen as impermissible. (shrink)

Decisions concerning children in the health care setting have engendered significant controversy and sparked ethics policies and statements, legal action, and guidelines regarding who ought to make decisions involving children and how such decisions ought to be made. Traditionally, parents have been the default decision-makers for children not only with regard to health care but with regard to other matters, such as religious practice and education. In recent decades, there has been a steady trend away from the view that parents (...) are in authority over their children and toward the view that children are rights-bearers who should be granted greater authority over themselves. The mature minor doctrine refers to the decision to grant mature minors the authority to make decisions traditionally reserved for their parents. This essay (1) documents the trend towards expanding the understanding of some minors as “mature” and hence as having the right and authority to give informed consent, (2) examines the reasons for which some commentators have a special interest in expanding the mature minor doctrine to the research setting and allowing minors to enroll in research without parental permission, and (3) defends the view that the mature minor doctrine, regardless of its application to clinical health care decisions, ought to be set aside in the research setting in favor of greater parental involvement. (shrink)

Traditionally, people were recognized as being dead using cardio-respiratory criteria: individuals who had permanently stopped breathing and whose heart had permanently stopped beating were dead. Technological developments in the middle of the twentieth century and the advent of the intensive care unit made it possible to sustain cardio-respiratory and other functions in patients with severe brain injury who previously would have lost such functions permanently shortly after sustaining a brain injury. What could and should physicians caring for such patients do? (...) Significant advances in human organ transplantation also played direct and indirect roles in discussions regarding the care of such patients. Because successful transplantation requires that organs be removed from cadavers shortly after death to avoid organ damage due to loss of oxygen, there has been keen interest in knowing precisely when people are dead so that organs could be removed. Criteria for declaring death using neurological criteria developed, and today a whole brain definition of death is widely used and recognized by all 50 states in the United States as an acceptable way to determine death. We explore the ongoing debate over definitions of death, particularly over brain death or death determined using neurological criteria, and the relationship between definitions of death and organ transplantation. (shrink)

Clinical investigators must engage in just subject recruitment and selection and avoid unduly influencing research participation. There may be tension between the practice of keeping payments to participants low to avoid undue influence and the requirements of justice when recruiting normal healthy volunteers for phase 1 drug studies. By intentionally keeping payments low to avoid unduly influenced participation, investigators, on the recommendation or insistence of institutional review boards, may be targeting or systematically recruiting healthy adult members of lower socio-economic groups (...) for participation in phase 1 studies. Investigators are at risk of routinely failing to fulfill the obligation of justice, which prohibits the systematic targeting and recruiting of subjects for reasons unrelated to the nature of the study. Insofar as we take seriously the obligation to engage in just subject recruitment and selection, I argue that we must acknowledge the implications low payments might have for subject recruitment and selection and examine the effect of low payments. If low payments de facto target the less well-off for phase 1 studies, we must defend the priority ranking of the obligation to avoid undue influence over the obligation of justice or adopt an alternative recruitment approach. This paper identifies a number of alternatives to the current system of low-value payments to research participants. (shrink)

(No abstract is available for this citation).

Public bioethics focuses on deliberating about, recommending, or establishing social policies or practices concerning health care and biotechnology. A brace of premises underlies much of the work of public bioethics. First, there is the view that, if one approaches reality and human life as if both were without ultimate significance, one will find that one shares a common public bioethics. That is, if one abstains not only from any religious concerns, but even from philosophical reflections on the circumstance that life (...) might have ultimate meaning, one will be able to articulate a common neutral moral perspective that all persons can share and that can be the basis of a common public bioethics. The second premise is that the controversies in bioethics arise from the presence of religious belief, especially Christian belief, which supports a set of moral commitments that generate controversies that make the framing of public policy difficult. The view is that there is significant disagreement among persons who hold religious positions, particularly Christians, and that in public bioethics we should strive to eliminate these controversies by relying on a neutral moral framework. This paper documents and challenges these premises. It demonstrates that Christian bioethics finds itself already embedded in the field of secular moral controversy before it adds the perspectives it brings. (shrink)

Peter Dabrock argues that western Christian roots have shaped the western European mindset, that of believers and secular thinkers alike, such that (1) western Europeans hold the concept of human dignity as a central moral category and believe that respect for human dignity should frame social and political decisions and respect for human dignity is the foundation of bioethics, (2) Christians and secular thinkers can engage each other on secular terms using the shared language and focus on human dignity, and (...) (3) such engagement using a common moral focus/lens facilitates dialogue and convergence on issues in bioethics. Dabrock's analysis and conclusions raise a number of important points for discussion. This essay examines three elements of his analysis that are particularly important for assessing his overall claim about a common Christian and secular morality in western Europe and for understanding the relationship between such a vision and Christian bioethics. (shrink)

