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Increased work complexity and financial strain in the health care sector have led to higher demands on staff to handle ethical issues. These demands can elicit stress reactions, that is, moral distress. One way to support professionals in handling ethical dilemmas is education and training in ethics. This article reports on a controlled prospective study evaluating a structured education and training program in ethics concerning its effects on moral distress. The results show that the participants were positive about the training program. Moral distress did not change significantly. This could be interpreted as competence development, with no effects on moral distress. Alternatively, the result could be attributed to shortcomings of the training program, or that it was too short, or it could be due to the evaluation instrument used. Organizational factors such as management involvement are also crucial. There is a need to design and evaluate ethics competence programs concerning their efficacy. [ABSTRACT FROM AUTHOR]

This qualitative study explores how 29 Swedish patients with Multiple Endocrine Neoplasia type 1 (MEN1) experience living with the condition, appraisal of the clinical follow-up program, and surveys their future expectations. The aim of this study is to build knowledge about this patient group in order to provide optimal care. The participants describe physical, psychological, and social limitations in their daily activities and how these limitations influence quality of life. Our findings indicate that a majority of patients have adjusted to their situation, describing themselves as being healthy despite physical symptoms and treatment. The participants received decent care in the clinical follow-up program, - however, greater effort should be put into patient information. These patients might benefit from genetic counseling. Health professionals involved should recognize their potential impact and influence on a patient's ability to adjust to these circumstances. Antonovsky;s Sense of Coherence theory is used to discuss these findings. [ABSTRACT FROM AUTHOR]

Large international biobank studies can make substantial contributions to scientific research by validation of the biological importance of previous research and by identification of previously unknown causes of disease. However, regulations for patient consent that are too strict and discrepancies in national policies on informed consent might hinder progress. Therefore, establishment of common ground for ethical review of biobank research is essential. In this essay, broad consent is defined on a scale between strictly specified (eg, for a specific study) and blanket consent (ie, with no restrictions regarding the purpose of the research). Future research includes that which might not be planned or even conceptualised when consent is obtained. In conclusion, broad consent and consent for future research are valid ethically and should be recommended for biobank research provided that: personal information related to research is handled safely; donors of biological samples are granted the right to withdraw consent; and new research studies or changes to the legal or ethical authority of a biobank are approved by an ethics-review board. [ABSTRACT FROM AUTHOR]

In this review we investigate how assessments of quality of life (QoL) can be used in daily clinical practice. The focus is on individualized QoL assessments, but computerized-adaptive testing and interpretation of QoL scores are also considered. Quality of life (QoL) measurements have been used relatively infrequently in clinical practice, although individualized care planning and follow-up based on QoL information may lead to better outcomes of treatment and informed and autonomous decision-making by patients. A recent approach in assessing QoL is by individualized measures, which tap QoL as defined by the individual patient. Individualized QoL instruments, such as the Schedule for the Evaluation of Individual Quality of Life (SEIQoL) and the Patient-Generated Index (PGI), have obvious appeal for use in clinical practice, since they incorporate topics of greatest concern to the individual patient, while also capturing their ratings and weightings. However, before general use in daily clinical practice can be recommended, some aspects of these instruments require further research, particularly issues concerning reliability, feasibility, interpretation and effectiveness. [ABSTRACT FROM AUTHOR]

Rare disease patients are more likely to receive a rapid molecular diagnosis nowadays thanks to the wide adoption of next-generation sequencing. However, many cases remain undiagnosed even after exome or genome analysis, because the methods used missed the molecular cause in a known gene, or a novel causative gene could not be identified and/or confirmed. To address these challenges, the RD-Connect Genome-Phenome Analysis Platform (GPAP) facilitates the collation, discovery, sharing, and analysis of standardized genome-phenome data within a collaborative environment. Authorized clinicians and researchers submit pseudonymised phenotypic profiles encoded using the Human Phenotype Ontology, and raw genomic data which is processed through a standardized pipeline. After an optional embargo period, the data are shared with other platform users, with the objective that similar cases in the system and queries from peers may help diagnose the case. Additionally, the platform enables bidirectional discovery of similar cases in other databases from the Matchmaker Exchange network. To facilitate genome-phenome analysis and interpretation by clinical researchers, the RD-Connect GPAP provides a powerful user-friendly interface and leverages tens of information sources. As a result, the resource has already helped diagnose hundreds of rare disease patients and discover new disease causing genes., (© 2022 The Authors. Human Mutation published by Wiley Periodicals LLC.)

