Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization (...) of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs. (shrink)

In this article, I seek to answer the following cluster of questions: What would a characteristically African, and specifically relational, conception of a criminal trial’s final end look like? What would the Afro-relational approach prescribe for sentencing? Would its implications for this matter forcefully rival the kinds of penalties that judges in South Africa and similar jurisdictions typically mete out? After pointing out how the southern African ethic of ubuntu is well understood as a relational ethic, I draw out (...) of it a certain conception of reconciliation that I advance as a strong candidate for being the proper final end of a criminal trial. I argue that, far from requiring forgiveness, seeking reconciliation can provide strong reason to punish offenders. Specifically, a reconciliatory sentence is one that roughly has offenders reform their characters and compensate their victims in ways the offenders find burdensome, thereby disavowing the crime and tending to foster cooperation and mutual aid. I argue that this novel account of punishment is a prima facie attractive alternative to more familiar retributive and deterrence rationales, and that it entails that widespread practices such as imprisonment and mandatory minimum sentences are unjust. (shrink)

& The functional equivalence of overt movements and dynamic imagery is of fundamental importance in neuroscience. Here, we investigated the participation of the neocortical motor areas in a classic task of dynamic imagery, Shepard and Metzler's mental rotation task, by time-resolved single-trial functional Magnetic Resonance Imaging (fMRI). The subjects performed the mental-rotation task 16 times, each time with different object pairs. Functional images were acquired for each pair separately, and the onset times and..

As an essential companion to Plato's Apology and Crito, Socrates Against Athens provides valuable historical and cultural context to our understanding of the trial.

Objectives: To describe the concerns and priorities of key stakeholders in a developing country regarding ethical obligations held by researchers and perceptions of equity or “what is fair” for study participants in an HIV/AIDS clinical drug trial. Design: Qualitative study with focus groups. Setting: Teaching and referral hospital and rural health centre in western Kenya. Participants: Potential HIV/AIDS clinical trial participants, clinician researchers, and administrators. Results: Eighty nine individuals participated in a total of 11 focus groups over a (...) four month period. The desire for continued drug therapy, most often life long, following an HIV/AIDS clinical trial was the most common priority expressed in all focus groups. Patients with and without HIV/AIDS also thought subsidisation of drug therapies and education were critical forms of compensation for clinical trial participation. Financial incentives were considered important primarily for purchasing drug therapy as well as obtaining food. Patients noted a concern for the potential mismanagement of any money offered. Clinician researchers and administrators felt strongly that researchers have a moral obligation to participants following a trial to provide continued drug therapy, adverse event monitoring, and primary care. Finally, clinician researchers and administrators stressed the need for thorough informed consent to avoid coercion of study participants. Conclusions: Kenyan patients, clinician researchers, and administrators believe that it would be unfair to stop antiretroviral therapy following an HIV/AIDS clinical trial and that researchers have a long term obligation to participants. (shrink)

BackgroundIn clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant’s true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers of participants of a clinical (...) class='Hi'>trial on Pemba Island, Tanzania.MethodsA total of 254 caregivers were assigned to receive a pamphlet, an oral information session or a pamphlet and an oral information session about the clinical trial procedures, their rights, benefits and potential risks. Their post-intervention knowledge was assessed using a questionnaire. One group of caregivers had not received any information when they were interviewed.ResultsIn contrast to the pamphlet, attending an information session significantly increased caregivers’ knowledge for some of the questions. Most of these questions were either related to the parasite or to the trial design.ConclusionsIn conclusion, within our trial on Pemba Island, a pamphlet was found to not be a good form of conveying clinical trial information while an oral information session improved knowledge. Not all caregivers attending an information session responded correctly to all questions; therefore, better forms of communicating information need to be found to achieve a truly informed consent. (shrink)