Health care reform poses numerous challenges. A core challenge is to make health care more efficient and effective without causing more harm than benefit. Additionally, those fashioning health-care policy must encourage patients to exercise caution and restraint when expending scarce resources; restrict the ability of politicians to advance their careers by promising alluring but costly entitlements, many of which they will not be able to deliver; face the demographic challenges of an aging population; and avoid regulations that create significant inefficiencies (...) and restrict access to health care. Given such real-world challenges, how should health care be reformed in the United States or elsewhere? This number of The Journal of Medicine and Philosophy examines many of the complex issues that must be considered in reforming a health-care system. (shrink)

It now seems technically feasible to culture human embryos beyond the “fourteen‐day limit,” which has the potential to increase scientific understanding of human development and perhaps improve infertility treatments. The fourteen‐day limit was adopted as a compromise but subsequently has been considered an ethical line. Does it remain relevant in light of technological advances permitting embryo maturation beyond it? Should it be changed and, if so, how and why? What justifications would be necessary to expand the limit, particularly given that (...) doing so would violate some people's moral commitments regarding human embryos? Robust stakeholder engagement preceded adoption of the fourteen‐day limit and should arguably be part of efforts to reassess it. Such engagement could also consider the need for enhanced oversight of human embryo research. In the meantime, developing and implementing reliable oversight systems should help foster high‐quality research and public confidence in it. (shrink)

It now seems technically feasible to culture human embryos beyond the “fourteen‐day limit,” which has the potential to increase scientific understanding of human development and perhaps improve infertility treatments. The fourteen‐day limit was adopted as a compromise but subsequently has been considered an ethical line. Does it remain relevant in light of technological advances permitting embryo maturation beyond it? Should it be changed and, if so, how and why? What justifications would be necessary to expand the limit, particularly given that (...) doing so would violate some people's moral commitments regarding human embryos? Robust stakeholder engagement preceded adoption of the fourteen‐day limit and should arguably be part of efforts to reassess it. Such engagement could also consider the need for enhanced oversight of human embryo research. In the meantime, developing and implementing reliable oversight systems should help foster high‐quality research and public confidence in it. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Editors’ NoteJames M. DuBois, Ana S. Iltis, and Heidi A. WalshFrom childhood, David Slakter had undergone tests and invasive procedures to monitor his nephritis. It was not a surprise when in 2015, doctors told him he needed a kidney transplant. The wife of a childhood friend was a close match and gave him one of her kidneys. Before his transplant, aerobic exercise was difficult; a few months after (...) transplant, Slakter could ride his bike, hike, and work out with a personal trainer. He no longer had to weigh food or gauge his potassium consumption, a concern for people with kidney failure. For Slakter, “life post-transplant has been a significant improvement.”Individuals or family members of those who have received an organ transplant from a living or deceased donor share their stories in this issue of Narrative Inquiry in Bioethics. The symposium is titled “Receiving the Gift of Life: Stories from Organ Transplant Recipients.” Organ transplantation can extend an individual’s life by decades. It can also greatly improve an individual’s quality of life, as was Slakter’s experience. At the same time, organ transplantation is expensive and stressful. Recipients can experience complications, including organ rejection, and there are few appealing alternatives.After her heart transplant, author Leilani R. Graham required four open-heart surgeries, ECMO, and an intra-aortic balloon pump. She experienced delirium, necrotizing pneumonia, and severe muscular atrophy that required her to re-learn how to walk. She struggled with weight gain, explosive mood swings, hair loss, and was terrified that her body would reject the new heart. For Graham, “[Transplant] was not the miracle [she] was hoping for.” Graham says she felt unprepared for and inadequately informed about what to expect after her transplant, which left her “battered, beaten, and bruised” with a 12-inch line from neck to navel and “bullet holes” up and down her torso from the chest tubes. When reflecting on her experience post-transplant, Graham says, “It wasn’t the physical trauma that hurt the most. It was that no one seemed surprised [by the aftereffects of transplant].” Seemingly no one, that is except Graham, who calls on transplant providers to “prioritize empathy.”The symposium editors are Jason T. Eberl and Tristan McIntosh. Three commentary articles, written by Macey Leigh Levan, Heather Lannon, and Vidya A. Fleetwood, Roslyn B. Mannon & Krista L. Lentine, offer important insights into the authors’ stories. The editors thank Mid-America Transplant, the UCSF Lung Transplant Program, Donor Connect, William L. Freeman, MD, MPH, MJIL, CIP, Janet Monk, and the individuals who gave anonymous donations to support the publication of this issue, an open-access VOICES edition of the symposium, and accompanying teaching guides.The research article in this issue, “‘A Shell of My Former Self’: Using Figurative Language to Promote Communication about Patient Suffering,” was written by Tyler Tate, Elizabeth Stein, and Robert A. Pearlman. The relief of suffering is a primary goal of medicine. However, the authors note that clinicians often miss or ignore suffering because they focus on the causes rather than the experience of suffering, or the subjective nature of suffering makes it difficult to discuss. The authors believe that “the key to communicating about suffering lies in finding [End Page vii] the right kind of words to describe the experience” and say that figurative language offers a promising approach. In their research, the authors performed qualitative analysis on 52 works of literature and identified 254 excerpts of figurative language with themes of non-physical or psychological suffering. The authors found 13 salient themes: brokenness, diminishment, disorientation, drowning, emptiness, imprisonment, battle, darkness, isolation, invisibility, lifelessness, punishment, and torture. The authors reiterate that developing a shared language of suffering could foster a therapeutic patient-clinician relationship and improve clinicians’ ability to recognize and address a patient’s experience of suffering.María Susana Ciruzzi wrote the first of two case studies included in this issue. “The Sword of King Solomon” addresses a tragic and difficult subject—how to navigate the situation posed by conjoined twins when “any decision will produce damage and suffering.” The case involves two infant male patients born at 37 weeks gestation as omphalo-ischiopagus conjoined twins... (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)

