Proper procedures for informed consent are widely recognized as an ethical requirement for biomedical research involving human beings, in particular as a means to respect the autonomy and personal integrity of potential and actual research participants.

Research ethics, once a platform for declaring intent, discussing moral issues and providing advice and guidance to researchers, has developed over time into an extra-legal regulatory system, complete with steering documents (ethics guidelines), overseeing bodies (research ethics committees) and formal procedures (informed consent). The process of institutionalizing distrust is usually motivated by reference to past atrocities committed in the name of research and the need to secure the trustworthiness of the research system. This article examines some limitations of this approach. (...) First, past atrocities cannot provide the necessary justification unless institutionalized distrust is a necessary or efficient means to prevent future ones – and there are several reasons to doubt this. Second, the efficacy of ethics review in safeguarding morally acceptable research depends on the moral competence and integrity of individual researchers – the very qualities that institutionalized distrust calls into question. Third, ethics guidelines cannot, as is sometimes assumed, educate or guide researchers in moral behaviour unless they already possess considerable capacity for moral judgment. Fourth, institutionalized distrust is a potential threat to the moral competence and integrity of researchers by encouraging a blinkered view of ethical issues, inducing moral heteronomy through incentives, and alienating them to research ethics. We conclude that the moral problem posed by inappropriate short-term behaviour on behalf of researchers is dwarfed by the potential long-term consequences if their moral competence is allowed to deteriorate. Measures must therefore be taken to ensure that researchers are equipped to take their individual responsibility and are not obstructed from so doing. (shrink)

There is a growing interest in ethical competence-building within nursing and health care practising. This tendency is accompanied by a remarkable growth of ethical guidelines. Ethical demands have also been laid down in laws. Present-day practitioners and researchers in health care are thereby left in a virtual cross-fire of various legislations, codes, and recommendations, all intended to guide behaviour. The aim of this paper was to investigate the role of ethical guidelines in the process of ethical competence-building within health care (...) practice and medical research. A conceptual and critical philosophical analysis of some paragraphs of the Helsinki Declaration and of relevant literature was performed. Three major problems related to ethical guidelines were identified, namely, the interpretation problem (there is always a gap between the rule and the practice, which implies that ethical competence is needed for those who are to implement the guidelines); the multiplicity problem (the great number of codes, declarations, and laws might pull in different directions, which may confuse the health care providers who are to follow them); and the legalisation problem (ethics concerns may take on a legal form, where ethical reflection is replaced by a procedure of legal interpretations). Virtue ethics might be an alternative to a rule based approach. This position, however, can turn ethics into a tacit knowledge, leading to poorly reflected and inconsistent ethical decisions. Ethical competence must consist of both being (virtues) and doing (rules and principles), but also of knowing (critical reflection), and therefore a communicative based model is suggested. (shrink)

BackgroundInvoluntary treatment is a key issue in healthcare ethics. In this study, ethical issues relating to involuntary psychiatric treatment are investigated through interviews with Swedish psychiatrists.MethodsIn-depth interviews were conducted with eight Swedish psychiatrists, focusing on their experiences of and views on compulsory treatment. In relation to this, issues about patient autonomy were also discussed. The interviews were analysed using a descriptive qualitative approach.ResultsThe answers focus on two main aspects of compulsory treatment. Firstly, deliberations about when and why it was justifiable (...) to make a decision on involuntary treatment in a specific case. Here the cons and pros of ordering compulsory treatment were discussed, with particular emphasis on the consequences of providing treatment vs. refraining from ordering treatment. Secondly, a number of issues relating to background factors affecting decisions for or against involuntary treatment were also discussed. These included issues about the Swedish Mental Care Act, healthcare organisation and the care environment.ConclusionsInvoluntary treatment was generally seen as an unwanted exception to standard care. The respondents’ judgments about involuntary treatment were typically in line with Swedish law on the subject. However, it was also argued that the law leaves room for individual judgments when making decisions about involuntary treatment. Much of the reasoning focused on the consequences of ordering involuntary treatment, where risk of harm to the therapeutic alliance was weighed against the assumed good consequences of ensuring that patients received needed treatment. Cases concerning suicidal patients and psychotic patients who did not realise their need for care were typically held as paradigmatic examples of justified involuntary care. However, there was an ambivalence regarding the issue of suicide as it was also argued that risk of suicide in itself might not be sufficient for justified involuntary care. It was moreover argued that organisational factors sometimes led to decisions about compulsory treatment that could have been avoided, given a more patient-oriented healthcare organisation. (shrink)

