For decades a debate has played out in the literature about who bioethicists are, what they do, whether they can be considered professionals qua bioethicists, and, if so, what professional responsibilities they are called to uphold. Health care ethics consultants are bioethicists who work in health care settings. They have been seeking guidance documents that speak to their special relationships/duties toward those they serve. By approving a Code of Ethics and Professional Responsibilities for Health Care Ethics Consultants, the American Society (...) for Bioethics and Humanities (ASBH) has moved the professionalization debate forward in a significant way. This first code of ethics focuses on individuals who provide health care ethics consultation (HCEC) in clinical settings. The evolution of the code's development, implications for the field of HCEC and bioethics, and considerations for future directions are presented here. (shrink)

Pediatric palliative care is specialized medical care for children who live with serious and life-limiting illnesses, with the central goal to improve quality of life for both children and their families. Presently, a majority of pediatric palliative care referrals are based on the traditional consultative model, in which primary providers serve as the gatekeepers to palliative care access. It is well-known that racial and ethnic healthcare disparities exist across the continuum of care, fraught with healthcare providers’ biases that impact the (...) care delivered. This includes the referral practices, allocation and utilization of palliative care services, and leaving vulnerable children and families with potentially unmet palliative care needs. We make the moral argument that the establishment of standard referral criteria for pediatric palliative care services is one simple step that must be taken to begin to address and hopefully ameliorate the impact of providers’ biases and disparities that exist within pediatric palliative care. (shrink)

Clinical ethics has been developing in paediatric healthcare for several decades. However, information about how paediatricians use clinical ethics case consultation services is extremely limited. In this project, we analysed a large set of case records from the clinical ethics service of one paediatric hospital in Australia. We applied a paediatric-specific typology to the case referrals, based on the triadic doctor–patient–parent relationship. We reviewed the 184 cases referred to the service in the period 2005–2014, noting features including the type (...) of case, the referring department(s) and the patient9s age at referral. The two most common types of referral involved clinician uncertainty about the appropriate care pathway for the child (26% of total referrals) and situations where the child9s parents disagreed with the doctors’ recommendations for the child9s care (22% of total referrals). Referrals came from 28 different departments. Cancer, cardiology/cardiac surgery and general medicine referred the highest numbers of cases. The most common patient age groups were children under 1, and 14–15 years old. For three controversial areas of paediatric healthcare, clinicians had initiated processes of routine review of cases by the clinical ethics service. These insights into the way in which one very active paediatric clinical ethics service is used further our understanding of the work of paediatric clinical ethics, particularly the kinds of ethically challenging cases that paediatricians view as appropriate to refer for clinical ethics support. (shrink)

Our society has long sanctioned, at least tacitly, a degree of conflict of interest in medical practice and clinical research as an unavoidable consequence of the different interests of the physician or clinical investigator, the patient or clinical research subject, third party payers or research sponsors, the government, and society as a whole, to name a few. In the past, resolution of these conflicts has been left to the conscience of the individual physician or clinical investigator and to professional organizations. (...) The public is no longer willing to allow health care providers to wholly govern their own conflicts of interest for several reasons. These include: new forms of health care financing and delivery that provide innovative and lucrative opportunities for physician or insurer enrichment at patient expense; the increased importance of commercial research support as peer-reviewed governmental research support has decreased; evidence that physicians and clinical investigators too frequently resolve conflicts of interest in their own favor; and a general societal mistrust of authority. This volume represents a multidisciplinary effort, drawing from philosophy, medicine, law, economics and public policy to identify and categorize conflicts of interest in medical practice and clinical research, and, where possible, to offer a mechanism for resolving them. Part I addresses conflicts of interest from a theoretical perspective, offering basic concepts and analytical frameworks. The second part discusses two topics prominent in current health care policy debates--self-referral and financial incentives to limit care. Part III examines conflicts of interest generated by pharmaceutical industry involvement in clinical practice and research. The final section deals with conflicts of interest in clinical research in several contexts, including institutional reviews boards, clinical trials, Cooperative Research and Development Agreements between government and private researchers, brokerage of research subjects by Contract Research Organizations, and cost-effectiveness studies. (shrink)