Background The involvement of pregnant women in vaccine clinical trials presents unique challenges for the informed consent process. We explored the expectations and experiences of the pregnant women, spouses/partners, health workers and stakeholders of the consent process during a Group B Streptococcus maternal vaccine trial. Methods We interviewed 56 participants including pregnant women taking part in the trial, women not in the trial, health workers handling the trial procedures, spouses, and community stakeholders. We conducted 13 in-depth (...) interviews and focus group discussions with 23 women in the trial, in-depth interviews with 5 spouses, and 5 women not in the trial, key informant interviews with 5 health workers and 5 other stakeholders were undertaken. Results Decision-making by a pregnant woman to join a trial was done in consultation with spouse, parents, siblings, or trusted health workers. Written study information was appreciated by all but they suggested the use of audio and visual presentation to enhance understanding. Women stressed the need to ensure that their male partners received study information before their pregnant partners joined a clinical trial. Confidentiality in research was emphasised differently by individual participants; while some emphasised it for self, others were keen to protect their family members from being exposed, for allowing them to be involved in research. However, others wanted their community participation to be acknowledged. Conclusion We found that pregnant women make decisions to join a clinical trial after consulting with close family. Our findings suggest the need for an information strategy which informs not only the pregnant woman, but also her family about the research she is invited to engage in. (shrink)

As an essential companion to Plato's _Apology_ and _Crito,_ _Socrates Against Athens_ provides valuable historical and cultural context to our understanding of the trial.

Background Ethical decision‑making and behavior of nurses are major factors that can affect the quality of nursing care. Moral development of nurses to making better ethical decision-making is an essential element for managing the care process. The main aim of this study was to examine and comparison the effect of training in ethical decision-making through lectures and group discussions on nurses’ moral reasoning, moral distress and moral sensitivity. Methods In this randomized clinical trial study with a pre- and post-test (...) design, 66 nurses with moral reasoning scores lower than the average of the community were randomly assigned into three equal groups (n = 22) including two experimental groups and one control group. Ethical decision-making training to experimental groups was provided through the lectures and group discussions. While, the control group did not receive any training. Data were collected using sociodemographic questionnaire, the nursing dilemma test (NDT), the moral distress scale (MDS) and the moral sensitivity questionnaire (MSQ). Unadjusted and adjusted binary logistic regression analysis was reported using the odds ratio (OR) and 95% confidence intervals. Results Adjusted regression analysis showed that the probability of increasing the nursing principle thinking (NPT) score through discussion training was significantly higher than lecture (OR: 13.078, 95% CI: 3.238–15.954, P = 0.008), as well as lecture (OR: 14.329, 95% CI: 16.171–2.005, P < 0.001) and discussion groups compared to the control group (OR: 18.01, 95% CI: 22.15–5.834, P < 0.001). The possibility of increasing moral sensitivity score through discussion training was significantly higher than lecture (OR: 10.874, 95%CI: 6.043–12.886, P = 0.005) and control group (OR: 13.077, 95%CI: 8.454–16.774, P = 0.002). Moreover, the moral distress score was significantly reduced only in the trained group compared to the control, and no significant difference was observed between the experimental groups; lecture group vs. control group (OR: 0.105, 95% CI: 0.015–0.717, P = 0.021) and discussion group vs. control group (OR: 0.089, 95% CI: 0.015–0.547, P = 0.009). Conclusions The results of this study indicate that ethical decision-making training is effective on empowerment of ethical reasoning. Whereas the group discussion was also effective on increasing the ethical sensitivity, it is recommended the training plan provided in this study to be held as workshop for all nurses in health and treatment centers and placed in curricular plan of nursing students. Registration This randomized clinical trial was registered in Iranian Registry of Clinical Trials under code (IRCT2015122116163N5) in 02/07/2016. (shrink)

BackgroundAs the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enrol their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words.DiscussionParents want to do their best for their children, and socially and legally their role is to (...) care for and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual parents will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make.SummaryDiscussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future research on the conduct of trials, and ultimately, may help improve the experience of trial recruitment for all parties. (shrink)

Leszek Kolakowski delves into some of the most intellectually vigorous questions of our time in this remarkable collection of essays garnished with his characteristic wit. Ten of the essays have never appeared before in English. "Exemplary.

Clinical research employing the randomized clinical trial has, traditionally, been understood to pose an ethical dilemma. On the one hand, each patient ought to get the treatment that best meets her needs, as judged by the patient in consultation with her doctor. On the other hand, the method most helpful to advancing our understanding about what treatments are indeed best able to meet patient needs is the randomized trial, which necessitates that each patient's care is decided not by (...) physician judgment or patient choice but instead by random assignment. The tension can be described as a conflict between the interests of individual patients who are sick today, and the interests of the group of people who will become sick in the future and would benefit from advances in medical understanding. How one ought to balance these important and often competing interests is an important ethical question that resists easy resolution. (shrink)

