Chiropractors commonly treat children for a variety of ailments by manipulating the spine to correct a ‘vertebral subluxation’ or a ‘vertebral subluxation complex’ alleged to be a cause of disease. Such treatment might begin soon after a child is born. Both major American chiropractic associations – the International Chiropractic Association and the American Chiropractic Association – support chiropractic care for children, which includes subluxation correction as a treatment or preventive measure. I do not know of any credible evidence to support (...) chiropractic subluxation theory. Any attempt to manipulate the immature, cartilaginous spine of a neonate or a small child to correct a putative chiropractic subluxation should be regarded as dangerous and unnecessary. Referral of a child to a chiropractor for such treatment should not be considered lest a bad outcome harms the child or leads to a charge of negligence or malpractice. (shrink)

Researchers conducting large community-based studies among underserved populations may collect data on health conditions that are little-acknowledged in the local setting, and for which there are few if any services for referral of participants who need follow-up diagnosis and care. In the design and planning of studies for such settings, investigators and research ethics committees may struggle to determine what constitutes effective referral and whether it is reasonably available. We offer a guiding framework for referral planning, informed (...) by our experiences of research in the field and of service on research ethics committees, to support evaluation of local referral resources and consideration of the benefits, burdens and risks of referral in the local setting. The framework addresses both the impact of referral on the well-being of the people who would be referred and the impact that referral of study participants would have on local people outside the study. We use a sustained discussion of three field-based case examples to illustrate the ethical concerns at issue and to demonstrate the use of the referral planning framework. (shrink)

The referral is the key source of information that enables radiologists and radiographers to provide quality services. However, the frequency of suboptimal referrals is widely reported. This research reviews the literature to illuminate the challenges suboptimal referrals present to the delivery of care in radiology departments. The concept of suboptimal referral includes information, that is; missing, insufficient, inconsistent, misleading, hard to interpret or wrong. The research uses the four ethical principles ofnon-maleficence, beneficence, AutonomyandJusticeas an analytic framework.Suboptimal referrals can (...) causeharmby hindering safe contrast-media administration, proper radiation protection by justification of procedures, and compassionate patient care. Suboptimal referrals also hinder promoting patientbenefitsfrom the correct choice of imaging modality and protocol, an optimal performed examination, and an accurate radiology report. Additionally, patientautonomyis compromised from the lack of information needed to facilitate benefit–risk communication. Finally, suboptimal referrals challengejusticebased on lack of reasonable patient prioritising and the unfairness caused by unnecessary examinations.These findings illuminate how suboptimal referrals can inhibit good health and well-being for patients in relation to safety, missed opportunities, patient anxiety and dissatisfaction. The ethical challenges identified calls for solutions. Referral-decision support tools and artificial intelligence may improve referral quality, when implemented. Strategies addressing efforts of radiology professionals are inevitable, including gatekeeping, shared decision-making and inter-professional communication; thereby raising awareness of the importance of good referral quality and promoting commitment to ethical professional conduct. (shrink)

Purpose This paper aims to expose the challenges facing the attempt by Jamaica to introduce a new digital ID system without adequate regard to public consultation and the rights of citizens. Design/methodology/approach The method used is critical text analysis and policy analysis, providing background and relevant factors leading up to the legislative changes under review. Extensive literature sources were consulted and the relevant sections of the Jamaican constitution referenced and analysed. Findings The case study may have national peculiarities not applicable (...) in other jurisdictions. Its introduction acknowledges that the Jamaican Government may amend and re-submit the legislation, absent the flawed clauses. The paper however will remain valid given its detailed analysis and exposure of risks associated with biometric data collection, face recognition technology and data storage flaws. Practical implications It will be a practical example of the risks associated with flawed biometric data collection and the role of Courts in reviewing such legislation. Referrals to the Courts can be used as a remedy, as occurred not only in Jamaica but also in many other jurisdictions, including India and Kenya. Social implications The paper foregrounds the rights of citizens to be consulted on the collection and storage of their sensitive biometric data. The social implications and risks of violating the constitutional rights of citizens were made evident, and can be an example to other jurisdictions. Originality/value The paper is the first of its kind to provide detailed data and analysis on an outright rejection by the Courts of a country's ID legislation on grounds that it violated the constitution and rights of citizens. It shows the ethical and social challenges in proposing and implementing legislation without adequate public consultation on such sensitive matters as biometric data. It also exposes some of the challenges of artificial intelligence and face recognition technologies in ID data collection, including flaws related to race, gender and coding. (shrink)

IntroductionCerebral visual impairment is an important cause of visual impairment in western countries. Perinatal hypoxic-ischemic damage is the most frequent cause of CVI but CVI can also be the result of a genetic disorder. The majority of children with CVI have cerebral palsy and/or developmental delay. Early diagnosis is crucial; however, there is a need for consensus on evidence based diagnostic tools and referral criteria. The aim of this study is to develop guidelines for diagnosis and referral in (...) CVI according to the grade method.Patients and MethodsWe developed the guidelines according to the GRADE method 5 searches on CVI were performed in the databases Medline, Embase, and Psychinfo, each with a distinct topic.ResultsBased on evidence articles were selected on five topics: 1. Medical history and CVI-questionnaires 23. 2. Ophthalmological and orthoptic assessment 37. 3. Neuropsychological assessment 5. 4. Neuroradiological evaluation and magnetic resonance imaging 9. 5. Genetic assessment 5.ConclusionIn medical history taking, prematurity low birth weight and APGAR Scores are important. Different questionnaires are advised for children under the age of 3 years, older children and for specific risk groups. In ophthalmological examination, eye movements, specially saccades, accommodation, crowding, contrast sensitivity and visual fields should be evaluated. OCT can show objective signs of trans-synaptic degeneration and abnormalities in fixation and saccades can be measured with eye tracking. Screening of visual perceptive functioning is recommended and can be directive for further assessment. MRI findings in CVI in Cerebral Palsy can be structured in five groups: Brain maldevelopment, white and gray matter lesions, postnatal lesions and a normal MRI. In children with CVI and periventricular leukomalacia, brain lesion severity correlates with visual function impairment. A differentiation can be made between cortical and subcortical damage and related visual function impairment. Additional assessments can be necessary to complete the diagnosis of CVI and/or to reveal the etiology. (shrink)

BackgroundGeneral practitioners often act as gatekeeper, authorizing patients’ access to hospital care. This gatekeeping role became even more important during the current COVID-19 crisis as uncertainties regarding COVID-19 made estimating the desirability of hospital referrals (for outpatient or inpatient hospitalization) complex, both for COVID and non-COVID suspected patients. This study explored Dutch general practitioners’ experiences and ethical dilemmas faced in decision making about hospital referrals in times of the COVID-19 pandemic.MethodsSemi-structured interviews with Dutch general practitioners working in the Netherlands were (...) conducted. Participants were recruited via purposive sampling. Thematic analysis was conducted using content coding.ResultsFifteen interviews were conducted, identifying four themes: one overarching regarding (1) COVID-19 uncertainties, and three themes about experienced ethical dilemmas: (2) the patients’ self-determination vs. the general practitioners’ paternalism, (3) the general practitioners’ duty of care vs. the general practitioners’ autonomy rights, (4) the general practitioners’ duty of care vs. adequate care provision.ConclusionsLack of knowledge about COVID-19, risks to infect loved ones, scarcity of hospital beds and loneliness of patients during hospital admission were central in dilemmas experienced. When developing guidelines for future crises, this should be taken into account. (shrink)

Total knee arthroplasty (TKA) is a commonly implemented elective surgical treatment for end-stage osteoarthritis of the knee, demonstrating high success rates when assessed by objective medical outcomes. However, a considerable proportion of TKA patients report significant dissatisfaction postoperatively, related to enduring pain, functional limitations, and diminished quality of life. In this conceptual analysis, we highlight the importance of assessing patient-centred outcomes routinely in clinical practice, as these measures provide important information regarding whether surgery and postoperative rehabilitation interventions have effectively remediated (...) patients’ real-world “quality of life” experiences. We propose a novel precision medicine approach to improving patient-centred TKA outcomes through the development of a multivariate machine-learning model. The primary aim of this model is to predict individual postoperative recovery trajectories. Uniquely, this model will be developed using an interdisciplinary methodology involving non-linear analysis of the unique contributions of a range of preoperative risk and resilience factors to patient-centred TKA outcomes. Of particular importance to the model’s predictive power is the inclusion of a comprehensive assessment of modifiable psychological risk and resilience factors that have demonstrated relationships with TKA and other conditions in some studies. Despite the potential for patient psychological factors to limit recovery, they are typically not routinely assessed preoperatively in this patient group, and thus can be overlooked in rehabilitative referral and intervention decision-making. This represents a research-to-practice gap that may contribute to adverse patient-centred outcomes. Incorporating psychological risk and resilience factors into a multivariate prediction model could improve the detection of patients at risk of sub-optimal outcomes following TKA. This could provide surgeons and rehabilitation providers with a simplified tool to inform postoperative referral and intervention decision-making related to a range of interdisciplinary domains outside their usual purview. The proposed approach could facilitate the development and provision of more targeted rehabilitative interventions on the basis of identified individual needs. The roles of several modifiable psychological risk and resilience factors in recovery are summarised, and intervention options are briefly presented. While focusing on rehabilitation following TKA, we advocate for the broader utilisation of multivariate prediction models to inform individually-tailored interventions targeting a range of health conditions. (shrink)

The closed-off management of the university during coronavirus disease 2019 may be associated with an elevated odds of psychological and behavioral issues among college students. We aimed to use the stress-process model to explore the potential mechanisms for this phenomenon. A total of 924 college students were recruited via posters, peer referrals, and class attendance. Among them, 82 were probable depression, 190 were probable anxiety, and 69 were internet addiction. Parallel mediation was used to test this theoretical model. For personal (...) resources, the perceived risk of COVID-19 was positively associated with psychological distress via negative coping style and internet addiction via negative coping style or self-esteem. For social resources, the perceived risk of COVID-19 was positively associated with psychological distress and internet addiction via roommate relationships. Negative coping styles and roommate relationships are possible psychological mechanisms linking the perceived risk of COVID-19, psychological distress, and internet addiction. (shrink)