Different ideas of the normative relevance of autonomy can give rise to profoundly different action-guiding principles in healthcare. If autonomy is seen as a value rather than as a right, it can be argued that patients’ decisions should sometimes be overruled in order to protect or promote their own autonomy. We refer to this as paternalism in the name of autonomy. In this paper, we discuss different elements of autonomy (decision-making capacity, efficiency, and authenticity) and arguments in favor of paternalism (...) for the sake of autonomy that have been proposed in the bioethical debate. We argue that if autonomy is valuable, then paternalism for the sake of autonomy may be justified. However, policies allowing paternalism in the name of autonomy may be self-defeating. (shrink)

Randomized and double-blind clinical trials are widely regarded as the most reliable way of studying the effects of medical interventions. According to received wisdom, if a new drug or treatment is to be accepted in clinical practice, its safety and efficacy must first be demonstrated in such trials. For ethical and scientific reasons, it is generally considered necessary to monitor a trial in various ways as it proceeds and to analyze data as they accumulate. Monitoring and interim analyses are often (...) conducted by a so-called data monitoring committee (DMC), a group of experts independent of both sponsors and investigators. On the basis of DMC recommendations, sponsors sometimes decide to discontinue trials .. (shrink)

In spite of the growing interest in nursing ethics, few studies have focused on ethical dilemmas experienced by nurses working with clinical studies as ‘research nurses’. The aim of the present study was to describe and explore ethical dilemmas that Swedish research nurses experience in their day-to-day work. In a qualitative study a purposeful sample of six research nurses from five wards of differing disciplines in four Swedish hospitals was interviewed. The analysis displayed several examples of ethical dilemmas, primarily tensions (...) between the nurses’ obligations to the study and to the patients involved. A guiding moral principle for the nurses was patient-centeredness, where the interest of research must not override the interest of the patient. In situations where tensions between research and patient interests occurred, and doctors and nurses disagreed upon the judgement, the nurses sometimes chose to follow the doctors’ advice, and thus acted against their own moral judgment. Such situations seemed to create feelings of moral distress among the nurses. They described their profession as being ‘invisible’ and as lacking opportunities for ethical competence building. The conclusion is that research nurses frequently experience severe and difficult ethical dilemmas in their daily work. They need to be acknowledged as a particular profession in the health care organisation and encouraged to develop their specific ethical competence. (shrink)

The number of legal and nonlegal ethical regulations in the biomedical field has increased tremendously, leaving present-day practitioners and researchers in a virtual crossfire of legislations and guidelines. Judging by the production and by the way these regulations are motivated and presented, they are held to be of great importance to ethical practice. This view is shared by many commentators. For instance, Commons and Baldwin write that, within the nursing profession, patient care can be performed unethically or ethically depending on (...) the professional standards the nurses have set for themselves. They also hold that such standards are set when nurses become aware of the ethical codes available. As nurses are often not familiar with the codes, they do not all conform to them. Commons and Baldwin argue that nurses' ability to deal with ethical dilemmas is effectively secured with education on guidelines, creating a “barrier” between personal and professional values. (shrink)

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. (shrink)

This paper highlights a feature common to many ethical guidelines—namely, the idea that the interests of the individual shall always prevail over the interests of science and society. The paper presents how some major ethical guidelines treat the balancing of research interests against those of research subjects and spells out the difficulties in interpreting the principle of the primacy of the individual in a way that can be action-guiding. It suggests various alternative interpretations of the primacy of the individual and (...) argues that they do not hold. Finally, the implications of this analysis for ethical guidelines are discussed. (shrink)