IntroductionLifestyle modifications are part of comprehensive treatment plans to help manage the symptoms of pre-existing chronic conditions. However, behavior change is notoriously difficult as patients often lack the necessary support. The present manuscript outlines the development of a Green Health Prescription pathway that was designed to link patients with appropriate lifestyle interventions and to support attendance. Strengths, Weaknesses, Opportunities, and Threats analysis was undertaken in three focus groups to highlight areas of strength and weakness within the proposed pathway prior to (...) delivery. The SWOT analyses revealed that the pathway was supported by all three focus groups. Weaknesses and threats were identified including sustainability of nature-based interventions in terms of funding, the need to connect patients with appropriate interventions based on their physical and mental health needs, and the requirement to have a “one-stop shop” for information to ensure that the pathway was accessible for all service-users and healthcare professionals. Results were addressed and considered throughout the development of the pathway.DiscussionThe Green Health Prescription pathway was launched in 2019 and gave patients the ability to receive a prescription from a healthcare professional, community service, or to self-refer. The pathway allows patients to contact a consultant, via a telephone service, who is trained to match them with a programme that the patient believes will be enjoyable and that fits their treatment needs. Data collection to assess the efficacy of the pathway is ongoing. (shrink)

Initiating clinical ethics support in psychiatry and maintaining its continuity appear to be easy. This is contradicted by the observed delay or lack of CESiP, e.g. ethics consultation. On the basis of a published literature search and the discussion of practical experiences over 2.5 years 10 tasks and relating challenges of initiating and maintaining CESiP are formulated and illustrated by examples. Referral to experiences is grounded on the systematic documentation of ca. 100 CESiP activities. The tasks and challenges (...) illustrate how CESiP was initiated and maintained in child and adolescent, adult and forensic psychiatry. Each example is followed by a “rule of thumb” that was found useful in our centre. Discussion: Suggestions I–III are of organisational nature, IV–X have explicit ethical content concerning the ethos or professionalism of the ethics consultant and CES practice. Their realisation requires a minimum of stability of CESiP and considerable consultancy experience. (shrink)

Practices such as physician assisted suicide, even if legal, engender a range of moral conflicts to which many are oblivious. A recent proposal for physician assisted suicide provides an example by calling upon physicians opposed to suicide to refer patients to other, more sympathetic, physicians. However, the proposal does not address the moral concerns of those physicians for whom such referral would be morally objectionable. Keywords: collaboration, euthanasia, intrinsic evil, material cooperation, projects, referral, toleration CiteULike Connotea Del.icio.us What's (...) this? (shrink)

The original data reported by Benjamin Libet and colleagues are reinterpreted, taking into account the facilitation which is experimentally demonstrated in the first of their series of articles. It is shown that the original data equally well or better support a quite different set of conclusions from those drawn by Libet. The new conclusions are that it takes only 80 ms for stimuli to come to consciousness and that “subjective back-referral of sensations in time” to the time of the (...) stimulus does not occur. (shrink)

Society has historically not taken a benign view of genetic disease. The laws permitting sterilization of the mentally re tarded~ and those proscribing consanguineous marriages are but two examples. Indeed as far back as the 5th-10th centuries, B.C.E., consanguineous unions were outlawed (Leviticus XVIII, 6). Case law has traditionally tended toward the conservative. It is reactive rather than directive, exerting its influence only after an individual or group has sustained injury and brought suit. In contrast, state legislatures have not been (...) inhibited in enacting statutes. Many of their products can be characterized as hasty, unnecessary, ill-conceived, and based on the heart rather than the head. Moreover the lack of expert consultation sought has also been remarkable. One state legislature, for example, has advocated immunization for sickle cell anemia! Many others have enacted laws for the screening of inborn errors of metabolism, e.g., phenylketon uria, but have poorly defined the lines of responsibility to secure compliance. A spate of specific disease-related bills has emerged in the u.S. Congress, each seeking recognition and appropriations. Sickle cell anemia, hemophilia, Cooley's anemia and Tay-Sachs disease have been among the front-runners for support. Finally, in 1975, Congress has begun to examine an omnibus bill concerning all forms of genetic disease. The bill, termed the National Genetic Diseases Act is, however, still far from being enacted. (shrink)

