One of the most important questions in the ethics of human clinical research asks what obligations investigators owe the people who enroll in their studies. Research differs in many ways from standard care - the added uncertainties, for instance, and the nontherapeutic interventions such as diagnostic tests whose only purpose is to measure the effects of the research intervention. Hence arises the question whether a physician engaged in clinical research has the same obligations toward research subjects that he owes his (...) medical patients, or whether they differ in any fundamental way.Perhaps the most common answer is that the relationship is the same. Investigators, like physicians, are said to be fiduciaries of the volunteers who enroll in research trials. Each owes the best available medical care, which means that a physician can only justify enrolling his patient in research if the study meets the requirements of clinical equipoise, namely, that there is legitimate disagreement within the medical community as to whether the standard treatment or the investigational intervention is superior. (shrink)

Ingmar Persson and Julian Savulescu argue that non-traditional forms of cognitive enhancement (those involving genetic engineering or pharmaceuticals) present a serious threat to humanity, since the fruits of such enhancement, accelerated scientific progress, will give the morally corrupt minority of humanity new and more effective ways to cause great harm. And yet it is scientific progress, accelerated by non-traditional cognitive enhancement, which could allow us to dramatically morally enhance human beings, thereby eliminating, or at least reducing, the threat from the (...) morally corrupt minority. I argue that this apparently intractable dilemma is less difficult to resolve than Persson and Savulescu suppose. Their analysis of non-traditional cognitive enhancement overstates the risks and undervalues the benefits that such enhancement might provide. Once the benefits are better described, it is clear that non-traditional cognitive enhancement could be the means of our survival, not of our destruction. (shrink)

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now (...) are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)

The right not to know is underappreciated in policy-making. Despite its articulation in medical law and ethics, policy-makers too easily let other concerns override the right not to know. This observation is triggered by a recent decision of the Dutch government on embryo selection for Huntington’s disease. This is a monogenetic debilitating disease without cure, leading to death in early middle age, and thus is a likely candidate for preimplantation genetic diagnosis. People possibly affected with the Huntington gene do not (...) always want to know their genetic status themselves, which is very burdensome knowledge. For prospective parents, this creates a difficulty in having unaffected children through embryo selection without knowing their own genetic status. A solution is provided by the exclusion test: it allows embryo selection while honouring the parents’ right not to know. The Dutch government however disallowed the exclusion test and chose to allow PGD on Huntington only for parents who test themselves first. To avoid “unnecessary” in-vitro fertilisation procedures for unaffected parents, prospective parents are “forced to know” before they can conceive through embryo selection. This article analyses the scope of the right not to know in the context of embryo selection against Huntington’s disease. It concludes that the right not to know implies that PGD against Huntington should be allowed by means of the exclusion test. (shrink)

The practice of coercive measures in psychiatry is controversial. Although some have suggested that it may be acceptable if patients are a danger to others or to themselves, others committed themselves to eliminate it. Ethical, legal and clinical considerations become more complex when the mental incapacity is temporary and when the coercive measures serve to restore autonomy. We discuss these issues, addressing the conflict between autonomy and beneficence/non-maleficence, human dignity, the experiences of patients and the effects of coercive measures. We (...) argue that an appeal to respect autonomy and/or human dignity cannot be a sufficient reason to reject coercive measures. All together, these ethical aspects can be used both to support and to reject a non-seclusion approach. The total lack of controlled trials about the beneficial effects of coercive measures in different populations however, argues against the use of coercive measures. (shrink)

A recent discussion on cognitive enhancers has caused some controversy in the ethics and neuroscience fields by coming out in favour of making neuropharmaceuticals with enhancing properties available for general consumption. We highlight in this brief commentary why concerns regarding efficacy and safety, demands on resources, and public health are substantive enough to warrant serious reconsideration before pharmaceutical performance enhancement can be widely supported.

