In late 1949 the former Soviet Union conducted an open trial of eight Japanese physicians and researchers and four other military servicemen in Khabarovsk, a city in eastern Siberia. Despite its strong ideological tone and many obvious shortcomings such as the lack of international participation, the trial established beyond reasonable doubt that the Japanese army had prepared and deployed bacteriological weapons and that Japanese researchers had conducted cruel experiments on living human beings. However, the trial, together (...) with the evidence presented to the court and its major findings — which have proved remarkably accurate — was dismissed as communist propaganda and totally ignored in the West until the 1980s. This paper reviews the 1949 Khabarovsk trial, examines the West's dismissal of the proceedings as mere propaganda and draws some moral lessons for bioethics today. As an important historical case, set in the unique socio-political context of the Cold War, the West's dismissal of the trial powerfully illustrates some perennial ethical issues such as the ambivalence of evidence and the power of ideology in making (or failing to make) cross-national and cross-cultural factual and moral judgments. (shrink)

To monopolize the scientific data gained by Japanese physicians and researchers from vivisections and other barbarous experiments performed on living humans in biological warfare programs such as Unit 731, immediately after the war the United States government secretly granted those involved immunity from war crimes prosecution, withdrew vital information from the International Military Tribunal for the Far East, and publicly denounced otherwise irrefutable evidence from other sources such as the Russian Khabarovsk trial. Acting in “the national interest” and (...) for the security of the US, authorities in the US tramped justice and morality, and engaged in what the English common law tradition clearly defines as “complicity after the fact.” To repair this historical injustice, the US government should issue an official apology and offer appropriate compensation for having covered up Japanese medical war crimes for six decades. To help prevent similar acts of aiding principal offender in the future, international declarations or codes of human rights and medical ethics should include a clause banning any kind of complicity in any unethical medicine—whether before or after the fact—by any state or group for whatever reasons. (shrink)

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)

This paper considers dimensions of animate life that are readily “embodied” by phenomenologists and by other philosophy and science researchers as well. The paper demonstrates how the practice of “embodying” short-circuits veritable phenomenological accounts of experience through a neglect of attention to Husserl’s basic conception of, and consistent concern with, animate organism. The paper specifies how in doing so, the practice muddies a clear distinction between the body ‘I have’ and the body ‘I am’, and a clear account of their (...) lived conjunction in existential fit. In turn, the paper shows how the practice falls short of recognizing synergies of meaningful movement created by animate organisms; how it is tethered to talk of posture and sensation over kinesthesia and dynamics; and how, in general, the practice of embodying generates static rather than dynamic understandings of everyday life. The paper then critically considers how such liabilities preclude in-depth phenomenological insights into topics such as ‘ownership’ and ‘agency,’ and why inquiries into the nature of animate organisms require nothing less than fine-tuned attention to foundational experiences of animate life, including foundational ontogenetical experiences that undergird adult proficiencies and abilities, and hence fine-tuned attention to learning and to retaining what is learned in kinesthetic memory. (shrink)

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)

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.

Context Physicians are regularly confronted with research that is funded or presented by industry. Objective To assess whether physicians discount for conflicts of interest when weighing evidence for prescribing a new drug. Design and setting Participants were presented with an abstract from a single clinical trial finding positive results for a fictitious new drug. Physicians were randomly assigned one version of a hypothetical scenario, which varied on conflict of interest: ‘presenter conflict’, ‘researcher conflict’ and ‘no conflict’. Participants 515 randomly (...) selected Fellows in the American College of Obstetricians and Gynecologists' Collaborative Ambulatory Research Network; 253 surveys (49%) were returned. Main object measures The self-reported likelihood that physicians would prescribe the new drug as a first-line therapy. Results Physicians do not significantly discount for conflicts of interest in their self-reported likelihood of prescribing the new drug after reading the single abstract and scenario. However, when asked explicitly to compare conflict and no conflict, 69% report that they would discount for researcher conflict and 57% report that they would discount for presenter conflict. When asked to guess how favourable the results of this study were towards the new drug, compared with the other trials published so far, their perceptions were not significantly influenced by conflict of interest information. Conclusion While physicians believe that they should discount the value of information from conflicted sources, they did not do so in the absence of a direct comparison between two studies. This brings into question the effectiveness of merely disclosing the funding sources of published studies. (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)