BackgroundInformed consent as stipulated in regulatory human research guidelines requires volunteers to be well-informed about what will happen to them in a trial. However, researchers may be faced with the challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. This study aimed to find out volunteers’ comprehension of informed consent and voluntary participation in Human Immunodeficiency Virus (HIV) clinical trials during the registration cohort.MethodsWe conducted a qualitative study among (...) volunteers who were enrolled in the registration cohort of HIV clinical trials in Dar es Salaam, Tanzania. A purposive sampling strategy was used to obtain twenty study participants. The data were collected between June and September 2020 using a semi-structured interview guide. In-depth interviews were used to collect the data to obtain deep insights of the individual study participants on the comprehension of informed consent and participation in the clinical trial. A thematic analysis approach was used to analyze the data. Themes and subthemes were supported by the quotes from the participants.ResultsVolunteers described comprehension of informed consent from different perspectives. They reported that various components of the informed consent such as study procedure, confidentiality, risk and benefits were grasped during engagement meetings. Furthermore, the volunteers’ decision to participate in the registration cohort was voluntary. However, trial aspects such as health insurance, free condoms, and medical checkups could have indirectly influenced their reluctance to withdraw from the study.ConclusionEngagement meetings may increase the comprehension of informed consent among potential participants for HIV clinical trials. However, trial incentives may influence participation, and thus future research should focus on the challenges of giving incentives in the study. This will ensure comprehension and voluntary participation in the context of HIV clinical trials. (shrink)

In this case study from litigation, we show how ghostwriting of clinical trial results can contribute to the manipulation of data to favor the study medication. Study 329 for paroxetine pediatric use was negative for efficacy and positive for harm. Yet the ghostwritten publication from this study concluded that paroxetine provided evidence of efficacy and safety and continues to be influential. Despite the role of named authors in revisions of the manuscript, the sponsor company remained in control of the (...) message. (shrink)

In this response article, we challenge a core assumption that lies at the centre of a round table discussion regarding the Pharmacogenetics to Avoid Loss of Hearing trial. The round table regards a genetic test for a variant that increases the risk of deafness if a carrier is given the antibiotic gentamicin. The idea is that rapid testing can identify neonates at risk, providing an opportunity to prevent giving an antibiotic that might cause deafness. We challenge the assumption that (...) a positive test unequivocally guides antibiotic choice because, aside from the risk of deafness, all antibiotics for neonatal sepsis are equivalent. We argue that this assumption is faulty and has particularly troubling moral consequences. We claim that giving an alternative to gentamicin is potentially providing inferior treatment and thereby may increase the risk of death. Parents and doctors are faced with a terrible choice as a result of positive point-of-care testing : give gold-standard treatment and risk deafness or give second line care and risk death. While we do not indicate an answer to this choice, what we do argue is that such a deep and difficult choice is one that may make parents wish genetic testing was never undertaken, and therefore, contra some authors in the round table, provides a reason to gain specific consent for POCT. (shrink)

ObjectiveCo-morbid insomnia and sleep apnea is a common and debilitating condition that is more difficult to treat compared to insomnia or sleep apnea-alone. Emerging evidence suggests that cognitive behavioral therapy for insomnia is effective in patients with COMISA, however, those with more severe sleep apnea and evidence of greater objective sleep disturbance may be less responsive to CBTi. Polysomnographic sleep study data has been used to predict treatment response to CBTi in patients with insomnia-alone, but not in patients with COMISA. (...) We used randomized controlled trial data to investigate polysomnographic predictors of insomnia improvement following CBTi, versus control in participants with COMISA.MethodsOne hundred and forty five participants with insomnia and sleep apnea [apnea-hypopnea index ≥ 15] were randomized to CBTi or no-treatment control. Mixed models were used to investigate the effect of pre-treatment AHI, sleep duration, and other traditional, and novel [quantitative electroencephalography ] polysomnographic predictors of between-group changes in Insomnia Severity Index scores from pre-treatment to post-treatment.ResultsCompared to control, CBTi was associated with greater ISI improvement among participants with; higher AHI, less wake after sleep onset, and less N3 sleep. No quantitative electroencephalographic, or other traditional polysomnographic variables predicted between-group ISI change.DiscussionAmong participants with COMISA, higher OSA severity predicted a greater treatment-response to CBTi, versus control. People with COMISA should be treated with CBTi, which is effective even in the presence of severe OSA and objective sleep disturbance. (shrink)

