Showing papers in "Journal of Medical Ethics in 2011"

Retractions in the scientific literature: is the incidence of research fraud increasing?

Abstract: Background Scientific papers are retracted for many reasons including fraud (data fabrication or falsification) or error (plagiarism, scientific mistake, ethical problems). Growing attention to fraud in the lay press suggests that the incidence of fraud is increasing. Methods The reasons for retracting 742 English language research papers retracted from the PubMed database between 2000 and 2010 were evaluated. Reasons for retraction were initially dichotomised as fraud or error and then analysed to determine specific reasons for retraction. Results Error was more common than fraud (73.5% of papers were retracted for error (or an undisclosed reason) vs 26.6% retracted for fraud). Eight reasons for retraction were identified; the most common reason was scientific mistake in 234 papers (31.5%), but 134 papers (18.1%) were retracted for ambiguous reasons. Fabrication (including data plagiarism) was more common than text plagiarism. Total papers retracted per year have increased sharply over the decade (r=0.96; p Conclusions Levels of misconduct appear to be higher than in the past. This may reflect either a real increase in the incidence of fraud or a greater effort on the part of journals to police the literature. However, research bias is rarely cited as a reason for retraction.

Why and how do journals retract articles? An analysis of Medline retractions 1988–2008

Abstract: Background Journal editors are responsible for what they publish and therefore have a duty to correct the record if published work is found to be unreliable. One method for such correction is retraction of an article. Anecdotal evidence suggested a lack of consistency in journal policies and practices regarding retraction. In order to develop guidelines, we reviewed retractions in Medline to discover how and why articles were retracted. Methods We retrieved all available Medline retractions from 2005 to 2008 and a one-in-three random selection of those from 1988 to 2004. This yielded 312 retractions (from a total of 870). Details of the retraction including the reason for retraction were recorded by two investigators. Results Medline retractions have increased sharply since 1980 and currently represent 0.02% of included articles. Retractions were issued by authors (63%), editors (21%), journals (6%), publishers (2%) and institutions (1%). Reasons for retraction included honest error or non-replicable findings (40%), research misconduct (28%), redundant publication (17%) and unstated/unclear (5%). Some of the stated reasons might have been addressed by corrections. Conclusions Journals9 retraction practices are not uniform. Some retractions fail to state the reason, and therefore fail to distinguish error from misconduct. We have used our findings to inform guidelines on retractions.

Retractions in the scientific literature: do authors deliberately commit research fraud?

Abstract: Background Papers retracted for fraud (data fabrication or data falsification) may represent a deliberate effort to deceive, a motivation fundamentally different from papers retracted for error. It is hypothesised that fraudulent authors target journals with a high impact factor (IF), have other fraudulent publications, diffuse responsibility across many co-authors, delay retracting fraudulent papers and publish from countries with a weak research infrastructure. Methods All 788 English language research papers retracted from the PubMed database between 2000 and 2010 were evaluated. Data pertinent to each retracted paper were abstracted from the paper and the reasons for retraction were derived from the retraction notice and dichotomised as fraud or error. Data for each retracted article were entered in an Excel spreadsheet for analysis. Results Journal IF was higher for fraudulent papers (p 2 =8.71; p Conclusions This study reports evidence consistent with the ‘deliberate fraud’ hypothesis. The results suggest that papers retracted because of data fabrication or falsification represent a calculated effort to deceive. It is inferred that such behaviour is neither naive, feckless nor inadvertent.

‘Unbearable suffering’: a qualitative study on the perspectives of patients who request assistance in dying

Abstract: Background One of the objectives of medicine is to relieve patients9 suffering. As a consequence, it is important to understand patients9 perspectives of suffering and their ability to cope. However, there is poor insight into what determines their suffering and their ability to bear it. Purpose To explore the constituent elements of suffering of patients who explicitly request euthanasia or physician-assisted suicide (EAS) and to better understand unbearable suffering from the patients9 perspective. Patients and methods A qualitative study using in-depth face-to-face interviews was conducted with 31 patients who had requested EAS. The grounded theory approach was used to analyse the data. Results Medical, psycho-emotional, socio-environmental and existential themes contributed to suffering. Especially fatigue, pain, decline, negative feelings, loss of self, fear of future suffering, dependency, loss of autonomy, being worn out, being a burden, loneliness, loss of all that makes life worth living, hopelessness, pointlessness and being tired of living were constituent elements of unbearable suffering. Only patients with a psychiatric (co)diagnosis suffered unbearably all the time. Conclusions Unbearable suffering is the outcome of an intensive process that originates in the symptoms of illness and/or ageing. According to patients, hopelessness is an essential element of unbearable suffering. Medical and social elements may cause suffering, but especially when accompanied by psycho-emotional and existential problems suffering will become ‘unbearable’. Personality characteristics and biographical aspects greatly influence the burden of suffering. Unbearable suffering can only be understood in the continuum of the patients9 perspectives of the past, the present and expectations of the future.