Placebo-controlled trials are controversial when individuals might be denied existing beneficial medical interventions. In the case of malaria, most patients die in rural villages without healthcare facilities. An artesunate suppository that can be given by minimally skilled persons might be of value when patients suddenly become too ill for oral treatment but are several hours from a facility that can give injectable treatment for severe disease. In such situations, by default, no treatment is (or can be) given until the patient (...) reaches a facility, making the placebo control design clinically relevant; alternative bioequivalence designs at the facility would misrepresent reality and risk incorrect conclusions. We describe the ethical issues underpinning a placebo-controlled trial in severe malaria. To protect patients and minimise risk, all patients were referred immediately to hospital so that each had a higher chance of prompt treatment through participation. There was no difference between artesunate and placebo in patients who reached clinic rapidly; among those who could not, a single artesunate suppository significantly reduced death or permanent disability, a finding of direct and indirect benefit to patients in participating villages and elsewhere. (shrink)

Objective To evaluate the questions asked during the informed consent process by adult and adolescent participants as well as their parents in five interventional regulatory studies conducted at our center from 2018 to 2019. Methods The study protocol was approved by Institutional Ethics Committee [EC/OA-116/2019]. Consent narratives in the source documents for the studies were evaluated. Questions asked were classified as per Indian Council of Medical Research’s (ICMR) guidelines (2017). We evaluated total number of questions, nature of questions and whether (...) there was an association between education, gender, phase of trials, physician taking consent and number questions being asked. Results A total of five studies that had N = 297 consent narratives were evaluated. Narratives of n = 284 adult participants/Guardians and of n = 13 children were analysed. A total of 374 questions were asked of which children asked only 10 questions. A total of 131/284 (40%) of the participants did not ask any question. Among the participants who asked questions, the majority132/171 (77%) participants asked about risks related to investigational products followed by questions related to study procedures 83/171 (49%). Participants/guardians with higher education (relative to those who were educated upto the secondary school and primary school) and those who consented for Phase III studies (relative to Phase I studies) asked significantly more questions (p < 0.0001). Conclusion A majority of the queries were related to the risks associated with the investigational products. Educational status and the Phase of the trial were found to be significantly associated with the number of questions being asked. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Conflicts—and Consensus—about Conflicts of Interest in MedicineMatthew K. Wynia and Bette–Jane Crigger*This fascinating collection of essays about individual experiences of conflict of interest leaves little doubt that physicians remain divided about the importance, impact and meaning of conflicts of interest in their work. These essays offer differing views about what conflicts of interest look and feel like “on the ground” and about whether specific conflicts of interest are bad, (...) just a fact of life, or maybe even good.Conflict, Conflict EverywhereThese essays situate conflict of interest in a variety of contexts: the treatment recommendations a physician makes for an individual patient; the relationship between teaching physician and medical student or practicing physician and health care organization; the interaction between academic researchers and industry collaborators or professional bodies and industry supporters. In this, the narratives taken together reflect the scope of concern about conflict of interest in medicine familiar in the literature. In his classic 1993 essay, Dennis Thompson noted that concerns about conflict of interest encompass issues of physician self–referral, risk sharing between physicians and health care institutions, gifts from industry, hospital purchasing practices, as well as sponsored research and research with patients (Thompson 1993). To that list have subsequently been added relationships with industry in medical education at all levels, physicians’ service as consultants to industry or members of industry speakers bureau, and development of clinical practice guidelines (Lo & Fields 2009).That almost none of these essays draw attention to some widely publicized situations of conflict of interest—for example, gifts to physicians or the provision of drug samples—should, we think, be seen more as an artifact of the authors’ varied individual experiences than as a failure by the authors to engage key concerns in the ongoing professional and public debate. It could also be that the authors, asked to submit personal stories, assumed that yet another essay about the ‘traditional’ issues in the conflicts of interest literature would be seen as redundant, routine or even boring. Or, there is the tantalizing possibility that the absence of some of the more familiar conflicts from these narratives is the early fruit of efforts to address these traditional issues through policies governing interactions between physicians and industry promulgated by academic medical centers and health systems, medical specialty societies, and industry.One significant area of concern that has emerged in recent years is conflict of interest in the development of clinical practice guidelines. E.g., Choudry et al. 2002; Sniderrman & Furberg 2009; Guyatt et al. 2010. Although none of the essays in this [End Page 101] collection address it head on, Perlmutter touches on several key issues. His depiction of how an FDA committee process limited the input he was able to provide as an expert, undermined his potential to contribute to the professional dialogue, and raised concerns about the objectivity of the drug approval process echoes concerns about objectivity, the role of expert opinion, and the presence on guideline development panels of individuals with financial interests in the recommendations to be developed that have been explored at some length in the literature, most recently by the Institute of Medicine in reports on evidentiary standards (Eden et al 2011) and principles for guideline development (Graham et al. 2011).Conflict of Interest or Dual Agency?Several essays set out physicians’ experience in navigating situations of diverging expectations. Bierut, for example, reflects on the disjunction between the goals and products of academic researchers and commercial sponsors. She saw herself advancing basic knowledge and was forced to grapple with the reality of sponsors’ goals to advance commercial ends as well. Nagldinne and Mikulec each recall struggles to reconcile their obligation to exercise professional judgment on behalf of patients with the demands of health care organizations focussed also on the bottom line. Cruz–Flores attests to the challenge of making recommendations for care when one is both a practicing clinician and a clinical investigator engaged in research that might offer benefit to a patient for whom there are limited options.Thompson defined conflicts of interest as “a set of conditions in which professional judgment concerning a primary interest (such as a patient’s welfare or the validity of... (shrink)

Researchers studying at-risk and socially disenfranchised child and adolescent populations are facing ethical dilemmas not previously encountered in the laboratory or the clinic. One such set of ethical challenges involves whether to: (a) share with guardians research derived information regarding participant risk, (b) provide participants with service referrals, or (c) report to local authorities problems uncovered during the course of investigation. The articles assembled for this special section address the complex issues of deciding if, when, and how to (...) report or provide referrals for research participants who are minors (referred to hereafter as minor research participants). This paper focuses on two factors underlying these decisions: the validity of risk estimates and meta-ethical positions on scientific responsibility. It is suggested that, before sharing information about minor research participants investigators should do the following: critically examine the diagnostic validity of developmental measures, include the scope and limitations of information sharing in informed consent procedures, and become familiar with state reporting laws. I discuss the impact of the traditionally accepted act utilitarian meta-ethical position on the investigator-participant relationship, and I recommend consideration of alternative positions as a step toward developing a research ethic of scientific responsibility and care. (shrink)

Patients in around 20 countries worldwide are now offered online access to at least some of their medical records. Access includes test results, medication lists, referral information, and/or the very words written by clinicians (so-called ‘open notes’). In this paper, I discuss the possibility of one unintended negative consequence of patient access to their clinical notes—the potential to increase ‘nocebo effects’. A growing body of research shows that nocebo effects arise by engaging perceptual and cognitive processes that influence negative (...) expectancies, and as a consequence, adverse health effects. Studies show that increased awareness about the side effects of medications, the framing of information and the socioemotional context of care can increase the risk of nocebo effects. Connecting research into the nocebo effect with open notes provides preliminary support for the hypothesis that patient access to clinical notes might be a forum for facilitating unwanted nocebo effects. Furthermore, current findings indicate that we might expect to see systematic differences in how nocebo effects are experienced among different patient populations. The ethical implications of the tension between transparency and the potential for harm are discussed, with an emphasis on what open notes might mean for justice and equity in clinical care for a range of already marginalised patient populations. I argue that to resolve these challenges does not thereby justify ‘closed notes’, and conclude with suggestions for how health systems and clinicians might adapt to this innovation to reduce the risk of potential nocebo effects arising via this novel route. (shrink)

Diabetes is a chronic and systemic disease that has reached epidemic proportions. An estimated 17 million Americans have diabetes, and an additional 16 million individuals are considered to have pre-diabetes. Studies have shown that timely screening and referral are necessary to maintain healthy blood glucose levels and slow the progression of diabetes-related complications. Furthermore, lifestyle changes can prevent or delay the onset of Type 2 diabetes for high-risk individuals.The Division of Diabetes Translation at the Centers for Disease Control (...) and Prevention undertook an analysis of diabetes-related legislation across the nation. More specifically, state laws, rules and regulations mandating health insurance coverage for diabetes-related supplies and services were examined according to Sample Purchasing Specifications for Services Related to Diabetes—an evidence-based model of standards of care for persons with diabetes. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The TripletsManeesh BatraI am a neonatologist and for the majority of my clinical time I care for babies and their families at a large University-based referral neonatal intensive care unit (NICU) in the United States. In 2003, I first visited this rural Ugandan hospital shortly after the opening of a special care baby nursery there, and have been involved with development of that program ever since.Uganda is a (...) beautiful, land-locked country in East Africa with a sordid political history. It is a developing country that is poor, mostly rural with a high fertility rate and a life expectancy of 42 years. The government spends $5 per capita per year on healthcare. The district with the hospital has a population of 500,000, the majority of which is rural. Access to health services is poor, even by Ugandan standards, and child mortality is in the higher band in the country.Most people in the region live in extended family clans. A common home is made of earth, with a grass roof, and a jerry can out front for collecting water from the well. It is an exquisitely lush landscape with fecund soil. At the hospital, there is limited electricity, lab support, medications, blood supplies, and health care workers. For the 200 bed hospital (that accommodates upwards of 400 inpatients when necessary, no one is turned away) there are four to seven Ugandan doctors, who do everything from C-sections, to colostomies, to HIV care to resuscitate babies in the NICU. For a ward of 20-80 patients there are one to two nurses, and maybe a nursing aide. Families do the majority of the care in the hospital, even in the NICU. Mum's express breast milk, perform tube feeds, wash the linens, notify staff when an IV infiltrates, and keep babies warm.Day OneAnother beautiful morning, with fresh instant coffee in hand, birds chirping and kids playing outside. It is good to be back. Over the last eight years, I've [End Page 78] made some close friends here and its good to be among them again. Every time I visit and return home, I leave a piece of me here, and bring back something new with me. This morning that feeling is overwhelming me, an incredible inspiration swells. I am not tired and I want to be busy. It is no wonder that this is where I was inspired to pursue caring for babies as my career. Over these years, it has been amazing to see the staff care for the community's babies and mums here. As an outsider, an opinioned one at that, I feel burdened at the thought of these babies dying somewhat needlessly. Is it really no-one's fault? How should one act in the face of scarcity, knowing there is a better standard to be had if only circumstances were different?I walked into the NICU to find triplets had arrived! Born at about 33 weeks they were two months early. Since they weighed around 1.5kg (about 3 lbs) each, they were at very high risk of dying —however, it was absolutely incredible to see the way they were tucked in by the skilled team. Within an hour of delivery—they were in incubators with IVs, having their hypoglycemia corrected, and two out of three were on oxygen (all of them had their O2 saturations checked). The three babies were tucked in so calmly, with the finest skill and expertise neonatal care anywhere has to offer. In stark contrast to the first admissions I witnessed years ago, the nurses now knew exactly what to do and how to do it. As a result, they had saved many lives and restored hope among the mums of the region that there was somewhere to go to get help. This success resulted in a healthy swagger among the staff because they could intervene successfully.These were spontaneous triplets to this young mum, who already had three other children. She looked tired when she walked into the NICU one hour (yes one hour) after delivering the trio, but if I hadn't known prior, there was no way to know... (shrink)