Background A morally sound framework for benefit-sharing is crucial to minimize research exploitation for research conducted in developing countries. However, in practice, it remains uncertain which stakeholders should be involved in the decision-making process regarding benefit-sharing and what the implications might be. Therefore the study aimed to empirically propose a framework for benefit-sharing negotiations in research by taking HIV vaccine trials as a case. Methods The study was conducted in Tanzania using a case study design and qualitative approaches. Data were (...) collected using in-depth interviews (IDI) and focus group discussions (FGD). A total of 37 study participants were selected purposively comprising institutional review board (IRB) members, researchers, community advisory board (CAB) members, a policymaker, and HIV/AIDS advocates. Deductive and inductive thematic analysis approaches were deployed to analyze collected data with the aid of MAXQDA version 20.4.0 software. Results The findings indicate a triangular relationship between the research community, researched community and intermediaries. However, the relationship ought to take into consideration the timing of negotiations, the level of understanding between parties and the phase of the clinical trial. The proposed framework operationalize partnership interactions in community-based participatory research. Conclusion In the context of this study, the suggested framework incorporates the research community, the community being researched, and intermediary parties. The framework would guarantee well-informed and inclusive decision-making regarding benefit-sharing in HIV vaccine trials and other health-related research conducted in resource-limited settings. (shrink)

I begin by discussing the ways in which a would-be blamer's own prior conduct towards the person he seeks to blame can undermine his standing to blame her. This provides the basis for an examination of a particular kind of 'bar to trial' in the criminal law – of ways in which a state or a polity's right to put a defendant on trial can be undermined by the prior misconduct of the state or its officials. The examination (...) of this often neglected legal phenomenon illuminates some central features of the criminal law and the criminal process, and some of the preconditions for the legitimacy of the criminal law in a liberal republic. (shrink)

The term ‘locked-in’ syndrome (LIS) describes a medical condition in which persons concerned are severely paralyzed and at the same time fully conscious and awake. The resulting anarthria makes it impossible for these patients to naturally communicate, which results in diagnostic as well as serious practical and ethical problems. Therefore, developing alternative, muscle-independent communication means is of prime importance. Such communication means can be realized via brain–computer interfaces (BCIs) circumventing the muscular system by using brain signals associated with preserved cognitive, (...) sensory, and emotional brain functions. Primarily, BCIs based on electrophysiological measures have been developed and applied with remarkable success. Recently, also blood flow–based neuroimaging methods, such as functional magnetic resonance imaging (fMRI) and functional near-infrared spectroscopy (fNIRS), have been explored in this context. After reviewing recent literature on the development of especially hemodynamically based BCIs, we introduce a highly reliable and easy-to-apply communication procedure that enables untrained participants to motor-independently and relatively effortlessly answer multiple-choice questions based on intentionally generated single-trial fMRI signals that can be decoded online. Our technique takes advantage of the participants’ capability to voluntarily influence certain spatio-temporal aspects of the blood oxygenation level–dependent (BOLD) signal: source location (by using different mental tasks), signal onset and offset. We show that healthy participants are capable of hemodynamically encoding at least four distinct information units on a single-trial level without extensive pretraining and with little effort. Moreover, realtime data analysis based on simple multi-filter correlations allows for automated answer decoding with a high accuracy (94.9%) demonstrating the robustness of the presented method.. (shrink)

Translational science is a 21st century mission. Government officials and industry leaders are making huge investments in an attempt to transform more basic science discoveries into therapeutic applications. Scientists and policymakers express great excitement about the medical advances that could come with the current bench-to-bedside campaign.A key step in translational science is the move from animal and other preclinical studies to initial human testing. Researchers ability to predict human effects is limited, and first-in-human tests present significant uncertainty. Participants in this (...) form of research face risks and can experience serious, even lethal, harm. Well-known incidents involving Jolee Mohr and Jesse Gelsinger, as well as subjects in the 2006 study of the investigational agent TGN1412, show the dangers that can arise in early human research.The bench-to-bedside campaign will need many volunteers to participate in early human testing. Investigators and regulators must not allow the policy enthusiasm for translational science to overshadow the commitment to protect human subjects. Participants in exploratory research are diverse and as a group lack characteristics usually associated with vulnerable populations, such as impaired decisional ability or economic or educational disadvantage. (shrink)