The objective of the paper is to present the differences in the grounds of appeal and the appeal proceedings against judgments issued by a court composed of representatives of the public in a criminal trial at first instance. At present, citizens are allowed to adjudicate most often in one of three forms: persons adjudicating independently without the participation of a professional factor, who are not professionals in the field of law and criminal procedure (e.g. judges of the peace in (...) the common law system); a jury composed of citizens and adjudicating mostly on guilt of the accused; or lay judges adjudicating all aspects of the case in one panel together with professional judges. However, the participation of laymen in adjudication is not a prevailing rule. Many countries legal systems do not allow the citizens to co-decide in criminal cases. The paper also indicates the arguments for the democratization of the judiciary through a wider admission of citizens to participate in criminal justice. This issue has been examined on the background of three aspects of democracy: representative, deliberative and participatory. (shrink)

BackgroundInformed consent is an ethical and legal requirement for research involving human participants. However, few studies have evaluated the process, particularly in Africa.Participants in a case control study designed to identify correlates of immune protection against tuberculosis (TB) in South Africa. This study was in turn nested in a large TB vaccine efficacy trial.The aim of the study was to evaluate the quality of consent in the case control study, and to identify factors that may influence the quality of (...) consent.Cross-sectional study conducted over a 4 month period.MethodsConsent was obtained from parents of trial participants. These parents were asked to complete a questionnaire that contained questions about the key elements of informed consent (voluntary participation, confidentiality, the main risks and benefits, etc.). The recall (success in selecting the correct answers) and understanding (correctness of interpretation of statements presented) were measured.ResultsThe majority of the 192 subjects interviewed obtained scores greater than 75% for both the recall and understanding sections. The median score for recall was 66%; interquartile range (IQR) = 55%–77% and for understanding 75% (IQR = 50%–87%). Most (79%) were aware of the risks and 64% knew that they participated voluntarily. Participants who had completed Grade 7 at school and higher were more likely (OR = 4.94; 95% CI = 1.57 – 15.55) to obtain scores greater than 75% for recall than those who did not. Participants who were consented by professional nurses who had worked for more than two years in research were also more likely (OR = 2.62; 95% CI = 1.35–5.07) to obtain such scores for recall than those who were not.ConclusionNotwithstanding the constraints in a developing country, in a population with low levels of literacy and education, the quality of informed consent found in this study could be considered as building blocks for establishing acceptable standards for public health research. Education level of respondents and experience of research staff taking the consent were associated with good quality informed consent. (shrink)

An emerging consensus regards domestic amnesties for international crimes as generally inconsistent with international law. This legal consensus rests on a norm against impunity: the chief role of international criminal law, and of the fledgling International Criminal Court , is to end impunity for violators of the worst of criminal acts. But the anti-impunity norm, and the anti-amnesty consensus that has arisen from it, now face serious difficulties. The ICC's role in the ongoing conflict in Northern Uganda illustrates the deadlock (...) that has now emerged between countries wishing to retain the power to use domestic politics and criminal law as tools for negotiation with current or outgoing perpetrators, on the one side, and the ICC's determination to apply a consistent international anti-impunity norm, on the other. The paper argues that the anti-impunity norm itself is based on a narrowly retributivist conception of criminal justice. A broader norm for democratic accountability, by contrast, would continue to prefer prosecutions over amnesties in international law, less for the opportunity for deserved retribution for perpetrators than for the public enactment of the deliberative procedures associated with the rule of law.Keywords: amnesty; impunity; international law; international criminal court. (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)

Visual cortical prostheses (VCPs) have the potential to provide artificial vision for visually impaired persons. However, the nature and utility of this form of vision is not yet fully understood. Participants in the early feasibility trial for the Orion VCP were interviewed to gain insight into their experiences using artificial vision, their motivations for participation, as well as their expectations and assessments of risks and benefits. Analyzed using principles of grounded theory and an interpretive description approach, these interviews yielded (...) six themes, including: the irreducibility of benefit to device functionality, mixed expectations for short-term device functionality and long-term technological advancement of visual prostheses, and a broad range of risks, concerns, and fears related to trial participation. We argue that these narratives motivate a nuanced set of ethical considerations related to the complex relationship between functionality and benefit, the intersection of user experience with disability justice, and the import of expectations and indirect risks on consent. (shrink)

Volume 19, Issue 10, October 2019, Page 97-98.

