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Background: An important difference between explanatory and pragmatic clinical trials concerns eligibility criteria. Eligibility criteria are restrictive in explanatory trials, while pragmatic trials are more inclusive or even all-inclusive., Methods: To better understand the diverging views regarding eligibility criteria, we examine the contrast between theoretical and clinical medicine, and 3 different research contexts: laboratory research, population studies and clinical trials. In each context we review the purpose for selecting study subjects or research material, as well as the type of inductive inference or generalization that is sought by such selection., Results: In each context, selection concerns different things and serves different purposes: In the laboratory, selection concerns the homogenous research material that will help isolate a causal signal. In the epidemiological context selection concerns the (random) sampling method, designed to produce a representative sample of the population. In the clinical trial setting, selection concerns patients in need of care. Restrictive eligibility criteria become inappropriate in the care setting because the aim of the trial is not to represent a population nor to isolate a causal signal, but to find out which patients benefit from treatment., Conclusion: The idea of selecting patients comes from methods that belong to theoretical medicine. In the care setting, most clinical trials should be pragmatic and as inclusive as possible., (Copyright © 2024 The Authors. Published by Elsevier Masson SAS.. All rights reserved.)

Objectives: To investigate the perspectives of doctors involved with voluntary assisted dying in Victoria regarding the Voluntary Assisted Dying Act 2017 (Vic) and its operation., Design, Setting, Participants: Qualitative study; semi-structured interviews with 32 doctors who had participated in the voluntary assisted dying system during its first year of operation (commenced 19 June 2019). Doctors were interviewed during April-July 2020., Results: Three major themes related to problems during the first year of operation of the Act were identified: the statutory prohibition of health professionals initiating discussions with their patients about voluntary assisted dying; the Department of Health and Human Services guidance requirement that all doctor-patient, doctor-pharmacist, and pharmacist-patient interactions be face-to-face; and aspects of implementation, including problems with the voluntary assisted dying online portal, obtaining documentary evidence to establish eligibility, and inadequate resourcing of the Statewide Pharmacy Service., Conclusions: Doctors reported only limited concerns about the Victorian voluntary assisted dying legislation, but have had some problems with its operation, including implications for the accessibility of voluntary assisted dying to eligible patients. While legislative change may resolve some of these concerns, most can be ameliorated by improving the processes and systems., (© 2021 AMPCo Pty Ltd.)

The coronavirus disease 2019 (COVID-19) pandemic is disproportionately affecting older people and those with underlying comorbidities. Guidelines are needed to help clinicians make decisions regarding appropriate use of limited NHS critical care resources. In response to the pandemic, the National Institute for Health and Care Excellence published guidance that employs the Clinical Frailty Scale (CFS) in a decision-making flowchart to assist clinicians in assessing older individuals' suitability for critical care. This commentary raises some important limitations to this use of the CFS and cautions against the potential for unintended impacts. The COVID-19 pandemic has allowed the widespread implementation of the CFS with limited training or expert oversight. The CFS is primarily being used to assess older individuals' risk of adverse outcome in critical care, and to ration access to care on this basis. While some form of resource allocation strategy is necessary for emergencies, the implementation of this guideline in the absence of significant pressure on resources may reduce the likelihood of older people with frailty, who wish to be considered for critical care, being appropriately considered, and has the potential to reinforce the socio-economic gradient in health. Our incomplete understanding of this novel disease means that there is a need for research investigating the short-term predictive abilities of the CFS on critical care outcomes in COVID-19. Additionally, a review of the impact of stratifying older people by CFS score as a rationing strategy is necessary in order to assess its acceptability to older people as well as its potential for disparate impacts., (© The Author(s) 2020. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