With so much attention being paid to the development and refinement of appropriate criteria and tests for death, little attention has been given to the broader conceptual issues having to do with its definition or with the relation of a definition to its criterion. The task of selecting the correct criterion is, however, virtually impossible without proper attention to the broader conceptual setting in which the definition operates as the key feature. All of the issues I will discuss arise because (...) of this lack of concern with conceptual matters. Such problems as incorrectly diagnosing a patient as dead prior to the harvesting of his or her organs, defending the idea that death is reversible, and advocating a brainstem criterion of death, are all, I believe, errors that derive from this misplaced emphasis. (shrink)

Ever so often in the UK, there is a flurry of activity around the information requirements of donor-conceived individuals. In April 2013, it was the launch of a report from the Nuffield Council on Bioethics that brought the issue back to public consciousness.1Since 1991, information about treatment with donor gametes or embryos has been collected by the Human Fertilisation and Embryology Authority . Since then, over 35 000 donor-conceived individuals have been born through treatment in licensed clinics. Medical information and (...) information about donors’ appearance are collected by clinics, and donors are encouraged to put together a ‘pen portrait’ giving information about themselves for any resulting children. One focus of the new report is on improving the quality and quantity of information available about donors.Traditionally, gamete and embryo donations were practised on an anonymous basis, so that those born as a result of such donation may receive only non-identifying information about the donor when they reach the age of 18 . This changed in 2005 when donor anonymity was removed so that anyone donating after that time could be identified to individuals born as a result of the treatment. Those who have donated in the past are also able to reregister as identifiable donors. Much concern was expressed at the time that this would exacerbate the shortage of donors although the Nuffield Council on Bioethics reports that, 8 years on, those clinics that actively recruit donors appear to be successful in finding sufficient donors. The report recommends that the option of anonymous donation should not be reintroduced.A big issue of debate in the UK has been, and continues to be, whether parents should tell their …. (shrink)

Cognitive science is beginning to make a contribution to the science-and-religion dialogue by its claims about the nature of both scientific and religious knowledge and the practices such knowledge informs. Of particular importance is the distinction between folk knowledge and abstract theoretical knowledge leading to a distinction between folk science and folk religion on the one hand and the reflective, theoretical, abstract form of thought that characterizes both advanced scientific thought and sophisticated theological reasoning on the other. Both folk science (...) and folk religion emerge from commonsense reasoning about the world, a form of reasoning bequeathed to us by the processes of natural selection. Suggestions are made about what scientists and theologians can do if they accept these claims. (shrink)

OBJECTIVES: To study whether linguistic analysis and changes in information leaflets can improve readability and understanding. DESIGN: Randomised, controlled study. Two information leaflets concerned with trials of drugs for conditions/diseases which are commonly known were modified, and the original was tested against the revised version. SETTING: Denmark. PARTICIPANTS: 235 persons in the relevant age groups. MAIN MEASURES: Readability and understanding of contents. RESULTS: Both readability and understanding of contents was improved: readability with regard to both information leaflets and understanding with (...) regard to one of the leaflets. CONCLUSION: The results show that both readability and understanding can be improved by increased attention to the linguistic features of the information. (shrink)

The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining ‘ethics regulation system for biomedical research’ as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research on humans. This (...) framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities. (shrink)

This essay discusses the developments and trends of research in legalargumentation of the last 25 years. The essay starts with a survey of thevarious approaches which can be distinguished: the logical approach, therhetorical approach, and the dialogical approach. Then it identifies varioustopics in the research, which constitute the various components of aresearch programme of legal argumentation: the philosophical component, thetheoretical component, the reconstruction component, the empiricalcomponent, and the practical component. It concludes with a discussion ofthe main trends in the research (...) of the last 25 years. (shrink)