An analogy is sometimes drawn between the proper treatment of conscientious objectors in healthcare and in military contexts. In this paper, I consider an aspect of this analogy that has not, to my knowledge, been considered in debates about conscientious objection in healthcare. In the USA and elsewhere, tribunals have been tasked with the responsibility of recommending particular forms of alternative service for conscientious objectors. Military conscripts who have a conscientious objection to active military service, and whose objections are deemed (...) acceptable, are required either to serve the military in a non-combat role, or assigned some form of community service that does not contribute to the effectiveness of the military. I argue that consideration of the role that military tribunals have played in determining the appropriate form of alternative service for conscripts who are conscientious objectors can help us to understand how conscientious objectors in healthcare ought to be treated. Additionally, I show that it helps us to address the vexed issue of whether or not conscientious objectors who refuse to provide a service requested by a patient should be required to refer that patient to another healthcare professional. (shrink)

The purposes of research were to describe the neonatal clinicians' personal views and attitudes on neonatal ethical decision-making, to identify factors that might affect these attitudes and to compare the attitudes between neonatal physicians and neonatal nurses in Taiwan. Research was a cross-sectional design and a questionnaire was used to reach different research purposes. A convenient sample was used to recruit 24 physicians and 80 neonatal nurses from four neonatal intensive care units in Taiwan. Most participants agreed with suggesting a (...) do not resuscitate (DNR) order to parents for dying neonates (86.5%). However, the majority agreed with talking to patients about DNR orders is difficult (76.9%). Most participants agree that review by the clinical ethics committee is needed before the recommendation of ‘DNR’ to parents (94.23%) and nurses were significantly more likely than physicians to agree to this (p=0.043). During the end-of-life care, most clinicians accepted to continue current treatment without adding others (70%) and withholding of emergency treatments (75%); however, active euthanasia, the administration of drug to end-of-life, was not considered acceptable by both physicians and nurses in this research (96%). Based on our research results, providing continuing educational training and a formal consulting service in moral courage for neonatal clinicians are needed. In Taiwan, neonatal physicians and nurses hold similar values and attitudes towards end-of-life decisions for neonates. In order to improve the clinicians' communication skills with parents about DNR options and to change clinicians' attitudes for providing enough pain-relief medicine to dying neonates, providing continuing educational training and a formal consulting service in moral courage are needed. (shrink)

Observations with respect to the relationship between symptoms and diseases can seriously be biased by selection phenomena. This selection may occur from the general population, via consultation behavior, diagnostic and therapeutic activities of the general practitioner, and by referral.Relationships may be suggested and reproduced even if they do not exist in unselected populations, as a product of diagnostic routines. Correction for selection bias can only be achieved by choosing proper comparison groups. While this can be done in a (...) general practice setting, this is almost impossible after referral, as is demonstrated in this paper. Surprisingly, the most unbiased estimation of the relationship between symptoms and diseases after referral can be made from patient groups that are referred for reason unrelated to the disease under study. (shrink)

A businessperson acts,quabusinessperson, in two institutional contexts which in principle are completely distinct, and normally entail two different ways of relating to other people; on the one hand as an actor in the market, and on the other as the employees’ manager. We shall assume that different sets of norms govern how to relate to trading partners in the market and how to relate to subordinates in the company. The moral problems which arise in the two different institutions for conducting (...) human relations consequently also differ. The main problem relating to market operations originates in the fact that one achieves the most desirable consequences when the objective as such is difficult to justify on moral grounds. Profit is the target, if necessary at the expense of the person one is dealing with. In this context—i.e. in the market—altruistic considerations, or acting out of consideration for the other party, can produce socially undesirable results. The problems confronting the businessperson as manager are of a different nature. We shall not be considering all aspects of management or consultancy ethics, only what we regard as in principle the fundamental problem, one which in fact applies to all management in modern society. (shrink)