This article investigates what notions of “just health care” are found at three Swedish hospitals among health care personnel and whether these notions are relevant to what priorities are actually made. Fieldwork at all three hospitals and 114 in-depth interviews were conducted. Data have been subject to conceptual and ethical analysis and categorisation. According to our findings, justice is an important idea to health care personnel at the studied hospitals. Two main notions of just health care were found. The main (...) idea was the notion of “equal treatment according to need”, the basic idea being that differences in treatment should be justified by differences in needs. The competing idea that merit should affect the treatment received is occasionally encountered, the idea here being that patients, by acting irresponsibly, may no longer deserve to be treated strictly according to needs. In practice, priorities are made on grounds that only partly comply with the basic idea of justice in health care, as it is understood by staff at the studied hospitals. Exceptions are made due to regional differences, considerations of cost-effectiveness, economic incentives, tradition, the daily patient flow, research, private alternatives, patient influence and favouritism of health care personnel. (shrink)

In the long-running debate on the interest of the dead, Joan C. Callahan argues against such interests and although Søren Holm for practical reasons is prepared to consider posthumous interests, he does not see any moral basis to support such interests. He argues that the whole question is irresolvable, yet finds privacy interests where Tutankhamen is concerned. Callahan argues that there can be reasons to hold on to the fiction that there are posthumous interests, namely if it is comforting for (...) the living and instrumental for society. Thus, despite arguing against the position that the dead have any interests or for any moral basis for such interests, these “interests” are still taken into consideration in the end. This shows the unsatisfactory basis of their positions and indicates the tenacity of the moral intuition that the dead can have moral claims on the living. One example of a posthumous interest is the interest in one’s good name. Here we argue that it is an interest of moral significance. This implies that if individuals restrict use of their sample when they are still alive, those restrictions apply after their death. Further, it implies that one should be concerned with the reputation of historic persons. Research that defeats these interests calls for justification. We have suggested two lines of thinking along which such a discussion could go: investigating the truth-value of the good name and the relevance of bringing it into possible disrepute. (shrink)

In a Swedish setting physicians are unlikely to give explicitly paternalistic reasons when asked about their attitudes towards patients’ involvement in decision-making. There is considerable risk that they will disguise their paternalism by giving ‘socially correct answers’. We suggest that disguised paternalism can be revealed with the help of indexes based on certain responses in postal questionnaires. The indexes were developed using material from a study examining attitudes of Swedish physicians to physician-assisted suicide (PAS). Apart from being asked about their (...) attitudes, they were asked to prioritise between different arguments for and against PAS. One argument for PAS was: “PAS should be permitted out of respect for patients’ autonomy”. One argument against PAS was: “PAS should not be permitted since the non-maleficence principle in this case takes precedence over respecting patients’ autonomy”. Responses to the latter argument formed the cornerstone of a disguised-paternalism index, while an autonomy index was based on answers to the former argument. Applying our indexes to data from the PAS survey, we found that female GPs, surgeons, and older male physicians were least paternalistic. Among female physicians one finds both the most autonomy-respecting groups (female surgeons and GPs) and the least autonomy-respecting groups (female oncologists and psychiatrists); together with older male physicians in general, female GPs are the group displaying least disguised paternalism. We suggest that questionnaires exploring paternalism might be improved by including case-specific questions or statements by which to explore disguised paternalism. Here our indexes might be useful tools. (shrink)

Decision-making capacity is a key concept in contemporary healthcare ethics. Previous research has mainly focused on philosophical, conceptual issues or on evaluation of different tools for assessing patients’ capacity. The aim of the present study is to investigate how the concept and its normative role are understood in Swedish psychiatric care. Of special interest for present purposes are the relationships between decisional capacity and psychiatric disorders and between health law and practical ethics.