Recently, there has been increasing interest in methodological aspects of advanced imaging, including the role of guidelines, recommendations, and experts’ consensus, the practice of self-referral, and the risk of diagnostic procedure overuse. In a recent Delphi study of the European Association for Nuclear Medicine (EANM), panelists were asked to give their opinion on 47 scientific questions about imaging in prostate cancer. Nine additional questions exploring the experts’ attitudes and opinions relating to the procedure of consensus building itself were (...) also included. The purpose was to provide insights into the mechanism of recommendation choice and consensus building as seen from the experts’ point of view. Results: Regarding the factors likely to influence the willingness to refer a patient for imaging, the most voted were incorporation into guidelines and data from scientific literature, while personal experience and personal relationship were chosen by a small minority. Regarding the recommendations more relevant to prescribe an imaging procedure, it resulted the incorporation into guidelines promoted by scientific societies (59% of votes); these guidelines also resulted the more trusted. With respect to patients’ preferences considered when prescribing an imaging procedure, the most voted was accuracy, resulted more important than easy access and time to access to the procedure. The majority of the experts expressed the opinion that there is a scarce use of imaging procedures in prostate cancer. With respect to the most relevant factor to build consensus, it resulted the transparency of the process (52% of votes), followed by multidisciplinarity of contributors. The main obstacle to incorporation of modern imaging procedures into guidelines resulted the lack of primary literature on clinical impact. Conclusions: Firstly, the panelists portray themselves as having Evidence-Based Medicine oriented and scientifically inclined attitudes and preferences. Secondly, guidelines and recommendations from scientific societies, especially clinical ones, are positively taken into account as factors influencing decisions, but panelists tend to consider their own appraisal of the scientific literature as more relevant. Thirdly, in respect of overuse, panelists do not think that advanced diagnostic procedures are overutilized in the specific case of Prostate Cancer, but rather they are underutilized. (shrink)

The doctor-patient relationship -- Consent, choice, and refusal : adults with capacity -- Treating adults who lack capacity -- Children and young people -- Confidentiality -- Health records -- Contraception, abortion, and birth -- Assisted reproduction -- Genetics -- Caring for patients at the end of life -- Euthanasia and physician assisted suicide -- Responsibilities after a patient's death -- Prescribing and administering medication -- Research and innovative treatment -- Emergency situations -- Doctors with dual obligations -- Providing treatment and (...) care in detention settings -- Education and training -- Teamwork, referral, delegation, and shared care -- Public health dimensions of medical practice -- Reducing risk, clinical error, and poor performance. (shrink)

Background: Health researchers must weigh the benefits and risks of publishing their findings.Objective: To explore differences in decision making between rural health researchers and managers on the publication of research from small identifiable populations.Method: A survey that investigated the attitudes of Australian rural general practitioners to nurse practitioners was explored. Decisions on the study’s publication were analysed with bioethical principles and health service management ethical decision-making models.Results: Response rate was 78.5% . 84–94% of GP responders considered it to be undesirable (...) for nurse practitioners to initiate referrals to medical specialists , to initiate diagnostic imaging and to prescribe medication .Bioethical analysis: It was concluded that the principle of beneficence outweighed the principle of non-maleficence and that a valid justification for the publication of these results existed.Decision-making models of health service managers: On the basis of models of ethical decision making in health service management, the decisions of the area’s health managers resulted in approval to publish this project’s results being denied. This was because the perceived risks to the health service outweighed benefits. Confidentiality could not be ensured by publication under a regional nom de plume.Conclusions: A conflict of interests between rural researchers and health managers on publication of results is shown by this case study. Researchers and managers at times owe competing duties to key stakeholders. Both weigh the estimated risks and benefits of the effect of research findings. This is particularly true in a rural area, where identification of the subjects becomes more likely. (shrink)

BackgroundDefensive practice occurs when physicians provide services, such as tests, treatments and referrals, mainly to reduce their perceived legal or reputational risks, rather than to advance patient care. This behaviour is counter to physicians’ ethical responsibilities, yet is widely reported in surveys of doctors in various countries. There is a lack of qualitative research on the drivers of defensive practice, which is needed to inform strategies to prevent this ethically problematic behaviour.MethodsA qualitative interview study investigated the views and experiences of (...) physicians in Australia on defensive practice and its contribution to low value care. Interviewees were recruited based on interest in medico-legal issues or experience in a health service involved in ‘Choosing Wisely’ initiatives. Semi-structured interviews averaged 60 min in length. Data were coded using the Theoretical Domains Framework, which encapsulates theories of behaviour and behaviour change.ResultsAll participants (n = 17) perceived defensive practice as a problem and a contributor to low value care. Behavioural drivers of defensive practice spanned seven domains in the TDF: knowledge, focused on inadequate knowledge of the law and the risks of low value care; skills, emphasising patient communication and clinical decision-making skills; professional role and identity, particularly clinicians’ perception of patient expectations and concern for their professional reputation; beliefs about consequences, especially perceptions of the beneficial and harmful consequences of defensive practice; environmental context and resources, including processes for handling patient complaints; social influences, focused on group norms that encourage or discourage defensive behaviour; and emotions, especially fear of missing a diagnosis. Overall, defensive practice is motivated by physicians’ desire to avoid criticism or scrutiny from a range of sources, and censure from their professional peers can be a more potent driver than perceived legal consequences.ConclusionsThe findings call for strengthening knowledge and skills, for example, to improve clinicians’ understanding of the law and their awareness of the risks of low value care and using effective communication strategies with patients. Importantly, supportive cultures of practice and organisational environments are needed to create conditions in which clinicians feel confident in avoiding defensive practice and other forms of low value care. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Clinical Bioethics at NIH:History and A New VisionJohn C. Fletcher (bio)On July 3, 1995, Dr. John I. Gallin, Director of the Magnuson Clinical Center of the National Institutes of Health (NIH), convened a one-day "Conference on the Future of Clinical Bioethics at the National Institutes of Health Intramural Program." Conferees included NIH officials and a panel of consultants from bioethics programs around the nation.1 The subject was the future (...) of NIH's intramural bioethics program and specifically a vision of a new multi-component program, presented by Dr. Gallin, the first speaker. Dr. Harold Varmus, Director of NIH, was there to assure his support for Dr. Gallin's vision. This author, honored to be second speaker, was invited to sketch a brief history of bioethics at NIH. The present article reviews some of this history and then reports on Dr. Gallin's proposal, points of consensus among speakers and conferees, and the search for a Chief of the Clinical Bioethics Program.History of Bioethics at NIHIt is often said that NIH is a well-kept secret as the nation's leading biomedical research facility. Also, few people know that NIH has a long history in bioethics. Some key events in that history are shown in Figure 1, beginning with two that occurred prior to the birth of bioethics. NIH made an early policy response to protect human subjects of research and to find acceptable limits for scientific freedom. The Clinical Center (CC), a 550-bed research hospital, opened in 1953. A subcommittee of the Medical Board, the Clinical Research Committee (CRC), was formed for prior group review of all studies with normal volunteers. The traditional practice was for researchers themselves to decide when studies would begin, which subjects to recruit, and whether informed consent would be sought. The CRC intervention bit into this tradition. In addition, patient studies that posed significant risks or departed widely from medical practice were reviewed by referral from the Clinical Directors of the various Institutes. Was this CRC an early institutional review [End Page 355] board (IRB)? As a guest researcher, I was permitted to observe the CRCs meetings between 1966 and 1969. It functioned much like an IRB but had no community or non-scientist members. Other IRB-like review groups undoubtedly existed prior to the CRC. Robert Levine (personal communication, September 7, 1995) recalls that Beth Israel Hospital in Boston had one in 1938. Historical research is clearly needed on the earliest forms of research review.Table 1. Bioethics at NIHEventYearClinical Research Committee1953Surgeon-General's PPO #1291966NIGMS funds Hastings Genetics Group1973OPRR's Mission1974NLM's grant to KennedyInstitute for Bibliography of Bioethics1974Recombinant DNA Advisory Committee1974STEP Series Bioethics Speakers1975Pre-IRBs at the CC1975-76Assistant for Bioethics to Director, CC1977RAC-Human Gene Therapy Subcommittee1983Lipsett Proposal (ICD)1983Liaison Group, CC1983Bioethics Program, CC1985Durable Power of Attorney for Researchwith Incapacitated Subjects1985-86NLM funds National Reference Centerfor Bioethics Literature1985National Institute for Nursing Research1986Bioethics Post-Doctoral Fellows Program1989ELSI Program1989Bioethicists on CC-IRBs1989CC-Ethics Committee1990Office of Human Subjects Research1992 [End Page 356]Between 1963 and 1967, the media exposed instances of ethically troubling research, and Beecher (1966) and Pappworth (1967) published sharp criticisms of the weak state of research ethics. In 1966, Surgeon-General William Stewart and NIH Director James Shannon issued a policy requiring local group review of all research involving human subjects before making an application for NIH peer review (Surgeon General 1966). The policy was the first in any nation to mandate ethics committees for clinical research. However, it did not apply to the NIH intramural program until Congress passed the National Research Act in 1974 (Public Law 93-348; 202, 88 Stat. 342, 1974). This lag permitted NIH intramural investigators the luxury of feeling above the norms imposed on ordinary mortals and guaranteed more resistance to the inevitable change to come. Resistance to change marked the intramural program from the mid-1960s to the mid-1970s... (shrink)