A businessperson acts,quabusinessperson, in two institutional contexts which in principle are completely distinct, and normally entail two different ways of relating to other people; on the one hand as an actor in the market, and on the other as the employees’ manager. We shall assume that different sets of norms govern how to relate to trading partners in the market and how to relate to subordinates in the company. The moral problems which arise in the two different institutions for conducting (...) human relations consequently also differ. The main problem relating to market operations originates in the fact that one achieves the most desirable consequences when the objective as such is difficult to justify on moral grounds. Profit is the target, if necessary at the expense of the person one is dealing with. In this context—i.e. in the market—altruistic considerations, or acting out of consideration for the other party, can produce socially undesirable results. The problems confronting the businessperson as manager are of a different nature. We shall not be considering all aspects of management or consultancy ethics, only what we regard as in principle the fundamental problem, one which in fact applies to all management in modern society. (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)

This article describes the situated nature of two intertwined dimensions of the context of medical encounters - expertise and compliance - within the interactional practices of referrals and accounts of referrals. Families who display their expertise and compliance have referral and account sequences with notably different features compared to sequences with families who display a lack of compliance and expertise. The display of expertise significantly affects the course of the interaction, and asymmetrical sequences often occur in interactions when the (...) professionals see families' expertise and compliance as problematic. (shrink)

In recent years, the model of shared decision-making has become increasingly promoted as the preferred standard in doctor-patient communication. As the model considers doctor and patient as coe-qual partners that negotiate their preferred treatment options in order to reach a shared decision, shared de-cision-making notably leaves room for the usage of argumentation in the context of medical consultation. A paradigm example of argumentative conflict in consultation is the discussion that emerges between doctors and their patients concerning antibiotics as (...) a method of treatment for what is presumed to be a viral infec-tion. In this paper, a case of such argumentative conflict is studied, using the extended pragma-dialectical theory to argumentation. It is examined how a patient and her physician manoeuvre strategically in order to maintain a balance between dialectical reasonableness and rhetorical effectiveness, as well as an equilibri-um between patient participation and evidence-based medication, while arguing their case for and against antibiotics respectively. (shrink)

The structure of ethics work in a hospital is complex. Professional ethics, research ethics and clinical ethics committees (CECs) are important parts of this structure, in addition to laws and national and institutional codes of ethics. In Norway all hospital trusts have a CEC, most of these discuss cases by means of a method which seeks to include relevant guidelines and laws into the discussion. In recent years many committees have received more cases which have concerned questions of principle. According (...) to Ellen Fox and co-authors the traditional CEC model suffers from a number of weaknesses. Therefore, in their organization a separate body deals with organizational matters. In this paper, we discuss what is gained and what is lost by creating two separate bodies doing ethics consultation. We do this through an analysis of detailed minutes of CEC discussions in one CEC during a 6-year period. 30 % of all referrals concerned matters of principle. Some of these discussions originated in a dilemma related to a particular patient. Most of the discussions had some consequences within the hospital organization, for clinical practice, for adjustment of guidelines, or may have influenced national policy. We conclude that a multiprofessional CEC with law and ethics competency and patient representation may be well suited also for discussion of general ethical principles. A CEC is a forum which can help bridge the gap between clinicians and management by increasing understanding for each others’ perspectives. (shrink)

No profession has undergone as much scrutiny in the past several decades as that of medicine. Indeed, one might well argue that no profession has ever undergone so much change in so short a time. An essential part of this change has been the growing insistence that competent, adult patients have the right to decide about the course of their own medical treatment. However, the familiar and widely accepted principle of patient self-determination entails a corollary that has received little attention (...) in the growing literature on the ethics of physician-patient relations: if patients are to direct the course of their own medical treatment, then physicians are at least sometimes to be guided in their actions on behalf of patients by values that are not, and may even be incompatible with, their own values. Unless it is supposed that it would be best if physicians were simply to accommodate any and all patient requests, a possibility I consider and reject in this paper, there are bound to be numerous instances of legitimate moral conflict between the preferences of physicians and patients. In this paper, I examine the implications of this sort of moral conflict from the standpoint of the integrity of the physician. -/- Critical to a proper appreciation of the significance of this conflict is a distinction that the literature on biomedical ethics has largely failed to draw: that between medical paternalism and physician integrity. (shrink)