While new generations of implantable brain computer interface devices are being developed, evidence in the literature about their impact on the patient experience is lagging. In this article, we address this knowledge gap by analysing data from the first-in-human clinical trial to study patients with implanted BCI advisory devices. We explored perceptions of self-change across six patients who volunteered to be implanted with artificially intelligent BCI devices. We used qualitative methodological tools grounded in phenomenology to conduct in-depth, semi-structured interviews. (...) Results show that, on the one hand, BCIs can positively increase a sense of the self and control; on the other hand, they can induce radical distress, feelings of loss of control, and a rupture of patient identity. We conclude by offering suggestions for the proactive creation of preparedness protocols specific to intelligent—predictive and advisory—BCI technologies essential to prevent potential iatrogenic harms. (shrink)

Chronic migraine is a difficult disease to diagnose, and its pathophysiology remains undefined. Its symptoms affect the quality of life and daily living tasks of the affected person, leading to momentary disability. This is a pilot, randomized, controlled, double-blind clinical trial study with female patients between 18 and 65 years old with chronic migraine. The patients underwent twelve mindfulness sessions paired with anodal transcranial direct-current stimulation over the left dorsolateral prefrontal cortex, with current intensity of 2 mA applied for (...) 20 min, three times a week for 4 weeks. In addition, 20 min of mindfulness home practices were performed by guided meditation audio files. A total of 30 participants were evaluated after the treatment, and these were subdivided into two groups—active tDCS and sham tDCS, both set to mindfulness practice. The FFMQ-BR, MIDAS, and HIT-6 questionnaires were used to evaluate the outcomes. After the treatment, the active mindfulness and tDCS group showed better results in all outcomes. The sham group also showed improvements, but with smaller effect sizes compared to the active group. The only significant difference in the intergroup analysis was the outcome evaluated by HIT-6 in the post treatment result. Our results provide the first therapeutic evidence of mindfulness practices associated with left DLPFC anodal tDCS with a consequent increase in the level of full attention and analgesic benefits in the clinical symptoms of patients with chronic migraine. (shrink)

IntroductionTranscranial magnetic stimulation is a consolidated procedure for the treatment of depression, with several meta-analyses demonstrating its efficacy. Theta-burst stimulation is a modification of TMS with similar efficacy and shorter session duration. The geriatric population has many comorbidities and a high prevalence of depression, but few clinical trials are conducted specifically for this age group. TBS could be an option in this population, offering the advantages of few side effects and no pharmacological interactions. Therefore, our aim is to investigate the (...) efficacy of TBS in geriatric depression.Clinical trial registration[https://clinicaltrials.gov/ct2/], identifier [NCT04842929]. (shrink)

The attitudes of women patients with cancer were explored when they were invited to participate in one of three randomised trials that included chemotherapy at two university centres and a satellite centre. Fourteen patients participating in and 15 patients declining trials were interviewed. Analysis was based on the constant comparative method. Most patients voiced positive attitudes towards clinical research, believing that trials are necessary for further medical development, and most spontaneously argued that participation is a moral obligation. Most trial (...) decliners, however, described a radical change in focus as they faced the actual personal choice. Almost no one got an impression of clinical equipoise between treatments in the trials, and most patients expressed discomfort with randomisation. A patient’s choice to participate was mainly determined by whether the primary focus was on treatment effect or on adverse effects. Both knowledge about and feelings towards trials originated mostly from the media, although paradoxically the media were largely seen as untrustworthy. Mistrust was shown towards the pharmaceutical industry, and although most patients originally trusted that doctors primarily pursued the interest of patients, they did not trust the adequacy of doctors or industry in maintaining self-regulation. Thus, public control measures were judged to be essential. (shrink)

I begin by discussing the ways in which a would‐be blamer's own prior conduct towards the person he seeks to blame can undermine his standing to blame her (to call her to account for her wrongdoing). This provides the basis for an examination of a particular kind of ‘bar to trial’ in the criminal law – of ways in which a state or a polity's right to put a defendant on trial can be undermined by the prior misconduct (...) of the state or its officials. The examination of this often neglected legal phenomenon illuminates some central features of the criminal law and the criminal process, and some of the preconditions for the legitimacy of the criminal law in a liberal republic. (shrink)

In this book, William H. F. Altman argues that it is not order of composition but reading order that makes Euthyphro, Apology of Socrates, Crito, and Phaedo “late dialogues,” and shows why Plato’s decision to interpolate the notoriously “late” Sophist and Statesman between Euthyphro and Apology deserves more respect from interpreters.