In light of recent successful uterus transplantations, it is reasonable to expect that womb transplants will become more commonplace in the future. If this happens, important questions emerge about who should receive the donated wombs. Some arguments have been advanced that suggest that potential recipients should be screened for their anticipated childrearing capacity, as one component of a comprehensive process for determining eligibility. The main arguments provided in support of this position have to do with the presumed responsibility of the state to protect future children from harm, and with avoiding complicity for any resulting harm experienced by the child born through the transplanted uterus. The purpose of this paper is to reject this position, based on two main criticisms: (1) screening potential uterus recipients for anticipated childrearing ability, but not also screening other kinds of morally equal family builders, is unjustly discriminatory; and (2) with respect to actions performed in good faith (e.g. providing a transplantable uterus to someone for the purpose of having a child), one is not morally blameworthy for the consequences of those actions (a) that one did not intend, and (b) that were directly caused by someone else, and (c) where others are directly responsible for making sure that those consequences do not come about. These criticisms are sufficient for concluding that the state is not justified in assessing the anticipated childrearing capacity of potential uterus recipients, and this is so regardless of whether or not there is a scarcity of transplantable uteruses available., (© 2019 John Wiley & Sons Ltd.)

Screening asymptomatic people with a resting electrocardiogram (ECG) has been theorized to detect latent cardiovascular disease. However, resting ECG screening is not recommended for numerous populations, such as asymptomatic middle-aged (sedentary) people, as it is not sufficiently sensitive to detect coronary artery disease. While the issues raised in this article are largely common to all screening programs, this review focuses on 2 distinct programs: (1) screening elite athletes for conditions associated with sudden cardiac death (SCD); and (2) screening people aged ≥65 years for atrial fibrillation (AF). These 2 settings have recently gained attention for their promise and concerns regarding prevention of SCD and stroke, respectively. If screening is to be done, it must be done well. Organizations conducting screening must consider a range of legal, ethical, and logistical responsibilities that arise from the beginning to the end of the process. This includes consideration of who to screen, timing of screening, whether screening is mandatory, consent issues, and auditing systems to ensure quality control. Good infrastructure for interpretation of ECG results according to expert guidelines and follow-up testing for abnormal screening results, including a pathway to treatment, are essential. Finally, there may be significant implications for those diagnosed with cardiac disease, including insurance, employment, the ability to play sport, and mental health issues. There are several legal risks, and the best protective measures are good communication systems, thorough clinical record-keeping, careful handling of eligibility questions for those diagnosed, and reference to expert guidelines as the standard of care., (Copyright © 2019 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Following the recent condemnation of the National Health Service charging regulations by medical colleges and the UK Faculty of Public Health, we demonstrate that through enactment of this policy, the medical profession is betraying its core ethical principles. Through dissection of the policy using Beauchamp and Childress' framework, a disrespect for autonomy becomes evident in the operationalisation of the charging regulations, just as a disregard for confidentiality was apparent in the data sharing Memorandum of Understanding. Negative consequences of the regulations are documented to highlight their importance for clinical decision makers under the principles of beneficence and non-maleficence. Exploration of the principle of justice illuminates the core differentiation between the border-bound duties of the State and borderless duties of the clinician, exposing a fundamental tension., Competing Interests: Competing interests: JMKR was a member of Medact Migrant Solidarity Group but she has written this piece in her academic role., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: National guidelines require programmes use subjective assessments of social support when determining transplant suitability, despite limited evidence linking it to outcomes. We examined how transplant providers weigh the importance of social support for kidney transplantation compared with other factors, and variation by clinical role and personal beliefs., Methods: The National survey of the American Society of Transplant Surgeons and the Society of Transplant Social Work in 2016. Using a discrete choice approach, respondents compared two hypothetical patient profiles and selected one for transplantation. Conditional logistic regression estimated the relative importance of each factor; results were stratified by clinical role (psychosocial vs medical/surgical providers) and beliefs (outcomes vs equity)., Results: Five hundred and eighy-four transplant providers completed the survey. Social support was the second most influential factor among transplant providers. Providers were most likely to choose a candidate who had social support (OR=1.68, 95% CI 1.50 to 1.86), always adhered to a medical regimen (OR=1.64, 95% CI 1.46 to 1.88), and had a 15 years life expectancy with transplant (OR=1.61, 95% CI 1.42 to 1.85). Psychosocial providers were more influenced by adherence and quality of life compared with medical/surgical providers, who were more influenced by candidates' life expectancy with transplant (p<0.05). For providers concerned with avoiding organ waste, social support was the most influential factor, while it was the least influential for clinicians concerned with fairness (p<0.05)., Conclusions: Social support is highly influential in listing decisions and may exacerbate transplant disparities. Providers' beliefs and reliance on social support in determining suitability vary considerably, raising concerns about transparency and justice., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Background: Since pregnant women are severely underrepresented in clinical research, many take the position that the exclusion of pregnant women from research must be justified unless there are compelling "scientific reasons" for their exclusion. However, it is questionable whether this approach renders research with pregnant women fair. This paper analyzes and evaluates when research with pregnant women can be considered as fair and what constitutes scientific reasons for exclusion., Methods: Conceptual ethical and methodological analysis and evaluation of fair inclusion., Results: Fair inclusion of pregnant women means (1) that pregnant women who are eligible are not excluded solely for being pregnant and (2) that the research interests of pregnant women are prioritized, meaning that they ought to receive substantially more attention. Fairness does not imply that pregnant women should be included in virtually every research project, as including only a few pregnant women in a population consisting only of women will not help to determine the effectiveness and safety of a treatment in pregnant women. Separate trials in pregnant women may be preferable once we assume, or know, that effects of interventions in pregnant women differ from the effects in other subpopulations, or when we assume, or know, that there are no differences. In the latter case, it may be preferable to conduct post-marketing studies or establish registries. If there is no conclusive evidence indicating either differences or equivalence of effects between pregnant and non-pregnant women, yet it seems unlikely that major differences or exact equivalence exist, the inclusion of pregnant women should be sufficient. Depending on the research question, this boils down to representativeness in terms of the proportion of pregnant and non-pregnant women, or to oversampling pregnant women., Conclusions: Fair inclusion of pregnant women in research implies that separate trials in pregnant women should be promoted. Inclusion of pregnant women has to be realized at the earliest phases of the research process. In addition to researchers and research ethics committees, scientific advisory councils, funders, drug regulatory agencies, pharmaceutical companies, journal editors and others have a joint responsibility to further develop the evidence base for drug use in pregnant women.