Clinical ethics consultation has developed from local pioneer projects into a field of growing interest among both clinicians and ethicists. What is needed are more systematic studies on the ethical challenges faced in clinical practice and problem solving through ethics consultation from interdisciplinary perspectives. The Thematic Issue covers a range of topics and includes five recent studies from various European countries and the USA, focusing on issues such as the ethical difficulties of end of life decisions, experiences with (...) newly developed or well established ethics consultation services, and the expectations of physicians in various clinical fields who are still unfamiliar with clinical ethics consultation. The papers included illustrate the interface between different socio-cultural contexts and their ways of dealing with clinical ethics consultation. They deepen the dialogue on clinical ethics consultation that has emerged at the European and International level. (shrink)

Background: We were finding volunteers for functional magnetic resonance imaging studies with abnormalities requiring referral surprisingly frequently. The bioethics surrounding the incidental findings are not straightforward and every imaging institution will encounter this situation in their normal volunteers. Yet the implications for the individuals involved may be profound. Should all participants have review of their imaging by an expert and who should be informed? Methods: The normal volunteers that were imaged with magnetic resonance (MR) which were reviewed by a (...) consultant neuroradiologist. All participants completed a volunteer consent form in addition to a standard departmental MR safety screening form. The volunteer screening form requires the general practitioner details to be completed and asks the participant to consider closely the possibility and implications of finding an unexpected but potentially serious abnormality before signing. Results: 525 different individuals were scanned as normal volunteers, the mean age was 35-years and 330 were males. Of these 525, 46 had definite significant abnormalities (8.8%), mean age 50-years. Conclusion: We have found a high rate of incidental abnormalities amongst individuals participating in imaging studies at our institution. It is our current practice to inform the research study participant of the findings, counsel them and inform their primary care physician. We think that it is advisable for researchers utilising MR imaging of the brain to have access to trained neuroradiologists, a protocol in place to deal with this problem and take consent in a way that allows the participant to realise the possibility of an abnormal finding. (shrink)

This paper explores the intersections between Elliot D. Cohen’s Logic-Based Therapy and Amy Morin’s "13 Things Mentally Strong Women Don’t Do" (HarperCollins 2019) with a focus on the ways that they shed light on and mutually support each other. With its six-step method (including the identification of Cardinal Fallacies, the refutation of those fallacies, the reinforcement of their corresponding Guiding Virtues, the use of Uplifting Philosophies, and the implementation of plans of action), Logic-Based Therapy and Consultation provides a systematic (...) rational framework for understanding how our interpretation of facts and our opinions/value judgments about those facts interact in order to form habits, i.e., patterns of thoughts, feelings, and behavior, that can lead to a fulfilling or a not-so-fulfilling life. For its part, "13 Things that Mentally Strong Women Don’t Do" 1) helps us understand how these habits specifically affect women, 2) provides uplifting philosophies from a woman’s perspective, and 3) contributes to plans of actions by suggesting practical exercises for implementing these plans, all in order to help us develop those good habits or virtuous patterns of thought, feelings, and behavior that allow us to live our best lives. (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)