In Corneille’s Horace the hero is brought to trial for having defended Rome’s integrity by killing his own sister. The fifth act of the play is devoted to this trial, but should also be read like an allegorical re-enactment of the Querelle du Cid, during which Corneille himself was put to a kind of a ”trial’’ by colleagues and critics scandalized by the moral and ideological audacity of this first play dedicated to a criminal hero. Our paper (...) tries to point out in detail the analogies that authorize such a reading. (shrink)

BackgroundMany journals prohibit the use of declarative titles that state study findings, yet a few journals encourage or even require them. We compared the effects of a declarative versus a descriptive title on readers’ perceptions about the strength of evidence in a research abstract describing a randomized trial.MethodsStudy participants (medical or dental students or doctors attending lectures) read two abstracts describing studies of a fictitious treatment (Anticox) for a fictitious condition (Green’s syndrome). The first abstract (A1) described an uncontrolled, (...) 10-patient, case series, and the second (A2) described a randomized, placebo-controlled trial involving 48 patients. All participants rated identical A1 abstracts (with a descriptive title) to provide baseline ratings and thus reduce the effects of inter-individual variability. Participants were randomized so that half rated a version of A2 with a descriptive title and half with a declarative title. For each abstract, participants indicated their agreement with the statement “Anticox is an effective treatment for pain in Green’s syndrome” using 100 mm visual analogue scales (VAS) ranging from “disagree completely” to “agree completely.” VAS scores were measured by an investigator who was unaware of group allocation.ResultsOne hundred forty-four participants from four centres completed the study. There was no significant difference between the declarative and the descriptive title groups’ confidence in the study conclusions as expressed on VAS scales—in fact, the mean difference between A1 and A2 was smaller for the declarative title group than that for the descriptive title group (32.6 mm, SD 27.4 vs. 39.8 mm, SD 22.6, respectively, p = 0.09).ConclusionsWe found no evidence that the use of a declarative title affected readers’ perceptions about study conclusions. This suggests that editors’ fears that declarative titles might unduly influence readers’ judgements about study conclusions may be unfounded, at least in relation to reports of randomized trials. However, our study design had several limitations, and our findings may not be generalizable to other situations. (shrink)

There are more large-scale pregnancy trials that implement lifestyle interventions than ever before; yet, there is a dearth of information on pregnant peoples’ experiences in such trials. Contemporary lifestyle pregnancy trials draw on epigenetics and DOHaD research to design and justify prenatal interventions on the material environment to reduce health risks in future generations. This article draws on ethnographic data from a prenatal trial in the United Kingdom and focuses specifically on the experiences of pregnant participants during the intervention (...) phase. In this article, I develop the politics of postgenomic reproduction as a feminist and critical race framework to examine the complex and mercurial stakes of contemporary pregnancy trials. I argue that narratives of control and responsibility in epigenetic models are echoed and preceded by participants’ own embodied experience. The pregnant narratives show at once how their bodies are exposed to unpredictable and uncontrollable environmental exposures and that they are required to respond as if they have absolute control and responsibility. Attending to trial participants’ narratives from a feminist and critical race framework reveals how individualized lifestyle interventions are deeply political and racial, and carry implications for how pregnancy trials influence postgenomic reproduction. (shrink)

ABSTRACTDespite being held in something approaching universal esteem for its capacity to promote prosocial behavior and inhibit antisocial behavior, empathy has recently become the recipient of strong criticism from some of today’s leading academics. Two of the more high-profile criticisms of empathy have come from philosopher Jesse Prinz and psychologist Paul Bloom, each of whom challenges the view that empathy has an overall beneficial influence on human behavior. In this essay, I discuss the basis of their criticisms as well as (...) why I am not compelled by their arguments to believe that empathy does more harm than good. In the process of responding to empathy’s critics, I discuss the important role that empathy plays in our moral lives. I argue that, rather than employing rational considerations to minimize the role that empathy plays in our moral and political judgments, such considerations are put to better use by expanding empathy when conducive to the common good and suppressing it when it opposes th... (shrink)

On 6 September 1966, the prime minister of South Africa, Dr HF Verwoerd was killed by Mr Tsafendas, a Portuguese national of Greek descent, in parliament by stabbing him in the chest. Mr Tsafendas was a messenger in parliament. At the enquiry trial of Mr Tsafendas, he was found unfit to stand trial on the ground that he suffered from schizophrenia. The psychiatric evidence during the enquiry trial was reviewed and discussed under the following headings: Diagnosis of (...) schizophrenia; Consideration of cultural factors in forensic psychiatric settings; Delusional infestation v. extreme overvalued beliefs; Simulation of psychosis; Ethical considerations in criminal capacity and trial competency assessments. Lessons from the Mr Tsafendas enquiry trial for forensic psychiatrists where a defendant previously diagnosed with schizophrenia commits a prominent political murder, are summarised. It is emphasised that the personhood of an accused referred for forensic observation should be respected and protected, instead of focusing exclusively on a specific diagnosis. (shrink)