ObjectivesTo identify and analyse ethical considerations raised when individuals with body dysmorphic disorder consult for non-surgical cosmetic procedures.MethodsEthical analysis was conducted addressing the issues of best interests and capacity to consent for non-surgical cosmetic procedures in individuals with BDD. Analysis was informed by the findings of semistructured interviews with non-surgical cosmetic practitioners and mental health professionals.FindingsNon-surgical cosmetic interventions were viewed not to be in the best interests of individuals with BDD, as they fail to address core psychological issues, result in (...) dissatisfaction post-procedure, and risk harm. Referral to mental health services was advocated, however numerous obstacles to this were perceived. The issue of capacity to consent to non-surgical cosmetic procedures raised questions regarding whether standard capacity assessment is sensitive to the manner in which BDD may influence decision-making processes. In addition, concerns were voiced that decisions made by individuals with BDD in this context may be judged foolish, and thus wrongly equated with lack of capacity.Discussion/conclusionsEthical analysis, informed by the available evidence base, suggests that it is generally not in the best interests of individuals with BDD to undergo non-surgical cosmetic intervention, and referral to mental health services is indicated. Analysis of capacity draws parallels between BDD and anorexia nervosa, as decision-making capacity in both conditions can be impaired by pathological values derived from the disorder. Means of differentiating clinical assessment of pathological values from inappropriate value judgements are advocated, in order to safeguard against the latter encroaching into capacity assessment. (shrink)

Background Factors that could potentially act as facilitators and barriers to successful recruitment strategies in perinatal clinical trials are not well documented. The objective was to assess lay persons’ understanding of the informed consent for randomized clinical trial in emergency obstetric and newborn care. Methods This was a qualitative study conducted among survivors of severe obstetric complications who were attending the post-natal clinic of Kawempe National Referral Hospital, Uganda, 6–8 weeks after surviving severe obstetric complications during pregnancy or childbirth. (...) The study that involved 18 in-depth interviews was conducted from June 1, 2019 to July 6, 2019. The issues explored included perceptions of the purpose and necessity to conduct such research how research-related information would be disclosed, and what could be the potential benefits and risks of participation. The data was analyzed by thematic analysis. Results Respondents felt that research was necessary to investigate the cause, prevention or complications of an illness, especially as much was known about some pregnancy and newborn complications. Most believed that the emergency contexts affects whether and what prospective participants may understand if information about research was disclosed. Whereas they did not see the value of procedures like randomization, they felt that if these and any other procedures necessary should be done transparently and fairly. The decisions to participate would significantly be influenced by possibility of risk to the unborn baby or the newborn. Solidarity was an important influence on decision-making. Conclusions Respondents valued participation in RCTs in emergency obstetric and newborn care. However, they expressed concerns and valued openness, transparency and accountability with regard to how clinical trials information is disclosed and the decision-making process for clinical trial participation. While autonomy and solidarity are contradictory values, they complement each other during decision-making for informed consent. (shrink)

On November 14, 1996, an in-depth report on the recruiting and testing practices of Lilly Pharmaceuticals appeared in the Wall Street Journal. Laurie Cohen reported that most pharmaceutical companies had difficulty recruiting healthy subjects to participate in testing of “untried and potentially dangerous” drugs. These companies often had to pay subjects up to $250 a day to ensure adequate enrollment, and some even gave referral bonuses to doctors who sent potential subjects their way. Cohen then exposed how Lilly was (...) able to keep costs down: by recruiting homeless alcoholics to serve as research guinea pigs. “In many ways,” Cohen reported, “the practice is mutually beneficial. For Lilly, it is efficient and limits the risk that subjects will sue if harmed by an experiment or divulge particulars of a drug.” And the subjects “get several weeks or months of free room and board, and in interviews they express voluble gratitude for what they often call easy money.”. (shrink)

Some participants will get HIV-infected in HIV prevention trials, despite risk reduction measures. The subsequent treatment responsibilities of sponsor-investigators have been widely debated, especially where access to antiretroviral therapy (ART) is not available. In this paper, we explore two accounts of beneficence to establish whether they can shed light on sponsor-investigator responsibilities. We find the notion of general beneficence helpful insofar as it clarifies that some beneficent actions will be obligatory where they can be dispensed without scuppering the trial. (...) We find the notion of specific beneficence helpful insofar as it directs investigators to attend to the needs of trial participants; however the range of interventions that could be provided remains unhelpfully broad. We then examine accounts of the investigator-participant relationship to narrow the range of interventions that investigators should provide, concluding that health-care, and HIV infection, are appropriate foci. We conclude that when investigators are able to meet the ART needs of their participants (e.g. referral, assisted referral or direct provision) without sacrificing trial quality, they must do so. However, there is little of this explicit direction to be found in the account of specific beneficence itself, but rather it is found in accounts of the relationship that are compatible with beneficence. (shrink)

Conscience is typically invoked in healthcare to defend a right to conscientious objection, that is, the refusal by healthcare professionals to perform certain activities in the name of personal moral or religious views. On this approach, freedom of conscience should be respected when the individual is operating in a professional capacity. Others would argue, however, that a conscientious professional is one who can set aside one’s own moral or religious views when they conflict with professional obligations. The debate on conscientious (...) objection has by and large crystallised around these two positions, with compromise positions aiming at striking a balance between the two, for instance, by arguing for referral requirements by objecting healthcare professionals.In this article, I suggest that the debate on conscientious objection in healthcare could benefit from being reframed as a problem around demandingness rather than one about freedom of conscience and moral integrity. Being a professional, and a healthcare professional specifically, typically requires taking on additional burdens compared with non-professionals. For instance, healthcare professionals are expected to take on themselves higher risks than the rest of the population. However, it is also widely agreed that there are limits to the additional risks and burdens that healthcare professionals should be expected to take on themselves. Thus, a question worth exploring is whether, among the extra burdens that healthcare professionals should be expected to take on themselves as a matter of professional obligation, there is the burden of acting against one’s own conscience. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:It's Not Always Just a RashAdam BossertI looked at the emergency department track board and saw a patient waiting for a provider who was "roomed" in a hallway stretcher with a chief complaint of a rash. I briefly considered his ultimate disposition, "He's probably fine. He can't be that sick if he was triaged as safe for the hallway." I was tired and close to the end of an (...) overnight shift and thought he would be a quick turnaround, likely discharged, since rashes are typically benign. I walked over to his stretcher after a quick chart biopsy that highlighted his mildly increased heart [End Page 24] rate on arrival as well as his history of polysubstance use and homelessness."Hey doc, I don't feel so good.""I'm sorry to hear that. What's specifically bothering you?""I am itching all over with these bumps. My skin is red, and I also think I'm withdrawing since I have body aches and chills."The interview continued.I discovered his last heroin use was approximately eight hours prior to arrival. I thought he was an ideal candidate for buprenorphine since he was actively withdrawing. I was recently licensed to prescribe this medication and excited to use my license for the first time. He declined the suggestion, however, preferring methadone instead. Buprenorphine can precipitate withdrawal if not given long enough after opioid use or if an incorrect dose is given; thus, many patients are hesitant to take it. He also stated he was predominantly here for his rash and did not want rehabilitation placement. I ordered our initiation methadone dose as well as a screening COVID-19 test and a urine drug screen test, which are both needed for rehabilitation placement in case he changed his mind.His rash was highly suspicious for scabies. He was covered with red bumps that spared only his face, some in linear distributions, and was actively scratching his arms and legs during the interview. I prefer oral ivermectin over topical permethrin for the homeless population simply for ease of administration, lower cost, and increased compliance. He received ivermectin for his scabies and knew he could return to the emergency department for a repeat dose if he was unable to fill a prescription.What happened next is, in my experience, an all-too-common scenario.The patient told me that the methadone is "doing nothing." I explained he could no longer take buprenorphine since he already received methadone, which only made him more frustrated. Unfortunately, I am restricted with the amount of methadone I can give in the emergency department, largely due to the drug's long half-life, and thus I was unable to give him more, let alone attempt titrating to his tolerance.Opioid withdrawal is not a life-threatening diagnosis; these patients are not typically admitted to the hospital. The management consists of initiating either methadone or buprenorphine, symptomatic treatment and then outpatient referral or rehabilitation placement. I explained the options to him, and he requested to be discharged since he was deferring rehabilitation. He was discharged. I was able to treat his rash but his chronic illness, opioid use disorder, was not controlled.I discharge a patient in opioid withdrawal or who has opioid use disorder almost every day, and I think most emergency medicine physicians would echo that statement. The disposition is not wrong from the perspective of the individual physician, but it feels like the system has failed these patients when I think of the frequency that they return and their baffling risk of overdose. The latter can be reduced by giving patients Narcan, the drug to reverse opioid overdose, upon discharge but this is just placing a bandage over the problem and not all emergency departments can fund this risk-reduction tool.I saw my patient's COVID-19 result return as I wrapped up my shift. It was positive. And, of course, he was in our department's hallway the whole time, only intermittently using his mask. I suddenly realized that while yes, he was withdrawing, he also may have had a symptomatic COVID-19 infection! I quickly reopened his chart, only to... (shrink)

Research on sexual violence is fraught with ethical and methodological challenges due to its sensitive nature. This paper describes the ethical and methodological challenges encountered in planning and conducting two exploratory studies on sexual violence that included in-depth interviews of eight female adolescent rape survivors in Ibadan and four married women in Lagos Nigeria who were raped, forced to perform sexual acts and sexually deprived. The first challenge encountered was an Institutional Review Board (IRB) requirement to obtain parental permission from (...) adolescents, when such a requirement may place the adolescent at risk if a parent was a perpetrator of sexual violence. Using arguments emphasizing the Council for International Organization for Medical Sciences guidelines helped convince the IRB to provide a waiver of parental consent. Second, the privacy required to conduct in-depth interviews for rape survivors was difficult to achieve because five of the rape survivors were apprentices who work in public settings which are typically used to conduct business in the informal sector. To overcome this challenge, interviews were conducted in safe locations, investigator's offices and homes of survivors. The culture of silence associated with sexual violence posed a challenge because it encourages perpetration of violence with impunity causing rape survivors to suffer in silence. None of the affected adolescents had sought judicial redress for rape despite availability of stringent punishment for this behaviour. Referral information was provided on where survivors could seek care. Interviews with the women could not be recorded on audio-tapes because of concerns that their partners might identify their voices from the tapes and punish them for this. Although research on sexual violence poses ethical and methodological challenges, it is not only desirable but also feasible to conduct such research in ways that ensure safety of participants. (shrink)

