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A traditional ethic of medicine asserts that physicians have special obligations to individual patients with whom they have a clinical relationship. Contemporary trends in US healthcare financing like bundled payments seem to threaten traditional conceptions of special obligations of individual physicians to individual patients because their population-based focus sets a tone that seems to emphasise responsibilities for groups of patients by groups of physicians in an organisation. Prior to undertaking a cogent debate about the fate and normative weight of special obligations and a traditional ethic for contemporary healthcare, we need a deeper examination of what the traditional ethic of special obligations really means. Here we offer a conception of ‘doubly distributed’ special obligations. Physicians and similarly minded healing professionals abiding by a traditional ethic have always spread their devotion and attention across multiple patients and have shared responsibilities with physician and non-physician colleagues in much the same way devoted parents have frequently distributed their special obligations across multiple children and across multiple parents. By taking up the extended analogy of parent we argue that doubly distributing special obligations need not contradict the possibility of special obligations in restructured collective forms of healthcare delivery and financing.

Background If trials of therapeutic interventions are to serve society9s interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world9s nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial9s stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.

Biotechnological inventions are sometimes based upon the traditional knowledge of indigenous communities about the beneficial properties of plants and animals. Some institutions have adopted the uniqueness of traditional knowledge approach, which maintains that the indigenous communities have sui generis rights to a share of the profits from these inventions. Others have adopted the protection of inventive steps approach, which maintains that the inventors are entitled to the full profits from the invention if it involves a non-obvious and novel inventive step. The article analyzes this debate at the Convention on Biological Diversity, at the World Intellectual Property Organization, and at the World Trade Organization. It concludes that the adherents of the uniqueness of traditional knowledge approach have not justified their claims.

Recent federal regulations allow for emergency research without prospective consent provided that additional protections for the subjects are provided. One of these is community consultation.To determine how to feasibly consult the community and what to do with the findings.In connection with an ongoing study of l-arginine for brain injury at a public hospital's trauma center, we consulted three sets of community representatives using different methods. To sample the entire population of the county, we conducted a random-digit dialing survey (456 residents). To sample individuals served by the hospital, we interviewed a convenience sample of 566 patients and individuals in the waiting area. To sample particularly interested individuals, we conducted a series of public meetings (114 participants). In each case, the same instrument was used to ascertain their attitudes toward the study in general and toward its major features (randomization, waiver of consent, location, risks/benefits). To control for framing effects, items were randomly presented in a positive or negative fashion.All methods proved feasible, but telephone surveys were most efficient and guaranteed the desired demography. Even for a very low-risk study, only 79.75% of respondents would be willing to participate. The rate of approval for the major features was lower, with only 67.78% approving of the risk/benefit ratio, 53.7% approving of randomization, 57.66% approving of the consent waiver, and 44.45% approving of the location. The most significant factors affecting the rate of approval were the method of consultation and the framing of items (both p.001), age, ethnicity, and previous research participation (all p.01).Community consultation is feasible, but its results depend heavily on method of consultation, framing of questions, and choice of community. It may well demonstrate unexpectedly substantial opposition. There needs to be a better definition of the process and a better understanding of how to respond to its results.

Continuing the discussion begun in the March 2006 issue of the Kennedy Institute of Ethics Journal, this paper further documents the failure of the United States to adequately consider possible modifications in the traditional robust system of intellectual property rights as applied to biotechnology. It discusses concrete suggestions for alternative disclosure requirements, for exemptions for research tools, and for improved access to clinical advances. In each of these cases, the modifications might be more responsive to the full set of relevant values.

The vertical transmission trials conducted in a variety of developing countries by researchers from more developed countries illustrate a variety of crucial ethical issues. Three crucial issues are the injustice of the use of placebo control groups, the coerciveness of the offer to participate, and the exploitation of Third World countries. This paper examines each of these issues separately. It develops a new standard for when such control groups are acceptable. It concludes that the issue of coercive offers is not well founded. It also concludes that concerns about exploitation are better addressed by assurances about the future care of the subjects in the trial than by assurances of availability of the drugs in the country in general.