Respect for autonomy is typically considered a key reason for allowing physician assisted suicide and euthanasia. However, several recent papers have claimed this to be grounded in a misconception of the normative relevance of autonomy. It has been argued that autonomy is properly conceived of as a value, and that this makes assisted suicide as well as euthanasia wrong, since they destroy the autonomy of the patient. This paper evaluates this line of reasoning by investigating the conception of valuable autonomy. (...) Starting off from the current debate in end-of-life care, two different interpretations of how autonomy is valuable is discussed. According to one interpretation, autonomy is a personal prudential value, which may provide a reason why euthanasia and assisted suicide might be against a patient’s best interests. According to a second interpretation, inspired by Kantian ethics, being autonomous is unconditionally valuable, which may imply a duty to preserve autonomy. We argue that both lines of reasoning have limitations when it comes to situations relevant for end-of life care. It is concluded that neither way of reasoning can be used to show that assisted suicide or euthanasia always is impermissible. (shrink)

Queen Christina of Sweden was unconventional in her time, leading to hypotheses on her gender and possible hermaphroditic nature. If genetic analysis can substantiate the latter claim, could this bring the queen into disrepute 300 years after her death? Joan C. Callahan has argued that if a reputation changes, this constitutes a change only in the group of people changing their views and not in the person whose reputation it is. Is this so? This paper analyses what constitutes change and (...) draws out the implications to the reputation of the dead. It is argued that a reputation is a relational property which can go through changes. The change is “real” for the group changing their views on Queen Christina and of a Cambridge kind for the long dead queen herself. Cambridge changes result in new properties being acquired, some of which can be of significance. (shrink)

Although stability is a central notion in several academic disciplines, the parallelsremain unexplored since previous discussions of the concept have been almostexclusively subject-specific. In the literature we have found three basic conceptsof stability, that we call constancy, robustness, and resilience. They are all foundin both the natural and the social sciences. To analyze the three concepts we introducea general formal framework in which stability relates to transitions between states. Itcan then be shown that robustness is a limiting case of resilience, (...) whereas neitherconstancy nor resilience can be defined in terms of the other. Hence, there are twobasic concepts of stability, both of which are used in both the social and the naturalsciences. This congruence in the concepts of stability is of particular interest forendeavours to construct models that represent both natural and social phenomena. (shrink)

Two questionnaires directed to Swedish physicians and a sample of the Swedish population investigated attitudes towards physician-assisted suicide (PAS). The aim of the present work was to analyse qualitative data from these questionnaires in order to explore how respondents reason about PAS. Data were analysed in two steps. First, we categorized different kinds of responses and identified pro and con arguments. Second, we identified general conclusions from the responses. The data reflect the differences in attitudes towards PAS among the public (...) and physicians, with the former mainly in favour of PAS and the latter mainly against. There was, however, considerable agreement about what requirements must be met before PAS could be considered ethical. Many arguments against PAS concerned the professional role of physicians, which indicates that it may not be assisted suicide as such that many PAS opponents disagree with, but rather that it is handled by physicians in the regular health-care system. (shrink)

Plagiarism is plaguing research publications in many fields. It is problematic by being misleading about who deserves credit for scientific results, images, text or ideas, by involving scientific fraud and by distorting meta-analyses. However, different research traditions put different emphasis on the originality of text. Traditional rules regarding correct quotation seem to fit the humanities and many social sciences better than the natural and engineering sciences. This article suggests that we should stop applying a common standard regarding plagiarism to all (...) research fields and instead openly acknowledge that there are differences in what aspects of a paper are important to scientific development in different research areas. More specifically, the article discusses, as a thought experiment, whether the introduction of software supporting text production for research publications in the natural and engineering sciences – thereby further reducing the importance of who created what sentences – would be unacceptable or, quite the reverse, a means to further promote scientific progress. It is concluded that there are no valid principled arguments against introducing such software support for text production in scientific papers, while there are several advantages. Correctly handled, using such software would not involve plagiarism, because it would not be misleading about who deserves credit. (shrink)

This paper defends the right not to know personal health information, while it discards the right of research participants to receive individual research results. Disagreement regarding the right not to know stems from two different conceptions of autonomy, leading to opposing normative conclusions. Researchers occasionally have good reason to inform research participants about incidental findings in spite of the absence of a right to know such information. Such decisions have to be made by health care personnel and researchers on a (...) case by case basis, although external support for the decisions may be available. (shrink)

