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)

Biography of Sukhlalji Sanghavi, philosopher and Jaina thinker.

Believing that p, assuming that p, and imagining that p involve regarding p as true—or, as we shall call it, accepting p. What distinguishes belief from the other modes of acceptance? We claim that conceiving of an attitude as a belief, rather than an assumption or an instance of imagining, entails conceiving of it as an acceptance that is regulated for truth, while also applying to it the standard of being correct if and only if it is true. We argue (...) that the second half of this claim, according to which the concept of belief includes a standard of correctness, is required to explain the fact that the deliberative question whether to believe that p is transparent to the question whether p. This argument raises various questions. Is there such a thing as deliberating whether to believe? Is the transparency of the deliberative question whether to believe that p the same as the transparency of the factual question whether I do believe that p? We will begin by answering these questions and then turn to a series of possible objections to our argument. (shrink)

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)

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)

The maturing of metaethics has been accompanied by widespread, but relatively unarticulated, discontent that mainstream metaethics is fundamentally on the wrong track. The malcontents we have in mind do not simply champion a competitor to the likes of noncognitivism or realism; they disapprove of the supposed presuppositions of the existing debate. Their aim is not to generate a new theory within metaethics, but to go beyond metaethics and to transcend the distinctions it draws between metaethics and normative ethics and between (...) cognitivism and non-cognitivism. In our experience, the differences with traditional metaethics go deep enough that it can feel as if two different paradigms are talking past each other. We attempt to bring clarity and focus to this rather inchoate debate by simultaneously articulating the general issues involved and engaging in a detailed case study of one of the prominent representatives of this discontent, Christine Korsgaard. We argue that Korsgaard fails to go beyond metaethics–indeed, fails even to provide a theory within metaethics. Our strategy for showing this is to argue that her claims are compatible with both cognitivism and non-cognitivism. We have argued elsewhere that her distinctive claims are compatible with realism. Here we focus on the crucial role that claims about agency and the will seem to play her in work and, according to our interpretation, in her attempts to go beyond mainstream metaethics. We show in detail that these claims are actually compatible with non-cognitivism. Though our discussion often focuses on her work in particular, it has clear implications for other attempts to obviate the debates of traditional metaethics. (shrink)

Female genital alteration is any cutting, removal or destruction of any part of the external female genitalia. Various FGA practices are common throughout the world. While most frequent in Africa and Asia, transglobal migration has brought ritual FGA to Western nations. All forms of FGA are generally considered undesirable for medical and ethical reasons when performed on minors. One ritual FGA procedure is the vulvar nick. This is a small laceration to the vulva that does not cause morphological changes. Besides (...) being performed as a primary ritual procedure it has been proposed as a substitute for more extensive forms of FGA. Measures advocated or taken to reduce the burden of FGA can be punitive or non-punitive. Even if it is unethical to perform VN, we argue that it also is unethical to attempt to suppress it through punishment. First, punishment of VN is likely to cause more harm than good overall, even to those ostensibly being protected. Second, punishment is likely to exceed legitimate retributive ends. We do not argue in favor of performing VN. Rather, we argue that non-punitive strategies such as education and harm reduction should be employed. (shrink)

The present commentary on it greatly contributes to the understanding of thisvery important work. In fact, it is a good expositary commentary, lucidly explaning the knotty points. It evinces deep study and understanding of Navya-Nyaya and its methodology.yhus, the sukhabodhika Tippanika represents a positive and distinctive contribution to the vast commercial literature on the Tattvacimtamani.

Mesenchymal stem cells (MSCs) are present in fat tissues throughout the body, yet little is known regarding their biological role within epidural fat. We hypothesize that debridement of epidural fat and/or subsequent loss of MSCs within this tissue, disrupts homeostasis in the vertebral environment resulting in increased inflammation, fibrosis, and decreased neovascularization leading to poorer functional outcomes post‐injury/operatively. Clinically, epidural fat is commonly considered a space‐filling tissue with limited functionality and therefore typically discarded during surgery. However, the presence of MSCs (...) within epidural fat suggests that itis more biologically active than historically believed and may contribute to the regulation of homeostasis and regeneration in the dural environment. While the current literature supports our hypothesis, it will require additional experimentation to determine if epidural fat is an endogenous driver of repair and regeneration and if so, this tissue should be minimally perturbed from its original location in the spinal canal. Also see the video abstract here https://youtu.be/MIol_IWK1os. (shrink)

Comparative Political Philosophy: Studies Under the Upas Tree examines four major traditions of political philosophy and discusses similarities in their key ideas and assumptions. An intellectually daring enterprise, this fascinating volume focuses on key texts from Chinese, Indian, Western and Islamic political philosophy.

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)

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)

The value of any kind of data is greatly enhanced when it exists in a form that allows it to be integrated with other data. One approach to integration is through the annotation of multiple bodies of data using common controlled vocabularies or ‘ontologies’. Unfortunately, the very success of this approach has led to a proliferation of ontologies which itself creates obstacles to integration. The Open Biomedical Ontologies (OBO) consortium has set in train a strategy to overcome this problem. Existing (...) OBO ontologies, including the Gene Ontology, are undergoing a process of coordinated reform and new ontologies being created on the basis of an evolving set of shared principles governing ontology development. The result is an expanding family of ontologies designed to be interoperable, logically well-formed, and to incorporate accurate representations of biological reality. We describe the OBO Foundry initiative, and provide guidelines for those who might wish to become involved. (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)

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)

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)

Jaina Philosophy and Religion.. Translated by Nagin J. Shah. Motilal Banarsidass, Delhi 1998. xxv, 469 pp. Rs. 450.

This experiment investigated the effect of format (line vs. bar), viewers’ familiarity with variables, and viewers’ graphicacy (graphical literacy) skills on the comprehension of multivariate (three variable) data presented in graphs. Fifty-five undergraduates provided written descriptions of data for a set of 14 line or bar graphs, half of which depicted variables familiar to the population and half of which depicted variables unfamiliar to the population. Participants then took a test of graphicacy skills. As predicted, the format influenced viewers’ interpretations (...) of data. Specifically, viewers were more likely to describe x–y interactions when viewing line graphs than when viewing bar graphs, and they were more likely to describe main effects and “z–y” (the variable in the legend) interactions when viewing bar graphs than when viewing line graphs. Familiarity of data presented and individuals’ graphicacy skills interacted with the influence of graph format. Specifically, viewers were most likely to generate inferences only when they had high graphicacy skills, the data were familiar and thus the information inferred was expected, and the format supported those inferences. Implications for multivariate data display are discussed. (shrink)