Pharmacogenetics offers the prospect of an era of safer and more effective drugs, as well as more individualized use of drug therapies. Before the benefits of pharmacogenetics can be realized, the ethical issues that arise in research and clinical application of pharmacogenetic technologies must be addressed. The ethical issues raised by pharmacogenetics can be addressed under six headings: (1) regulatory oversight, (2) confidentiality and privacy, (3) informed consent, (4) availability of drugs, (5) access, and (6) clinicians' changing responsibilities in the era of pharmacogenetic medicine. We analyze each of these categories of ethical issues and provide policy approaches for addressing them.

Background. Utility techniques are the most commonly used means to assess patient preferences for health outcomes. However, whether utility techniques produce valid measures of preference has been difficult to determine in the absence of a gold standard. Objective. To introduce and demonstrate two methods that can be used to evaluate how well utility techniques measure patients' preferences. Subjects and Design. Patients treated for advanced prostate cancer (n = 57) first ranked eight health states in order of preference. Four utility techniques were then used to elicit patients' utilities for each health state. Measures. The rating scale, standard gamble, time trade-off, and a modified version of willingness-to-pay techniques were used to elicit patients' utilities. Technique performance was assessed by computing a differentiation and inconsistency score for each technique. Results. Differentiation scores indicated the rating scale permitted respondents to assign unique utility values to about 70% of the health states that should have received unique values. When the other techniques were used, about 40% or less of the health states that should have received unique utility scores actually did receive unique utility scores. Inconsistency scores, which indicate how often participants assign utility scores that contradict how they value health states, indicated that the willingness-to-pay technique produced the lowest rate of inconsistency (10%). However, this technique did not differ significantly from the rating scale or standard gamble on this dimension. Conclusions. Differentiation and inconsistency offer a means to evaluate the performance of utility techniques, thereby allowing investigators to determine the extent to which utilities they have elicited for a given decision problem are valid. In the current investigation, the differentiation and inconsistency methods indicated that all four techniques performed at sub-optimal levels, though the rating scale out-performed the standard gamble, time trade-off, and willingness-to-pay techniques.

This paper presents a standard for assessing the validity of placebo-controlled trials in circumstances in which such trials might be unjustly denying appropriate therapies to members of the control group. This standard categorizes the types of risks that can or cannot be imposed upon consenting research subjects in such control groups. The paper also shows how needed research can be conducted while respecting the proposed ethical standard. Both the problem and the proposed standard are illustrated by reference to the major trials of the thrombolytic agents.

Men who pursue active treatment for metastatic prostate cancer face a choice between medical or surgical castration. While both alternatives have documented side-effects (e.g. loss of libido, breast enlargement and tenderness, hot flashes, and nausea), their psychosocial impacts are not well understood. As part of a study of patients' treatment decision making, we have sought to construct a patient-based measure of the salient disease and treatment-related qualities of life experienced by these men subsequent to treatment. Focus groups (15 with patients, two with wives) were used to develop candidate Likert scale questionnaire items representing quality of life issues that patients said were important. These items were combined with assessments of symptoms, comorbidity, and generic measures of functional status and well-being in a mail survey of patients treated at the Houston VAMC and two other Houston hospitals (n = 201, response rate = 63%). Psychometric analyses (principal components and multitrait scaling) were used to identify distinct dimensions of life quality; correlations with generic measures, and symptom reports were used in validation analyses. Qualitative analyses of focus group data identified three major domains of life quality: self-perceptions, anxiety about the effects of treatment, and concern with the process of decision making and treatment. Psychometric analyses identified nine reliable and valid indicators of prostate cancer-related quality of life: body image, sexual problems, spouse affection, spouse worry, masculinity, cancer-related self-image, cancer distress, cancer acceptance, and regret of treatment decision. Internal consistency (alpha) ranged form 0.71 to 0.90. Correlations with reference scales (e.g. MOS Mental Health Index, Profile of Mood States) and symptom status supported concurrent validity. Prostate cancer patients perceive a number of important psychosocial consequences of their treatment. These consequences are represented by nine scales comprising a brief (35 items) disease and treatment sensitive health-related quality of life instrument, which we will use in monitoring the outcomes of patients' treatment choices.

