A Future for Migrants with Acute Heart Problems Seeking Asylum?

This paper discusses the future of migrants with acute heart problems and without permanent permission to remain in the country where they are seeking asylum. What does the country they have traveled to owe them? Specifically, what healthcare services are they entitled to? This may seem a niche problem, but numbers of migrants with acute heart problems could increase in the future. Besides, similar problems could be raised by, for instance, traumatized migrants with acute needs for healthcare services for other serious conditions. The paper identifies the issues and some positions on them. Arguments for and against these positions are explored. This particular set of problems in healthcare ethics creates several challenges, at both national and international levels, concerning access to transplantation, public willingness to donate organs, optimal use of organs, justice and fairness, and potential conflicts of law, politics and ethics, as well as issues revolving around interaction and communication (or lack of it) between agencies and professions.

Paternal consent in prenatal research: ethical aspects.

The role of mothers in prenatal research has been discussed extensively. Significantly less work has been done on the father's role. In this article, focusing on ethical issues, we seek to redress this imbalance. Examining the father's position in research conducted on pregnant women, we ask whether or not paternal consent ought to be required in addition to that of the pregnant woman. Having distinguished between different concepts of father and mother, we proceed by giving an overview of the reasons for requiring consent of the woman who is carrying the child. We then examine which of these reasons apply to the biological father, and show that some of them are relevant to the father. The case, roughly speaking, revolves around privacy issues, the father's future legal responsibilities, and the likelihood that he will care about the health and wellbeing of his future child. These factors in the decision problem should all be recognized, as should the fact that they can in principle be trumped by other considerations.

A framework for the ethical assessment of chimeric animal research involving human neural tissue.

BACKGROUND: Animal models of human diseases are often used in biomedical research in place of human subjects. However, results obtained by animal models may fail to hold true for humans. One way of addressing this problem is to make animal models more similar to humans by placing human tissue into animal models, rendering them chimeric. Since technical and ethical limitations make neurological disorders difficult to study in humans, chimeric models with human neural tissue could help advance our understanding of neuropathophysiology. MAIN BODY: In this article, we examine whether the introduction of human neural tissue and any consequent cognitive change is relevant to the way we ought to treat chimeras. We argue that changes in cognitive abilities are morally relevant to the extent that they increase the capacities that affect the moral status of any entity, including awareness, autonomy, and sociability. We posit that no being, regardless of species, should be treated in a way that is incommensurate with its moral status. Finally, we propose a framework that can be used to guide ethical assessment of research involving chimeras with advanced cognitive capacities. CONCLUSION: We advance this framework as a useful tool for bringing relevant considerations to the forefront for those considering the ethical merit of proposed chimeric research. In doing so, we examine concepts relevant to the question of how any entity may be treated, including moral status, dignity, and capacities.

Ethical considerations in chimera research.

The development of human pluripotent stem cells has opened up the possibility to analyse the function of human cells and tissues in animal hosts, thus generating chimeras. Although such lines of research have great potential for both basic and translational science, they also raise unique ethical issues that must be considered.

Identifying challenges to communicating with patients about their imminent death.

The research literature suggests that physicians' attitudes regarding disclosing a diagnosis of cancer have changed, from nondisclosure to full disclosure. Physicians' attitudes towards disclosing a patient's prognosis are likewise said to have changed, although not to the same degree. The aim of this study was to identify inherent challenges in communicating information about imminent death. It included one set of interviews with patients and another set with doctors, and subsequent discussions of ways to overcome obstacles to patients' understanding their situation. Patients were diagnosed with leukemia, myeloma, or lung cancer; the doctors were hematologists and lung oncologists. The two sets of interviews were analyzed separately using a content analysis model developed by Graneheim and Lundman. For each set of interviews, eight content areas were defined as belonging to an area of interest and scrutinized for the information they included regarding communicating prognoses to patients. The main finding was a discrepancy between patients' desire to be fully informed regarding their prognosis and physicians' reluctance to offer a prognosis until a patient had overt signs of approaching death. We conclude that existing guidelines for disclosure of bad news should be modified to encourage disclosure and discussion of uncertain prognostic information, unless a patient is clearly opposed to receiving such information or otherwise not a suitable partner for dialogue.