Facebook activity of residents and fellows and its impact on the doctor–patient relationship

Abstract: Aim Facebook is an increasingly popular online social networking site. The purpose of this study was to describe the Facebook activity of residents and fellows and their opinions regarding the impact of Facebook on the doctor–patient relationship. Methods An anonymous questionnaire was emailed to 405 residents and fellows at the Rouen University Hospital, France, in October 2009. Results Of the 202 participants who returned the questionnaire (50%), 147 (73%) had a Facebook profile. Among responders, 138 (99%) displayed their real name on their profile, 136 (97%) their birthdates, 128 (91%) a personal photograph, 83 (59%) their current university and 76 (55%) their current position. Default privacy settings were changed by 61% of users, more frequently if they were registered for >1 year (p=0.02). If a patient requested them as a ‘friend’, 152 (85%) participants would automatically decline the request, 26 (15%) would decide on an individual basis and none would automatically accept the request. Eighty-eight participants (48%) believed that the doctor–patient relationship would be altered if patients discovered that their doctor had a Facebook account, but 139 (76%) considered that it would change only if the patient had open access to their doctor9s profile, independent of its content. Conclusions Residents and fellows frequently use Facebook and display personal information on their profiles. Insufficient privacy protection might have an impact the doctor–patient relationship.

Retractions in the medical literature: how many patients are put at risk by flawed research?

Abstract: Background Clinical papers so flawed that they are eventually retracted may put patients at risk. Patient risk could arise in a retracted primary study or in any secondary study that draws ideas or inspiration from a primary study. Methods To determine how many patients were put at risk, we evaluated 788 retracted English-language papers published from 2000 to 2010, describing new research with humans or freshly derived human material. These primary papers—together with all secondary studies citing them—were evaluated using ISI Web of Knowledge. Excluded from study were 468 basic science papers not studying fresh human material; 88 reviews presenting older data; 22 case reports; 7 papers retracted for journal error and 23 papers unavailable on Web of Knowledge. Overall, 180 retracted primary papers (22.8%) met the inclusion criteria. Subjects enrolled and patients treated in 180 primary studies and 851 secondary studies were combined. Results Retracted papers were cited over 5000 times, with 93% of citations being research related, suggesting that ideas promulgated in retracted papers can influence subsequent research. Over 28 000 subjects were enrolled—and 9189 patients were treated—in 180 retracted primary studies. Over 400 000 subjects were enrolled—and 70 501 patients were treated—in 851 secondary studies which cited a retracted paper. Papers retracted for fraud (n=70) treated more patients per study (p Conclusions Many patients are put at risk by retracted studies. These are conservative estimates, as only patients enrolled in published clinical studies were tallied.

Courteous but not curious: how doctors' politeness masks their existential neglect. A qualitative study of video-recorded patient consultations

Abstract: Objective To study how doctors care for their patients, both medically and as fellow humans, through observing their conduct in patient–doctor encounters. Design Qualitative study in which 101 videotaped consultations were observed and analysed using a Grounded Theory approach, generating explanatory categories through a hermeneutical analysis of the taped consultations. Setting A 500-bed general teaching hospital in Norway. Participants 71 doctors working in clinical non-psychiatric departments and their patients. Results The doctors were concerned about their patients9 health and how their medical knowledge could be of service. This medical focus often over-rode other important aspects of the consultations, especially existential elements. The doctors actively directed the focus away from their patients9 existential concerns onto medical facts and rarely addressed the personal aspects of a patient9s condition, treating them in a biomechanical manner. At the same time, however, the doctors attended to their patients with courteousness, displaying a polite and friendly attitude and emphasising the relationship between them. Conclusions The study suggests that the main failing of patient–doctor encounters is not a lack of courteous manners, but the moral offence patients experience when existential concerns are ignored. Improving doctors9 social and communication skills cannot resolve this moral problem, which appears to be intrinsically bound to modern medical practice. Acknowledging this moral offence would, however, be the first step towards minimising the effects thereof.