This essay explores a tragic event that happened in China, which garnered much attention, the Li case: a young woman who was nine months pregnant and her baby died as a result of the failure to receive a medically necessary c-section due to the hospital having failed to secure her family's consent for the c-section. Differing from some critiques, this essay argues that the Li case should not be used to blame the Confucian family-determination model that has been applied in (...) Chinese society for thousands of years. Based on summarizing the reasons supporting the model, this essay indicates that it is an integral part of the model that, in emergency or special cases, the physician must take medical action to save the patient, without the need to secure the consent of a family member. In order to prevent tragic cases like the Li case from happening, we recommend that relevant Chinese laws be further developed and specified and that, most importantly, Chinese physicians must cultivate the Confucian virtue of benevolence in their practice of taking care of patients in a virtuous way, along with patients’ families. (shrink)

Quantitative estimates of risk, and their comparison with quantitative estimates of benefit, contribute usefully to decision-making in many fields. In medicine, our assessments of the probability of harm, and of the likelihood of benefit, resulting from many procedures are at present very limited. Moreover, the comparison of risk and of benefit is difficult to make in any quantitative way, whether for a procedure in general or, even more so, for its application in any particular patient. Yet it must be ethically (...) insecure to propose or to use a procedure without some assessment, however approximate, of the hazards involved, and without some indication of whether those hazards will be clearly offset by the likelihood of benefit that should result from use of the procedure. (shrink)

In contrast to most Western countries, routine offer of prenatal screening is considered problematic in the Netherlands. The main argument against offering it to every pregnant woman is that women would be brought into a moral dilemma when deciding whether to use screening or not. This paper explores whether the active offer of a prenatal screening test indeed confronts women with a moral dilemma. A qualitative study was developed, based on a randomised controlled trial that aimed to assess the decision-making (...) process of women when confronted with a test offer. A sample of 59 women was interviewed about the different factors balanced in decision-making. Participants felt themselves caught between a need for knowledge and their unwillingness to take on responsibility. Conflict was reported between wishes, preferences and ethical views regarding parenthood; however, women did not seem to be caught in a choice between two or more ethical principles. Participants balanced the interests of the family against that of the fetus in line with their values and their personal circumstances. Therefore, we conclude that they are not so much faced with an ethical dilemma as conflicting interests. We propose that caregivers should provide the opportunity for the woman to discuss her wishes and doubts to facilitate her decision. This approach would help women to assess the meaning of testing within their parental duties towards their unborn child and their current offspring. (shrink)

A survey of 106 medical students assessing their interest in and attitudes to medical ethics in the curriculum is reported by the authors. Results indicate that 64 per cent of the students rated the importance of medical ethics to good medical care as high or critical and 66 per cent desired to learn more about the topic. However, in reports of patient encounters identifying ethical issues, less than six per cent of the students reported a frequency of more than one (...) such patient encounter per week. The students also demonstrated a greater awareness of more obvious ethical issues than of more subtle, less publicised issues. When asked how medical ethics should be taught, the students clearly affirmed a desire for an integrated exposure to the subject throughout the medical curriculum. Possible implications of these findings for medical education are discussed. (shrink)

A recent paper in this journal (1) suggests that involving terminally ill patients in choices concerned with Cardio-Pulmonary Resuscitation (CPR) produces 'psychological pain' and therefore is ill-advised. Such a claim rests on anecdotal observations made by the authors. In this paper I suggest that drawing conclusions in ethics, no less than in science, requires a rigorous framework and cannot be relegated to personal observation of a few cases. The paper concludes by suggesting that patients, if we acknowledge their valid interest (...) in making their own choices, must themselves be allowed to make a prior choice about choosing. Those who may not wish to choose may properly be relieved of this burden and may allow another to choose for them. Routinely allowing others to make choices for competent adults, however, is likely to decrease communication with the dying patient and to introduce an atmosphere of suspicion and fear and to exclude the competent patient from his/her rightful place in the community. (shrink)

OBJECTIVES: To analyse the attitudes of medical personnel towards terminally ill patients and their right to be fully informed. DESIGN: Self-administered questionnaire composed of 56 closed questions. SETTING: Three general hospitals and eleven health centres in Granada (Spain). The sample comprised 168 doctors and 207 nurses. RESULTS: A high percentage of medical personnel (24.1%) do not think that informing the terminally ill would help them face their illness with greater serenity. Eighty-four per cent think the patient's own home is the (...) best place to die: 8.9% of the subjects questioned state that the would not like to be informed of an incurable illness. CONCLUSION: In our opinion any information given should depend on the patient's personality, the stage of the illness and family circumstances. Our study confirms that a hospital is not the ideal environment for attending to the needs of the terminally ill and their families. (shrink)