Objectives: There is an increased interest in patient preferences informing the development and authorisation of medical products. A requirement for robust and meaningful results of such studies is that patients adequately understand the risks and benefits associated with treatments for which their preferences are elicited. This study aims to determine the influence of an educational tool, compared with traditional written information on patient preferences elicited in a discrete choice experiment (DCE)., Methods: Treatment preferences of Swedish patients with rheumatoid arthritis (RA) were assessed using a DCE. Patients were recruited via clinics, a research panel, and the Swedish Rheumatism Association. Respondents received training materials either as plain written text or as an online educational tool. The educational tool was designed to enhance understanding of the written text by using graphics, pictograms, icon arrays, spoken text, and click-on functions. Data were analysed using random parameter logit models., Results: 675 patients with RA were included in the analysis. The patients received either a written information (n = 358) or information via an educational tool (n = 317). Respondents receiving the educational tool placed relatively more importance on all included side effects in their decision making, compared to respondents receiving the written text, who placed greater importance on treatment effectiveness and administration methods., Conclusion: Compared to the respondents receiving the written text, the decisions of respondents receiving the educational tool were more influenced by medication side effects. Further research is needed to provide guidance on how and when to use educational tools to inform and elicit patients' preferences., Practice Implications: The ways in which attributes are presented to patients significantly impacts preferences measured in a DCE., Competing Interests: Conflict of interest KSB, JV, MH, EB, MF and UK have no conflict of interest to declare. KR is supported by the Birmingham NIHR Biomedical Research Centre and is a member of the Research into Inflammatory Arthritis Centre Versus Arthritis and the MRC Versus Arthritis Centre for Musculoskeletal Ageing Research., (Copyright © 2021 Elsevier B.V. All rights reserved.)

The premise of Open Science is that research and medical management will progress faster if data and knowledge are openly shared. The value of Open Science is nowhere more important and appreciated than in the rare disease (RD) community. Research into RDs has been limited by insufficient patient data and resources, a paucity of trained disease experts, and lack of therapeutics, leading to long delays in diagnosis and treatment. These issues can be ameliorated by following the principles and practices of sharing that are intrinsic to Open Science. Here, we describe how the RD community has adopted the core pillars of Open Science, adding new initiatives to promote care and research for RD patients and, ultimately, for all of medicine. We also present recommendations that can advance Open Science more globally., (Published by Oxford University Press on behalf of the American Medical Informatics Association 2020.)

Purpose: This study aims to determine research participants' preferences for receiving genetic risk information when participating in a scientific study that uses genome sequencing., Methods: A discrete choice experiment questionnaire was sent to 650 research participants (response rate 60.5%). Four attributes were selected for the questionnaire: type of disease, disease penetrance probability, preventive opportunity, and effectiveness of the preventive measure. Panel mixed logit models were used to determine attribute level estimates and the heterogeneity in preferences. Relative importance of the attribute and the predicted uptake for different information scenarios were calculated from the estimates. In addition, this study estimates predicted uptake for receiving genetic risk information in different scenarios., Results: All characteristics influenced research participants' willingness to receive genetic risk information. The most important characteristic was the effectiveness of the preventive opportunity. Predicted uptake ranged between 28% and 98% depending on what preventive opportunities and levels of effectiveness were presented., Conclusion: Information about an effective preventive measure was most important for participants. They valued that attribute twice as much as the other attributes. Therefore, when there is an effective preventive measure, risk communication can be less concerned with the magnitude of the probability of developing disease.