An exploratory open-label multicentre phase I/II trial evaluating the safety and efficacy of postnatal or prenatal and postnatal administration of allogeneic expanded fetal mesenchymal stem cells for the treatment of severe osteogenesis imperfecta in infants and fetuses: the BOOSTB4 trial protocol.

INTRODUCTION: Severe osteogenesis imperfecta (OI) is a debilitating disease with no cure or sufficiently effective treatment. Mesenchymal stem cells (MSCs) have good safety profile, show promising effects and can form bone. The Boost Brittle Bones Before Birth (BOOSTB4) trial evaluates administration of allogeneic expanded human first trimester fetal liver MSCs (BOOST cells) for OI type 3 or severe type 4. METHODS AND ANALYSIS: BOOSTB4 is an exploratory, open-label, multiple dose, phase I/II clinical trial evaluating safety and efficacy of postnatal (n=15) or prenatal and postnatal (n=3, originally n=15) administration of BOOST cells for the treatment of severe OI compared with a combination of historical (1-5/subject) and untreated prospective controls (≤30). Infants<18 months of age (originally<12 months) and singleton pregnant women whose fetus has severe OI with confirmed glycine substitution in COL1A1 or COL1A2 can be included in the trial.Each subject receives four intravenous doses of 3×106/kg BOOST cells at 4 month intervals, with 48 (doses 1-2) or 24 (doses 3-4) hours in-patient follow-up, primary follow-up at 6 and 12 months after the last dose and long-term follow-up yearly until 10 years after the first dose. Prenatal subjects receive the first dose via ultrasound-guided injection into the umbilical vein within the fetal liver (16+0 to 35+6 weeks), and three doses postnatally.The primary outcome measures are safety and tolerability of repeated BOOST cell administration. The secondary outcome measures are number of fractures from baseline to primary and long-term follow-up, growth, change in bone mineral density, clinical OI status and biochemical bone turnover. ETHICS AND DISSEMINATION: The trial is approved by Competent Authorities in Sweden, the UK and the Netherlands (postnatal only). Results from the trial will be disseminated via CTIS, ClinicalTrials.gov and in scientific open-access scientific journals. TRIAL REGISTRATION NUMBERS: EudraCT 2015-003699-60, EUCT: 2023-504593-38-00, NCT03706482.

Which patient groups should be asked to participate in first-in-human trials of stem-cell-based therapies?

The aims of this article are to consider (1) whether there are medical and societal differences among diseases regarding which patient groups should be asked to participate in first-in-human (FIH) trials of stem-cell-based therapies; (2) any differences in the light of values generally endorsed by different types of ethical theories, since the question in the title of this article is value laden, and its answer depends on which values one wants to promote and protect, and how they are ranked in importance; (3) whether the answer to that question is disease-specific, or whether it depends on factors common to several diseases. To illustrate these problems, we use Parkinson's disease (PD) and Huntington's disease (HD), between which there are important medical and societal differences. Moreover, research on stem-cell-based therapies for these diseases is being translated from research to practice. This approach to the problem can be applied to decision making about similar problems raised by other diseases that exhibit the same types of differences.

The principle of proportionality revisited: interpretations and applications.