Court-ordered caesarean sections against the explicit wishes of the pregnant woman have been criticised as violations of the woman's fundamental right to autonomy and to the inviolability of the person--particularly, so it is argued, because the fetus in utero is not yet a person. This paper examines the logic of this position and argues that once the fetus has passed a certain stage of neurological development it is a person, and that then the whole issue becomes one of balancing of (...) rights: the right-to-life of the fetal person against the right to autonomy and inviolability of the woman; and that the fetal right usually wins. (shrink)

David Hyman and Charles Silver are quite right. Opinion 6.01 in the American Medical Association's Code of Medical Ethics is difficult to defend. Ties between compensation and outcomes need not mislead patients into thinking that results are guaranteed; they are widely used in other fields with considerable success, even if they have some disadvantages; they can potentially bring patients more actively into decision-making about whether and from whom to purchase which medical care; and, if carefully tuned, they can promote quality (...) by aligning providers’ welfare more closely with patients’.The purpose of this commentary is thus not to disagree with the fundamental thesis that result-based compensation arrangements can be appropriate and useful in the health-care setting. Rather, the objective is to “cut the next swath,” so to speak. While Hyman and Silver are right that RBCAs have potential to do good, they may be overly optimistic about benefits, while underestimating the potential limitations and hazards. (shrink)

Eduard Seidler sets his discussion of the teaching of medical ethics in the Federal Republic of Germany against an historical background. Immediately after the Second World War the freshness of the memory of the 'Nuremberg Medical Trials' influenced the way in which moral dilemmas were treated in Germany. At the present time no systematic instruction in medical ethics is provided in either undergraduate or postgraduate or continuing medical education. As a result of this, an inquiry was set up in 1977/78. (...) Questionnaires were sent out with a view to collecting information on how subjects referring to medical ethics are treated during medical training. The inquiry showed that no special discipline can claim to be the only competent one for medical ethics, but that everyone has something to contribute. Dr Seidler concludes by stating that basic curricula related to the problems of medical ethics would have to be developed and should be carried on continuously within the training programme. (shrink)

Group-orientated supervision is provided continually to student nurses during their education. In the supervision process it is necessary to create a relationship between the supervisor and the supervisee that is based on an ethical, trusting relationship. The aim of the study was to investigate supervisors’ (n = 18) experiences of the ethical dimensions of ongoing group-orientated supervision. An additional aim was to describe the supervisors’ values by which they are guided in supervision. Data were collected by means of an open-ended (...) questionnaire and analysed using the hermeneutic transformative process. The findings revealed the following themes: respect and responsibility; carefulness and sensitivity; reflection and confirmation; and genuineness and fairness. The values guiding the supervisors were dignity, normative ethics, privacy and confidentiality. (shrink)

Genetics and genetic testing raise key issues for insurance and employment. Governmental and public concern galvanised the British insurance industry into developing a code of practice. The history of the development of the code, issues of genetic discrimination, access to medical information, consent and the dangers of withholding information and the impact on the equity of pooled risk are explored. Proactive steps by the Association of British Insurers suggest that moral reflection not legislation is the way forward.