Background: There is increasing interest in involving patient preferences for benefits and risks in regulatory decision making. Therefore, it is essential to identify patient perspectives regarding the value of patient preference information (PPI)., Objectives: The aim of this study was to explore how patients with rheumatoid arthritis (RA) value the use of PPI in regulatory decision making regarding medical products., Methods: Regulators and patients with RA were interviewed to gather initial insights into opinions on the use of PPI in regulatory decisions regarding medical products. The interviews were used to draft and validate the interview guide for focus groups with patients with RA. Participants were purposively sampled in collaboration with the Swedish Rheumatism Association in Stockholm and Uppsala. Each focus group consisted of three to six patients (18 in total). All interviews were audio-recorded, transcribed verbatim, and analysed using content analysis., Results: According to the participants, PPI could lead to regulators considering patients' needs, lifestyles and well-being when making decisions. PPI was important in all stages of the medical product lifecycle. Participants reported that, when participating in a preference study, it is important to be well-informed about the use of the study and the development, components, administration, and risks related to the medical products., Conclusions: Patients thought PPI could be valuable to consider in regulatory decisions. It is essential for patients to be well-informed when asked for their preferences. Research on information materials to inform patients in preference studies is needed to increase the value of PPI in regulatory decision making.

Background: Understanding of how cardiovascular risk information influence individuals is critical for the practice of risk assessment and the management of patients with cardiovascular disease., Objectives: The objective of this study was to investigate change in mental distress among research participants after undergoing a cardiovascular risk assessment and receiving individual test results., Methods: In 2017, a questionnaire measuring mental distress after taking part in a risk assessment was distributed among 615 participants in the Swedish Cardiopulmonary Bio Image Study in Uppsala, Sweden, aged 50-64 years. Outcome measures were re-assessed after three months (30% were lost to follow-up)., Results: There were no differences in outcomes after three months for participants with normal test results or for participants who were referred to primary health care. Mental distress increased in participants who were referred to the hospital, and were further explained by the fact that these participants were diagnosed with coronary artery stenosis., Conclusions: CV risk information can be provided to individuals with lower levels of risk without concerns of inducing mental distress. However, in order to prevent unnecessary worry in contexts similar to this study, one should be prepared for different risk outcomes and plan for support for individuals with higher risk. The increased utility of powerful, yet not fully mature, imaging techniques requires careful considerations extending beyond medical risks and benefits; the clinician must also take into account the risk of mental distress and secure support when necessary., Competing Interests: The authors have declared that no competing interests exist.

Background: Endeavors have been made to found and incorporate ethical values in most aspects of healthcare, including health technology assessment. Health technologies and their assessment are value-laden and could trigger problems with dissemination if they contradict societal norms. Per WHO definition, preconception expanded carrier screening is a new health technology that warrants assessment. It is a genetic test offered to couples who have no known risk of recessive genetic diseases and are interested pregnancy. A test may screen for carrier status of several autosomal recessive diseases and X-linked at one go. The technique has been piloted in the Netherlands and is discussed in other countries. The aim of the study was to examine values and value conflicts that healthcare experts recounted in relation to the discussion of implementation and use of preconception ECS in Sweden., Methods: We interviewed ten experts, who were associated with influencing health policymaking in Sweden. We employed systematizing expert interviews, which endeavor to access experts' specialist knowledge. There were four female and six male informants, of which four were physicians, three bioethicists, one a legal expert, one a theologian and one a political party representative in the parliament. The participants functioned as members of two non-governmental bodies and three governmental organizations. We employed thematic analysis to identify themes, categories and subcategories., Results: Two main themes surfaced: values and value conflicts. The main categories of Respect for persons, Solidarity, Human dignity, Do no harm, Health and Love formed the first theme, while values conflicting with autonomy and integrity respectively, constituted the second theme. Concepts relating to respect for persons were the most commonly mentioned among the participants, followed by notions alluding to solidarity. Furthermore, respondents discussed values conflicting with Swedish healthcare ones such as equality and solidarity., Conclusions: The experts highlighted values and concepts that are distinctive of welfare states such as Sweden and delineated how preconception ECS could challenge such values. Moreover, the analysis revealed that certain values were deemed more substantive than others, judging by the extent and detail of inference; for example, respect for persons and solidarity were on top of the list.