The ‘patient's physician one-step removed’: the evolving roles of medical tourism facilitators

Abstract: Background Medical tourism involves patients travelling internationally to receive medical services. This practice raises a range of ethical issues, including potential harms to the patient9s home and destination country and risks to the patient9s own health. Medical tourists often engage the services of a facilitator who may book travel and accommodation and link the patient with a hospital abroad. Facilitators have the potential to exacerbate or mitigate the ethical concerns associated with medical tourism, but their roles are poorly understood. Methods 12 facilitators were interviewed from 10 Canadian medical tourism companies. Results Three themes were identified: facilitators9 roles towards the patient, health system and medical tourism industry. Facilitators9 roles towards the patient were typically described in terms of advocacy and the provision of information, but limited by facilitators9 legal liability. Facilitators felt they played a positive role in the lives of their patients and the Canadian health system and served as catalysts for reform, although they noted an adversarial relationship with some Canadian physicians. Many facilitators described personally visiting medical tourism sites and forming personal relationships with surgeons abroad, but noted the need for greater regulation of their industry. Conclusion Facilitators play a substantial and evolving role in the practice of medical tourism and may be entering a period of professionalisation. Because of the key role of facilitators in determining the effects of medical tourism on patients and public health, this paper recommends a planned conversation between medical tourism stakeholders to define and shape facilitators9 roles.

Acceptability of financial incentives to improve health outcomes in UK and US samples

Abstract: In an online study conducted separately in the UK and the US, participants rated the acceptability and fairness of four interventions: two types of financial incentives (rewards and penalties) and two types of medical interventions (pills and injections). These were stated to be equally effective in improving outcomes in five contexts: (a) weight loss and (b) smoking cessation programmes, and adherence in treatment programmes for (c) drug addiction, (d) serious mental illness and (e) physiotherapy after surgery. Financial incentives (weekly rewards and penalties) were judged less acceptable and to be less fair than medical interventions (weekly pill or injection) across all five contexts. Context moderated the relative preference between rewards and penalties: participants from both countries favoured rewards over penalties in weight loss and treatment for serious mental illness. Only among US participants was this relative preference moderated by perceived responsibility of the target group. Overall, participants supported funding more strongly for interventions when they judged members of the target group to be less responsible for their condition, and vice versa. These results reveal a striking similarity in negative attitudes towards the use of financial incentives, rewards as well as penalties, in improving outcomes across a range of contexts, in the UK and the USA. The basis for such negative attitudes awaits further study.

Moral experience: a framework for bioethics research

Abstract: Theoretical and empirical research in bioethics frequently focuses on ethical dilemmas or problems. This paper draws on anthropological and phenomenological sources to develop an alternative framework for bioethical enquiry that allows examination of a broader range of how the moral is experienced in the everyday lives of individuals and groups. Our account of moral experience is subjective and hermeneutic. We define moral experience as "Encompassing a person's sense that values that he or she deem important are being realised or thwarted in everyday life. This includes a person's interpretations of a lived encounter, or a set of lived encounters, that fall on spectrums of right-wrong, good-bad or just-unjust". In our conceptualisation, moral experience is not limited to situations that are heavily freighted with ethically-troubling ramifications or are sources of debate and disagreement. Important aspects of moral experience are played out in mundane and everyday settings. Moral experience provides a research framework, the scope of which extends beyond the evaluation of ethical dilemmas, processes of moral justification and decision-making, and moral distress. This broad research focus is consistent with views expressed by commentators within and beyond bioethics who have called for deeper and more sustained attention in bioethics scholarship to a wider set of concerns, experiences and issues that better captures what is ethically at stake for individuals and communities. In this paper we present our conceptualisation of moral experience, articulate its epistemological and ontological foundations and discuss opportunities for empirical bioethics research using this framework.

