The Declaration of Helsinki and the Council of the International Organization of Medical Sciences provide guidance on standards of care and prevention in clinical trials. In the current and increasingly challenging research environment, the ethical status of a trial design depends not only on protection of participants, but also on social value, feasibility, and scientific validity. Using the example of a study assessing efficacy of a vaccine to prevent human papilloma virus in HIV-1 infected adolescent girls in low resource countries (...) without access to the vaccine, we compare several trial designs which rank lower on some criteria and higher on others, giving rise to difficult trade-offs. This case demonstrates the need for developing more nuanced guidance documents to help researchers balance these often conflicting criteria. (shrink)

We present the case of a 36-year-old woman who has experienced three lost pregnancies; during the most recent loss, a full term pregnancy, she almost died from complications of placental abruption. She is now completing the 34th week of gestation and is experiencing symptoms similar to those under which she lost the previous pregnancy. Despite a lack of specific medical indications, the patient and her husband firmly but politely request that the attending obstetrician/perinatologist perform an immediate cesarean section in order (...) to alleviate the couple’s anxiety about possibly never having a family. Discussing the case are an experienced perinatologist, a neonatologist, a regional perinatal center coordinator, and a clinical ethicist. (shrink)

BackgroundIn the Canadian Alliance for Healthy Hearts and Minds (CAHHM) cohort, participants underwent magnetic resonance imaging (MRI) of the brain, heart, and abdomen, that generated incidental findings (IFs). The approach to managing these unexpected results remain a complex issue. Our objectives were to describe the CAHHM policy for the management of IFs, to understand the impact of disclosing IFs to healthy research participants, and to reflect on the ethical obligations of researchers in future MRI studies.MethodsBetween 2013 and 2019, 8252 participants (...) (mean age 58 ± 9 years, 54% women) were recruited with a follow-up questionnaire administered to 909 participants (40% response rate) at 1-year. The CAHHM policy followed a restricted approach, whereby routine feedback on IFs was not provided. Only IFs of severe structural abnormalities were reported.ResultsSevere structural abnormalities occurred in 8.3% (95% confidence interval 7.7–8.9%) of participants, with the highest proportions found in the brain (4.2%) and abdomen (3.1%). The majority of participants (97%) informed of an IF reported no change in quality of life, with 3% of participants reporting that the knowledge of an IF negatively impacted their quality of life. Furthermore, 50% reported increased stress in learning about an IF, and in 95%, the discovery of an IF did not adversely impact his/her life insurance policy. Most participants (90%) would enrol in the study again and perceived the MRI scan to be beneficial, regardless of whether they were informed of IFs. While the implications of a restricted approach to IF management was perceived to be mostly positive, a degree of diagnostic misconception was present amongst participants, indicating the importance of a more thorough consent process to support participant autonomy.ConclusionThe management of IFs from research MRI scans remain a challenging issue, as participants may experience stress and a reduced quality of life when IFs are disclosed. The restricted approach to IF management in CAHHM demonstrated a fair fulfillment of the overarching ethical principles of respect for autonomy, concern for wellbeing, and justice. The approach outlined in the CAHHM policy may serve as a framework for future research studies.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/nct02220582. (shrink)

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The ethical principle of ‘respect for persons’ in clinical research has traditionally focused on protecting individuals’ autonomy rights, but respect for participants also includes broader, although less well understood, ethical obligations to regard individuals’ rights, needs, interests and feelings. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we conducted exploratory, qualitative interviews with participants in a clinical genomics implementation study. We interviewed 40 participants in English or Spanish (...) about their experiences with respect in the study and perceptions of how researchers in a hypothetical observational study could convey respect or a lack thereof. Most interviewees were female, identified as Hispanic/Latino or non-Hispanic white, reported annual household income under US$60 000 and did not have a Bachelor’s degree ; 30% had limited health literacy. We identified four key domains for demonstrating respect: personal study team interactions, with an emphasis on empathy, appreciation and non-judgment; study communication processes, including following up and sharing results with participants; inclusion, particularly ensuring materials are understandable and procedures are accessible; and consent and authorisation, including providing a neutral informed consent and keeping promises regarding privacy protections. While the experience of respect is inherently subjective, these findings highlight four key domains that may meaningfully demonstrate respect to potential and current research participants. Further empirical and normative work is needed to substantiate these domains and evaluate how best to incorporate them into the practice of research. (shrink)

Opponents of male circumcision have increasingly used human rights positions to articulate their viewpoint. We characterize the meaning of the term “human rights.” We discuss these human rights arguments with special attention to the claims of rights to an open future and to bodily integrity. We offer a three-part test under which a parental decision might be considered an unacceptable violation of a child's right. The test considers the impact of the practice on society, the impact of the practice on (...) the individual, and the likelihood of adverse impact. Infant circumcision is permissible under this test. We conclude that infant circumcision may be proscribed as violating local norms, even though it does not violate human rights. (shrink)