The principle of proportionality is used in many different contexts. Some of these uses and contexts are first briefly indicated. This paper focusses on the use of this principle as a moral principle. I argue that under certain conditions the principle of proportionality is helpful as a guide in decision-making. But it needs to be clarified and to be used with some flexibility as a context-dependent principle. Several interpretations of the principle are distinguished, using three conditions as a starting point: importance of objective, relevance of means, and most favourable option. The principle is then tested against an example, which suggests that a fourth condition, focusing on non-excessiveness, needs to be added. I will distinguish between three main interpretations of the principle, some primarily with uses in research ethics, others with uses in other areas of bioethics, for instance in comparisons of therapeutic means and ends. The relations between the principle of proportionality and the precautionary principle are explored in the following section. It is concluded that the principles are different and may even clash. In the next section the principle of proportionality is applied to some medical examples drawn from research ethics and bioethics. In concluding, the status of the principle of proportionality as a moral principle is discussed. What has been achieved so far and what remains to be done is finally summarized.

The need for a standard for informed consent for collection of human fetal material.

The ISSCR has developed the Informed Consent Standards for Human Fetal Tissue Donation and Research to promote uniformity and transparency in tissue donation and collection. This standard is designed to assist those working with and overseeing the regulation of such tissue and reassure the wider community and public.

Between uncertainty and certainty.

In this study, 10 hematologists and 10 lung oncologists were interviewed regarding the information they provide to patients in four situations of uncertainty: determining the treatment that is in the patient's best interest; recurrence or progression of the patient's disease; determining when to withdraw life-prolonging treatment; discussing death, addressing questions such as whether the patient will die from the disease, and when. The primary finding is that delivery of information to patients with low survival rates can be improved by more and better disclosure by physicians at an earlier stage. The crucial point for physicians is to ascertain the wishes of patients, to learn what to reveal about what patients should expect, short term and long term, as death approaches.

The ethics of regenerative medicine.

Most developments in regenerative medicine have in common that there are many uncertainties and knowledge gaps. These features make the evaluation of long-term consequences of the available options difficult and have consequences for the ethical issues raised. This paper presents an overview of ethical issues raised in regenerative medicine, using as a starting point a list of stakeholders and their interests. Ethical issues are introduced via a simplified account of a project that focuses on several difficult problems, as well as a conceptual framework consisting of the following key concepts: present situation, goals, difficulties on the road toward the goals, and strategies for dealing with the difficulties. The list of ethical issues discussed includes safety and efficacy, patient consent, information, professional responsibilities, as well as equity and fairness. The issues and the underlying values need to be clarified, specified, debated, and ranked in order of importance. A particular problem is that values sometimes clash: Certain values can be achieved only at the expense of others. If and when values clash, principles are available that can guide the decision making. The paper comments on two such principles with implications for the particular issue of patient access to experimental treatments: the precautionary principle and the principle of proportionality. The paper ends with some conclusions for the future.

[The priority-setting platform and its conditions]. / Prioriteringsplattformen kan stärka förtroendet för vården - En stötta för rättvis fördelning av våra gemensamma resurser.

The platform for priority-setting contains key ideas about the mission, goals and values of health care in Sweden. The basic idea is that health care resources should be distributed primarily according to need and effect, and secondarily according to cost-effectiveness. Nobody should be discriminated against on the basis of their gender, age, religion, ethnic origin or political views. We also need to distinguish between the health-related needs that we, as a society, have agreed should be met by publicly funded health care and needs for which there is no such agreement. The mission of health care can, and ought to, remain unchanged, even if, or as, this classification changes. The platform should not be abandoned, since it helps to maintain trust in our publicly financed health care system.

Ethical Considerations in Crossing the Xenobarrier.

Chimeras have been an important part of animal research for decades. Yet crossing the species barrier has always been seen as potentially morally problematic. In recent years, advances in chimeric research and the attendant possibilities-organ xenotransplantation, cognitive enhancement, and others-have given rise to further ethical concern. This contribution surveys the main ethical questions that have been discussed in the literature. We examine two arguments-from the order of nature and from human dignity-which aim to show that chimerization is inherently wrong. Finding the first untenable and the second largely inapplicable, we then turn to two unconvincing arguments designed to show that chimerization must necessarily lead to negative outcomes. Having thus found that no blanket statements can be made on the ethics of chimerization, we examine two important parameters relevant to the ethical evaluation of proposed chimeric research: the argument from moral status and from risk.