Muslim patients and cross-gender interactions in medicine: an Islamic bioethical perspective

Abstract: As physicians encounter an increasingly diverse patient population, socioeconomic circumstances, religious values and cultural practices may present barriers to the delivery of quality care Increasing cultural competence is often cited as a way to reduce healthcare disparities arising from value and cultural differences between patients and providers Cultural competence entails not only a knowledge base of cultural practices of disparate patient populations, but also an attitude of adapting one's practice style to meet patient needs and values Gender roles, relationship dynamics and boundaries are culture specific, and are frequently shaped by religious teachings Consequently, religion may be conceptualised as a cultural repertoire, or dynamic tool-kit, by which members of a faith adapt and negotiate their identity in multicultural societies The manner in which Islamic beliefs and values inform Muslim healthcare behaviours is relatively under-investigated In an effort to explore the impact of Islam on the relationship between patients and providers, we present an Islamic bioethical perspective on cross-gender relations in the patient-doctor relationship We will begin with a clinical scenario highlighting three areas of gender interaction that bear clinical relevance: dress code, seclusion of members of the opposite sex and physical contact Next, we provide a brief overview of the foundations of Islamic law and ethical deliberation and then proceed to develop ethicolegal guidelines pertaining to gender relations within the medical context At the end of this reflection, we offer some practice recommendations that are attuned to the cultural sensitivities of Muslim patient populations

Transcranial magnetic stimulation: a historical evaluation and future prognosis of therapeutically relevant ethical concerns

Abstract: Transcranial Magnetic Stimulation (TMS) is a non-invasive neurostimulatory and neuromodulatory technique increasingly used in clinical and research practices around the world. Historically, the ethical considerations guiding the therapeutic practice of TMS were largely concerned with aspects of subject safety in clinical trials. While safety remains of paramount importance, the recent US Food and Drug Administration approval of the Neuronetics NeuroStar TMS device for the treatment of specific medication-resistant depression has raised a number of additional ethical concerns, including marketing, off-label use and technician certification. This article provides an overview of the history of TMS and highlights the ethical questions that are likely arise as the therapeutic use of TMS continues to expand.

Ethical practice in internet research involving vulnerable people: lessons from a self-harm discussion forum study (SharpTalk)

Abstract: The internet is widely used for health information and support, often by vulnerable people. Internet-based research raises both familiar and new ethical problems for researchers and ethics committees. While guidelines for internet-based research are available, it is unclear to what extent ethics committees use these. Experience of gaining research ethics approval for a UK study (SharpTalk), involving internet-based discussion groups with young people who self-harm and health professionals is described. During ethical review, unsurprisingly, concerns were raised about the vulnerability of potential participants. These were dominated by the issue of anonymity, which also affected participant safety and consent. These ethical problems are discussed, and our solutions, which included: participant usernames specific to the study, a closed website, private messaging facilities, a direct contact email to researchers, information about forum rules displayed on the website, a ‘report’ button for participants, links to online support, and a discussion room for forum moderators. This experience with SharpTalk suggests that an approach to ethics, which recognises the relational aspects of research with vulnerable people, is particularly useful for internet-based health research. The solutions presented here can act as guidance for researchers developing proposals and for ethics committees reviewing them.

What do our patients understand about their trial participation? Assessing patients' understanding of their informed consent consultation about randomised clinical trials

Abstract: Background Ethically, informed consent regarding randomised controlled trials (RCTs) should be understandable to patients. The patients can then give free consent or decline to participate in a RCT. Little is known about what patients really understand in consultations about RCTs. Methods Cancer patients who were asked to participate in a randomised trial were surveyed using a semi-standardised interview developed by the authors. The interview addresses understanding, satisfaction and needs of the patients. The sample included eight patients who participated in a trial and two who declined. The data were analysed on the basis of Mayring9s qualitative analysis. Results Patients9 understanding of informed consent was less developed than anticipated, especially concerning key elements such as randomisation, content and procedure of RCTs. Analysing the result about satisfaction of the patients, most of the patients described their consultations as hectic and without advance notice. Health limitations due to cancer played a decisive role. However, most of the patients perceived their physician to be sympathetic. Analysing the needs of patients, they ask for a clear informed consent consultation with enough time and adequate advance notice. Conclusion This study fills an important empirical research gap of what is ethically demanded in an RCT consultation and what is really understood by patients. The qualitative approach enabled us to obtain new results about cancer patients9 understanding of informed consent, to clarify patients9 needs and to develop new ideas to optimise the informed consent.