Hospitalized older patients are more vulnerable to physical or cognitive functional decline. Inpatient rehabilitation programs improve significantly their functional status and may prevent their admission to nursing homes. While inpatient rehabilitation institutions have established admission criteria that can be seen as objective, the risk of bias remains and raises the question of equitable access for more vulnerable populations such as older patients. This paper reviews some established eligibility criteria for inpatient rehabilitation by examining a framework used in Montreal, Québec, Canada for assessing rehabilitation eligibility and by applying this framework to a case study. It also highlights the unique ethical challenges presented by the assessment of older patients. We conclude that in order to appropriately protect the vulnerable population of older patients in the context of priority setting and allocation of scarce resources, there is a need to establish more specific criteria that can better guide the assessment of this particular population.

Background: The scarcity of human organs requires the transplant community to make difficult allocation decisions. This process begins at individual medical centers, where transplant teams decide which patients to place on the transplant waiting list. Each transplant center utilizes its own listing criteria to determine if a patient is eligible for transplantation. These criteria have historically considered preexisting affective and psychotic disorders to be relative or absolute contraindications to transplantation. While attitudes within the field appear to be moving away from this practice, there is no data to confirm that eligibility criteria have changed., Main Body: There are no nationwide guidelines detailing the manner in which affective and psychotic disorders should impact transplant eligibility. Individual transplant centers thus form their own transplant eligibility criteria, resulting in significant inter-institution variability. Data from the 1990s indicates that the majority of transplant programs considered certain psychiatric illnesses, such as active schizophrenia, to be absolute contraindications to transplantation. A review of literature reveals that no comprehensive data has been collected on the topic since that time. Furthermore, the limited data available about current practices suggests that psychiatric illness continues to be viewed as a contraindication to transplantation at some transplant centers. In light of this finding, we review psychiatric literature that examines the impact of affective and psychotic disorders on transplant outcomes and conclude that the presence of these disorders is not an accurate predictor of transplant success. We then discuss the requirements of justice as they relate to the creation of a just organ allocation system., Conclusion: We conclude that transplant eligibility criteria that exclude patients with affective and psychotic disorders on the basis of their psychiatric diagnosis alone are unjust. Just listing criteria must incorporate only those factors that have a causative effect on posttransplant morbidity and mortality. Justice also demands that we eliminate current inter-institution practice variations in favor of national transplant eligibility criteria. Given the limited data available about current practices, we call for an updated study investigating the manner in which affect and psychotic disorders impact transplant eligibility determinations.