In 1992, the United States Supreme Court, in Planned Parenthood of Southeastern Pennsylvania v. Casey, upheld the ruling in Roe v. Wade, namely that women have a right “to choose to have an abortion before viability and to obtain it without undue interference from the State.”1 However, since this ruling, some states have imposed regulations that greatly limit this right by restricting access. Texas is a recent example of this. Two proposed restrictions in House Bill 2, which will be discussed (...) in detail below, will force all but eight clinics that are located in metropolitan areas to shut down. The U.S. Supreme Court put the proposed restrictions on hold in October 2014, allowing several clinics to remain open while the restrictions are being appealed in the U.S. Court of Appeals for the Fifth Circuit. If the restrictions are passed, however, those clinics will be forced to shut down and, as a result, many women in Texas will be required to travel more than 100 miles in order to access a safe and legal abortion. Much of the focus of these restrictions has been on women and rightly so. However, I want to turn the attention to physicians. The requirements exacerbate unfair treatment of abortion providers compared with other physicians. Abortion providers face threats from the public—some of which turn into violent attacks—and they are often ostracized by their fellow medical practitioners. There are so few abortion providers to begin with and the proposed requirements limit these physicians’ opportunities to practice the branch of medicine of their choosing. Although the HB 2 requirements may not result in an unconstitutional undue burden on physicians, the challenges created by the bill limit physicians’ abilities to provide abortions. As a result of these limits, HB 2 creates an unconstitutional undue burden for women seeking abortions by creating barriers directed at abortion providers and clinic staff who are willing and able to provide abortions. The first of the two controversial HB 2 requirements is the admitting privileges requirement: “A physician performing or inducing an abortion must, on the date the abortion is performed or induced, have active admitting privileges at a hospital that is located not further than 30 miles from the location at which the abortion is performed or induced.”2 The second requirement is the ambulatory surgical center requirement: “The minimum standards for an abortion facility must be equivalent to the minimum standards adopted under [Texas Health & Safety Code] [...] for ambulatory surgical centres.”3 In order to meet these state-mandated obligations, some abortion clinics would have to spend more than $1 million in upgrades if they wish to remain open. The District Court decided that the ambulatory surgical center requirement places an unconstitutional undue burden on women, and that the two requirements together place an undue burden on women in Texas and especially in the Rio Grande Valley where the nearest clinic is a couple hundred miles away.4 Later, the U.S. Court of Appeals for the Fifth Circuit reversed the District Court’s decision and argued, “the admitting privileges requirement is constitutional on its face.”5 While the regulations are being appealed, the Supreme Court granted a stay of injunction, allowing about twelve abortion clinics to reopen until a final decision regarding the regulations is made. The District Court ruled that the purpose of the two regulations was to create a substantial obstacle for women seeking abortions in Texas. While the defendants argued that the regulations were designed to make abortions safer and reduce risk, the Court decided that this was not the case. An abortion, especially a first-term abortion, is a very safe procedure and is safer than many other routine surgical procedures. As stated in Planned Parenthood v. Casey, “Unnecessary health regulations that have the purpose or effect of presenting a substantial obstacle to a woman seeking an abortion impose an undue burden on the right.”6 The undue burden in this case is imposed, not through restricting women’s access directly, but by restricting physicians’ freedom to perform abortions. The admitting privileges requirement has reduced the number of physicians who can perform abortions and the ambulatory surgical center requirement has reduced the number of clinics where abortions can be performed. The American Medical Association states, “[t]he Principles of Medical Ethics of the AMA do not prohibit a physician from performing an abortion in accordance with good medical practice and under circumstances that do not violate the law.”7 This means that physicians are not required to perform abortions, except in emergency situations, but can as long as the procedure is done safely and does not violate the law. The new Texas regulations, however, are so restrictive that few abortion providers, limited to only four urban areas, can legally perform abortions. Physicians do not have an absolute right to perform abortions as opposed to women who have an absolute right to have access to an abortion. Physicians do face many challenges that other professionals face in terms of obtaining qualifications and finding work. Abortion providers, however, face challenges that most other physicians do not. The restrictions imposed by these regulations exacerbate unfair treatment toward abortion providers and place further obstacles in their path in terms of providing the service they want and are qualified to provide. Both abortion clinics and abortion providers are being treated differently from other medical clinics and physicians. For instance, “grandfathering of existing facilities and the granting of waivers from specific requirements is prohibited for abortion providers, although other types of ambulatory surgical facilities are frequently granted waivers or are grandfathered.”8 Many abortion clinics cannot afford the necessary upgrades. Furthermore, it is extremely expensive to open a brand new clinic that complies with the ambulatory surgical center requirements. Being grandfathered in would be the only option available to abortion clinics that cannot afford the upgrade. However, unfair treatment of abortion clinics and providers is preventing those clinics from being grandfathered into the new system. As a result, many abortion clinics may be forced to close. Admitting privileges are proving difficult or impossible for physicians both to obtain and, for those who have already been granted privileges, to keep. Dr. Sherwood Lynn, an obstetrician-gynecologist who has performed abortions for decades, describes the process of obtaining admitting privileges and the difficulties abortion providers face. After sending in an application a physician must wait for the hospital to send them the required materials, “but if the address of the practice on the application is of an abortion provider or clinic, [the hospital] won’t send [them] the package of materials required. [They] simply can’t apply.”9 Dr. Lynn and several other physicians have surmised that hospitals are only withholding privileges from qualified physicians who perform abortions and that other physicians do not face this discriminatory treatment. Hospitals have also revoked privileges granted to physicians after learning that the physicians perform abortions. For instance, in Texas two doctors, “received notices [...] informing them that their admitting privileges to the University General Hospital of Dallas have been revoked, with the hospital’s CEO claiming the hospital was unaware they were providing abortion care and that the hospital believed such care would damage its reputation.”10 What is curious about this revocation is that, “federal and state laws [...] forbid hospitals from discriminating against doctors who perform abortions,” and yet hospitals are clearly doing just that.11 Dr. Pamela Richter, another abortion provider in Texas, had her temporary admitting privileges revoked with no explanation and because of this, the clinic where she performed abortions, Reproductive Services, can no longer provide abortions at all.12 As the hospital gave no reason for the revocation, it not clear Dr. Richter’s privileges were revoked because she performs abortions. Dr. Richter, however, has performed over 17,000 abortions and her privileges were revoked soon after HB 2 was introduced.13 According to the Texas Hospital Association, giving admitting privileges to doctors who do not work for the hospital is expensive and time-consuming but this does not account for the fact that hospitals are revoking previously granted privileges from physicians whom they learn are providing abortion services.14 As mentioned previously, the District Court found that the admitting privileges requirement and the ambulatory surgical center requirement do not further ensure the health and safety of women undergoing an abortion. Several physicians have testified to this fact. Dr. Lynn stated in an interview: The admitting privileges requirements are [...] absolutely unnecessary. If you have a number of patients waiting for procedures, and something happens and a patient needs to be transferred to a hospital, you’re not going to leave everyone else and go to the hospital. That makes no sense. You’re going to refer that person to a gynecologist at the hospital. There is no safety issue involved here. If a patient shows up with an emergency, every hospital is required to admit that patient. They have to by law.15 It is rare that complications will arise from an abortion performed in a clinic. Dr. Richter, for example, has performed more than 17,000 abortions and not once had to send a patient to a hospital because of complications resulting from the procedure. According to Dr. Lynn even if abortion providers were granted privileges to hospitals, it is unlikely that they will exercise them. In essence, having admitting privileges at a hospital does nothing to further ensure the safety of an already safe procedure. The only result of the admitting privileges requirement is to limit certain physicians’ ability to perform legal abortions. Not only do the HB 2 requirements fail to further ensure the health and safety of women, the HB 2 requirements may actually create more health risks to women who cannot access the eight remaining clinics. The first risk is that the remaining clinics would have an influx of patients that they may not be able to handle, forcing women to wait longer for an appointment. As stated by the District Court, “[e]ven assuming every woman in Texas who wants an abortion [...] could travel to one of the four metropolitan areas where abortions will still be available, the cumulative results of HB 2 are that, at most, eight providers would have to handle the abortion demand of the entire state.”16 Furthermore, “[t]hat the State suggests that these seven or eight providers could meet the demand of the entire state stretches credulity.”17 Abortion is a time sensitive procedure. It is safest when performed early in a pregnancy. The increase in patients to these remaining clinics, assuming all women in Texas can access them, will increase wait times and may force women to have abortions later in pregnancy. In the worst-case scenario, a woman would not see an abortion provider at all before viability. Such instances may be rare, but they are possible. In such cases, women’s access to legal abortions becomes impossible and thereby violate the ruling in Roe. Clinics may be able to avoid the aforementioned problems if they hire more physicians. However, there are two barriers to hiring more physicians. First, as mentioned previously, admitting privileges to Texas hospitals are difficult, if not impossible, for abortion providers to obtain. Second, given the negative treatment of abortion providers by anti-abortion groups, many physicians are not willing to perform abortions. The harassment abortion providers face is unique to those physicians and many physicians will not perform abortions for that reason. In an article published in the Austin Chronicle, anti- abortion activist Abby Johnson, “discusses how her group investigated appraisal district records to find the new location of where an Austin abortion physician plans to work.”18 Johnson states, “These abortionists are feeling the pressure from the pro-life movement in Texas. I think they feel like they’re on the run. And that’s how we want to keep it.”19 If the HB 2 requirements are passed and there remain at most eight abortion providers in Texas, these activists will concentrate on those clinics and, “the dangerous impact of their intimidation tactics will be exacerbated.”20 Even if the number of physicians needed to meet the demand in Texas can obtain admitting privileges and work at one of the remaining clinics, they may choose not to do such work because they are putting themselves at risk. The harm abortion providers face from such anti-abortion groups is not unique to Texas. There are stories from all over the country and from other countries where abortion is legal of physicians receiving death threats. Dr. George Tiller, an abortion provider in Kansas, was killed outside his church and had received numerous death threats prior to this. The HB 2 requirements are making it so that abortion providers either cannot provide their services any longer or will face increased threats and increased danger to themselves. Physicians are allowed to conscientiously object to providing medical interventions in certain circumstances for moral and religious reasons. However, there are limits on this right. According to the American Congress of Obstetricians and Gynecologists, “[w]hen conscientious refusals conflict with moral obligations that are central to the ethical practice of medicine, ethical care requires that the physician provide care despite reservations or that there be resources in place to allow the patient to gain access to care in the presence of conscientious refusal.”21 I would argue fear for one’s safety in the face of immediate threats is perhaps a stronger ground on which to refuse to provide care than a personal belief that abortion is immoral or against one’s religion. ACOG also states, “[p]roviders with moral or religious objections should either practice in proximity to individuals who do not share their views or ensure that referral processes are in place so that patients have access to the service that the physician does not wish to provide.”22 This responsibility has been largely disputed by the medical community but in cases of rape, incest, and health risks to women, referrals must be made without exception. However, under the requirements of HB 2, working in proximity to an abortion provider may not be possible because they are so geographically limited. Referrals are supposed to be made within reason. Some areas of Texas, such as the Rio Grande Valley, are up to 200 miles away from the nearest clinic that would remain open if HB 2 is passed. Referrals may simply not be feasible given the geographical distances and the decreasing number of available physicians. As mentioned above, there are two risks to the health and safety of women as a result of HB 2. The second of these is that if a woman cannot access one of the remaining clinics, she may seek out a more convenient but illegal and unsafe abortion, which is far more likely to result in a dangerous complication. Dr. Lynn states, “[b]ecause of the restrictions lawmakers impose, women will seek abortions illegally, and we’re going to see a rise in septic abortions.”23 Some areas of Texas might effectively revert back to a pre-Roe era where abortions were performed in unsanitary conditions by unqualified people resulting in dangerous medical complications far more often than legal abortion procedures do now. Physicians like Dr. Lynn who want to prevent this from happening generally cannot do so without facing legal sanction. Physicians have a duty to provide safe medical care and if they cannot obtain admitting privileges, they cannot exercise this duty. ACOG released a statement expressing their objections to the new requirements. They state that HB 2 is, “plainly intended to restrict the reproductive rights of women in Texas through a series of requirements that improperly regulate medical practice and interfere with the patient-physician relationship.”24 Executive Vice-President of ACOG, Hal C. Lawrence III stated: The Texas bills set a dangerous precedent of a legislature telling doctors how to practice medicine and how to care for individual patients. ACOG opposes legislative interference, and strongly believes that decisions about medical care must be based on scientific evidence and made by licensed medical professionals, not the state or federal government.25 Abortion is one of only a few areas of medicine where the legislature imposes so many regulations restricting particular physicians’ ability to practice medicine. Not only are abortions providers being regulated by the state, they are also facing clear discrimination from others within the medical community. The state is closing down clinics that do not meet the ambulatory surgical center requirements and hospitals are denying physicians admitting privileges because they perform abortions. In summary, abortion providers are being discriminated against both by the legislature and other members of the medical community. Other physicians who do not perform abortions are not denied admitting privileges on discriminatory grounds. Clinics that cannot afford upgrades to become an ambulatory surgical center are being grandfathered in, while abortion clinics are being forced to close down. Ob-Gyns who conscientiously object to performing abortions and who are not located in close proximity to at least one abortion provider cannot effectively fulfill their duty to refer patients. Lastly, given the barriers these regulations will create, there will likely be a rise in complications resulting from abortions provided under grossly unsafe conditions. Physicians, whose duty it is to provide safe and effective medical care, are being denied the right to exercise this duty. While this denial may not be unconstitutional, it is certainly unjust and discriminatory and creates obstacles that other physicians do not face. Most importantly, these obstacles are creating an undue burden for women. The HB 2 requirements do not increase the health and safety of abortions; all they do is create substantial obstacles for women. In light of these observations, the requirements seem to me to be in clear violation of Casey, in which it was decided that, “[u]nnecessary health regulations that have the purpose or effect of presenting a substantial obstacle to a woman seeking an abortion impose an undue burden on that right.”26 These regulations do just what Casey was meant to prohibit and this is accomplished through limiting physicians’ ability to practice safe abortions across the state of Texas. Therefore, the HB 2 requirements may not impose an undue burden on doctors but they do impose an undue burden on women. PDF available: Rachel Hill, "Texas HB 2," Voices in Bioethics. References: 1 Planned Parenthood of Southeastern Pennsylvania v. Casey, pg. 2. 2 Whole Women’s Health v. Lakey, pg. 2. 3 Ibid. 4 Ibid., 4. 5 Ibid., 2. 6 Planned Parenthood v. Casey, pg. 16 7 AMA Code of Medical Ethics, “Opinion 2.01 – Abortion,” American Medical Association. 8 Whole Women’s Health v. Lakey, pg. 10. 9 Dr. Sherwood Lynn, “A Texas Ob-Gyn Details the Horrific Consequences of Abortion Restrictions,” Cosmopolitan. 10 Feminist Newswire, “Texas Hospitals Revoke Admitting Privileges to Abortion Providers,” Feminist Majority Foundation Blog. 11 Ibid. 12 Ibid. 13 Ibid. 14 Glenn Hegar, “Texas Hospital Association’s Statement of Opposition to Section 2 of the Committee Substitute for Senate Bill 5,” Texas Hospital Association. 15 Dr. Lynn, “A Texas Ob-Gyn.” 16 Whole Women’s Health v. Lakey, pg. 10. 17 Ibid. 18 Mary Tuma, “Undercover Audio Reveals Anti-Abortion Tactics: Anti-abortion activists monitor and track providers, patients,” Austin Chronicle. 19 Ibid. 20 Ibid. 21 Committee on Ethics, “The Limits of Conscientious Refusal in Reproductive Medicine,” The American Congress of Obstetricians and Gynecologists. 22 Ibid. 23 Dr. Lynn, “A Texas Ob-Gyn.” 24 “Ob-Gyns Denounce Texas Abortion Legislation: Senate Bill 1 and House Bill 2 Set Dangerous Precedent,” The American Congress of Obstetricians and Gynecologists. 25 Ibid. 26 Planned Parenthood v. Casey, pg. 16. (shrink)