The limits of empathy: problems in medical education and practice

Abstract: Empathy is commonly regarded as an essential attribute for doctors and there is a conviction that empathy must be taught to medical students. Yet it is not clear exactly what empathy is, from a philosophical or sociological point of view, or whether it can be taught. The meaning, role and relevance of empathy in medical education have tended to be unquestioningly assumed; there is a need to examine and contextualise these assumptions. This paper opens up that debate, arguing that 'empathy', as it is commonly understood, is neither necessary nor sufficient to guarantee good medical or ethical practice.

The return of individual research findings in paediatric genetic research

Abstract: The combination of the issue of return of individual genetic results/incidental findings and paediatric biobanks is not much discussed in ethical literature. The traditional arguments pro and con return of such findings focus on principles such as respect for persons, autonomy and solidarity. Two dimensions have been distilled from the discussion on return of individual results in a genetic research context: the respect for a participant's autonomy and the duty of the researcher. Concepts such as autonomy and solidarity do not fit easily in the discussion when paediatric biobanks are concerned. Although parents may be allowed to enrol children in minimal risk genetic research on stored tissue samples, they should not be given the option to opt out of receiving important health information. Also, children have a right to an open future: parents do not have the right to access any genetic data that a biobank holds on their children. In this respect, the guidelines on genetic testing of minors are applicable. With regard to the duty of the researcher the question of whether researchers have a more stringent duty to return important health information when their research subjects are children is more difficult to answer. A researcher's primary duty is to perform useful research, a policy to return individual results must not hamper this task. The fact that vulnerable children are concerned, is an additional factor that should be considered when a policy of returning results is laid down for a specific collection or research project.

Should the practice of medicine be a deontological or utilitarian enterprise

Abstract: There is currently an unrecognised conflict between the utilitarian nature of the overall NHS and the basic deontology of the doctor-patient interaction. This conflict leads to mistrust and misunderstanding between managers and clinicians. This misunderstanding is bad for both doctors and managers, and also leads to waste of time and resources, and poorer services to patients. The utilitarian thinkers (mainly managers and politicians) tend to value finite, short term, evidence based technical interventions, delivered according to specifications and contracts. They appear happy to break care up into smaller pieces, which can then be commissioned from multiple providers. The deontological thinkers (mainly doctors and other clinicians) tend to think about care delivered through a long term continuous relationship, and regard that relationship as therapeutic and salutogenic in itself. To them breaking care up into smaller fragments is a denial of what caring is really about. Very rarely are either or both sides of this debate fully aware of where their powerfully felt and often well argued positions start from. In this paper we offer an appraisal of the strengths and weaknesses of both moral viewpoints as applied in the UK NHS context and we suggest a way in which they can be reconciled, provided neither is pushed too far or too hard against the other. We believe this reconciliation would be good for patients, doctors, managers and improve the service as a whole.

Public attitudes to the use in research of personal health information from general practitioners' records: a survey of the Irish general public

Abstract: Introduction Understanding the views of the public is essential if generally acceptable policies are to be devised that balance research access to general practice patient records with protection of patients9 privacy. However, few large studies have been conducted about public attitudes to research access to personal health information. Methods A mixed methods study was performed. Informed by focus groups and literature review, a questionnaire was designed which assessed attitudes to research access to personal health information and factors that influence these. A postal survey was conducted of an electoral roll-based sample of the adult population of Ireland. Results Completed questionnaires were returned by 1575 (40.6%). Among the respondents, 67.5% were unwilling to allow GPs to decide when researchers could access identifiable personal health information. However, 89.5% said they would agree to ongoing consent arrangements, allowing the sharing by GPs of anonymous personal health information with researchers without the need for consent on a study-by-study basis. Increasing age (by each 10-year increment), being retired and primary level education only were significantly associated with an increased likelihood of agreeing that any personal health information could be shared on an ongoing basis: OR 1.39 (95% CI 1.18 to 1.63), 2.00 (95% CI 1.22 to 3.29) and 3.91 (95% CI 1.95 to 7.85), respectively. Conclusions Although survey data can be prone to response biases, this study suggests that prior consent agreements allowing the supply by GPs of anonymous personal health information to researchers may be widely supported, and that populations willing to opt in to such arrangements may be sufficiently representative to facilitate valid and robust consent-dependent observational research.