To improve healthcare policymaking, commentators have recommended the use of evidence, health technology assessment, priority setting, and public engagement in the process of policymaking. Preconception expanded carrier screening, according to the World Health Organization's definition, is a novel health technology and therefore warrants assessment, part of which involves evaluating ethical and social implications. We examined ten Swedish policymakers' perspectives on ethical and social aspects of preconception expanded screening through in-depth expert interviewing, using a semi-structured questionnaire. Respondents were affiliated to governmental and non-governmental institutions that directly influence healthcare policymaking in Sweden. The interviews were recorded, transcribed verbatim, and analyzed via inductive thematic analysis method, which generated seven themes and several subthemes. Policymakers harbored concerns regarding the economics, Swedish and international political respects, implementation procedures, and societal effects, which included long-term ones. Moreover, participants detailed the role of public engagement, research, and responsibility in regard to preconception expanded carrier screening implementation. Since this is a qualitative study, with a small non-random sample, the results may not be generalizable to all policymakers in Sweden. However, the results give a profound insight into the process and interpretative knowledge of experts, in the Swedish milieu and the extent of readiness of Sweden to implement a preconception expanded carrier screening program.

Objective: It is well known that research participants want to receive genetic risk information that is about high risks, serious diseases and potential preventive measures. The aim of this study was to explore, by qualitative means, something less well known: how do healthy research participants themselves make sense of genetic risk information?, Method: A phenomenographic approach was chosen to explore research participants' understanding and assessment of genetic risk. We conducted four focus-group (N=16) interviews with participants in a research programme designed to identify biomarkers for cardiopulmonary disease., Results: Among the research participants, we found four ways of understanding genetic risk: as a binary concept, as an explanation, as revealing who I am (knowledge of oneself) and as affecting life ahead., Conclusion: Research participants tend to understand genetic risk as a binary concept. This does not necessarily imply a misunderstanding of, or an irrational approach to, genetic risk. Rather, it may have a heuristic function in decision-making., Practical Implications: Risk communication may be enhanced by tailoring the communication to the participants' own lay conceptions. For example, researchers and counselors should address risk in binary terms, maybe looking out for how individual participants search for threshold figures., (Copyright © 2017 Elsevier B.V. All rights reserved.)

The development of mental disorders constitutes a complex phenomenon driven by unique social, psychological and biological factors such as genetics and epigenetics, throughout an individual's life course. Both environmental and genetic factors have an impact on mental health phenotypes and act simultaneously to induce changes in brain and behavior. Here, we describe and critically evaluate the current literature on gene-environment interactions and epigenetics on mental health by highlighting recent human and animal studies. We furthermore review some of the main ethical and social implications concerning gene-environment interactions and epigenetics and provide explanations and suggestions on how to move from statistical and epigenetic associations to biological and psychological explanations within a multi-disciplinary and integrative approach of understanding mental health., (© 2018 Elsevier Inc. All rights reserved.)

There is a growing concern in the ethics literature and among policy makers that de-identification or coding of personal data and biospecimens is not sufficient for protecting research subjects from privacy invasions and possible breaches of confidentiality due to the possibility of unauthorized re-identification. At the same time, there is a need in medical science to be able to identify individual patients. In particular for rare disease research there is a special and well-documented need for research collaboration so that data and biosamples from multiple independent studies can be shared across borders. In this article, we identify the needs and arguments related to de-identification and re-identification of patients and research subjects and suggest how the different needs may be balanced within a framework of using unique encrypted identifiers.