IntroductionThe National Institute for Health and Care Excellence guidelines acknowledge the importance of the parent–infant relationship for child development but highlight the need for further research to establish reliable tools for assessment, particularly for parents of children under 1 year. This study explores the acceptability and psychometric properties of a co-developed tool, ‘Me and My Baby’.Study designA cross-sectional design was applied. The MaMB was administered universally with mothers during routine 6–8-week Health Visitor contacts. The sample comprised 467 mothers. Dimensionality of (...) instrument responses were evaluated via exploratory and confirmatory ordinal factor analyses. Item response modeling was conducted via a Rasch calibration to evaluate how the tool conformed to principles of ‘fundamental measurement’. Tool acceptability was evaluated via completion rates and comparing ‘completers’ and ‘non-completers’ demographic differences on age, parity, ethnicity, and English as an additional language. Free-text comments were summarized. Data sharing agreements and data management were compliant with the General Data Protection Regulation, and University of York data management policies.ResultsHigh completion rates suggested the MaMB was acceptable. Psychometric analyses showed the response data to be an excellent fit to a unidimensional confirmatory factor analytic model. All items loaded statistically significantly and substantially on a single underlying factor. The item response modeling showed that most MaMB items fitted the Rasch model. item reliability was high yet the test yielded little information on each respondent, as highlighted by the relatively low ‘person separation index’ of 0.1.Conclusion and next stepsMaMB reliably measures a single construct, likely to be infant bonding. However, further validation work is needed, preferably with ‘enriched population samples’ to include higher-need/risk families. The MaMB tool may benefit from reduced response categories and some modest item wording amendments. Following further validation and reliability appraisal the MaMB may ultimately be used with fathers/other primary caregivers and be potentially useful in research, universal health settings as part of a referral pathway, and clinical practice, to identify dyads in need of additional support/interventions. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:I Saw My ReflectionAdrienne Feller NovickI saw my reflection as I looked through the window of the isolation room. The image caused me to pause and look again. The reflection of sunlight had merged my image and the patient's together. For a moment, we seemed to be one person.She was pale with translucent skin, her bald head obscured under a colorful scarf. Her three children sat as still as (...) statues, staring at their mother wordlessly. Then, I realized her children appeared to be the same ages as my children. I felt a surge of emotions jumbled together, a mother should not die like this, leaving her young children motherless. She and I shared the exact same birthday; it could have been me in that hospital bed. However, I did not have a terminal diagnosis and my children were safe at home, complaining about doing homework. In the blink of an eye, without even recognizing what had just happened, I was face to face with my mortality.I tampered my emotions and held them back. I collected myself, and remembered the reason I was there. My professionalism took charge. I am a member of the Medical Ethics consultation service at a large healthcare system. A request was made to help with the ethical dilemma of a patient with a grave prognosis unwilling to discuss a hospice referral. The dilemma here represented two issues in conflict: patient autonomy and provider beneficence versus non-maleficence. Respect for autonomy allows each person the right to make informed decisions about their care that respect their values and personal beliefs. Provider beneficence is balanced by non-maleficence: beneficence is the expectation that physicians make treatment decisions in the best interest of the patient and non-maleficence guides physicians to minimize harm. This case called for analyzing the balance of autonomy with proportionality, weighing the risks versus the benefits of treatment decisions.I knocked on the door and they all turned and looked in my direction. The patient signaled me to enter. Although she was smiling, the sadness in the room was palpable. I introduced myself to the patient and her children and diplomatically explained the reason for my visit. I turned to the children and asked if there was anything I could get for them. I got three weak "no thanks." I asked the patient if I could stop by later. Then, I went to see my next patient. When I returned, I listened with rapt attention as she described the mosaic of her life story. When she finished, we sat together for a long time, neither of us speaking. Out of the blue, she told me she was not afraid of dying. She said she would welcome death to end her pain. She continued, explaining that her fear was that her children were not ready to accept her death. She was worried about how her death would hurt them, and all she wanted to do was to protect them. She reiterated her wish to be kept alive with all aggressive medical treatment possible. She communicated [End Page E6] that she understood and appreciated the severity of her condition. Her reason for continuing treatment was to give her children precious time. She said, "I would lie in front of a car to protect my children." As I was heading towards the door, her eyes welled up with tears. She thanked me for listening and for my kindness. We said our goodbyes. She remained full code and died four days later during cardiopulmonary resuscitation. I walked past her empty room later that day and kept walking.I was not prepared for how her death changed me. Throughout my career as a healthcare professional, I have primarily worked with patients at the end of their lives. I have seen many empty rooms following the death of a patient and helped countless people journey through their stages of grief towards acceptance. After I complete a consultation, I move on to the next patient. I do this every day. This time, something was different. After she died, I was not sleeping well, I had a hard time concentrating, I was not eating well, and I was... (shrink)