In lieu of an abstract, here is a brief excerpt of the content:An Encounter with the Art and Science of MedicineAnonymous Five“Let Nothing Upset YouLet Nothing Frighten YouEverything is ChangingOnly God is Changeless”—St. Theresa of AvilaSt. Teresa’s prayer is on the front cover of each of four binders dedicated to storing insurance authorizations, studies, references, and reports about our daughter’s brain tumor treatment. They represent our experience, what we learned, the information we were given, and the information we sought out. (...) I kept them in case our daughter ever wanted to understand how my husband and I arrived at a decision for her treatment that was in direct opposition to the strong recommendation of her primary treatment team of physicians.On December 10, 2003, I received an urgent call from our daughter’s neurologist requesting that we meet with the doctor late that afternoon. For six months prior to that appointment, our daughter had been telling us about odd sensations with breathing, nausea, and balance. Sometimes she would seem extremely distressed for a short period of time or report that her friends told her about doing or saying things that didn’t make sense and that she didn’t remember. We consulted a series of physicians as her symptoms became steadily more intense and more prevalent. Our family practice physician referred us to an allergy specialist and a pulmonologist. There were a number of tests for allergies and lung problems. As the tests and treatments did not help, our daughter became increasingly unwilling to go to doctor’s appointments. My husband and I were confused and deeply concerned about the lack of progress. The next series of referrals included a gastroenterologist and a neurologist. The gastroenterologist suggested our daughter had partial–complex epilepsy, concurred with our plan to see a neurologist, and mentioned she should have an MRI.I remember the neurologist putting the MRI scans up, pointing to the large dark spot which he called a “large mass” (5 cm), that could be either a cluster of blood vessels or a neoplasm. He said his office had arranged for us to meet a neurosurgeon the following day. We all remember the same thing about that visit—the image of the large dark mass on the scan—and the neurologists flat, brisk tone. We met with the neuro-surgeon the next day. Her team was kind and sympathetic—she was positive, up beat and direct. She did not think this mass was blood vessels. She thought it was a large tumor that needed to be removed right away. Our daughters surgery was scheduled for the following Friday—December 19, 2003. She had turned 15 on November 5.Four and a half hours after our daughter was wheeled into the operating room, her surgeon told us they had removed 98% of the tumor. She said there was no cure, but there was a good prognosis based on the surgical outcome. Several days later, she called us and said she had more data, and it looked like the resection was closer to 90%. The first pathology report, a “first impression” directly after surgery, described our daughter’s tumor as an astrocytoma, probably high grade. Three weeks after surgery, we met with a panel of doctors—two oncologists and radiologist—who explained that based on the final pathology report, our daughter’s tumor was classified as an ependymoma, grade 2. We were dismayed. First, there had been the change in the estimated success of the resection and now a complete shift in both grade and tumor type.The team recommended radiation to follow her surgery, which they said was standard treatment. We began to try to inform ourselves about her tumor. Her father, an agronomist, did an extensive search in PubMed to evaluate and sort through the literature on low–grade gliomas and radiation. What he could find was inconclusive and grim. Most reports in the literature suggested at best delayed mortality at five years after radiation. [End Page E7] Meanwhile, our daughter went through a spinal MRI and the preparatory “fitting” of the mask to immobilize her head during radiation.E7I consulted with a friend who had worked as an EKG tech. She urged... (shrink)

Within the research community, it is generally accepted that consent processes for research should be culturally appropriate and tailored to the context, yet researchers continue to grapple with what valid consent means within specific stakeholder groups. In this study, we explored the consent practices and attitudes regarding essential information required for the consent process within hospital-based trial communities from four referral hospitals in Vietnam. We collected surveys from and conducted semi-structured interviews with study physicians, study nurses, ethics committee members, (...) and study participants and family members regarding their experiences of participating in research, their perspectives toward research, and their views about various elements of the consent process. In our findings, we describe three interrelated themes related to the consent process: words and regulation; reimbursement, suspicions, and joining; and responsibilities. In general, stakeholders had highly varied perspectives of nghiên cứu and researchers used varying levels of detail regarding all aspects of the study in the consent process to build trust with and/or promote potential research participants’ choices about taking part in research. Findings additionally highlight how researchers felt that offering financial reimbursements in a hospital setting, where payment for services was routine, would be unfamiliar to participants and could raise suspicions about the research. Participants, however, focused their discussions on reimbursement or alternative reasons for joining the study, such as health related benefits or altruism. Finally, participants often relied on their physician to help them decide about joining a study or not. Further research is needed to understand how researchers and participants make sense of and practice consent, and how that impacts participants’ decision-making about research participation. To promote valid consent within this context, it is important to engage with hospital-based trial communities as a whole. The data from this study will inform future research on consent, guide the revisions of consent related policies within our research sites and point to several larger issues surrounding researcher-participant expectations, communication, and trust. (shrink)

The carbon emissions of global health care activities make up 4–5% of total world emissions, placing it on par with the food sector. Carbon emissions are particularly relevant for health care because of climate change health hazards. Doctors and health care professionals must connect their health care delivery with carbon emissions and minimize resource use when possible as a part of their obligation to do no harm. Given that reducing carbon is a global ethical priority, the informed consent process in (...) health care delivery must change. I argue that the expanded role of bioethicists in this climate crisis is to promote and support “green informed consent:” the sharing of climate information with patients, offering options for lower-carbon health care, and accepting the patient’s right to decline treatments which are deemed too carbon intensive for their values. (shrink)