The explanatory/pragmatic-trial distinction enjoys a burgeoning philosophical and medical literature and a significant contingent of support among philosophers and healthcare stakeholders as an important way to assess the design and results of randomized controlled trials. A major motivation has been the need to provide relevant, generalizable data to drive healthcare decisions. While talk of pragmatic and explanatory trials could be seen as convenient shorthand, the distinction can also be seen as harboring deeper issues related to inferential strategies used to (...) evaluate causal claims regarding medical treatments. A comprehensive, critical analysis of the distinction and underlying epistemological framework upon which the distinction is based, particularly with respect to treatment effectiveness, has yet to be forthcoming. I provide this, analyzing the distinction’s relationship to generalizability and cognate distinctions between ideal conditions and real-world practice, internal and external validity, and efficacy and effectiveness. I also analyze recent philosophical work that relies on the explanatory/pragmatic-trial distinction and that advocates for more pragmatic trials. I conclude that as an organizing principle for trial-design decisions and trial evaluation, the explanatory/pragmatic-trial distinction is conceptually problematic and not as useful as its proponents seem to think. Since some pragmatic-trial features can be inimical to establishing treatment effectiveness, pragmatic-trial features should not be conflated with pragmatic trials’ avowed goals. If the distinction is to be useful, it and some associated concepts, including generalizability, should be reformulated, lest they continue to underlie a medical epistemology that could contribute to methodologically flawed and potentially unethical advice for the design and interpretation of trials. (shrink)

When evaluating an innovative intervention in a randomised controlled trial , choosing an appropriate control intervention is necessary for a clinically meaningful result. An RCT reported in 2000 addressed the relative merits of two tidal volume ventilatory strategies, 6 ml/kg and 12 ml/kg , in patients with acute respiratory distress syndrome. Critics claim that the 12 ml/kg volume did not represent the clinical practice standard at that time, and that lower tidal volumes had been used in some patients prior (...) to randomisation. The trialists responded that current practice involved the use of a broad range of tidal volumes, including 12 ml/kg. Appropriate control interventions for RCTs can be ensured by: a systematic review of the relevant literature; a formal survey of expert clinicians; and publication of the proposed research protocol to solicit critical appraisal. A global survey of experts during the RCT’s design stage would have been of probative value in determining the appropriate control tidal volume. Hypothetical, but plausible, results of such a survey are presented and examined to demonstrate the value of this method. (shrink)

This paper seeks to argue that although fair trial standards are commonly portrayed as a set of minimum coherent standards applicable across a range of different legal traditions, there is a tension between those standards that accentuate the importance of individual will and autonomy and those that emphasise the importance of accurate outcome through an effective defence. This tension has been managed for the most part by enabling individuals to be represented by legal counsel who present the defence on (...) the basis of their clients’ instructions. Human rights law has recognised the importance of legal assistance at trial and pre-trial stages of criminal procedures. Despite this certain developments in domestic and international criminal processes have led to a growing number of cases being decided without an effective defence being provided by legal counsel. Such cases have been disposed on the basis of defendants’ ‘consent’ and this supposed autonomy has held sway over any effective defence. The paper begins by tracing different dimensions of the fair trial standards and exposes a tension between the need for defendants to exercise autonomy over their case and the need for an effective defence. The paper then argues that the right to counsel has acted as a bridge between these two competing demands. Recent developments are then reviewed which have served to impede counsel from providing an effective defence in the interests of the client’s freedom to choose how her case should be handled. The examples examined are the growing number of cases that are pleaded or diverted out of court with no real examination of the strength of the prosecution case, the emergence of special advocates who do not take instructions from defendants and the increasing tendency for defendants to represent themselves in certain types of cases. The paper concludes by arguing that we need to make a sharper distinction between individual rights and procedural standards and argues for greater attention to be given to the latter on the design of criminal procedure. (shrink)