While all states in the United States require certain vaccinations for school attendance, all but three allow for religious exemptions to receiving such vaccinations, and 18 allow for exemptions on the basis of other deeply held personal beliefs. The rights of parents to raise children as they see fit may conflict with the duty of the government and society to protect the welfare of children. In the U.S., these conflicts have not been settled in a uniform and consistent manner. We (...) apply a test that provides a concrete and formal rubric to evaluate such conflicts. For some vaccinations, based on the individual medical characteristics of the disease and the risks of being unvaccinated, the test would suggest that permitting conscientious exemptions is ethical. However, for vaccinations protecting against other diseases that are more severe or easily transmitted, the test would suggest that the federal government may ethically impose laws that deny such exemptions. (shrink)

Most experts would agree that the current medical malpractice system in the United States does not work effectively either to compensate victims fairly or prevent injuries caused by medical errors. Policy responses to a series of medical malpractice crises have not resulted in effective reform and have not altered the fundamental incentives of the stakeholders. In Medical Malpractice, economist Frank Sloan and lawyer Lindsey Chepke examine the U.S. medical malpractice process from legal, medical, economic, and insurance perspectives, analyze past (...) efforts at reform, and offer realistic, achievable policy recommendations. They review the considerable empirical evidence in a balanced fashion and assess objectively what works in the current system and what does not. Sloan and Chepke argue that the complexity of medical malpractice stems largely from the interaction of the four discrete markets that determine outcomes--legal, medical malpractice insurance, medical care, and government activity. After describing what the evidence shows about the functioning of medical malpractice, types of defensive medicine, and the effects of past reforms, they examine such topics as scheduling damages as an alternative to flat caps, jury behavior, health courts, incentives to prevent medical errors, insurance regulation, reinsurance, no-fault insurance, and suggestions for future reforms. Medical Malpractice is the most comprehensive treatment of malpractice available, integrating findings from several different areas of research and describing them accessibly in nontechnical language. It will be an essential reference for anyone interested in medical malpractice.Frank A. Sloan is J. Alexander McMahon Professor of Health Policy and Management and Professor of Economics at Duke University. He is the coauthor of The Price of Smoking and author or editor of many other books on health economics. Lindsey M. Chepke, an attorney, is a Research Associate at the Center for Health Policy at Duke University. (shrink)

Most experts would agree that the current medical malpractice system in the United States does not work effectively either to compensate victims fairly or prevent injuries caused by medical errors. Policy responses to a series of medical malpractice crises have not resulted in effective reform and have not altered the fundamental incentives of the stakeholders. In Medical Malpractice, economist Frank Sloan and lawyer Lindsey Chepke examine the U.S. medical malpractice process from legal, medical, economic, and insurance perspectives, analyze past (...) efforts at reform, and offer realistic, achievable policy recommendations. They review the considerable empirical evidence in a balanced fashion and assess objectively what works in the current system and what does not. Sloan and Chepke argue that the complexity of medical malpractice stems largely from the interaction of the four discrete markets that determine outcomes--legal, medical malpractice insurance, medical care, and government activity. After describing what the evidence shows about the functioning of medical malpractice, types of defensive medicine, and the effects of past reforms, they examine such topics as scheduling damages as an alternative to flat caps, jury behavior, health courts, incentives to prevent medical errors, insurance regulation, reinsurance, no-fault insurance, and suggestions for future reforms. Medical Malpractice is the most comprehensive treatment of malpractice available, integrating findings from several different areas of research and describing them accessibly in nontechnical language. It will be an essential reference for anyone interested in medical malpractice.Frank A. Sloan is J. Alexander McMahon Professor of Health Policy and Management and Professor of Economics at Duke University. He is the coauthor of The Price of Smoking and author or editor of many other books on health economics. Lindsey M. Chepke, an attorney, is a Research Associate at the Center for Health Policy at Duke University. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:From Impatience to EmpathyStephanie Pierce and Kavita Shah AroraWe gave J.H. a label the first time we met her, as many often do—“Uncooperative.” She was a patient with autism and intellectual delay who had presented to the emergency department (ED) with vaginal bleeding. After receiving the gynecology consult request from the emergency medicine physicians, we were already mentally formulating our recommendations based on the information they told us (...) over the phone. “Does not cooperate with exam,” “no acute surgical intervention is currently warranted,” and “recommend outpatient follow–up.”When we arrived in her room, she was sitting in the hospital bed surrounded by a protective shield of caregivers from her group home. We introduced ourselves as the gynecology team but it was obvious that J.H. could not communicate verbally. Upon speaking with her caregivers we learned that she had Cowden syndrome, a genetic disease that confers significantly increased risks for several types of cancer including endometrial, thyroid, and breast cancers. J.H. had also been having heavy vaginal bleeding, which was difficult for her caregivers to manage, and this was the reason she was brought into the emergency department. After attempting to gain as much information as we could from the caregivers, we started to perform an abdominal exam, which made J.H. extremely agitated. We quickly stopped the exam and the caregivers helped to calm J.H. We remember our mixture of emotions—bewilderment at the agitation and commotion in the exam room full of people, frustration at not being able to complete our exam fully, and annoyance that this “difficult patient” was taking up our limited time between surgical cases. Thankfully, these knee–jerk reactions were quickly replaced by feelings of concern for the patient and the realization of how frightening an experience this must be for her—being in a strange place with white walls and unfamiliar people, unable to communicate her thoughts.J.H.’s mother, her surrogate decision–maker, was not at the hospital that day but the caregivers told us that she had expressed a strong desire for her daughter to have a prophylactic hysterectomy due to her lifetime risk for developing uterine cancer as well as a permanent solution to the bleeding concerns. What had initially started as a simple ED consult was now turning into a complex question. The ethical and legal dilemma was obvious—whether to perform a major surgery that would irreversibly sterilize a patient who could not consent on her own behalf in order to minimize the potential risk of cancer later in life. While medical management could improve the bleeding and potentially reduce the risk of cancer, frequent exams would be necessary [End Page 19] to ensure that the medication was working and that premalignant changes were not occurring in J.H.’s uterus. However, based on our experience in the emergency department, J.H. would need anesthesia for such exams and it was doubtful the medications would completely normalize her elevated risk of uterine malignancy. We knew that in order to address this question, we would need to see J.H. again along with her mother to have a frank discussion about the risks and benefits of such a decision, and so we made plans to see her in our outpatient clinic.Several days later, J.H., her mother, and the group home caregivers arrived in the office. Anticipating a complex discussion, we had requested a representative from the hospital ethics committee to join us at the visit. We didn’t know what to expect meeting J.H.’s mother for the first time but as we sat in the room talking, it was obvious that she was truly trying to act in her daughter’s best interest. Similarly, it was touching to watch the faces of the caregivers from the group home as they nodded in solidarity with J.H.’s mother, also clearly wanting what was best for her and supporting her mother in this difficult decision. J.H., meanwhile, seemed content to sit silently with us during the discussion, surrounded as she was by people who cared deeply for her well–being.After extensive partnership with the ethics consultants... (shrink)