Why do parents enrol their children in research: a narrative synthesis

Abstract: Objective Recent legislation mandating the inclusion of children in clinical trials has resulted in an increase in the number of children participating in research. We reviewed the literature regarding the reasons parents chose to accept or decline an invitation to enrol their children in clinical research. Methods We searched for qualitative studies, written in the English language that considered the experiences of parents who had been invited to enrol their children in research. SCOPUS and Web of Knowledge electronic databases and reference lists of retrieved articles and review papers were searched. Retrieved articles were synthesised using the narrative synthesis method. Results 16 qualitative studies exploring the experiences of parents living in five countries whose children had a range of health conditions of varying severity were included. The health status of the child appeared to influence parents9 reasons for participation. Parents whose children had life threatening conditions often considered they had no choice but to participate and many welcomed the innovation offered through research participation. Such parents also viewed the risks of research less negatively than those whose children were healthy or in the stable stage of a chronic condition. This raises questions regarding the voluntariness of informed consent by such parents. Conclusions A tailored approach is needed when discussing research participation with parents of eligible children. While parents of healthy children may be more open to discussions of altruism, those whose children have life threatening illnesses should be given adequate information about the alternatives to, and risks of, research participation.

Death and legal fictions

Abstract: Advances in life-saving technologies in the past few decades have challenged our traditional understandings of death. Traditionally, death was understood to occur when a person stops breathing, their heart stops beating and they are cold to the touch. Today, physicians determine death by relying on a diagnosis of 'total brain failure' or by waiting a short while after circulation stops. Evidence has emerged, however, that the conceptual bases for these approaches to determining death are fundamentally flawed and depart substantially from the established biological conception of death. We argue that the current approach to determining death consists of two different types of unacknowledged legal fictions. These legal fictions were developed for practices that are largely ethically legitimate but need to be reconciled with the law. The considerable debate over the determination of death in the medical and scientific literature has not informed the public that vital organs are being procured from still-living donors and it seems unlikely that this information can remain hidden for long. Given the instability of the status quo and the difficulty of making the substantial legal changes required by complete transparency, we argue for a second-best policy solution: acknowledging the legal fictions involved in determining death to move in the direction of greater transparency. This may someday result in more substantial legal change to directly confront the challenges raised by life-sustaining and life-preserving technologies without the need for fictions.

Prevalence of depression in granted and refused requests for euthanasia and assisted suicide: a systematic review

Abstract: Background There is an established link between depression and interest in hastened death in patients who are seriously ill. Concern exists over the extent of depression in patients who actively request euthanasia/physician-assisted suicide (PAS) and those who have their requests granted. Objectives To estimate the prevalence of depression in refused and granted requests for euthanasia/PAS and discuss these findings. Methods A systematic review was performed in MEDLINE and PsycINFO in July 2010, identifying studies reporting rates of depression in requests for and cases of euthanasia/PAS. One author critically appraised the strength of the data using published criteria. Results 21 studies were included covering four countries. There was considerable heterogeneity in methods of assessing depression and selecting patients. In the highest quality studies, in the Netherlands and Oregon, 8–47% of patients requesting euthanasia/PAS had depressive symptoms and 2–17% of completed euthanasia/PAS cases had depressive symptoms. In the Netherlands, depression was significantly higher in refused than granted requests, and there was no significant difference in the rate of depression between euthanasia cases and similar patients who had not made a request for euthanasia. Conclusion It is unclear whether depression increases the probability of making a request for euthanasia/PAS, but in the Netherlands most requests in depressed patients are rejected, leaving a depression rate in cases that is similar to the surrounding population. Less evidence is available elsewhere, but some level of depression has been identified in patients undergoing euthanasia/PAS in all the countries studied. Whether the presence of depression is ever compatible with an ethical decision on euthanasia/PAS is discussed.