This paper distinguishes four major types of futility (physiological, imminent demise, lethal condition, and qualitative) that have been advocated in the literature either in a patient dependent or a patient independent fashion. It proposes five criteria (precision, prospective, social acceptability, significant number, and non-agreement) that any definition of futility must satisfy if it is to serve as the basis for unilaterally limiting futile care. It then argues that none of the definitions that have been advocated meet the criteria, primarily because their proponents have not paid sufficient attention to the problematic nature of the data supporting the use of their definitions.

Unlike medications, the dissemination of surgical procedures into practice is not regulated. Before marketing, pharmaceutical products are required to be shown safe and efficacious in comparative clinical trials which utilize bias-reducing strategies designed to reduce the distortion of estimates of treatment effect by predispositions towards the investigational intervention or control. Unless an investigational device is involved, the corresponding process for surgical innovations is usually unregulated and therefore may not be based upon adequate evidence. Given these differences, we sought to evaluate the state of clinical research on invasive procedures. We conducted a systematic review of publications from 1999–2008 that reported the results of studies evaluating the effects of invasive therapeutic procedures, focusing on trials which appeared to influence practice. Our objective was to determine what proportion of studies evaluating surgical procedures use a comparative clinical trial design and methods to control bias. This paper reports our results and raises concerns about the methodological, and therefore the ethical, quality of clinical research used to justify the implementation of surgical procedures into practice.

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences (CIOMS), the International Conference on Harmonization's standards for industry (ICH), and the CONSORT group's reporting norms (Consolidated Standards of Reporting Trials), in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's (FDA) body of regulations, and information sheets by the Department of Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”

The emergence of the human immunodeficiency virus (HIV) as a serious public health threat has rekindled long dormant debate about individual physicians' duty to treat potentially contagious patients. Because of the widely accepted common-law tenet of the "no duty [to treat] rule," previous work on a duty to treat focused on historical reviews, medical society position statements, and the ethical arguments upon which the statements are based. The passage of the Americans with Disabilities Act has rendered these discussions moot by creating, through federal civil rights mechanisms, a legal duty to treat patients with HIV, enforceable under considerable penalties. The paper also concludes that there has been inadequate attention paid to similar civil rights concerns of infected physicians.

Can a medical ethic be developed for a liberal state? This is the issue posed by the authors of both of the works under review. Brennan in Just Doctoring thinks that the answer is yes and that his theory of just doctoring provides just such an ethic. Emanuel in The Ends of Human Life thinks that the answer is no and that an adequate resolution of the dilemmas of medical ethics requires an alternative political philosophy, liberal commun itarianism.

The issue of biopiracy has attracted considerable attention in recent years. The Convention on Biological Diversity adopted a principle of state sovereignty over biological resources and the genetic information contained within those resources to address this issue. It is argued that this principle has not been adequately justified and that there are other solutions to the issue of biopiracy, based on different theories of justice, that deserve greater consideration. These alternatives include the common heritage of mankind principle and the global commons principle.

This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials.

This study examines the intravenous use of two thrombolytic agents [streptokinase (SK) and tissue plasminogen activator (tPA)] in the acute phase of myocardial infarction (MI). These two agents have very different costs and offer an excellent opportunity to study both the impact of economic factors on clinical decisionmaking and the potential for cost savings by limiting the use of expensive new therapeutic agents. A nationwide survey of the 5,792 acute care general hospitals listed in the American Hospital Association's 1988 data file was responded to by 2,651 hospitals (46%) and revealed that 2,384 of these responding hospitals (90%) were using thrombolytic therapy. For 2,200 of these 2,384 hospitals (92%), the respondent was a physician who primarily used one of the two drugs. Eight hundred eighty-six of these 2,200 physicians (40%) primarily used SK while 1,314 (60%) primarily used tPA. SK users were more concentrated in federal public hospitals (69% used SK) than in nonfederal public hospitals (47% used SK), and were least concentrated in private hospitals (36% used SK). There was no difference between the rate of SK vs tPA use in investor-owned and not-for-profit private hospitals. SK users most often (62%) cited various economic factors as the reason for their choice. The users of tPA primarily (73%) cited clinical preferability as the reason for their choice even though trials are still ongoing to see which drug is preferable. Several multivariate analyses shed light upon the association between choice of thrombolytic agent and various additional physician and hospital characteristics. These data clearly indicate that while new therapies are rapidly implemented by the medical community, considerations of cost have a substantial impact upon the pattern of implementation and reflect a desire to implement cost savings in the use of new drugs.