Empirical findings from a Swedish longitudinal screening study show that many of the research subjects had a limited understanding of the study. Nevertheless they were satisfied with the understanding they had and found it sufficient for informed continued participation. Were they wrong? In this paper, it is argued that the kind of understanding that is morally required depends partly on the kind of understanding on which the research subjects want to base their decisions, and partly on what kind of knowledge (...) they lack. Researchers must ensure that the information process is not flawed and that participants receive the information they want. To achieve this, new information efforts may be needed. Researchers must also ensure that research subjects have knowledge about aspects of importance to them. Lack of understanding may, however, be the result of conscious choices by research subjects to disregard some of the information because it is not important to them. Such choices should normally be respected. (shrink)

The aim of the present study was to describe and explore the perception of ethical guidelines and their role in ethical competence-building among Swedish physicians and research nurses. Twelve informants were interviewed in depth. The results demonstrated that the informants had a critical attitude towards ethical guidelines and claimed to make little use of them in practical moral judgements. Ethical competence was seen primarily as character-building, related to virtues such as being empathic, honest and loyal to patients. Ethical competence was (...) assumed to be learned through good examples, role models and practical experience, while ethical guidelines were not perceived as valuable in this process. In order to improve the staff's familiarity with and the usability of ethical guidelines, the workplace needs to provide opportunities for ethical dialogues. In such discussions, argumentation can improve, virtues can be developed and guidelines can be usefully invoked. (shrink)

Informed consent is central to modern research ethics. Informed consent procedures have mainly been justified in terms of respect for autonomy, the core idea being that it should be every competent individual’s right to decide for herself whether or not to participate in scientific studies. A number of conditions are normally raised with regard to morally valid informed consent. These include that potential research subjects get adequate information, understand those aspects that are relevant to them, and, based on that information, (...) make a voluntary decision whether or not to participate. These conditions are meant to guarantee that participation is genuinely the individual’s own choice and is coherent with his or her authentic interests. (shrink)

The main causes of suicide and how suicide could and should be prevented are ongoing controversies in the scientific literature as well as in public media. In the bill on public health from 2008, the Swedish Parliament adopted an overarching “Vision Zero for Suicide” and nine strategies for suicide prevention. However, how the VZ should be interpreted in healthcare is unclear. The VZ has been criticized both from a philosophical perspective and against the background of clinical experience and alleged empirical (...) claims regarding the consequences of regulating suicide prevention. This study is part of a larger research project in medical ethics with the overarching aim to explore whether the VZ is ethically justifiable. The aim is to enrich the normative discussion by investigating empirically how the VZ is perceived in healthcare. Interviews based on a semi-structured interview guide were performed with 12 Swedish psychiatrists. The interviews were analysed with descriptive qualitative content analysis aiming for identifying perceptions of the Vision Zero for Suicide as well as arguments for and against it. Though most of the participants mentioned at least some potential benefit of the Vision Zero for Suicide, the overall impression was a predominant skepticism. Some participants focused on why they consider the VZ to be unachievable, while others focused more on its potential consequences and normative implications. The VZ was perceived to be impossible to realize, nonconstructive or potentially counterproductive, and undesirable because of potential conflicts with other values and interests of patients as well as the general public. There were also important notions of the VZ having negative consequences for the working conditions of psychiatrists in Sweden, in increasing their work-related anxiety and thwarting the patient-physician relationship. (shrink)

Data from the 5–6 year control questionnaire of the ABIS study, a Swedish prospective screening of children for Type 1 diabetes, indicates a genuine trust in the researchers—very few participating families expressed concern about their participation. Nevertheless, a majority do not want their research data to be used beyond the agreement of the original consent. They want to be asked for renewed consent in such cases. A vast majority also want potential high-risk information about their child to be communicated to (...) them. Most participating families want this regardless of whether any preventive treatment is available. Although potential benefits for their child is a motivation for participation for a majority of the respondents, they also claim to be motivated by altruistic reasons. These results are compared to results from two similar studies in the UK. (shrink)