Parental attitudes towards and perceptions of their children's participation in clinical research: a developing-country perspective

Abstract: Background Paediatric clinical research faces unique challenges that compromise optimal recruitment of children into clinical trials. A main barrier to enrolment of children is parental misconceptions about the research process. In developing countries, there is a knowledge gap regarding parental perceptions of and attitudes towards their children9s participation in clinical trials. Objective To explore such perceptions and attitudes in Lebanese parents. Study design 33 in-depth interviews were conducted with parents with and without previous research experience. Interviews were tape-recorded, transcribed in colloquial Arabic, and later subjected to thematic analysis. Results Benefit/risk ratio assessment was a major determinant of parental consent. Fear of adverse events or painful procedures in research was a recurring theme in most interviews. Whereas perception of direct benefit to the child, trust in the physician or institution, financial gains or having a positive previous experience in research facilitated consent, a complex informed consent form and misunderstanding of the term ‘randomisation’ hindered parental approval of participation. Conclusion Lebanese parents have perceptions of and attitudes towards children9s participation in clinical trials that are similar to those reported from the industrialised world. Improving communication with parents and building trust between researchers and parents is important for successful recruitment. Investigators planning to conduct paediatric trials in developing countries need to simplify consent forms and devise new ways to explain randomisation.

Ethics of modifying the mitochondrial genome

Abstract: Recent preclinical studies have shown the feasibility of specific variants of nuclear transfer to prevent mitochondrial DNA disorders. Nuclear transfer could be a valuable reproductive option for carriers of mitochondrial mutations. A clinical application of nuclear transfer, however, would entail germ-line modification, more specifically a germ-line modification of the mitochondrial genome. One of the most prominent objections against germ-line modification is the fear that it would become possible to alter 'essential characteristics' of a future person, thereby possibly violating the child's right to an open future. As only the nuclear DNA would contain the ingredients for individual characteristics, modification of the mtDNA is often considered less controversial than modification of the nuclear DNA. This paper discusses the tenability of this dichotomy. After having clarified the concept of germ-line modification, it argues that modification of the mtDNA is not substantively different from modification of the nuclear DNA in terms of its effects on the identity of the future person. Subsequently the paper assesses how this conclusion affects the moral evaluation of nuclear transfer to prevent mtDNA disorders. It concludes that the moral acceptability of germ-line modification does not depend on whether it alters the identity of the future child-all germ-line modifications do-but on whether it safeguards the child's right to an open future. If nuclear transfer to prevent mtDNA disorders becomes safe and effective, then dismissing it because it involves germ-line modification is unjustified.

Two concepts of therapeutic optimism

Abstract: Researchers and ethicists have long been concerned about the expectations for direct medical benefit expressed by participants in early phase clinical trials. Early work on the issue considered the possibility that participants misunderstand the purpose of clinical research or that they are misinformed about the prospects for medical benefit from these trials. Recently, however, attention has turned to the possibility that research participants are simply expressing optimism or hope about their participation in these trials. The ethical significance of this therapeutic optimism remains unclear. This paper argues that there are two distinct phenomena that can be associated with the term ‘therapeutic optimism’—one is ethically benign and the other is potentially worrisome. Distinguishing these two phenomena is crucial for understanding the nature and ethical significance of therapeutic optimism. The failure to draw a distinction between these phenomena also helps to explain why different writers on the topic often speak past one another.

The right not to know: the case of psychiatric disorders

Abstract: This paper will consider the right not to know in the context of psychiatric disorders. It will outline the arguments for and against acquiring knowledge about the results of genetic testing for conditions such as breast cancer and Huntington’s disease, and examine whether similar considerations apply to disclosing to clients the results of genetic testing for psychiatric disorders such as depression and Alzheimer’s disease. The right not to know will also be examined in the context of the diagnosis of psychiatric disorders that are associated with stigma or for which there is no effective treatment.

On the very idea of a recovery model for mental health

Abstract: The recovery model has been put forward as a rival to the biomedical model in mental healthcare. It has also been invoked in debate about public policy for individual and community mental health and the broader goal of social inclusion. But this broader use threatens its status as a genuine model, distinct from others such as the biomedical model. This paper sets out to articulate, although not to defend, a distinct recovery model based on the idea that mental health is an essentially normative or evaluative notion. It also aims to show that, supposing this suggestion were to be followed, the norms informing our notion of recovery would be more appropriately construed as eudaimonic than as hedonic in character.