Background: Ethics rounds are one way to support healthcare personnel in handling ethically difficult situations. A previous study in the present project showed that ethics rounds did not result in significant changes in perceptions of how ethical issues were handled, that is, in the ethical climate. However, there was anecdotal evidence that the ethics rounds were viewed as a positive experience and that they stimulated ethical reflection., Aim: The aim of this study was to gain a deeper understanding of how the ethics rounds were experienced and why the intervention in the form of ethics rounds did not succeed in improving the ethical climate for the staff., Research Design: An exploratory and descriptive design with a qualitative approach was adopted, using individual interviews., Participants and Research Context: A total of 11 healthcare personnel, working in two different psychiatry outpatient clinics and with experience of participating in ethics rounds, were interviewed., Ethical Considerations: The study was based on informed consent and was approved by one of the Swedish Regional Ethical Review Boards., Findings: The participants were generally positive about the ethics rounds. They had experienced changes by participating in the ethics rounds in the form of being able to see things from different perspectives as well as by gaining insight into ethical issues. However, these changes had not affected daily work., Discussion: A crucial question is whether or not increased reflection ability among the participants is a good enough outcome of ethics rounds and whether this result could have been measured in patient-related outcomes. Ethics rounds might foster cooperation among the staff and this, in turn, could influence patient care., Conclusion: By listening to others during ethics rounds, a person can learn to see things from a new angle. Participation in ethics rounds can also lead to better insight concerning ethical issues., (© The Author(s) 2014.)

Ethicists, regulators and researchers have struggled with the question of whether incidental findings in genomics studies should be disclosed to participants. In the ethical debate, a general consensus is that disclosed information should benefit participants. However, there is no agreement that genetic information will benefit participants, rather it may cause problems such as anxiety. One could get past this disagreement about disclosure of incidental findings by letting participants express their preferences in the consent form. We argue that this freedom of choice is problematic. In transferring the decision to participants, it is assumed that participants will understand what they decide about and that they will express what they truly want. However, psychological findings about people's reaction to probabilities and risk have been shown to involve both cognitive and emotional challenges. People change their attitude to risk depending on what is at stake. Their mood affects judgments and choices, and they over- and underestimate probabilities depending on whether they are low or high. Moreover, different framing of the options can steer people to a specific choice. Although it seems attractive to let participants express their preferences to incidental findings in the consent form, it is uncertain if this choice enables people to express what they truly prefer. In order to better understand the participants' preferences, we argue that future empirical work needs to confront the participant with the complexity of the uncertainty and the trade-offs that are connected with the uncertain predictive value of genetic risk information., (© 2015 John Wiley & Sons Ltd.)

Health-care systems as well as legislators and society seem largely unprepared to face and manage the massive production of genetic risk information. Ethics committees and professional bodies usually do not involve the individuals directly concerned in defining guidelines for genetic risk communication. Therefore, they do not always reflect people's needs and preferences. We argue in this article that we currently experience a cultural shift in medicine where individuals' concerns and preferences regarding genetic risk information are playing a more significant role than before, and that this should have some normative implications. We are going toward a situation where individual citizens are approached as consumers by personal genomics companies [Prainsack: Account Res 2011;18:132-147]. In clinical and research contexts, individuals are also increasingly informed about their own responsibilities for counterbalancing their genetic risk by making individual health care and lifestyle choices. In this situation, communication of genetic risk information may rather be regulated like traffic and markets in which consumers' decision-making power has a fundamental role in the management and regulation of how a service should be provided, as well as in the creation of policy and legislation. We acknowledge that markets may be different depending on different genetic conditions. For example, genetic risk communication for rare diseases, where a close relationship with clinicians is of paramount significance, should be differently regulated than personal genetic profiles of complex diseases, where contributing risk factors related to lifestyle are modifiable by the individual., (© 2016 S. Karger AG, Basel.)