Background Innovative approaches are needed to allow for research in the emergency setting while not compromising either the rights or the interests of the subjects enrolled in such research. The emergency consent exception was developed to meet this need. Purpose The goal was to describe the timing of initial contact with relatives and the timing of obtaining informed consent for a research study in patients with severe traumatic brain injury. Methods The study was designed as a prospective, observational study of 129 patients enrolled in an emergency study of traumatic brain injury conducted under the emergency consent exception. Detailed descriptive information was collected both about the availability of relatives of patients enrolled in a study of traumatic brain injury to give prospective consent within the time period required for entering the study and about the extent to which they did give prospective consent during that time period. Results The number of patients with relatives who could be contacted by research staff increased with time after injury, with 3% (95% CI=0 to 6%), 25% (95% CI=18 to 32%), and 43% (95% CI=35 to 52%) having family at 1, 3, and 6 h, respectively postinjury. An additional 15% were available within the next 6 h. The median time after injury to the initial family contact by the research staff was 2.0 h for patients who had relatives already present at the hospital and 5.7 h for patients whose family had already been contacted by the hospital. The percentage of family members actually giving prospective research consent was much smaller; only 18% actually gave prospective consent within 6 h postinjury. The proportion of critically ill patients with family available to give prospective consent for enrollment in emergency research studies depends primarily on the time period allowed for enrollment in the individual study and the length of the transition from initial contact to completed prospective consent. Limitations The study was performed in a specific patient population and may not be generalizable to other settings. Conclusions Careful attention should be paid by investigators and IRBs as to whether the emergency consent exception is really required for a particular study, or whether the study could proceed using only prospective consent with a longer recruitment period, more research sites, and a higher yield of available family members giving prospective consent. Measures that could shorten the time between initial contact and obtaining informed consent (for example, allowing consent over the phone rather than requiring written consent) might decrease the need for the emergency consent exception. Clinical Trials 2007; 4: 631—637. http://ctj.sagepub.com

The European patent system allows for the introduction of moral issues into decisions about the granting of patents. This feature has greatly impacted European debates about the patenting of biotechnology. This essay explores the European experience, in both the European Union and the European Patent Organization. It argues that there has been great confusion surrounding these issues primarily because the Europeans have not developed a general theory about when exclusion from patentability is the best social mechanism for dealing with morally offensive technologies.

Human clinical research has become a huge economic enterprise (Morin et al. 2002; Noah 2002). Because the human subject at the center can be so easily marginalized, many commentators recommend spec...

In the development of biotechnology in the United States, many questions were raised about the appropriateness of applying to this area a traditional robust system of intellectual property rights. Despite these hesitations, the U.S. rejected suggested modifications. This was a mistake, and there is a need to develop a modified system that promotes more of the relevant ethical values.

Substantial progress has been made in developing treatments that reduce the risk of fractures in osteoporosis. However, available treatments are only partially effective, they are not widely used, and there is need to search for more effective means of fracture prevention. Currently known effective means of reducing fractures were found using randomized placebo-controlled trials. The use of placebo controls in clinical trials has been a subject of significant controversy in recent years. The Declaration of Helsinki revision of October 2000 caused great concern among clinical investigators about the future use of placebo controls if known effective therapeutic agents are available. A working group of ethicists, clinical trial design experts, and clinical investigators examined the current state of knowledge of osteoporosis treatment and trials. They concluded that if placebo controls put subjects at substantial risk of serious outcomes, they are not ethically permissible. Placebo controls in osteoporosis trials with fracture as the measured outcome are permissible only under narrowly defined conditions. Placebo controls may be used if competent, well-informed patients refuse approved therapies for sound reasons, there is a reasonable basis for substantial disagreement or lack of consensus among professionals about whether approved treatments are better than placebos, or subjects are refractory to known effective agents. Active control trials are permissible and desirable if they can be designed and conducted in ways that overcome the interpretive difficulties often associated with such trials.