Patient narratives from two investigational deep brain stimulation trials for traumatic brain injury and obsessive‐compulsive disorder reveal that injury and illness rob individuals of personal identity and that neuromodulation can restore it. The early success of these interventions makes a compelling case for continued post‐trial access to these technologies. Given the centrality of personal identity to respect for persons, a failure to provide continued access can be understood to represent a metaphorical identity theft. Such a loss recapitulates the pain (...) of an individual's initial injury or illness and becomes especially tragic because it could be prevented by robust policy. A failure to fulfill this normative obligation constitutes a breach of disability law, which would view post‐trial access as a means to achieve social reintegration through this neurotechnological accommodation. (shrink)

Wowbagger has a problem: how to make an infinitely long life meaningful. His answer to this problem is studiedly perverse. Presumably, part of his reason for taking on the project he does is that everyone likes a challenge—and the project of insulting everyone in the universe, in alphabetical order, is really challenging even if you’re immortal. Still, his response to the question ‘How shall I make my life meaningful?’ seems to be not so much an attempt to answer it as (...) to stick two fingers up at it. Can anyone find anything less perverse to say about that question? If the late and lamented Douglas Adams is to be believed, some beings can. The non-accidental immortals, the ‘serene bastards’ of Wowbagger’s envy, have no trouble coping with everlasting life. Adams does not tell us how they manage to cope; which is a pity, because many contemporary philosophers, notably Bernard Williams and Adrian Moore, see a conceptual problem here. They cannot conceive how anyone could cope with immortality, even in the rather minimal sense of ‘cope’ that Wowbagger manages. This paper argues that their arguments fail. An eternal life, I argue, can be meaningful, and under the right circumstances, will be more meaningful than any finite life could be, because free from a threat to meaningfulness that cannot be removed from any finite life. We therefore have reason to want eternal life lived under these circumstances. (shrink)

Pragmatic comparative effectiveness randomized controlled trials evaluate the effectiveness of one interventions under real-world clinical conditions. The results of ceRCTs are often directly generalizable to everyday clinical practice, providing information critical to decision-making by patients, clinicians, and healthcare policymakers. The PRECIS-2 framework identifies nine domains that serve to score a trial on a continuum between very explanatory to very pragmatic. According to the framework, pragmatic trials may have one or more of the following features: there are fewer eligibility criteria (...) for participants, in an... (shrink)

A new therapeutic approach is being developed for the treatment of Alzheimer's disease (AD). This approach involves the deliberate induction of an autoimmune response to amyloid‐β (Aβ) peptide, the constituent of neuritic plaques that is thought to cause the neurodegeneration and dementia in AD. If this approach is to be effective, antibodies must be produced that can selectively target the toxic forms of Aβ, while leaving the functionally‐relevant forms of Aβ and its precursor protein untouched. Furthermore, an approach needs to (...) be found that avoids provoking an acute neuroinflammatory response. The situation is made even more challenging by uncertainty regarding which isoforms of Aβ contribute to the pathogenesis of AD. BioEssays 25:283–288, 2003. © 2003 Wiley Periodicals, Inc. (shrink)

It has often been argued that if a clinician cannot decide which of two treatments to offer, a trial may be ethical, but it is unethical if she/he has a preference. Since individual clinicians usually have a preference, most trials could be judged unethical according to this line of argument. A recent important article in the New England Journal of Medicine argued that individual preferences are not as important as the collective uncertainty of informed clinicians. If clinicians are equally (...) divided, there is a state of collective equipoise and a trial is ethical. However, clinicians will seldom be exactly equally divided. We conducted an ethometric study to find out how much collective equipoise can be disturbed before the potential subjects in a trial think that it is unethical. Half of our subjects perceived a trial as unethical when equipoise was disturbed beyond 70:30. In other words, when 70 per cent of experts favour one treatment, 50 per cent of subjects would prefer that treatment to be administered rather than subjected to critical assessment. When equipoise is disturbed beyond 80:20, less than 3 per cent of subjects would consider human trials morally justifiable. (shrink)

There are differences in caregivers’ literacy and health literacy levels that may affect their ability to consent to children participating in clinical research trials. This study aimed to explore the effectiveness, and caregivers’ understandings, of the process of informed consent that accompanied their child’s participation in a dental randomized control trial (RCT). Telephone interviews were conducted with a convenience sample of ten caregivers who each had a child participating in the RCT. Pre-tested closed and open-ended questions were used, and (...) the findings were produced from an inductive analysis of the latter and a descriptive analysis of the former. Participants had limited understanding of the purpose of the RCT and rated the readability of the consent form more highly than they rated their understanding of the research. All felt that informed consent was vital, but some caregivers had not read the consent documents. Some caregivers enrolled their child in the RCT because they trusted the researchers, and the majority wanted to improve dental care for children. The informed consent process was not always effective despite high readability of the informed consent documents. Researchers must consider the health literacy of the study group, and actively engaging with caregivers to achieve meaningful informed consent may be challenging. Future research could explore participants’ perspectives of informed consent in populations with low health literacy and assess whether an underlying expectation not to comprehend health-related information may be a barrier to informed consent. (shrink)