Legal physician-assisted suicide in Oregon and The Netherlands: evidence concerning the impact on patients in vulnerable groups—another perspective on Oregon's data

Abstract: Battin et al examined data on deaths from physician-assisted suicide (PAS) in Oregon and on PAS and voluntary euthanasia (VE) in The Netherlands. This paper reviews the methodology used in their examination and questions the conclusions drawn from it-namely, that there is for the most part 'no evidence of heightened risk' to vulnerable people from the legalisation of PAS or VE. This critique focuses on the evidence about PAS in Oregon. It suggests that vulnerability to PAS cannot be categorised simply by reference to race, gender or other socioeconomic status and that the impetus to seek PAS derives from factors, including emotional state, reactions to loss, personality type and situation and possibly to PAS contagion, all factors that apply across the social spectrum. It also argues, on the basis of official reports from the Oregon Health Department on the working of the Oregon Death with Dignity Act since 2008, that, contrary to the conclusions drawn by Battin et al, the highest resort to PAS in Oregon is among the elderly and, on the basis of research published since Battin et al reported, that there is reason to believe that some terminally ill patients in Oregon are taking their own lives with lethal drugs supplied by doctors despite having had depression at the time when they were assessed and cleared for PAS.

Emergency research in children: options for ethical recruitment

Abstract: The paucity of research data to guide current paediatric practice has led to children being termed therapeutic orphans. This difficulty is especially pertinent to research in emergency situations, such as acute resuscitation or critical care, where accepted ethical standards for overall research, have historically created practical difficulties for researchers. The welcome establishment of organisations to support UK paediatric research is helping to ensure safer and more effective medications for children, however as the balance between protection and access at the heart of the paediatric research ethical debate shifts to ever increasing access for researchers to children, it remains crucial to ensure the protection for these vulnerable participants. The fundamental protection for research subjects, namely their full informed consent before any recruitment, is not tenable in true emergency situations and so other approaches are warranted if standards are to be improved by human subjects research in such areas. Proxy, deferred and retrospective consent have all been advocated as solutions to this difficulty and this paper explores the ethical justification for these approaches and their utility in safeguarding children and families in emergency situations when traditional informed consent, as currently defined, cannot be obtained in the necessary time frame to enable research.

An empirical study on the preferred size of the participant information sheet in research

Abstract: Background Informed consent is a requirement for all research. It is not, however, clear how much information is sufficient to make an informed decision about participation in research. Information on an online questionnaire about childhood development was provided through an unfolding electronic participant sheet in three levels of information. Methods 552 participants, who completed the web-based survey, accessed and spent time reading the participant information sheet (PIS) between July 2008 and November 2009. The information behaviour of the participants was investigated. The first level contained less information than might be found on a standard PIS, the second level corresponded to a standard PIS, and the third contained more information than on a standard PIS. The actual time spent on reading the information provided in three incremental levels and the participants9 evaluation of the information were calculated. Results 77% of the participants chose to access the first level of information, whereas 12% accessed the first two levels, 6% accessed all three levels of information and 23% participated without accessing information. The most accessed levels of information were those that corresponded to the average reading times. Conclusion The brief information provided in the first level was sufficient for participants to make informed decisions, while a sizeable minority of the participants chose not to access any information at all. This study adds to the debate about how much information is required to make a decision about participation in research and the results may help inform the future development of information sheets by providing data on participants9 actual needs when deciding about questionnaire surveys.

A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy

Abstract: Objectives To evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy. Methods The Consent-20 instrument was developed and piloted on 47 subjects. Subsequently, parents of 101 children undergoing first-time, diagnostic upper endoscopy performed under moderate IV sedation were prospectively and consecutively, blinded, randomised and enrolled into two groups that received either standard form-based informed consent or standard form-based informed consent plus a commercial (Emmi Solutions, Inc, Chicago, Il), sixth grade level, interactive learning module (electronic assisted consent). Anonymously and electronically, the subjects9 anxiety (State Trait Anxiety Inventory), satisfaction (Modified Group Health Association of America), number of questions asked, and attainment of informed consent were assessed (Consent-20). Statistics were calculated using t test, paired t test, and Mann Whitney tests. Results The ability to achieve informed consent, as measured by the new instrument, was 10% in the control form-based consent group and 33% in the electronic assisted consent group (p Conclusions This study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy. It also shows that even when necessary information was repeated electronically in a comprehensive and standardised video, informed consent as measured by our instrument was incompletely achieved. The supplemental information did, however, significantly improve understanding in a manner that did not negatively impact workflow, subject anxiety or subject satisfaction. Additional study of informed consent is required. Clinical trial registration number ClinicalTrials.gov Identifier NCT00899392.