The South African Choice on Termination of Pregnancy Act 92 of 1996 gives women the right to voluntary abortion on request. The reality factor, however, is that five years later there are still more ‘technically illegal’ abortions than legal ones. Amongst other factors, one of the main obstacles to access to this constitutionally enshrined human right is the right to conscientious objection/refusal. Although the right to conscientious objection is also a basic human right, the case of refusal to provide abortion (...) services on conscientious objection grounds should not be seen as absolute and inalienable, at least in the developing world. In the developed world, where referral to another service provider is for the most part accessible, a conscientious objector to abortion does not really put the abortion seeker’s life at risk. The same cannot be said in developing countries even when abortion is decriminalised. This is because referral procedures are fraught with major obstacles. Therefore, it is argued that the right to conscientious objection to abortion should be limited by the circumstances in which the request for abortion arises. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Removing the Mask: Hopeless Isolation to Intersex AdvocacyAlexandra von KlanStrangers undoubtedly perceive me as female, but I identify as an intersex woman. My karyotype is 46,XY, a typically defined marker of male biological sex, and I was born with undeveloped, non–functioning gonads. As an intersex person, I know firsthand the negative consequences of pathologizing intersex people’s lived experience by categorizing otherwise healthy, functioning organs and bodies as abnormal. The (...) following narrative recounts conversations and interactions with medical providers during my diagnosis and subsequent treatment of pure XY gonadal dys-genesis, sometimes referred to as Swyer Syndrome. I hope to elaborate upon emotionally significant actions and inactions of medical care providers to expose consequential effects on my emotional processing, physical health, and self–actualization.In December 1988, I was born with “typical” female genitalia. No one knew I was an intersex woman with 46,XY karyotype. Thus, there was no hesitation in the announcement of the birth of a girl in the delivery room or later, on my birth certificate. My parents raised me as a girl and dressed their firstborn in culturally normative feminine garments and accessories: lace frilly frocks, oversized bows, white stockings, and black patent leather Mary Jane’s. I embraced femininity and expressed this gender identity throughout my childhood and adolescence. I’m the eldest of six children split between two households.In January 2005, a month after my sixteenth birthday, delayed puberty and absent menstruation prompted an appointment to a local women’s health center. Nurses collected blood samples and administered an MRI scan on my pelvic region. A week later, my father received a perplexing phone call. An inexperienced doctor told him “there must be something wrong” with me, because lab results revealed I was “chromosomally male.” My father recalls the information presented like, based on the evidence, “your daughter may not be completely female,” and that is that. His impression was that she knew little about the subject and was a bit clueless. She did not mention Swyer Syndrome, or any diagnosis for that matter.Up to this point, I was unaware that a member of my extended family also had Swyer Syndrome. Born in the 1950s, secrecy engulfed her medical treatment and doctors warned her parents against revealing her true chromosomal sex in order to prevent the hysterical panic and depression they [End Page E14] thought the truth would bring. Years later, she sought her medical records and unearthed the truth. Shortly after my father received that dubious phone call, my relative’s endocrinologist provided a referral to his mentor, “Doctor A,” a clinical reproductive endocrinologist.Under Doctor A’s care, I experienced the first of many pelvic exams. Much to my discomfort, Doctor A inspected my semi–clothed body with a male resident in the room. As a people–pleasing teen, I granted permission for his presence; I didn’t voice my preference for a female alternative. Doctor A’s cold hands pressed around each undeveloped breast, pulled a gown away from my hips to inspect a sparse patch of pubic hair, and conducted an examination of my vaginal canal.Shortly after the examination, Doctor A charted Swyer Syndrome as the official diagnosis. Speaking to my father and me, he described my condition as an extremely rare genetic mutation. He told us that Swyer Syndrome was an intersex condition, a group of congenital disorders impacting a person’s internal or external reproductive systems, including endocrine function and genitalia. He explained I had atypical streak gonads instead of ovaries and that, despite having typical male sex chromosomes, I was still very much a girl. He disclosed that my vaginal canal was moderate in length, perhaps further evidence—or consolation—that my body possessed normative female reproductive attributes after all.Next, Doctor A identified a pressing medical concern—golf–ball–sized benign tumors had developed on each streak gonad; if allowed to remain, they would pose an increasing risk of malignancy. We scheduled an appointment for laparoscopic gonadectomy six months later. I left his office with a 3–month prescription for estrogen and progesterone oral tablets. On the way home, we drove to an electronics store where my father... (shrink)

A woman presents to her physician with a newly diagnosed condition that in her considered and informed judgment requires an elective surgical procedure. The physician, after speaking with her, agrees that this is an acceptable option. The procedure in question is in fact one of the commonest surgeries performed on American women. The physician is also aware that although the procedure is deemed elective in this and in most cases, research has shown that the consequences of not providing the procedure (...) when it is requested can be severe in terms of both physical and emotional sequelaewhich itself can add to the complexity and risk of the procedure. Presented with this option, the patient expresses dismay but also her resigned commitment to follow through with this referral, and leaves the office in tears. (shrink)

Health workers and support staff at Malawi’s major referral hospital, the Queen Elizabeth Central Hospital, Blantyre, were on strike between 5th and 19th October 2001. The health workers’ grievances included: lack of risk allowances; poor professional allowances; low salaries; and low housing allowances. The strike resulted in almost total closure of the 1500-bed hospital; only the burns and orthopaedic wards continued to serve patients. Volunteer staff, comprising the Red Cross, and nursing and medical students provided services. Verbal and (...) written threats by the authorities had minimal effect on terminating the strike; rather, they encouraged the resolve to continue with the industrial action. We report aspects of the genesis, progress and resolution of the strike. Although not much seems to have been achieved, both the employer and the workers need to draw lessons from the experience. (shrink)

SummaryIn 1968, a prospective study was started in collaboration with the Family Planning Association to try to provide a balanced view of the beneficial and harmful effects of different methods of contraception. This investigation is now in progress at seventeen clinics and over 17,000 women are under observation. At the time of recruitment, all these women were married white British subjects, aged 25–39 years, who voluntarily agreed to participate. Fifty-six per cent were using oral contraceptives, 25% were using a diaphragm (...) and 19% were using an intrauterine device. During follow-up each woman is questioned at return visits to the clinic and a record of pregnancies and their outcome, hospital referrals, changes in contraceptive methods and the results of cervical smears, is accumulated. Women who default are sent a postal questionnaire and, if this is not returned, are telephoned or visited in their homes to collect the necessary information.So far, data obtained during 56,000 woman-years of observation are available for analysis. Follow-up has been maintained with an annual lapse rate of about 0.3%due to withdrawal of co-operation or loss of contact; adherence to the method of contraception in use at recruitment has been reasonably good, and the reporting of pregnancies and hospital admissions appears to have been both reliable and unbiased.The present data include only 24 deaths, so the mortality associated with different contraceptive methods cannot yet be estimated. With regard to morbidity, however, our preliminary results closely resemble those obtained in the prospective study carried out by the Royal College of General Practitioners and in the principal retrospective studies carried out in Britain and the United States. Women who used oral contraceptives at the start of the study experienced adeficiencyof hospital referrals for cancer, benign lesions of the breast, menstrual disorders other than amenorrhoea, duodenal ulcer, and retention cysts of the ovary; they showed anexcessof referrals for cerebrovascular disease, cervical erosion, skin disorders, self-poisoning, migraine, venous thrombosis and embolism, hayfever, gallbladder disease, amenorrhoea, and sterility. Women who used a diaphragm showed adeficiencyof hospital referrals for carcinoma-in-situ and dysplastic lesions of the cervix uteri and accidental injury; and anexcessof referrals for haemorrhoids and cystitis. Women who used an IUD experienced anexcessof hospital referrals for anaemia, varicose veins and salpingitis. About half of these differences were predicted from other studies while some suggestive evidence already existed for a further five. Of the remaining six, some probably reflect the influence of selective factors or chance.Multiple pregnancies, stillbirths, malformations, the sex ratio and birthweight showed no consistent relationship to method of contraception. The outcome of unplanned pregnancies occurring in women using an IUD, however, was remarkably unfavourable both in terms of ectopic gestation and miscarriage.Clear evidence was found of impairment of fertility after discontinuation of oral contraceptives. Whether this is likely to lead to permanent sterility in some women is uncertain.The study has provided data on the efficacy of a wide variety of contraceptive methods. In general the failure rates are in keeping with those obtained in other large-scale studies, save that those for the diaphragm and the sheath are much lower than those usually quoted.The available evidence does not yet allow a final balance to be struck between the benefits and risks associated with the new methods of contraception that have become widely used during the last two decades. It seems clear, however, that there are no material risks associated with the use of the diaphragm apart from the risk of pregnancy and that there may be some unintended benefits. (shrink)

Background: Poor psychosocial work environments are considered critical factors of nurses’ intention to leave their profession. Workplace injustice has been proven to increase the incidence of psychiatric morbidity among workers. However, few studies have directly investigated the effect of workplace justice on nurses’ intention to leave their profession and the population attributable risk among nurses. Objective: This study identified factors associated with workplace justice and nurses’ intention to leave the profession. Method: A cross-sectional survey was conducted using a self-administered (...) structured questionnaire. Approximately 10% of all secondary referral centers in Taiwan were stratified and randomly sampled. Multiple logistic regression and population attributable risks were preformed to assess the effect of workplace justice on nurses’ intention to leave the nursing profession. Ethical considerations: This study was approved by the Research and Ethical Committee of National Taiwan University Hospital. Only nurses who consented to the study participated in the survey. Result: A total of 2268 nurses were recruited, of whom 1417 (62.5%) satisfactorily completed the questionnaire. The participants were classified and 342 (24.1%) of them were placed into the low workplace justice group. Nurses with low workplace justice had a higher intention of leaving the profession (adjusted odds ratio = 1.34, 95% confidence interval = 1.02–1.77). “Employees’ opinions are influential in hospital’s decision making” and “employees’ performance is evaluated fairly” were the most influential factors of the participants’ intention to quit. The adjusted population attributable risk was 3.7% for low workplace justice. Conclusion: This study has identified that workplace justice is a protective factor of nurses’ leaving their current profession. A fair performance appraisal system and increased autonomy at work are warranted to dissuade nurses from leaving the nursing profession. (shrink)