Pharmacogenetics--the effect of genotype on drug response--holds the promise of safer and more effective drug therapy. Genetic tests would be routinely given to patients prior to prescription of a drug, with therapeutic decisions based on the patient's drug-response profile. This paper examines the operational changes and the ethical, legal, and policy challenges that pharmacogenetic medicine poses for key actors in the health care system. Adaptation by drug companies, regulatory agencies, physicians, patients, insurers, and public funding agencies will be necessary to integrate pharmacogenetic medicine into health care.

Some attention is beginning to be paid in the recent literature of bioethics and health policy to a variety of ethical issues that arise in the business aspects of the practice of medicine. These include such questions as advertising in medicine, physician self-referral, physician fees, and conflicts of interest in clinical trials. These questions arise primarily, but not exclusively, in those settings in which physicians practice fee-for-service medicine, and there are many such settings in the United States and elsewhere. I want to suggest that the controversies surrounding these issues result from neither society in general nor physicians in particular having decided which of two models of the physician is the more appropriate model, and that progress in resolving these issues requires an unequivocal adoption of one of them. In the first section of this article, I will present an outline of these two models. In the next two sections

A fundamental assumption of utility-based analyses is that patient utilities for health states can be measured on an equal-interval scale. This assumption, however, has not been widely examined. The objective of this study was to assess whether the rating scale (RS), standard gamble (SG), and time trade-off (TTO) utility elicitation methods function as equal-interval level scales. We wrote descriptions of eight prostate-cancer-related health states. In interviews with patients who had newly diagnosed, advanced prostate cancer, utilities for the health states were elicited using the RS, SG, and TTO methods. At the time of the study, 77 initial and 73 follow-up interviews had. been conducted with a consecutive sample of 77 participants. Using a Rasch model, the boundaries (Thurstone Thresholds) between four equal score sub-ranges of the raw utilities were mapped onto an equal-interval logit scale. The distance between adjacent thresholds in logit units was calculated to determine whether the raw utilities were equal-interval. None of the utility scales functioned as interval-level scales in our sample. Therefore, since interval-level estimates are assumed in utility-based analyses, doubt is raised regarding the validity of findings from previous analyses based on these scales. Our findings need to be replicated in other contexts, and the practical impact of non-interval measurement on utility-based analyses should be explored. If cost-effectiveness analyses are not found to be robust to violations of the assumption that utilities are interval, serious doubt will be cast upon findings from utility-based analyses and upon the wisdom of expending millions in research dollars on utility-based studies.

In recent years, bioethics has increasingly become an international area of inquiry with major contributions being made not only in North America but also in Europe and in the Pacific Rim countries. This general observation is particularly true for research ethics. Little attention has been paid, however, to this internationalization of bioethics in general and research ethics in particular, and there are few studies comparing what has emerged in the different countries.

Successful practice of cardiovascular medicine requires familiarity with the complex ethical issues that accompany therapeutic innovation and diffusion. Even as technologies transition from experimental to standard care, challenges remain. Mechanical circulatory support devices, for instance, are increasingly conceptualized as conventional therapies. Despite this, or perhaps because of it, the ethical issues surrounding the use of these devices in patients with end-stage organ dysfunction are becoming increasingly apparent. In this paper, we provide an introduction to ethical considerations related to the use of ventricular assist devices (VADs) in end-stage organ failure, focusing on three stages or decision points: initiation, continued use, and deactivation. Our goal is not to exhaustively resolve these dilemmas but to illustrate how ethical considerations relate to decision making.

OBJECTIVES: To estimate resource consumption and the extent of futile care among patients admitted to the pediatric intensive care unit (PICU). STUDY DESIGN: A prospective cohort study of 353 consecutive admissions followed for 1334 patient-days during the PICU stay at the Texas Children's Hospital in Houston, Texas. Participants were 353 children and adolescents who were hospitalized in the PICU during September and October 1993. Three broad operational definitions of futility were developed to capture the maximum extent of resource consumption related to medical futility. Definition 1 (imminent demise futility) was developed by an objective, validated, severity of illness measure (Pediatric Risk of Mortality Score) to identify patients with high mortality risks. Definition 2 (lethal condition futility) was used to identify patients in the PICU whose long-term survival was unlikely. Definition 3 (qualitative futility) was used to identify patients with high morbidity. Resource consumption was measured according to the number of patient-days in the PICU and the Therapeutic Intervention Scoring System. RESULTS: Twenty-three (6.5%) patients representing 36 (2.7%) patient-days met at least one of the definitions of medical futility for some of the days when they were in the PICU. None of the patient-days that met any of the definitions of medical futility were associated with high resource consumption compared with non-futile care patient-days. CONCLUSIONS: Despite our use of broad definitions of medical futility, relatively small amounts of resources were used in futile PICU care. This suggests that attempts to reduce resource consumption in the PICU by focusing on medical futility are unlikely to be successful. (J PEDIATR 1996;128:742-7)