This article discusses gift authorship, the practice where co-authorship is awarded to a person who has not contributed significantly to the study. From an ethical point of view, gift authorship raises concerns about desert, fairness, honesty and transparency, and its prevalence in research is rightly considered a serious ethical concern. We argue that even though misuse of authorship is always bad, there are instances where accepting requests of gift authorship may nevertheless be the right thing to do. More specifically, we (...) propose that researchers may find themselves in a situation much similar to the problem of dirty hands, which has been frequently discussed in political philosophy and applied ethics. The problem of dirty hands is relevant to what we call hostage authorship, where the researchers include undeserving authors unwillingly, and only because they find it unavoidable in order to accomplish a morally important research goal. (shrink)

Human papillomavirus (HPV) infection is the world’s most common sexually transmitted infection. It is a prerequisite for cervical cancer, the second most common cause of death in cancer among women worldwide, and is also believed to cause other anogenital and head and neck cancers. Vaccines that protect against the most common cancer-causing HPV types have recently become available, and different countries have taken different approaches to implementing vaccination. This paper examines the ethics of alternative HPV vaccination strategies. It devotes particular (...) attention to the major arguments for and against one strategy: voluntary, publicly funded vaccination for all adolescent boys and girls. This approach seems attractive because it would protect more people against cervical cancer and other HPV-related cancers than less inclusive alternatives, without the sacrifice of autonomy that a comparably broad compulsory programme would require. Also, the herd immunity that it would likely generate would protect those who remain unvaccinated, a major advantage from a justice perspective. However, there is a possibility that a HPV vaccination programme targeting all adolescents of both sexes is not considered sufficiently cost-effective. Also, it might pose more difficulties for achieving informed consent than comparable vaccination programmes against other diseases. Ultimately, society’s choice of HPV vaccination strategy requires careful consideration not only of the values at stake but also of available and emerging scientific evidence. (shrink)

Many countries are now implementing human papillomavirus vaccination. There is disagreement about who should receive the vaccine. Some propose vaccinating both boys and girls in order to achieve the largest possible public health impact. Others regard this approach as too costly and claim that only girls should be vaccinated. We question the assumption that decisions about human papillomavirus vaccination policy should rely solely on estimates of overall benefits and costs. There are important social justice aspects that also need to be (...) considered. Policy makers should consider how to best protect individuals who will remain unvaccinated through no fault of their own. This is especially important if these individuals are already disadvantaged in other ways and if vaccinating other people increases their risk of infection. (shrink)

There is an increased focus on, and evidence of, children's capability to both understand and make decisions about issues relating to participation in medical research. At the same time there are divergent ideas of when, how and to what extent children should be allowed to decide for themselves. Furthermore, little is known about parents' views on these matters, an important issue since they often provide the formal consent. In this questionnaire study of 2500 families in south-east Sweden (with and without (...) research experience) we explored parents' views on issues relating to information, consent and research data. We found that parents are generally positive about supplying their child with individual information (93.3%; median age 7) and assuring the child's consent/assent to participation (74.3%; median age 12). However, parents' views vary regarding the extent to which children should influence research data: as many as 47–61% of our sample were opposed to children's rights to decide about the use and storage of biological samples and natural history data. Parents who are opposed to child consent and a wider influence on their research participation argue that parental authority and research quality are two important factors opposing enhanced child influence. Drawing on this, we underline the need to discuss how to balance children's rights against parental autonomy and research interests before implementing any standardized protocols granting children the right to consent and revoke data in long-term research. (shrink)

Although stability is a central notion in several academic disciplines, the parallels remain unexplored since previous discussions of the concept have been almost exclusively subject-specific. In the literature we have found three basic concepts of stability, that we call constancy, robustness, and resilience. They are all found in both the natural and the social sciences. To analyze the three concepts we introduce a general formal framework in which stability relates to transitions between states. It can then be shown that robustness (...) is a limiting case of resilience, whereas neither constancy nor resilience can be defined in terms of the other. Hence, there are two basic concepts of stability, both of which are used in both the social and the natural sciences. This congruence in the concepts of stability is of particular interest for endeavours to construct models that represent both natural and social phenomena. (shrink)

A wide variety of bioethical themes have recently been debated and researched in Sweden, including genetic screening, HPV vaccination strategies, end-of-life care, injustices and priority setting in healthcare, dual-use research, and the never-ending story of scientific fraud. Also, there are some new events related to Swedish biobanking that might be of general interest. Here we will concentrate on four themes: end-of-life care, dual-use research, scientific fraud, and biobanking.