BackgroundStudies on different methods to supplement the traditional informed consent process have generated conflicting results. This study was designed to evaluate whether participants who received group counseling prior to administration of informed consent understood the key components of the study and the consent better than those who received individual counseling, based on the hypothesis that group counseling would foster discussion among potential participants and enhance their understanding of the informed consent.MethodsParents of children participating in a trial of nutritional supplementation (...) were randomized to receive either group counseling or individual counseling prior to administration of the informed consent. To assess the participant's comprehension, a structured questionnaire was administered approximately 48-72 hours afterwards by interviewers who were blinded to the allocation group of the respondents.ResultsA total of 128 parents were recruited and follow up was established with 118 (90.2%) for the study. All respondents were aware of their child's participation in a research study and the details of sample collection. However, their understanding of study purpose, randomization and withdrawal was poor. There was no difference in comprehension of key elements of the informed consent between the intervention and control arm.ConclusionsThe results suggest that the group counseling might not influence the overall comprehension of the informed consent process. Further research is required to devise better ways of improving participants' understanding of randomization in clinical trials.Trial RegistrationClinical Trial Registry - India (CTRI): CTRI/2009/091/000612. (shrink)

The purpose of the work was to produce a framework to guide the development of meritorious clinical trial proposals. The framework consists of essential features of rigourous methodology, ethical acceptability, and a component referred to as "community context". These three domains were woven together in a checklist format under the headings of general, scientific and ethical considerations. Since texts concerning clinical trial methodology do not integrate ethics criteria and ethics guidelines do not provide detailed scientific criteria in obvious (...) and practical ways, we outline a more contemporary and comprehensive set of guidelines. (shrink)

Most proponents of restorative justice admit to the need to find a well defined place for the use of traditional trial and punishment alongside restorative justice processes. Concrete answers have, however, been wanting more often than not. John Braithwaite is arguably the one who has come the closest, and here I systematically reconstruct and critically discuss the rules or principles suggested by him for referring cases back and forth between restorative justice and traditional trial and punishment. I show (...) that we should be sceptical about at least some of the answers provided by Braithwaite, and, thus, that the necessary use of traditional punishment continues to pose a serious challenge to restorative justice, even at its current theoretical best. (shrink)

BackgroundAt present, adherence to antipsychotic treatment is often poor, leading to the recurrence of symptoms. This increases the likelihood of the patient experiencing disability and thus increases the disease burden for the patient, their family, and society as a whole. However, to date, there is no clear evidence regarding the effect of medication adherence interventions on outcomes for patients with schizophrenia. Moreover, the traditional intervention methods are limited by manpower and resources in low- and middle-income countries. Recent studies have demonstrated (...) that increasing a patient’s level of self-compassion may improve their treatment adherence. Online mental health care interventions have advantages in terms of feasibility and acceptability for patients with schizophrenia. In this regard, a WeChat-based self-compassion training protocol to improve patient treatment adherence was designed in this study and will be evaluated in the future to determine its impact on patients with schizophrenia.MethodsThe protocol for the randomized controlled trial is based on the SPIRIT 2013 statement. This parallel RCT will aim to recruit 392 patients with schizophrenia who will be randomized at a 1:1 ratio into a 3-week intervention or control group. Both groups will receive routine care. The intervention group will also receive WeChat-based self-compassion training, which requires participants to complete three tasks every day, including a reading task, a meditation task, and a self-compassion journal task. The control group will receive WeChat-based psychological health education, which will only require participants to read positive articles about psychological health every day. Medication adherence, self-compassion, stigma, and social support will be measured at baseline, immediately after the intervention, and 3 weeks after the intervention. Program feasibility will be evaluated throughout the course of the study, and acceptability will be measured immediately after the intervention.Expected results:The intervention described here will address the barriers to accessing mental health care for people with schizophrenia, including patients’ desire for independent management, difficulty accessing providers, and concerns about privacy and stigma. The current study provides guidance for clinical nurses to carry out psychological intervention, with the ultimate aim of addressing the problems associated with a shortage of psychological professionals in low- and middle-income countries. (shrink)