Objective: To study the perceptions of outcome and the diffusion into practice of innovative approaches such as palliative surgery and heart transplantation to treat hypoplastic left heart syndrome. Design: A forced-choice questionnaire was sent to 108 US neonatology section heads. Responses were analyzed using Wilcoxon matched pairs, χ2analysis, and multivariant logistic regression. Results: Ninety-three questionnaires (86%) were returned. All respondents discussed palliative surgery or transplantation or both with parents; 71 (76%) of 93 also discussed comfort care. Nineteen (24%) of 80 recommended comfort care only, 51 (64%) of 80 recommended surgery only, and 10 (12%) of 80 recommended both. Of the 61 respondents recommending one or both surgical procedures, palliative surgery was recommended by 44 and transplantation by 33. Respondents perceived that transplantation was associated with a lower 1-year mortality than palliative surgery (P Conclusions: Palliative surgery and transplantation are widely used to treat hypoplastic left heart syndrome. The continued availability of comfort care suggests that these surgical procedures are still in transition from experimental technology to standard of care. (Arch Pediatr Adolesc Med. 1996;150:487-490)

MORAL PLURALISM IS A VALUABLE ASPECT OF A free society but sometimes creates conflicts in medical care when individual physicians object to providing certain legal but morally controversial services, such as abortion, physician-assisted suicide (where it is legal), and palliative sedation to unconsciousness. Genuine conscience-based refusals (CBRs) are refusals in which a physician believes that providing the requested service would violate his or her core moral beliefs (religious or secular), thereby causing personal moral harm. Conscience-based refusals should be a “shield” to protect individual physicians from being compelled to violate their core moral beliefs rather than a “sword” to force their beliefs onto patients. This partially explains why many physicians who invoke CBRs refer their patients to physicians willing to provide the requested care. Savulescu has characterized CBRs as self-serving acts accomplished at the expense of patients. Others accept CBRs as legitimate acts to protect moral integrity despite the potential negative consequences for patients. Both characterizations neglect a complexity: society may obtain higherquality medical care in aggregate by accommodating some CBRs. In this Commentary, CBRs are addressed from this societal perspective.

The patient in a persistent vegetative state (hereafter, the PVS patient) has played a central role in recent American bioethical discussions and in recent litigation involving bioethical issues. From Quinlan’ to Cruzan and Wanglie, some of the most important cases involving ethical issues at the end of life have involved PVS patients. Major American medical groups such as the AMA and the American Academy of Neurology have adopted important policy statements on the care of such patients, statements that have been followed by at least one European group.I have always found this activity a bit of a mystery. There is, after all, a relatively clear consensus about decision-making at the end of life, a consensus embodied in such documents as a report from the President's Commission and a report from the Hastings Center.

OBJECTIVE To review the use of Natural Death Act declarations (living will procedures) in pediatric patients. The implementation of such declarations for children is now possible in six states, including Texas, by specific statutory provisions. DESIGN Retrospective study. SETTING Pediatric ICU in a university hospital. PATIENTS Records of patients who had a Texas Natural Death Act declaration, either discussed and signed or discussed only, were studied. Patients who had another vehicle of limiting care (e.g., a do-not-resuscitate order) were excluded from the study. MEASUREMENTS AND MAIN RESULTS Reviewed characteristics included age, primary diagnosis, and concurrent complications. Also examined were who raised the issue of limiting care (parent or physician), the initial reaction of the other party, what support was withdrawn, what support was added, the final outcome (including the time from implementing limited care to death), and the description of witnesses. Discussions were held with parents of 17 patients, and 13 Natural Death Act declarations were actually implemented. In all but three instances, the patient died within 4 hrs from the time support was withdrawn. The main supports that were withdrawn were ventilators and catecholamines. In half of the cases, morphine sulfate was added for anticipated pain relief and sedation. All decisions were reached by close consultation between the family and the physicians, with the physicians raising the issue in 11 of the 17 cases and the family raising the issue in six cases. In 15 of the 17 patients, consultation with the Bioethics Committee was not necessary. The majority of difficulties involved resolving issues that beset patients with HIV infections, and finding appropriate witnesses as prescribed by the statute. CONCLUSIONS We conclude that the Natural Death Act works well in situations involving dying children and their parents.