For children, the collateral damage of the COVID-19 pandemic response has been considerable. In this paper, we use the framework of evidence-based medicine to argue that child abuse is another negative side effect of COVID-19 lockdowns. While it was certain that school closures would have profound social and economic costs, it remains uncertain whether they have any effect on COVID-19 transmission. There is emerging evidence that lockdowns significantly worsened child abuse on a global scale. Low-income and middle-income countries are particularly (...) vulnerable to increases in child abuse. The best available external evidence from systematic research during the pandemic demonstrates an increase in the risk of child maltreatment, an increase in child maltreatment hospitalisations and a concerning decrease in official child maltreatment referrals. The paradoxical phenomenon of increased hospitalisations and decreased reports is unlikely to be explained by a genuine decrease in child abuse. We conclude that lockdowns have an unacceptably high risk of negative side effects for children, as evidenced by child abuse, the true extent of which appears to be masked by lockdown-related disruptions to schools and other surveillance systems. The desire for a sense of security may be a tempting bias towards emphasising the resilience of children, but it is ethically problematic to push children towards abuse in the name of public health. It is our view that the collateral damage of prolonged school closures for society’s most vulnerable members is a powerful ethical consideration against any pandemic response which involves their use. (shrink)

Although the use of ECT has declined dramatically from its inception, this decrease has recently shown signs of leveling out because of ECT's powerful therapeutic effect in severely ill depressed individuals who either do not respond to pharmacologic alternatives or are too ill to tolerate a relatively lengthy drug trial. Notwithstanding its therapeutic benefits, ECT has also remained a controversial treatment modality, particularly in the eye of the public. Given the unsavory qualities associated with the word “electroconvulsive,” claims of possible, (...) probable, or even certain brain damage with ECT have easily found listeners. A careful, nonselective assessment of data covering the areas of pathology, radiology, electrophysiology, biochemistry, and neuropsychology leads both to certain conclusions and to certain unanswered questions. ECT is not the devastating purveyor of wholesale brain damage that some of its detractors claim. For the typical individual receiving ECT, no detectable correlates of irreversible brain damage appear to occur. Still, there remains the possibility that either subtle, objectively undetectable persistent deficits, particularly in the area of autobiographic memory function, occur, or that a rarely occurring syndrome of more pervasive persistent deficits related to ECT use may be present. Clearly, more research directed toward answering these questions needs to be carried out so that the role of ECT can be more rigorously defined. While such research is pending, however, we cannot expect that the conditions that predispose to clinical referrals for ECT will disappear. Given the misery, anguish, and risk of death by suicide, starvation, or debilitation associated with severe depressive illness, for example, it still appears that ECT, at least for the present, must continue to be available. (shrink)

Ethnic minority status and female gender convey a risk for suicidal behavior, yet research of suicidality of ethnic minority female immigrants is scarce. The authors of this article conducted qualitative interviews with 15 young women in the Netherlands, who either had attempted suicide or contemplated suicide, and analyzed these in a narrative psychology tradition. Suicidality was associated with despair and frustration over the violation of the women’s personal autonomy and self-integrity regarding strategic life choices. Autonomy restrictions and violations followed (...) two patterns, which are interconnected with four criteria regarding the capacity for autonomy. Findings are discussed with referral to Durkheim and feminist theories of autonomy. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Road to RedemptionAnonymous TwoI “am Dr X.* and I am a trained and board certified neonatologist with some years of experience in a high volume NICU with complex pathologies. I have been dismissed from the care of your baby by the fetal surgeon who is not trained in what he’s attempting to do,” that was how I felt when I left the operating room (OR), after performing initial (...) resuscitation on a newborn with congenital diaphragmatic hernia (CDH) with very poor prenatal prognostic indices. CDH is a diaphragm abnormality that allows abdominal organs to move into the chest and restrict lung development. The better part of me knew not to make such a statement and chose not to do so, as this was about the family and a very sick baby, not the professional wrangling of two medical teams or the expression of frustration by a neonatologist who was morally conflicted.I work in a level four Neonatal Intensive Care Unit (NICU) and a very large one by any standard. Staff turnover had been an almost nonexistent issue in previous years because of the very conducive work environment of the NICU. Every team member (physician, nurse, respiratory therapist, pharmacist, etc.) felt like a stakeholder in providing optimal outcomes for the vulnerable neonates in the NICU.As change is the only constant thing in life, the hospital management decided to explore new frontiers and open a center for fetal medicine, with the hope of being a referral center in the region. They brought in a surgeon who came highly recommended for clinical acumen, but not for interpersonal relationship skills (unbeknownst to me). This surgeon, Dr Y., was hired to oversee the fetal center and build it into a center of excellence. Since this had to be a collaborative effort, other specialties (and subspecialties) had to be involved to make this a success. A representative from each of these specialties, including bioethics, was assigned to the fetal center team.The first inkling of a major problem occurred with the very first patient. The team met for the weekly meeting, reviewed the patient’s history and made a tentative plan, which included multidisciplinary counseling. This would require either a joint meeting with the patient or individual consults with the patient at her convenience. The following week at the weekly meeting, Dr Y. informed the group that he had met with the patient and counseled her and she had agreed to an extraordinary procedure for an oral lesion. In my opinion (and that of others), this lesion was not obstructive and could be immediately dealt with at delivery by an Otolaryngologist (ENT) surgeon, without putting the mother at risk for complications arising from the procedure being offered. There was a long discussion about why this was inappropriate [End Page E1] and why further imaging, discussion between the subspecialties and counseling should have been done prior to making this delivery plan. All felt this delivery plan could be remedied prior to delivery. However the surgeon had made plans with the obstetric team (who were at his mercy for financial/ political reasons) to continue with this plan. On the day of delivery, the NICU resuscitation team was called to another operating room instead of the labor and delivery room. I was even more appalled when I realized that the oral lesion was the size of a peanut! I felt like I failed in my obligation of veracity by avoiding the mother’s questions regarding the necessity of the procedure. Every member of my team felt the same and on several occasions I had to reassure concerned nurses that this was an aberrant occurrence that would not repeat itself... so I thought.I informed my departmental chairperson, Dr Z., who had a conversation with the fetal surgeon, Dr. Y., to inform him of my concerns and the effect of Dr. Y.’s actions on my group (physician, nurse practitioner, nurses). This led to being labeled unsupportive of Dr Y.’s goals and caused a less than cordial relationship towards me and the entire NICU group. The next week a picture of Dr Y. and the parents with the baby was on the front page... (shrink)

A balance needs to be struck between facilitating compassionate access to innovative treatments for those in desperate need, and the duty to protect such vulnerable individuals from the harms of untested/unlicensed treatments. We introduced a principle-based framework to evaluate such requests and describe its application in the context of recently evolved UK, US and European regulatory processes. 24 referrals were received by our quaternary children's hospital Clinical Ethics Committee over the 5-year period. The CEC-rapid response group evaluated individual cases within (...) 48-hours; the main referrers being haematology/oncology, immunology or transplant services. Most requests were for drug/vaccine/pre-trial access or biological/cellular therapies. The majority of individual requests were approved ; neutral or negative opinions were given in 5, including 3 group requests. Recently evolved regulatory processes share common criteria and conditions to our framework including: demonstration of clinical need; sound scientific basis with lack of viable alternative; risks-benefit/best interests evaluation; arrangements for fully informed consent; no compromise of arrangements to test treatment for licensing purposes; consideration of resource implications. There are differences between individual processes and with our framework, with respect to procedures, scope, application format, costs and obligation to make available all outcome data. Our experience has emphasized the need for an independent, principled, consistent, fair and transparent response to the increasing demand for innovative treatment on a compassionate basis. We believe that there is a need for harmonization of the recent proliferation of regulation and legislation in this area. (shrink)

Mobile applications and socio-sexual networking websites are used by outreach workers to respond synchronously to questions and provide information, resources, and referrals on sexual health and STI/HIV prevention, testing, and care to gay, bisexual and other men who have sex with men. This exploratory study examined ethical issues identified by online outreach workers who conduct online sexual health outreach for GB2M. Semi-structured individual interviews were conducted between November 2013 and April 2014 with online providers and managers to explore the benefits, (...) challenges, and ethical implications of delivering online outreach services in Ontario, Canada. Interviews were digitally recorded and transcribed verbatim. Thematic analyses were conducted, and member-checking, analyses by multiple coders, and peer debriefing supported validity and reliability. Four themes emerged on the ethical queries of providing online sexual health outreach for GB2M: managing personal and professional boundaries with clients; disclosing personal or identifiable information to clients; maintaining client confidentiality and anonymity; and security and data storage measures of online information. Participants illustrated familiarity with potential ethical challenges, and discussed ways in which they seek to mitigate and prevent ethical conflict. Implications of this analysis for outreach workers, researchers, bioethicists, and policy-makers are to: understand ethical complexities associated with online HIV prevention and outreach for GB2M; foster dialogue to recognize and address potential ethical conflict; and identify competencies and skills to mitigate risk and promote responsive and accessible online HIV outreach. (shrink)

The online version of the original article can be found under doi:10.1007/s11948-007-9045-2.

Suppose you perform two actions. The first imposes a risk of harm that, on its own, would be excessive; but the second reduces the risk of harm by a corresponding amount. By pairing the two actions together to form a set of actions that is risk-neutral, can you thereby make your overall course of conduct permissible? This question is theoretically interesting, because the answer is apparently: sometimes Yes, sometimes No. It is also practically important, because it bears (...) on the moral status of practices such as offsetting personal greenhouse gas (GHG) emissions. In this article we propose a criterion for distinguishing between cases where pairing risk-increasing and risk-reducing actions makes each action permissible, and those where it does not: the Principle of Aggregate Risk-Imposition. We work towards this by considering a range of examples that illustrate various illegitimate ways of pairing risk-increasing actions with risk-reducing ones, and asking what goes wrong in each case. We then use this criterion to evaluate GHG offsetting. Is offsetting a legitimate way of removing the risk-imposition associated with GHG emissions, or not? Controversially, we argue that this turns out to depend on the form that the offsetting takes. (shrink)

Utility discounting in intertemporal economic modelling has been viewed as problematic, both for descriptive and normative reasons. However, positive utility discount rates can be defended normatively; in particular, it is rational for future utility to be discounted to take into account model-independent outcomes when decision-making under risk. The resultant values will tend to be smaller than descriptive rates under most probability assignments. This also allows us to address some objections that intertemporal considerations will be overdemanding. A principle for utility (...) discount rates is suggested which is rooted in probability discounting. Utility discounting is defended against objections from Parfit (1984) and Broome (2005); Broome (2012). A sample utility discount rate is estimated. [Open access]. (shrink)