Cardiopulmonary diseases are major causes of death worldwide, but currently recommended strategies for diagnosis and prevention may be outdated because of recent changes in risk factor patterns. The Swedish CArdioPulmonarybioImage Study (SCAPIS) combines the use of new imaging technologies, advances in large-scale 'omics' and epidemiological analyses to extensively characterize a Swedish cohort of 30 000 men and women aged between 50 and 64 years. The information obtained will be used to improve risk prediction of cardiopulmonary diseases and optimize the ability to study disease mechanisms. A comprehensive pilot study in 1111 individuals, which was completed in 2012, demonstrated the feasibility and financial and ethical consequences of SCAPIS. Recruitment to the national, multicentre study has recently started., (© 2015 The Authors. Journal of Internal Medicine published by John Wiley & Sons Ltd on behalf of Association for Publication of The Journal of Internal Medicine.)

Background: One way to support healthcare staff in handling ethically difficult situations is through ethics rounds that consist of discussions based on clinical cases and are moderated by an ethicist. Previous research indicates that the handling of ethically difficult situations in the workplace might have changed after ethics rounds. This, in turn, would mean that the "ethical climate", i.e. perceptions of how ethical issues are handled, would have changed., Aim: To investigate whether ethics rounds could improve the ethical climate perceived by staff working in psychiatry outpatient clinics., Methods: In this quasi-experimental study, six inter-professional ethics rounds led by a philosopher/ethicist were conducted at two psychiatry outpatient clinics. Changes in ethical climate were measured at these clinics as well as at two control clinics at baseline and after the intervention period using the instrument Hospital Ethical Climate Survey., Results: Within-groups comparisons of median sum scores of ethical climate showed that no statistically significant differences were found in the intervention group before or after the intervention period. The median sum scores for ethical climate were significantly higher, both at baseline and after the intervention period (P ≤ 0.001; P = 0.046), in the intervention group., Conclusions: Ethics rounds in psychiatric outpatient clinics did not result in significant changes in ethical climate. Outcomes of ethics rounds might, to a higher degree, be directed towards patient-related outcomes rather than towards the staff's working environment, as the questions brought up for discussion during the ethics rounds concerned patient-related issues.

It is necessary to carry out randomised clinical cancer trials (RCTs) in order to evaluate new, potentially useful treatments for future cancer patients. Participation in clinical trials plays an important role in determining whether a new treatment is the best therapy or not. Therefore, it is important to understand on what basis patients decide to participate in clinical trials and to investigate the implications of this understanding for optimising the information process related to study participation. The aims of this study were to (1) describe motives associated with participation in RCTs, (2) assess if patients comprehend the information related to trial enrolment, and (3) describe patient experiences of trial participation. Questionnaires were sent to 96 cancer patients participating in one of nine ongoing clinical phase 3 trials at the Department of Oncology, Uppsala University Hospital in Sweden. Eighty-eight patients completed the questionnaire (response rate 92%); 95% of these were patients in adjuvant therapy and 5% participated in clinical trials on palliative care. Two main reasons for participation were identified: personal hope for a cure and altruism. Patients show adequate understanding of the information provided to them in the consent process and participation entails high patient satisfaction., (© 2014 John Wiley & Sons Ltd.)

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health (NIH) Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and timely topic.

There are an increasing number of medical research studies involving children, including many long-term birth cohort studies. Involving children raises many issues, and little is known about children's own views. This study explored children's views (N = 5,851) on participation in a long-term screening study for type 1 diabetes. The results show that children 10 to 13 years of age have in general a positive attitude to pediatric research and emphasized trust in researchers. The children stressed the importance to receive information and to be involved in decisions. The children also reported feeling concerned about blood sampling and disease risk. Researchers involved in long-term pediatric research need to address these issues to promote involvement and decrease worry., (© The Author(s) 2014.)

Research into rare diseases is typically fragmented by data type and disease. Individual efforts often have poor interoperability and do not systematically connect data across clinical phenotype, genomic data, biomaterial availability, and research/trial data sets. Such data must be linked at both an individual-patient and whole-cohort level to enable researchers to gain a complete view of their disease and patient population of interest. Data access and authorization procedures are required to allow researchers in multiple institutions to securely compare results and gain new insights. Funded by the European Union's Seventh Framework Programme under the International Rare Diseases Research Consortium (IRDiRC), RD-Connect is a global infrastructure project initiated in November 2012 that links genomic data with registries, biobanks, and clinical bioinformatics tools to produce a central research resource for rare diseases.