As various societies have created public commissions to help develop proposals for public policies relating to issues in bioethics, philosophers have sometimes been called upon to serve on the staff of, or to provide consultation to, these public bodies. This issue of the Journal is devoted to examining problems that arise as one tries to articulate the proper role of philosophers serving in these capacities. It includes articles by Frances M. Kamm ("The philosopher as insider and outsider"), Martin Benjamin ("Philosophical integrity and policy development in bioethics"), Richard W. Momeyer ("Philosophers and the public policy process: inside, outside, or nowhere at all?"), Paul T. Menzel ("Public philosophy: distinction without authority"), and E. Haavi Morreim (Physician investment and self-referral: philosophical analysis of a contentious debate").

This paper identifies four major forms of scholarship in bioethics: empirical research, the articulation of mid-level principles of bioethics, the relating of these principles to fundamental moral theories, and discussions of the bioethical implications of legal principles and health delivery policies. It develops a reflective equilibrium approach to the relation between these four forms of scholarship. It then presents, in light of this approach, criteria for quality research in each of these forms of scholarship in bioethics.

Objectives. To describe the medical follow-up ordered, the health care utilization, the appointment compliance, and the risk factors associated with noncompliance in patients who are discharged after a pediatric intensive care unit (PICU) stay.Methods. A prospective, analytic, cohort study of 111 critically ill children, age 1 day to 16 years, who were admitted to a 30-bed PICU in an urban, tertiary-care, pediatric teaching hospital compared children who were compliant with medical follow-up with those who were not. The main outcomes measured were emergent and unscheduled physician visits during the first 6 weeks after hospital discharge; compliance with ordered medical follow-up after hospital discharge; and comparisons of socioeconomic, demographic, and medical need factors between compliant and noncompliant children.Discharge orders for follow-up appointments with general pediatricians and subspecialists were collected from the chart at hospital discharge. Patients were contacted after hospital discharge to determine whether and when they received medical follow-up; 28% were found to be noncompliant. Risk factors associated with noncompliance were evaluated. Emergent and unscheduled physician visits were tracked during the first 6 weeks after hospital discharge.Results.Lack of follow-up orders at hospital discharge did not affect the frequency of emergent visits. Children fell into 2 groups: those who were 100% compliant and those with ≤67% compliance. No socioeconomic or demographic risk factors could be identified between the 2 groups. Compared with the 100% compliant patients, patients who were compliant with ≤67% of appointments were more severely ill, as defined by higher peak pediatric risk of mortality scores during their PICU stay (11.5 vs 8.4), longer PICU length of stays (10.1 days vs 4.6 days), and longer hospital length of stays (25.5 days vs 14 days). Most predictive of noncompliance was the number of medical appointments ordered by physicians. Patients with 3 or more appointments were less likely to be compliant with follow-up. After hospital discharge, children were more likely to visit a primary care physician compared with a subspecialist (95% vs 82%). When patients were ordered to see a specialist, scheduled appointments were much better attended than the recommended appointments (92% vs 67%).Conclusions. Lack of ordered medical follow-up did not affect emergent visits. In this group of critically ill children, a significant percentage (28%) did not receive timely medical follow-up. No socioeconomic or demographic risk factors were identified in noncompliant children. However, severity of illness (higher peak pediatric risk of mortality score, longer PICU stay, and longer hospital stay) and the number of follow-up appointments ordered were predictors of noncompliance. Potential exists for implementing strategies to improve compliance in identified populations.