Within and among societies, there are competing understandings of the status of children, including debates over whether they can bear rights and, if so, which rights they bear and against whom, and their capacity to make decisions and be held responsible and accountable for actions. There also are different understandings of what constitutes a family; what authority parents have over and regarding their children; and what should happen to children who are without parents because of death, desertion, or imprisonment. These (...) and other related debates reflect deep differences in worldviews, in how one understands the legitimate role of the state, in how one comes to know the proper way to raise children, and so on. The United Nations Convention on the Rights of the Child purports to reflect international convergence on the rights of children, on how decisions concerning children should be made, and on how children ought to be treated by the state and by their parents. This paper examines whether the Convention's framework for decision making concerning children is an appropriate framework for pediatric bioethics. Questions about how to make health care decisions for children ultimately are questions of who is in authority to make and judge such decisions. Establishing who is in authority, determining whether there are any limits to that authority and, if so, defining those limits should be the focus of efforts to develop and implement a pediatric decision-making framework. (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)

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)

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)

Socio-cultural shifts during the 1960s and 1970s included widespread secularization, challenges to authority and tradition, and an emphasis on individual choice. Healthcare and biomedical research advances accompanied these social changes, giving rise to numerous ethical and policy questions. The contemporary bioethics project emerged in this context with (at least) three aims: (1) to offer practical answers to these questions (often) in ways that (2) facilitate or support particular practices or goals (e.g., organ donation or human research) and that (3) appear (...) broadly applicable and legitimately enforceable. Philosophical thinking, which involves investigating and disambiguating concepts and categories, articulating conceptually clear definitions, and mapping arguments to identify premises, detect fallacies, and describe their logical implications, can undermine the practical goals of the bioethics project. This tension between the goals of bioethics and philosophical thinking might help to explain what some scholars see as a disinterest in philosophical thinking in bioethics today. (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)

The popularity and availability of global health experiences has increased, with organizations helping groups plan service trips and companies specializing in “voluntourism,” health care professionals volunteering their services through different organizations, and medical students participating in global health electives. Much has been written about global health experiences in resource poor settings, but the literature focuses primarily on the work of health care professionals and medical students. This paper focuses on undergraduate student involvement in short term medical volunteer work in resource (...) poor countries, a practice that has become popular among pre-health professions students. We argue that the participation of undergraduate students in global health experiences raises many of the ethical concerns associated with voluntourism and global health experiences for medical students. Some of these may be exacerbated by or emerge in unique ways when undergraduates volunteer. Guidelines and curricula for medical student engagement in global health experiences have been developed. Guidelines specific to undergraduate involvement in such trips and pre-departure curricula to prepare students should be developed and such training should be required of volunteers. We propose a framework for such guidelines and curricula, argue that universities should be the primary point of delivery even when universities are not organizing the trips, and recommend that curricula should be developed in light of additional data. (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)