Optimizing care in medical toxicology necessitates designing and conducting ethical research. Nevertheless, the context of medical toxicology can make clinical research ethically challenging for a variety of reasons: medical toxicology is typified by relative rare conditions; making precise and rapid diagnoses is often fraught with uncertainty; emergent and urgent clinical exigencies make consent difficult or impossible; and some exposures are stigmatized or related to illegal activities that can compromise collecting accurate data from patients. In this paper, we examine some of the ethical issues in medical toxicology research that are especially salient in effort to promote optimal research in the field. The particular issues to be addressed are as follows: (1) rare conditions and orphan agents, (2) randomization and control arms, (3) inclusion and exclusion criteria, (4) outcome measures, (5) consent, (6) confidentiality, (7) registries, (8) oversight, and (9) transparency and reporting. Thinking about these ethical issues prospectively will help researchers and clinicians appropriately navigate them.

Aims: To identify and explore features of ethical issues that senior clinicians faced as deployed medical directors (DMDs) to the British Field Hospital in Afghanistan as well as to determine the ethical training requirements for future deployments., Method: A qualitative study in two phases conducted from November 2014 to June 2015. Phase 1 analysed 60 vignettes of cases that had generated ethical dilemmas for DMDs. Phase 2 included focus groups and an interview with 13 DMDs., Findings: Phase 1 identified working with limited resources, dual conflict of meeting both clinical and military obligations and consent of children as the most prevalent ethical challenges. Themes found in Phase 2 included sharing clinical responsibilities with clinicians from other countries and not knowing team members' ways of working, in addition to the themes from Phase 1., Discussion: This study has drawn together examples of scenarios to form a repository that will aid future training. Recommendations included undertaking ethics training together as a team before, during and after deployment which must include all nationalities who are assigned to the same operational tour, so that different ethical views can be explored beforehand., Competing Interests: Competing interests: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

It is estimated that there are about four million people suffering from rare diseases in Germany. For roughly the last 20 years, there has been an increasing interest in therapeutic research for rare diseases. Drug research is highly regulated via numerous laws, regulations and ethical conventions that do not offer any waivers for clinical trials in rare diseases. Thus the ethical assessment of the clinical trial application for a rare disease is basically the same as for a common disease. As the ethical standards of clinical research, for example regarding informed consent, are derived from constitutional rights and have been codified in the German drug law, it is no surprise that they cannot depend on the frequency of a disease. A very important aspect of the ethical assessment is the biometric quality with regard to study design, sample size estimation and statistical analysis, as methodologically poor research with humans is per se unethical. Problems with sample size estimations and pilot studies will be addressed in more detail. Pilot studies should be avoided and sample size estimations should not assume overoptimistic effect sizes and should not increase the error probability beyond 5% two-sided.