Our starting point in this article is the debate between John Harris and Iain Brassington on whether or not there is a duty to take part in scientific research. We consider the arguments that have been put forward based on fairness and a duty to rescue, and suggest an alternative justification grounded in a hypothetical agreement: that is, because effective healthcare cannot be taken for granted, but requires continuous medical research, and nobody knows what kind of healthcare they will need, participating in research should be viewed from the perspective of a social contract, based on our mutual need for medical advances.

Incidental findings (IFs) are acknowledged to be among the most important ethical issues to consider in biobank research. Genome-wide association studies and disease-specific genetic research might reveal information about individual participants that are not related to the research purpose, but may be relevant to those participants' future health. In this article, we provide a synopsis of arguments for and against the disclosure of IFs in biobank research. We argue that arguments that do not distinguish between communications about pathogenic conditions and complex genetic risk for diseases fail, as preferences and decisions may be far more complex in the latter case. The principle of beneficence, for example, often supports the communication of incidentally discovered diseases, but if communication of risk is different, the beneficence of such communication is not equally evident. By conflating the latter form of communication with the former, the application of ethical principles to IFs in biobank research sometimes becomes too easy and frictionless. Current empirical surveys of people's desire to be informed about IFs do not provide sufficient guidance because they rely on the same notion of risk communication as a form of communication about actual health and disease. Differently designed empirical research and more reflection on biobank research and genetic risk information is required before ethical principles can be applied to support the adoption of a reasonable and comprehensive policy for handling IFs.

In Sweden, most patients are recruited into biobank research by non-researcher doctors. Patients' trust in doctors may therefore be important to their willingness to participate. We suggest a model of trust that makes sense of such transitions of trust between domains and distinguishes adequate trust from mistaken trust. The unique position of doctors implies, we argue, a Kantian imperfect duty to compensate for patients' mistaken trust. There are at least three kinds of mistaken trust, each of which requires a different set of countermeasures. First, trust is mistaken when necessary competence is lacking; the competence must be developed or the illusion dispelled. Second, trust is irrational whenever the patient is mistaken about his actual reasons for trusting. Care must therefore be taken to support the patient's reasoning and moral agency. Third, some patients inappropriately trust doctors to recommend only research that will benefit them directly. Such trust should be counteracted by nurturing a culture where patients expect to be asked occasionally to contribute to the common good., (© 2012 John Wiley & Sons Ltd.)

Murine cancer models have been extremely useful for analyzing the biology of pathways involved in cancer initiation, promotion, and progression. Interestingly, several murine cancer models also exhibit heterogeneity, genomic instability and an intact immune system. However, they do not adequately represent several features that define cancer in humans, including long periods of latency, the complex biology of cancer recurrence and metastasis and outcomes to novel therapies. Therefore, additional models that better investigate the human disease are needed. In the pet population, with special references to the dog, cancer is a spontaneous disease and dogs naturally develop cancers that share many characteristics with human malignancies. More than 40 years ago, optimization of bone marrow transplantation protocols was undertaken in dogs and recently novel targeted therapies such as liposomal muramyl tripeptide phosphatidylethanolamine and several tyrosine kinase inhibitors, namely masitinib (AB1010) and toceranib phosphate (SU11654), have been developed to treat dog tumors which have then been translated to human clinical trials. In this review article, we will analyze biological data from dog tumors and comparative features with human tumors, and new therapeutic approaches translated from dog to human cancer., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Aim: To estimate whether and when children dying from a malignancy are recognized as being beyond cure and to study patterns of care the last weeks of life., Methods: A nationwide retrospective medical record review was conducted. Medical records of 95 children (60% of eligible children) who died from a malignancy 2007-2009 in Sweden were studied., Results: Eighty-three children (87%) were treated without curative intent at the time of death. Children with haematological malignancies were less likely to be recognized as being beyond cure than children with brain tumours [relative risks (RR) 0.7; 95% confidence interval (CI) 0.6-0.9] or solid tumours (RR 0.8; 0.6-1.0). The transition to noncurative care varied from the last day of life to over four years prior to death (median 60 days). Children with haematological malignancies were treated with a curative intent closer to death and were also given chemotherapy (RR 5.5; 1.3-22.9), transfusions (RR 2.0; 1.0-4.0) and antibiotics (RR 5.3; 1.8-15.5) more frequently than children with brain tumours the last weeks of life., Conclusion: The majority of children dying from a malignancy were treated with noncurative intent at the time of death. The timing of a transition in care varied with the diagnoses, being closer to death in children with haematological malignancies., (©2013 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.)