Based on extensive questionnaire data, this paper focuses on parents’ views about children’s right to decide about participation in research. The data originates from 4000 families participating in a longitudinal prospective screening as 1997. Although current regulations and recommendations underline that children should have influence over their participation, many parents in this study disagree. Most (66%) were positive providing information to the child about relevant aspects of the study. However, responding parents were split about whether or not children should at (...) some point be allowed decisional authority when participating in research: 41.6% of the parents reported being against or unsure. Those who responded positively believed that children should be allowed to decide about blood-sampling procedures (70%), but to a less extent about participation (48.5%), analyses of samples (19.7%) and biological bank storage (15.4%). That as many as possible should remain in the study, and that children do not have the competence to understand the consequences for research was strongly stressed by respondents who do not think children should have a right to decide. When asked what interests they consider most important in paediatric research, child autonomy and decision-making was ranked lowest. We discuss the implications of these findings. (shrink)

Based on extensive clinical questionnaire data, this paper explores the relation between research subjects’ self-assessed understanding and actual knowledge of a large-scale predictive screening study, and its implications for the proper handling of information and consent routines in longitudinal studies. The intitial data show that low self-assessed understanding among participants was correlated with limited knowledge, concern over participation and collected samples, less satisfaction with information, and feeling passive or negative towards the study. Among those reporting high understanding, a non-negligible number (...) displayed a lack of knowledge regarding central aspects of the study. Regarding high assessed understanding, the multivariate analysis identified the main predictor variables to be knowledge, having a positive attitude towards participation and the study itself, being satisfied with information, having a stable psychosocial background and feeling calm regarding the handling of samples. These findings indicate that to evaluate participants' understanding through self-assessment may not be reliable method. Self-assessed understanding may rather be a good indicator of general attitudes than a tool for analysing content. The data also show that actual understanding varies considerably among participants, suggesting that more effort needs to be put into adjusting the information to the needs of different subgroups. It is argued that when doing this, researchers in longitudinal studies must be careful not to exhaust participants with excessive information that they do not want and that may cause them to drop out. The ethical relevance of obtaining repeated consents in longitudinal research is discussed. (shrink)

The aim of this study was to investigate patients' experiences of not being treated well in medical health care in Stockholm County, Sweden. The study was conducted by implementing qualitative content analysis using categorization of empirical material for 2006 and 2007 provided by the Patients' Advisory Committee (Patientnämnden) in Stockholm. Complaints about not being treated well accounted for 13% of all complaints to the Patients' Advisory Committee. A sample of those who complained about their medical treatment shows that about 30% (...) of these complaints also involved experiences of being badly received. Categorization of the complaints about being badly treated resulted in the following 11 categories: (1) rude, aggressive or arrogant behaviour; (2) being ignored; (3) being denied examinations or treatments; (4) lack of empathy among personnel; (5) lack of respect for personal integrity; (6) lack of time/waiting time; (7) personnel not separating private issues from their professional role; (8) injustice and discrimination; (9) sexual harassment; (10) coercion and violence and (11) unspecified bad treatment. In relation to the total number of patients, women were over-represented in all categories. In conclusion, what patients react most strongly against is when health-care personnel treat them disrespectfully by not abiding by established social norms. The results indicate that the combination of failure in medical treatment and not receiving an apology often leads patients to complain to the Patients' Advisory Committee. (shrink)

Clinical decisions are expected to be based on factual evidence and official values derived from healthcare law and soft laws such as regulations and guidelines. But sometimes personal values instead influence clinical decisions. One way in which personal values may influence medical decision-making is by their affecting factual claims or assumptions made by healthcare providers. Such influence, which we call ‘value-impregnation,’ may be concealed to all concerned stakeholders. We suggest as a hypothesis that healthcare providers’ decision making is sometimes affected (...) by value-impregnated factual claims or assumptions. If such claims influence e.g. doctor–patient encounters, this will likely have a negative impact on the provision of correct information to patients and on patients’ influence on decision making regarding their own care. In this paper, we explore the idea that value-impregnated factual claims influence healthcare decisions through a series of medical examples. We suggest that more research... (shrink)