Background: The value of screening for mental illness has increasingly been questioned in low prevalence settings due to high false positive rates. However, since false positive rates are related to prevalence, screening may be more effective in higher prevalence settings, including correctional institutions. We compared the yield (i.e. newly detected cases) and efficiency (i.e. false positives) of five screening protocols to detect mental illness in prisons against the use of mental health history taking (the prior approach to detecting mental illness)., Methods and Findings: We estimated the accuracy of the six approaches to detect an Axis I disorder among a sample of 467 newly admitted male inmates (83.1% participation rate). Mental health history taking identified only 41.0% (95% CI 32.1, 50.6) of all inmates with mental illness. Screening protocols identified between 61.9 and 85.7% of all cases, but referred between 2 and 3 additional individuals who did not have a mental illness for every additional case detected compared to the mental health history taking approach. In low prevalence settings (i.e. 10% or less) the screening protocols would have had between 4.6 and 16.2 false positives per true positive., Conclusions: While screening may not be practical in low prevalence settings, it may be beneficial in jails and prisons where the prevalence of mental illness is higher. Further consideration of the context in which screening is being implemented, and of the impacts of policies and clinical practices on the benefits and harms of screening is needed to determine the effectiveness of screening in these settings.

A psychiatric diagnosis today is asked to serve many functions-clinical, research, medicolegal, delimiting insurance coverage, service planning, defining eligibility for state benefits (eg, for unemployment or disability), as well as providing rallying points for pressure groups and charities. These contexts require different notions of diagnosis to tackle the particular problem such a designation is meant to solve. In a number of instances, a 'status' definition (ie, a diagnostic label or category) is employed to tackle what is more appropriately seen as requiring a 'functional' approach (ie, how well the person is able to meet the demands of a test of performance requiring certain capabilities, aptitudes or skills). In these instances, a diagnosis may play only a subsidiary role. Some examples are discussed: the criteria for involuntary treatment; the determination of criminal responsibility; and, assessing entitlements to state benefits. I suggest that the distinction between 'status' versus 'function' has not been given sufficient weight in discussions of diagnosis. It is in the functional domain that some of the problematic relationships between clinical psychiatry and the social institutions with which it rubs shoulders are played out. A status, signified by a diagnosis, has often been encumbered with demands for which it is poorly equipped. It is a reductive way of solving problems of management, allocation or disposal for which a functional approach should be given greater weight., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

During the past two years, much of my work at The Hastings Center has explored the implementation of health reform in the United States and its implications for poor and vulnerable groups. These projects include a study of access to care for undocumented patients and one that examines state-level decisions about health reform, including Medicaid expansion and the creation of health insurance "marketplaces." Both raise issues central to bioethics, including fairness, justice, and the stewardship of society's resources. Our nation spent about 2.7 trillion dollars on health care in 2012, and its major public health insurance programs represent over 20 percent of the federal budget. Despite these investments, there are troubling differences in life expectancy, infant mortality, and premature death depending on factors like income, race, ethnicity, gender, and where people live., (© 2013 by The Hastings Center.)

Candidate selection for liver transplantation presents challenging ethical issues that require balancing the principles of justice and utility. The goal of this study was to assess the opinions of U.S. transplant providers regarding the ways in which controversial medical and psychosocial characteristics influence patient eligibility for liver transplantation. An online, anonymous survey about adult patient characteristics was sent to providers (hepatologists, surgeons, psychiatrists, and social workers) at all 102 active adult liver transplant centers in the United States. A majority of the providers (251/444 or 56.5%) completed the survey. The providers were queried about 8 characteristics, and the 3 that were ranked most controversial were incarceration, marijuana use, and psychiatric diagnoses. Most providers identified a patient age ≥ 80 years (62.7%), a body mass index ≥ 45 kg/m2 (56.6%), and current incarceration with a lifetime sentence (54.7%) as absolute contraindications to liver transplantation. In a multivariate analysis, the identification of absolute contraindications varied significantly with the provider type, the center volume, and the geographical region. Less than half of the providers reported that their centers had written policies regarding most of the characteristics examined. In conclusion, providers differ significantly in their opinions on controversial patient characteristics and transplant contraindications. Along with a paucity of literature data on outcomes, these provider differences may play a role in the fact that many centers do not have formal policies for selecting patients with these characteristics. Evidence-based data on the outcomes of such patients are needed to guide the formation of written policies to better standardize eligibility criteria., (Copyright © 2013 American Association for the Study of Liver Diseases.)