The purpose of this article is to illustrate the role of sociology in the field of corporate social responsibility (CSR). It presents a case study conducted by a research group consisting of two University partners in association with a Swiss SME. This project attempted to draw conclusions from a specific sociological consultancy research project on the general possibilities and opportunities of sociology in applied research and operational sustainability consulting. On the basis of the project findings, the article reflects on the (...) extent to which sociology could profitably intervene, on the limitations for sociological research and consultations in this field and on the conclusions that can be drawn for future analyses. (shrink)

This paper investigates the key drivers behind the origins of value-for-money (VFM) audit in Canada and the aims, intents, and logics ascribed by the original proponents. Drawing on insights from governmentality and New Public Management, the paper utilizes analysis methods adapted from case study research to review a wide range of primary documentation (e.g., Hansards from the Public Accounts Committee, House of Commons debates, the so-called Wilson report and the FMCS study) and secondary documentation (newspaper articles, Office of the Auditor (...) General internal publications, journal articles). Major findings indicate a rise of a management consulting culture within the Auditor General’s office following the appointment of James Johnson Macdonell. VFM legislation effectively operationalized practices drawn from management consulting expertise by invitation of the consultant. It was offered as an answer to the growing scope and size of government, which had become problematized by the Auditor General in terms of parliament losing control over the public purse. The Auditor General’s invocation of financial crisis led to a substantial broadening of mandate and increase in resources for that office. (shrink)

Research ethics review is a critical aspect of the research governance framework for human subjects research. This usually requires that research protocols be submitted to a research ethics committee for review and approval. This has led to very rapid developments in the domain of research ethics, as RECs proliferate all over the globe in rhyme with the explosion in human subjects research. The work of RECs has increasingly become elaborate, complex, and in many cases urgent, necessitating supporting rules and procedures (...) of operation. Guidelines for elaborating standard operating procedures for the functioning of RECs have also been proposed. The SOPs of well-placed and well-resourced RECs have tended to pay much attention to details, resulting, as a consequence, in generally long, elaborate, intricate and complex SOPs; a model that can hardly be replicated by other committees, equally under ethics review pressures, but working under much more constraining conditions in resource-destitute environments. In this paper, we looked at the content and length of SOPs from African RECs and compared them to the World Health Organization ’s guidelines as the gold standard. We also looked at the SOPs from the Ethics Review and Consultancy Committee of the Cameroon Bioethics Initiative that we elaborated in a simplified way in 2013, and compared them to the WHO’s guidelines and to the other SOPs. Sixteen SOPs from 14 African countries were collected from various sources. Their average length was of 30 pages. By comparison to the guidance of the WHO, only six of them were found acceptable with more than 70 % of the criteria from the gold standard that were fully described. Among those six, two of them were very long and detailed, while the four remaining SOPs ranged from 16 to 24 pages. The ERCC SOPs are seven pages long but maintain all that is of essence for the rigorous, efficient and timely review of protocols. We are convinced that, because of their brevity, simplicity, clarity and user-friendliness, the ERCC SOPs recommend themselves as a model template to, at least, committees similarly situated and/or circumstanced as the ERCC of the Cameroon Bioethics Initiative is. In fact, brevity, clarity, simplicity and user-friendliness are recognized values. Whatever is brief and clear is better than what is not and saves time. What is simple and user-friendly is better than what is not even though the two have the same aims because it saves both time and mental energy. And if this be true in general, it is even truer of the context and its peculiar constraints that we are addressing. (shrink)

Ethics consultation has become an integral part of the fabric of U.S. health care delivery. This article summarizes the second edition of the Core Competencies for Health Care Ethics Consultation report of the American Society for Bioethics and Humanities. The core knowledge and skills competencies identified in the first edition of Core Competencies have been adopted by various ethics consultation services and education programs, providing evidence of their endorsement as health care ethics consultation (HCEC) standards. This (...) revised report was prompted by thinking in the field that has evolved since the original report. Patients, family members, and health care providers who encounter ethical questions or concerns that ethics consultants could help address deserve access to efficient, effective, and accountable HCEC services. All individuals providing such services should be held to the standards of competence and quality described in the revised report. (shrink)