Background and Objectives.When innovative, not yet fully proven therapies are introduced, physicians may have neither experience nor sufficient data in the medical literature to assist in their decision to discuss them with and/or recommend them to patients. Little is known about how physicians deal with this uncertainty. Moreover, when multiple physicians caring for a single patient have reached different conclusions regarding this new therapy, the potential for disagreement exists that could give rise to ethical issues as well as cause confusion to the patient. To explore these topics, we investigated the attitudes of specialists to therapies for two life-threatening diseases: hypoplastic left heart syndrome (HLHS) and short bowel syndrome.Methods.A forced choice questionnaire was distributed to the heads of neonatology, pediatric cardiology, and pediatric gastroenterology training programs asking about their outcome impressions and treatment recommendations and about the local availability of treatments. In addition, responses from specialists from the same institution were linked in a confidential manner to evaluate the frequency of disagreement within the same institution. Responses were analyzed using χ2 and Wilcoxon matched pair analysis as appropriate.Results.The overall rate of response was 79%. In institutions that had both neonatology and pediatric gastroenterology training programs, there was a 59% response rate compared with a 73% response rate from institutions that had both neonatology and cardiology programs. Significant differences were noted among specialists as to who would be involved in discussions of therapeutic options with patients in both HLHS and short bowel syndrome. Differences also were noted in the willingness of specialists to discuss and recommend therapies, in the perceived survival and quality of life by various specialists after transplant and palliative surgery, and in the local availability of various options. The neonatologists and gastroenterologists at the same institution disagreed on responses in 34% of the questions with only 1 of the 25 pairs in full agreement. In contrast, the neonatologists and pediatric cardiologists at the same institution disagreed in only 14% of the questions with 7 of the 28 pairs in full agreement.Conclusions.Substantial disagreement among specialists about new interventions was found. There seem to be fewer differences among specialists when dealing with the more mature therapy, HLHS. Two major ethical issues arise. First, there seems to be no accepted professional standard to which individuals can appeal when determining whether to discuss or recommend new, not-yet-fully-proven technologies. Second, there is the potential for much patient confusion when counseling physicians recommend different options. Colleagues as individuals and specialists as groups should talk to each other before individual discussions with families to ensure that there is a clear understanding of differing beliefs.

Brain death has been discussed extensively for the last 25 years. Most investigators now believe that requiring death of the entire brain as the criterion for brain death in the Uniform Determination of Death Act and the standard clinical tests of brain death outlined in the Report of the Medical Consultants to the President's Commission have produced a satisfactory resolution of the issues surrounding the determination of death. However, we show that satisfying the standard medical tests does not guarantee that all brain functions have actually ceased and that there is tension between the legal criterion and the standard clinical tests. After considering and rejecting six possible reconciliations, we present an alternative approach that does not acknowledge any sharp dichotomy between life and death and incorporates the proposition that the questions of when care can be unilaterally discontinued, when organs can be harvested, and when a patient is ready for the services of an undertaker should be answered independent of any single account of death.

This paper argues, contrary to what has sometimes been claimed, that public commissions need to be more philosophical than they have been in analyzing crucial bioethical issues. It argues (a) that the failure of the President's Commission to develop and use even simple distinctions between life and personhood led to flaws in both its discussion of death and its discussion of persistent vegetative patients, and (b) that its treatment of access to health care fails to develop a coherent approach precisely because it is based on no serious philosophical reflections about justice in health care.

This paper describes the activities of the Center for Ethics, Medicine, and Public Issues, a joint project of Baylor College of Medicine, the Institute of Religion of the Texas Medical Center, and Rice University. The center focuses on the clinical teaching of medical ethics, collaborative teaching and research involving ethicists and clinicians, and the training of future practitioners in the field. Problems as well as achievements in each of these areas are discussed.

This essay challenges the view that the provision of health care must take place within a competitive-free system. The author argues that, presuming that there is a requirement to meet the demands of those who cannot pay for health care, a competitive market provides a good way to deal with injustices within the health care system. The author concludes that the demands for justice are best met when indigent individuals use some portion of the funds they receive from the government to purchase one of the many competing forms of health care. This scheme requires a competitive market in the delivery of health care.