In this paper, we argue that the widespread practice in the United States of busing voters to the polling station on Election Day is an instance of paying people to vote. We defend a definition of what it means to pay people to vote, and on this definition, busing voters to the polling station is an instance of paying people to vote. Paying people to vote is illegal according to United States federal election law. However, the United States courts have (...) historically considered the practice of busing voters to the polling station legally permissible. The United States legal system, therefore, faces a dilemma: either the courts must change their interpretation of current federal election law such that busing voters to the polling station is a violation of federal election law, or federal election law must be changed so that at least some instances of paying people to vote are legally permissible. We argue that choosing either horn of the dilemma has a controversial implication for the United States legal system. (shrink)

In Cultural Hermeneutics, Mario J. Valdés offers a synthesis of the hermeneutic philosophies of Miguel de Unamuno and Paul Ricoeur, a dialectical method that has formed the basis for many of Valdés' own studies in comparative literature. As Valdés explains in these insightful essays, what Unamuno and Ricoeur shared in their hermeneutic studies was a theory of interpretation in which the meaning of a work of art comes into existence through the dialectical relationship between its creator and its readers, listeners, (...) or viewers. Contextualizing this hermeneutic concept as it appears in the works of both philosophers, Cultural Hermeneutics presents the basis for a profound understanding of the arts. (shrink)

This article defends the conclusion that the soccer World Cup in Qatar should not be boycotted by rich countries from the Global North. This conclusion is underpinned by considerations about the economic background conditions in guest workers’ home countries. Three arguments are considered for the view that the World Cup should be boycotted. It is argued that each of these arguments is unsound. Section 7 contains a discussion of an argument for a boycott that centers on the process through which (...) Qatar was awarded the World Cup. This argument is rejected. The article lists several ways in which guest workers in Qatar are wronged, but this fact about how guest workers are treated does not justify a boycott by rich countries from the Global North. (shrink)

Summarya) Bell tries to formulate more explicitly a notion of “local causality”: correlations between physical events in different space‐time regions should be explicable in terms of physical events in the overlap of the backward light cones. It is shown that ordinary relativistic quantum field theory is not locally causal in this sense, and cannot be embedded in a locally causal theory.b) Clauser, Home and Shimony criticize several steps in Bell's argument that any theory of local “beables” is incompatible with quantum (...) mechanics. It is contended that the Clauser‐Horne derivation of a Bell‐type inequality circumvents his weak steps. The Clauser‐Horne derivation must assume that there are no undetected correlations between choices of controllable variables in two space‐like separated regions. Methodological considerations support this assumption.c) In response to criticism by Shimony, Home, and Clauser, Bell tries to clarify the argument of “The theory of local beables”, and to defend as permissible the hypothesis of free variables.d) Bell's reply to an earlier criticism by Shimony, Clauser, and Home is answered. The convergence of Bell's position towards theirs is noted. (shrink)