In this paper I attempt to address what appears to be a novel theoretical and practical problem concerning physician-assisted suicide (PAS). This problem arises out of a newly created set of circumstances in which persons are hospitalized in jurisdictions where PAS, though now legally available to patients, remains morally contentious. When moral disagreements over PAS come to divide physicians, patients, and family members, it is quite likely they will today find their way to the hospital’s consulting ethicist, a member of (...) an emerging group of professionals charged with the responsibility (so we are told) of resolving moral conflict in the clinic. What can or should an ethics consultant do to fulfill this mandate in such circumstances? I argue that the now predominant conception of clinical ethics consultation is importantly deficient in that it provides no final guidance to ethicists on how they should respond in such cases. The ethicist may only recommend—or assist others to reach—solutions to moral disagreements falling within the limits of established norms. Since the normative landscape of PAS appears to be changing, whether it falls within these limits is unsettled. I conclude that the accepted goals of ethics consultation require a revised and expanded conception of the ethicist's role in cases involving PAS. I close by outlining what that revised understanding would look like and the further questions it raises. (shrink)

Current research suggests that nonclinical forensic psychologists[sup1] are appearing increasingly more often in the legal arena. We argue that many of the ethical dilemmas that face these psychologists differ from those encountered by clinical forensic psychologists. To test the accuracy of this assertion, 37 nonclinical forensic psychologists were surveyed to identify some of the ethical issues and dilemmas they have encountered while engaging in expert testimony or pretrial consulting. Respondents were asked also about how they have resolved these ethical issues (...) and whether they were aware of the "Specialty Guidelines for Forensic Psychologists" (Committee on Ethical Guidelines for Forensic Psychologists, 1991). Results of the survey are discussed in terms of the need for additional regulatory guidelines or professional standards that speak directly to the ethical issues confronting nonclinical, forensic expert witnesses and consultants. (shrink)

RESUMEN: El presente trabajo propone un análisis de los Derechos Fundamentales de los pueblos indígenas a la luz de los principios internacionales de Libre Determinación y Consulta Previa, como fundantes y presupuestos de los demás Derechos Indígenas. En consecuencia, se analiza el Derecho a la Consulta, que debe ser previa, libre, informada, de buena fe, culturalmente adecuada y con el propósito de obtener el consentimiento; donde todas éstas características son el estándar mínimo a cumplir en cualquier proyecto de desarrollo o (...) extractivo que afecte a pueblos indígenas, por lo que debe explicarse también el extractivismo al interior de los estados-nación y su modus operandi, que ha provocado la existencia de zonas y regiones que algunos autores caracterizan como “estados de excepción” o estados de “de no-derecho”. El análisis propuesto contrasta las bases mencionadas con algunos casos llevados ante la jurisdicción del Sistema Interamericano de Derechos Humanos, cuya última fase descansa en las sentencias de la Corte IDH.ABSTRACT: The present paper proposes an analysis of the Fundamental Rights of the indigenous peoples in the light of the international principles of Free Determination and Prior Consultation, as foundations and budgets of the other Indigenous Rights. Consequently, the Right to Consultation is analyzed, which must be prior, free, informed, in good faith, culturally appropriate and with the purpose of obtaining consent; where all these characteristics are the minimum standard to be met in any development or extractive project that affects indigenous peoples, so the extractivism within the nation-states and its modus operandi, which has caused the existence of zones and regions that some authors characterize as "states of exception" or "non-right" states. The proposed analysis contrasts the mentioned basis with some cases brought before the jurisdiction of the Inter-American Human Rights System, whose last phase rests on the judgments of the Inter-American Court.PALABRAS CLAVE: Libre determinación y consulta, Derechos Fundamentales, pueblos indígenas. KEYWORDS: Free determination and consultation, Fundamental Rights, indigenous peoples. (shrink)