BackgroundLittle is known about volunteers from Northern research settings who participate in vaccine trials of highly infectious diseases with no approved treatments. This article explores the motivations of HIV immunocompromised study participants in Canada who volunteered in a Phase II clinical trial that evaluated the safety and immunogenicity of an Ebola vaccine candidate.MethodsObservation at the clinical study site and semi-structured interviews employing situational and discursive analysis were conducted with clinical trial participants and staff over one year. Interviews were (...) recorded, transcribed and analysed using critical qualitative interpretivist thematic analytical techniques. Patterns were identified, clustered and sorted to generate distinct and comprehensive themes. We then reassembled events and contexts from the study participants’ stories to develop two ideal portraits based on "composite characters" based on study participants features. These provide ethnographically rich details of participants’ meaningful social worlds while protecting individual identities.ResultsTen of the 14 clinical trial participants, and 3 study staff were interviewed. Participant demographics and socio-economic profiles expressed limited contextual diversity. Half were men who have sex with men, half were former injection drug users experiencing homelessness, one was female, none were racialized minorities and there were no people from HIV endemic countries. Fully 90% had previous involvement in other clinical studies. Their stories point to particular socio-economic situations that motivated their participation as clinical labor through trial participation.ConclusionsOur findings support Fisher’s argument of “structural coercion” in clinical trial recruitment of vulnerable individuals experiencing precarious living conditions. Clinical trials should provide more detail of the structural socio-economic conditions and healthcare needs which lie “under consent” of study participants. Going well beyond an overly convenient narrative of altruism, ethical deliberation frameworks need to sufficiently address the structural conditions of clinical trials. We offer concrete possibilities for this and acknowledge that further research and clinical data should be made available underlying study participant contexts with regards to recruitment and participation in resource poor settings, in both the South and the North. (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)

Researchers designing a clinical trial may be aware of disputed evidence of serious risks from previous studies. These researchers must decide whether and how to describe these risks in their model informed consent document. They have an ethical obligation to provide fully informed consent, but does this obligation include notice of controversial evidence? With ACCORD as an example, we describe a framework and criteria that make clear the conditions requiring inclusion of important controversial risks. The ACCORD model consent document (...) did not include notice of prior trials with excess death. We develop and explain a new standard labeled risk in equipoise. We argue that our approach provides an optimal level of integrity to protect the informational needs of the reasonable volunteers who agree to participate in clinical trials. We suggest language to be used in a model consent document and the informed consent discussion when such controversial evidence exists. (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)

What happens at the end of a clinical trial for an investigational neural implant? It may be surprising to learn how difficult it is to answer this question. While new trials are initiated with increasing regularity, relatively little consensus exists on how best to conduct them, and even less on how to ethically end them. The landscape of recent neural implant trials demonstrates wide variability of what happens to research participants after an neural implant trial ends. Some former (...) research participants continue to receive support for their devices (e.g., battery and component replacements, software updates, etc.). Others, when safe, have their neural implants removed through surgical explantation. Still others continue to live with a deactivated neural implant embedded in their body. In the United States, there are no uniform requirements to provide services, of any kind, after an neural implant study ends, and other nations are similarly facing this challenge. The existence of a post-trial gap in an expanding neural implant research ecosystem invites obvious questions: What is owed to neural implant research participants post-trial, and why has providing it been so difficult to accomplish in practice? To take a step forward on this difficult issue, we assembled one group of stakeholders – researchers funded for neuroethics grants by the National Institutes of Health – to explore possible starting points on one topic: ethical guidance for post-trial care of research participants in neural implant trials. Based on shared concerns discussed in the expert workshop the current paper is a call to action. It reports the key areas of convergence from the meeting and highlights important next steps towards developing much needed guidance. (shrink)