The number of patients with young onset dementia (YOD) (that is before age 65) is estimated at 32,000 in France, and 5000 with onset dementia before 60 years. These patients differ from older ones by the greater number of rares causes (29%), heterogeneity of the presentation among the usual diseases, such as non-amnestic phenotypes of Alzheimer's disease, high frequency of frontal symptoms, and possible genetic origin. These aspects must be taken into account for the diagnosis, often more difficult than in older ones because patients have a little knowledge of the YOD, excepted in the genetics forms. YOD patients can still work or drive a car, and we should choose between the respect for autonomy and the security for the patient and their carers. YOD patients can be more often included in pharmacological trials because they have lower associated disorders. Individual non-pharmacological treatment should be priviledged because they don't easily accept collective activities with other patients over 60 years of age. Excepted for the very young patients (onset before 45), the survival is longer than in late onset dementia, with sometimes severe behavioral problems related to frontal syndrome. In France, the caregiving at home has been improved since the possibility for the YOD patients to receive a financial assistance reserved for the disabled patients, but admission to a nursing home before 60 is very difficult and increases the caregiver burden and perception of unfairness. There is a discrimination between young or older demented patients related to the great difficulty to meet the needs of younger patients, due to the rigidity of the medical and social systems. The presentation of a limited offer for the YOD patients must initiate reflections on our capacities to respect the autonomy and the dignity of the Alzheimer's patients regardless of age.

Certain restrictions on public funding for assisted reproductive technology (ART) are articulated and defended by recourse to a distinction between medical infertility and social infertility. We propose that underlying the prioritization of medical infertility is a vision of medicine whose proper role is to restore but not to improve upon nature. We go on to mark moral responses that speak of investments many continue to make in nature as properly an object of reverence and gratitude and therein (sometimes) a source of moral guidance. We draw on the work of Ludwig Wittgenstein in arguing for the plausibility of an appeal to nature in opposition to the charge that it must contain a logical fallacy. We also invite consideration of the moral plausibility of some appeal to nature. Finally, we examine what follows in the case of ART. Should medicine respect as natural limits that should not be overcome: the need for a man and a woman in reproduction; menopause; and even declining fertility with age? We must first ask ourselves to what degree we should defer to nature in the conduct of medicine, at least in the particular if not the general case. This will involve also asking ourselves what we think is natural and in what instances and spirit might we defy nature. Divergent opinions and policies concerning who should receive ART treatment and public funding are more easily understood in view of the centrality, complexity and fundamental nature of these questions., (© 2011 Blackwell Publishing Ltd.)

Objective: The donation of livers by living donors entails complex processes, both surgically and psychosocially, potentially involving risks in both domains. Thorough psychosocial evaluation is necessary to minimize those risks, yet little has been written about the donor assessment process. This article describes one such process, utilized by a transplant program in upstate New York., Method: Donor candidates undergo multiple psychosocial interviews early in the overall transplant evaluation process. Evaluators subsequently meet as a group, along with an independent ethicist, to determine psychosocial candidacy prior to final medical/surgical clearance., Results: Between 2003 and 2007, 416 donor candidates initiated and/or underwent full evaluation, resulting in a 17.5% surgery and 55.5% exclusion rate among those individuals. Of those ruled out, 20.8% were for (medical or psychosocial) reasons associated with the recipient, and 8.7% were for donor-related psychosocial issues., Conclusion: Given the primacy ofpsychosocial and ethical issues in living liver donor candidate evaluation, the multiple interview process, followed by team discussion and overseen by an ethicist removed from other transplant program functions, has advantages as a donor assessment model.

Current strategies to address global inequities in access to life-saving vaccines use averaged national income data to determine eligibility. While largely successful in the lowest income countries, we argue that this approach could lead to significant inefficiencies from the standpoint of justice if applied to middle-income countries, where income inequalities are large and lead to national averages that obscure truly needy populations. Instead, we suggest alternative indicators more sensitive to social justice concerns that merit consideration by policy-makers developing new initiatives to redress health inequities in middle-income countries., (© 2009 Blackwell Publishing Ltd.)