Ethical viewpoints for and against the use of supervised community treatment (SCT), also known as outpatient commitment and community treatment orders, are examined. The perspectives of writers on civil liberties are considered. This paper argues that while civil liberties are an important concern SCT is ethically justifiable in the circumscribed population of ‘revolving door’ patients it applies to. This is on the grounds that it enables individuals to actualise their positive liberty. The issue of insight into mental illness is also (...) considered and it is concluded that a further argument in favour of SCT comes from evidence that insight relates to neurobiological deficits. Limits to the ethical justifiability of SCT are considered with reference to individuals with substance dependency. The paper concludes that SCT is ethically permissible only in those with severe mental illness who have a history of losing capacity to consent to treatment and/or admission. (shrink)

In this essay we review a number of values and conflicts involved in human nutrition in order to clarify the sources of resistance to accepting a pump-fed patient on the part of nursing home nurses. The case illustrates the complexities of our feelings and values in the area of intrusion showing the need for continued reflection upon and revision of our intuitive reactions. The case also displays conflict resolution.

To meet the growing demands for yet more efficient and safer traffic, traffic control is deployed in all modes of transportation. In maritime transportation, traffic control is performed by Vessel Traffic Services (VTS). This paper describes research which is focused upon measurement of VTS operator performance. The concept of situation awareness is introduced as a means to describe and quantify VTS operator performance. Situation awareness is tested in a full scale interactive simulator. A scoring system for VTS operator performance accounts (...) for the specific characteristics of VTS operator work, such as accuracy and relevance of information. (shrink)

The possibility of early diagnosis and intervention is radically changed by the advent of genetic testing. The recent report of the Nuffield Council on Bioethics is timely and helpful. I have suggested, that not only the severity of the disability indicated by genetic information, and the accuracy of the data, ought to govern the approach to the implementation of screening for genetic disorders. In addition, assessment of the value of the information to those involved should be considered. The efficacy of (...) the available therapeutic measures, combined with the prognostic data are important indices of the value of the information. These measures fall into three categories and thus indicate that three different courses of intervention may be appropriate. Three approaches to diagnosis and intervention are then outlined, drawing on the experience of various clinical initiatives. (shrink)

This article reports on an exploratory study that used metaphoric objects as a therapeutic aid. During Rogerian therapy sessions, a metaphoric object was handed to clients. The metaphoric object was used as a reflection of an aspect of the client's being. The clients were asked to describe the effect the object had on them. The protocols obtained were subjected to a phenomenological analysis. The study indicates that metaphoric objects can be a useful therapeutic aid.

This article describes the ethical dilemmas encountered by the authors while conducting qualitative research with psychiatric patients as participants. The ethical conflicts are explored in terms of the principles of personal autonomy, voluntariness and awareness of the purpose of the study, with illustrations from the authors’ research experience. This study addresses the everyday life of psychiatric nursing in a psychiatric hospital as described by patients, nurses and nursing students. The data were collected in a university hospital in northern Finland, using (...) videotaped observations and recorded interviews. Although no definitive resolutions are proposed to the conflicts, the article endeavours to enhance awareness of the ethically perplexing situations possibly encountered by researchers during a study process. The institution where the study was conducted has a Research Board entitled to resolve ethical questions. The Ethics Review Committee of the Medical Faculty at the University and the Research Board of the University Hospital’s Department of Psychiatry reviewed and accepted this research plan. They also recommended solutions to some specific ethical problems that occurred in the course of the study. Moreover, some ethical dilemmas required further study and debate during the process. (shrink)

Much biomedical research cannot be performed without recruiting human subjects. Increasingly, volunteer registries are being developed to assist researchers with this challenging task. Yet, volunteer registries raise confidentiality issues. Having recently developed a registry of volunteers, the authors searched for normative guidance on how to implement the principle of confidentiality. The authors found that the protection of confidentiality in registries are based on the 10 key elements which are elaborated in detail in the Canadian Standards Association Model Code. This paper (...) describes how these 10 detailed key principles can be used during the developmental stages of volunteer registries. (shrink)

The paper traces the development of programmes of lectures and symposia in most British medical schools, which have developed into a postgraduate programme of research and publication. It is asserted that a morally neutral approach is a necessary prerequisite for wide multidisciplinary involvement, as is a high level of student participation in identifying topics for discussion. Alternative possibilities for formal teaching are discussed and pitfalls highlighted.

A study in the logic of theory change, examining the properties of maxichoice contraction and revision operations.