Most studies are inclined to report positive rather than negative or inconclusive results. It is currently unknown how clinicians appraise the results of a randomized clinical trial. For example, how does the study funding source influence the appraisal of an RCT, and do positive findings influence perceived credibility and clinical relevance? This study investigates whether psychiatrists’ appraisal of a scientific abstract is influenced by industry funding disclosures and a positive outcome. Dutch psychiatrists were randomized to evaluate a scientific abstract (...) describing a fictitious RCT for a novel antipsychotic drug. Four different abstracts were created reporting either absence or presence of industry funding disclosure as well as a positive or a negative outcome. Primary outcomes were the perceived credibility and clinical relevance of the study results. Secondary outcomes were the assessment of methodological quality and interest in reading the full article. Three hundred ninety-five psychiatrists completed the survey. Industry funding disclosure was found not to influence perceived credibility nor interpretation of its clinical relevance. A negative outcome was perceived as more credible than a positive outcome 0.43 to 1.18, p?), but did not affect clinical relevance scores. In this study, industry funding disclosure was not associated with the perceived credibility nor judgement of clinical relevance of a fictional RCT by psychiatrists. Positive study outcomes were found to be less credible compared to negative outcomes, but industry funding had no significant effects. Psychiatrists may underestimate the influence of funding sources on research results. The fact that physicians indicated negative outcomes to be more credible may point to more awareness of existing publication bias in the scientific literature. (shrink)

Limited research has been done among pregnant people participating in investigational drug trials. To enhance the ethical understanding of pregnant people’s perspectives on research participation, we sought to describe motives and risk perceptions of participants in a phase 1 trial of ledipasvir/sofosbuvir treatment for chronic Hepatitis C virus during pregnancy. Pregnant people with chronic HCV infection enrolled in an open-label, phase 1 study of LDV/SOF participated in semi-structured, in-depth interviews to explore their reasons for participation and experiences within the (...) study. Pregnant people took 12 weeks of LDV/SOF and were interviewed at enrollment and at the end of study. We recorded the interviews, transcribed them verbatim, coded them using NVivo software, and performed inductive thematic analysis. Nine women completed the study yielding 18 interview transcripts. We identified two themes regarding motives and one regarding risk perception. Motives— Women conceptualized study participation as part of the caregiving role they associate with motherhood; participating was viewed as an act of caregiving for their infants, their families, themselves, and other pregnant women with chronic HCV. Women also noted that they faced multiple barriers to treatment prior to pregnancy that created a desire to receive therapy through trial participation. Risk perception— Women acknowledged personal and fetal risk associated with participation. Acceptance of risk was influenced by women’s concepts of motherhood, preexisting knowledge of HCV and medical research, family members, intimate partners, or by the study design. Women enrolled in a phase 1 trial for chronic HCV therapy during pregnancy acknowledged risks of participation and were motivated by hopes for fetal and personal benefit and by lack of prenatal access to treatment. Ethical inclusion of pregnant people in research should acknowledge structural factors that contribute to vulnerability and data deficiencies for treatment in pregnancy. (shrink)

In 1902, the Calabrian brigand Giuseppe Musolino was tried on several counts of murder and many crimes of lesser magnitude. While the tale of the brigand’s 1898 false conviction, imprisonment, escape and then revenge sparked a national debate about the political and cultural meaning of brigandage, the trial came to focus on Musolino’s emotional state at the time of his crimes. Was he a cold-blooded and calculating killer who manipulated southerners into believing he was a folk hero? Or was (...) he an angry, passionate and insane murderer victimized by his own feelings? Both jurists and scientists weighed in to determine his culpability. By turning a political question of banditry or brigandage into a psychological question of morbid or criminal emotions, the trial politicized the criminal character. This article examines the perspectives on emotions that shaped Musolino’s trial, and how psychiatric knowledge came to challenge legal notions of insanity and culpability. It argues that the determination of emotions as motives served to de-legitimize the rationale and political motives of the defendant, in turn politicizing his emotions and character. At the same time, the cause of Musolino’s crime and his culpability represented the failures of national unification and the ongoing tensions between the North and South of Italy. The introduction of psychiatric expertise into the criminal court pushed judgement and punishment to examine increasingly who a person was as opposed to what that person had done. The court’s definition of who a person ‘was’, was a matter of how that person felt. (shrink)