Information from physicians and retention of information by patients - obstacles to the awareness of patients of progressing disease when life is near the end.

BACKGROUND: Discrepancies between the information that patients have received and the patients' awareness of their condition have frequently been observed in literature and given a number of different explanations. The chief contribution of this study is that by following patients over time it is possible not only to notice any changes in the patients' knowledge or awareness of their disease, but also to investigate the interview material for possible reasons for those changes. Since the study is based on two different groups of patients it will also be possible to notice if the category of disease matters for patients' awareness of their condition. METHODS: Twelve patients with malign haematological diseases or lung cancer were followed with interviews from diagnosis to cure or death, or at most for two years. The method is qualitative. Semi-structured interviews were conducted, transcribed into written text, and then used for a qualitative content analysis. RESULTS: During the process of analysis four different expressions (subcategories) emerged about the awareness of patients concerning their health status: informed and aware, not informed and not aware, aware though not informed, or not aware though informed. Then the search started for obstacles to the awareness of patients regarding their progressing disease and approaching death. Four kinds of obstacles were found: due to the physician, the patient, the physician and the patient in collusion, or neither to the physician nor the patient but the insidious way in which lung cancer (mostly) and haematological malignancies (occasionally) progress. CONCLUSION: To optimize the care of patients who wish to be informed and aware during their disease, it is important that the health care staff recognizes potential obstacles to the awareness of patients in order to minimize such obstacles. The physicians could improve their communication with patients with life-threatening diseases, and avoid having a narrow focus on the treatment calendar. The patients could be encouraged to have a more proactive attitude in their communication with their physician.

In the shadow of bad news - views of patients with acute leukaemia, myeloma or lung cancer about information, from diagnosis to cure or death.

BACKGROUND: Many studies have been published about giving and receiving bad messages. However, only a few of them have followed the patients all the way through a disease as is done in this study. Many studies have been written about patients' coping strategies. In this study we will keep within the bounds of coping through information only. The aim of the study is to investigate patients' views of information during the trajectory of their disease, whether their reactions differ from each other and whether they differ in different phases of the disease. METHODS: Twelve patients with malignant haematological diseases or lung cancer were followed with interviews from diagnosis to recovery or into the terminal phase or at most for two years. The method is qualitative, using semi-structured interviews. SETTING: Orebro University Hospital or the patient's home. RESULTS: All patients described themselves as well informed from the start but in later phases of their disease some of them came to express a great uncertainty about the progressing disease and about the approaching death. Most of them, regardless of whether they had a haematological malignancy or lung cancer, expressed a wish to be well informed all through the disease and even when the messages were bad. Different strategies for coping with information, however, affected how they then dealt with the information received. Four such coping strategies were found: 1) Information-dependent and accepting; 2) Information-dependent but denying; 3) Medically informed and accepting; 4) Medically informed but denying. CONCLUSION: To several patients there was an unmet need for information about the progressing disease and the approaching death. To optimize the care of these patients it seems important that the physician is aware of patients' need for information even when the news is bad. Knowing the patient's information strategy could probably function as a key for the physician to communicate with patients on these matters.

Familial hypercholesterolemia: ethical, practical and psychological problems from the perspective of patients.

The main aim of the study was to explore the extent to which familial hypercholesterolemia (FH) influences the life of the patients affected. The study employed a qualitative analysis of semi-structured interviews with 23 outpatients who were being treated following a diagnosis of heterozygous FH at a tertiary hospital in Göteborg, Sweden. Some interviewees reported concerns related to their medication and feelings of guilt when not complying with treatment recommendations. However, none of the respondents expressed sustained emotional distress or would have preferred to be ignorant of their diagnosis. Apart from being more observant about food intake, their awareness of FH did not appear to have had a substantial impact on their way of life. In fact, those who did not suffer from any other diseases generally regarded themselves as healthy. Discussing the genetic constitution with family members with whom they had close contact was natural, but informing distant family members was not.