Chairpersons of the hospital ethics committees (HECs) and BMT clinicians were compared with regard to their willingness to proceed with allogeneic BMT given select psychosocial risk factors. A self-administered questionnaire was sent to 62 HEC chairpersons at hospitals with an accredited BMT program; the response rate was 37%. Items included background information, followed by six case vignettes from a 2006 national survey on which BMT physicians, nurses and social workers agreed not to proceed with allogeneic BMT on the basis of the following risk factors: suicidal ideation; use of addictive, illicit drugs; history of non-compliance; absence of a caregiver; alcoholism; and mild dementia from early onset of Alzheimer's disease. Opinions regarding transplant differed in one case only, in a patient with mild dementia; 27% of HEC chairpersons recommended not proceeding with BMT, which was significantly lower than that of nurses (68%, P<0.001), physicians (63.5%, P<0.001) and social workers (51.9%, P=0.05). Qualitative data show patterns of informal reasoning, linking transplant decisions to patient's responsibility for their psychosocial risk factor(s), as well as to medical benefit and outcome.

Despite a growing global commitment to the provision of antiretroviral therapy (ART), its availability is still likely to be less than the need. This imbalance raises ethical dilemmas about who should be granted access to publicly-subsidized ART programmes. This paper reviews the eligibility and targeting criteria used in four case-study countries at different points in the scale-up of ART, with the aim of drawing lessons regarding ethical approaches to rationing. Mexico, Senegal, Thailand and Uganda have each made an explicit policy commitment to provide antiretrovirals to all those in need, but are achieving this goal in steps--beginning with explicit rationing of access to care. Drawing upon the case-studies and experiences elsewhere, categories of explicit rationing criteria have been identified. These include biomedical factors, adherence to treatment, prevention-driven factors, social and economic benefits, financial factors and factors driven by ethical arguments. The initial criteria for determining eligibility are typically clinical criteria and assessment of adherence prospects, followed by a number of other factors. Rationing mechanisms reflect several underlying ethical theories and the ethical underpinnings of explicit rationing criteria should reflect societal values. In order to ensure this alignment, widespread consultation with a variety of stakeholders, and not only policy-makers or physicians, is critical. Without such explicit debate, more rationing will occur implicitly and this may be more inequitable. The effects of rationing mechanisms upon equity are critically dependent upon the implementation processes. As antiretroviral programmes are implemented it is crucial to monitor who gains access to these programmes.

This article examines the possibility of genetic discrimination in life insurance and discusses the inability of current Australian legislation to deal adequately with genetic test result information. Genetic information has certain features that distinguish it from other medical information and thus a specialist legislative package is required to regulate its use. This article outlines how current practices in the life insurance industry are inconsistent with notions of human rights. Several legislative options are suggested and examined. Given the negative and damaging impact that adverse selection is likely to have on the life insurance industry should the use of all genetic test results be prohibited, an approach which modifies the current regime is recommended. This includes a comprehensive review scheme and the introduction of additional insurance products tailored to individuals suffering from various genetic illnesses or predispositions to future disease.

The United States Medicaid programme aims to provide public health insurance to certain categories of the low-income population. Considerable non-uniformity exists within the programme because each of the 50 states, Washington, DC and 5 territories are individually responsible, within broad federal guidelines, for its administration. The non-uniformity shows up in different eligibility requirements, benefits and health care provider reimbursement rates. This paper examines reimbursement rate variations across individual programmes and discusses how these variations affect health care provider participation. Dual market theory suggests, and empirical results conclude that low reimbursement rates cause health care providers to participate less fully in the programme. Variations in access to medical care because of differences in reimbursement rates thereby create severe horizontal and vertical inequities across programmes. To reduce these inequities, the federal government might offer earmarked grants for the mandated purpose of raising reimbursement rates to a uniform percentage of private rates in all programmes.