Are fake diagnoses and false or misleading certificates permissible means of helping patients? This question is examined in relation to four examples from Swedish health care: the sterilisation case, the asylum case, the virginity case, and the adoption case.We argue that both consequentialist and deontological ethical theories, to be reasonable, need to balance values, principles, and interests such as wellbeing, truthfulness, autonomy, personal integrity, trust in the medical profession, and abidance by national legislation.We conclude that it can be justifiable for (...) physicians to fake diagnoses and write false or misleading certificates in order to help patients when not doing so has dire consequences. However, physicians must also consider the long-term effects of making exceptions to honest, non-deceitful behaviour based on the best empirical evidence available. Otherwise valuable social practices might erode and public confidence in physicians be threatened. (shrink)

The number of legal and nonlegal ethical regulations in the biomedical field has increased tremendously, leaving present-day practitioners and researchers in a virtual crossfire of legislations and guidelines. Judging by the production and by the way these regulations are motivated and presented, they are held to be of great importance to ethical practice. This view is shared by many commentators. For instance, Commons and Baldwin write that, within the nursing profession, patient care can be performed unethically or ethically depending on (...) the professional standards the nurses have set for themselves. They also hold that such standards are set when nurses become aware of the ethical codes available. As nurses are often not familiar with the codes, they do not all conform to them. Commons and Baldwin argue that nurses' ability to deal with ethical dilemmas is effectively secured with education on guidelines, creating a “barrier” between personal and professional values. (shrink)

Fetal alcohol spectrum disorders is an umbrella term covering several conditions for which alcohol consumption during pregnancy is taken to play a causal role. The benefit of individuals being identified with a condition within FASD remains controversial. The objective of the present study was to identify ethical aspects and consequences of diagnostics, interventions, and family support in relation to FASD. Ethical aspects relating to diagnostics, interventions, and family support regarding FASD were compiled and discussed, drawing on a series of discussions (...) with experts in the field, published literature, and medical ethicists. Several advantages and disadvantages in regards of obtaining a diagnosis or description of the condition were identified. For instance, it provides an explanation and potential preparedness for not yet encountered difficulties, which may play an essential role in acquiring much needed help and support from health care, school, and the social services. There are no interventions specifically evaluated for FASD conditions, but training programs and family support for conditions with symptoms overlapping with FASD, e.g. ADHD, autism, and intellectual disability, are likely to be relevant. Stigmatization, blame, and guilt are potential downsides. There might also be unfortunate prioritization if individuals with equal needs are treated differently depending on whether or not they meet the criteria for a specific condition. The value for the concerned individuals of obtaining a FASD-related description of their condition – for instance, in terms of wellbeing – is not established. Nor is it established that allocating resources based on whether individuals fulfil FASD-related criteria is justified, compared to allocations directed to the most prominent specific needs. (shrink)

In a previous paper in the Journal of Medical Ethics, the authors argued that the research ethical principle stating that the individual shall have priority over science, found in many guidelines, is utterly unclear and because of this should be explicated or otherwise deleted. In a recent commentary, Parker argued that this leaves us defending a position that would allow totalitarian regimes to pursue glory at the expense of its citizens. The present response addresses this and similar accusations.

The objective of the present paper is to explore parents' views on safety and confidentiality, information and consent, the importance of different kinds of research, and their responsibilities regarding children's participation. A questionnaire was distributed to 2500 families in south-east Sweden with children born during the years 1997–1999; 1302 responded. The sample was chosen to include views of families with and without earlier research experience. A clear majority of responding parents stated that parents have a moral responsibility to let their (...) children participate in research that is considered important, safe and moderately time-consuming. Respondents stressed the importance of thorough review and control of research involving children. Respondents also found it important that parents are guaranteed the right to decide about their children's participation and that they are thoroughly informed on central aspects of the study. (shrink)