BackgroundIn 2004, patient advocate groups were major players in helping pass and implement significant public policy and funding initiatives in stem cells and regenerative medicine. In the following years, advocates were also actively engaged in Washington DC, encouraging policy makers to broaden embryonic stem cell research funding, which was ultimately passed after President Barack Obama came into office. Many advocates did this because they were told stem cell research would lead to cures. After waiting more than 10 years, many of (...) these same patients are now approaching clinics around the world offering experimental stem cell-based interventions instead of waiting for scientists in the US to complete clinical trials. How did the same groups who were once the strongest supporters of stem cell research become stem cell tourists? And how can scientists, clinicians, and regulators work to bring stem cell patients back home to the US and into the clinical trial process?DiscussionIn this paper, we argue that the continued marketing and use of experimental stem cell-based interventions is problematic and unsustainable. Central problems include the lack of patient protection, US liability standards, regulation of clinical sites, and clinician licensing. These interventions have insufficient evidence of safety and efficacy; patients may be wasting money and time, and they may be forgoing other opportunities for an intervention that has not been shown to be safe and effective. Current practices do not contribute to scientific progress because the data from the procedures are unsuitable for follow-up research to measure outcomes. In addition, there is no assurance for patients that they are receiving the interventions promised or of what dosage they are receiving. Furthermore, there is inconsistent or non-existent follow-up care. Public policy should be developed to correct the current situation.ConclusionThe current landscape of stem cell tourism should prompt a re-evaluation of current approaches to study cell-based interventions with respect to the design, initiation, and conduct of US clinical trials. Stakeholders, including scientists, clinicians, regulators and patient advocates, need to work together to find a compromise to keep patients in the US and within the clinical trial process. Using HIV/AIDS and breast cancer advocate cases as examples, we identify key priorities and goals for this policy effort. (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)

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)

The bioethics literature has paid little attention to matters of informed reproductive decision-making among women of childbearing age who have chronic kidney disease (CKD), 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)

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)

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)

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 (CKD), 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)

Issues in bioethics often turn, at least in part, on the law and regulatory requirements. Consisting of chapters that address particular bioethics topics from the law’s perspective, this fascinating book includes: an introduction to the American legal system papers identifying the principal ways in which the law influences discussions and decisions concerning each of the topics highlighted supplemental papers on certain areas that address the influence and status of the law in countries other than the United States. Covering traditional topics (...) in bioethics, such as determinations of death and health care decisions for vulnerable groups, this study also explores emerging areas such as conflicts of interest in research, genetics, and privacy and confidentiality in the electronic age. Incisive and thought-provoking, this volume provides readers with a rich context for understanding the intersection between the law on bioethics and the central issues in bioethics. (shrink)

Survival after solid-organ transplantation has improved significantly, and many contemporary transplant recipients are of childbearing potential. There are limited data to guide decision-making surrounding pregnancy after transplantation, variations in clinical practice, and significant knowledge gaps, all of which raise significant ethical issues. Post-transplant pregnancy is associated with an increased risk of maternal and fetal complications. Shared decision-making is a central aspect of patient counselling but is complicated by significant knowledge gaps. Stakeholder interests can be in conflict; exploring these tensions can (...) help patients to evaluate their options and inform their deliberations. We argue that uniform, evidence-based recommendations for pregnancy after solid organ transplantation are needed. Conducting research, including patient-engaged studies, in this area should be priority for the transplant community. (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 (IRB) 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)

This volume brings together a set of critical essays on the thought of Professor Doctor H. Tristram Engelhardt Jr., Co-Founding Editor of the Philosophy and Medicine book series. Amongst the founders of bioethics, Professor Engelhardt, looms large. Many of his books and articles have appeared in multiple languages, including Italian, Romanian, Portuguese, Spanish, and Chinese. The essays in this book focus critically on a wide swath of his work, in the process elucidating, critiquing, and/or commending the rigor and reach of (...) his thought. This volume compasses analyses of many different aspects of Engelhardt's work, including social and political philosophy, biopolitics, the philosophy of medicine, and bioethics. It brings together internationally known scholars to assess key elements of Engelhardt's work. (shrink)