Background: Medical registries serve patients as beneficiaries of quality standards and new treatment opportunities. However, it has been argued that registries threaten patient privacy interests and should therefore be more strictly regulated., Methods and Results: With the European Treatment and Outcome Study for Chronic Myeloid Leukemia as a concrete example we identify and describe how four of the major arguments put forward for stricter regulation fail., Conclusion: We conclude that medical registries should be promoted both for research and quality control, and that the regulatory bureaucratic burden should be reduced., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

The participation of children in medical research raises many ethical issues, in particular regarding assent. However, little is known about children's own views on participation. This study presents results from interviews with children 10-12 years old with and without experience in a large-scale longitudinal screening study. We identified five themes: (1) knowledge about research, (2) a sense of altruism, (3) shared decision-making and right to dissent, (4) notions of integrity, privacy, and access, and (5) understanding of disease risk and personal responsibilities. We conclude that the children feel positive towards medical research, and want to take an active part in decisions and have their integrity respected. However, the study also indicates that children who had participated in longitudinal screening had a limited understanding, suggesting the vital importance of providing information appropriate to their age and maturity. This information should be provided out of respect for the children as persons, but also to promote their willingness to continue participating in longitudinal studies.

A common feature of the European ethical and legal regulatory framework is that biobank-based research has a significant potential of providing new benefits to European citizens in terms of new medical treatment, and this research is therefore something that should be promoted. At the same time the legislatures are concerned, and rightly so, about the integrity of patients and healthy volunteers who provide samples and data. There is now ample evidence of how biobank-based research has provided great opportunities for new care. At the same time there are a growing number of reports about rash judgments about integrity by ethical review boards and data inspection authorities that are not in the best interest of patients. It is here argued that legislatures, ethical review boards, and data inspection authorities need to adopt a wider view of integrity and take into consideration the patients' interest in a sound scientific basis for medical diagnosis and treatment.

There are currently multiple international bodies suggesting legal and ethical frameworks for regulating international biobank research. One will for obvious reasons find inconsistencies in terminology and differences in procedures suggested for biobank research among all those guidelines, emanating from many different moral and legal traditions. A central question is whether this constitutes a threat to making progress in international biobank research, as some have argued. In this book, Chapter 1 suggests that there are sufficient and well-established instruments and ethical principles available to guide research in this area. Basically I argue that there is no need for a top-down superstructure of detailed rules and guidelines to be imposed on biobank researchers. With the existing ethical review boards (ERBs) playing a central role guided by well-established ethical guidelines (e.g., the Helsinki Declaration) and solutions to specific ethical problems suggested in the literature, self-regulation by researchers providing arguments for balancing of interests in association with different research initiatives and protocols will be sufficient. Traditional information and consent procedures suffice and data protection implies a sovereign right of the individual citizen to grant the use of biobank material and personal data that is needed for biobank research. Clearly, there may still be inconsistencies in terminology when researchers of different nationalities meet in common enterprises, but both they and the ERBs are well equipped to sort out what is actually meant and propose different instruments for, for example, coding following recently established nomenclatures. The existing ERBs should play the key role, guided by the sound argumentation of the researchers in their applications to the board.