The present paper deals with the problem of evaluating empirical evidence for therapeutic decisions in medicine. The article discusses the views of Nancy Cartwright and John Worrall on the function that randomization plays in ascertaining causal relations with reference to the therapies applied. The main purpose of the paper is to present a general idea of alternative method of evaluating empirical evidence. The method builds on data analysis that makes use of rough set theory. The first attempts to apply the (...) method show that it is an interesting alternative to randomized controlled trials. (shrink)

It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for participants. There is evidence that such a competition is a predictor of low study accrual, with increased competition tied to increased recruitment shortfalls. But there is no consensus on what steps, if any, institutions should take to approach this issue. In this article, we argue (...) that an institutional policy that prioritises some trials for recruitment ahead of others is ethically permissible and indeed prima facie preferable to alternative means of addressing recruitment competition. We motivate this view by appeal to the ethical importance of minimising the number of studies that begin but do not complete, thereby exposing their participants to unnecessary risks and burdens in the process. We then argue that a policy of prioritisation can be fair to relevant stakeholders, including participants, investigators and funders. Finally, by way of encouraging and helping to frame future debate, we propose some questions that would need to be addressed when identifying substantive ethical criteria for prioritising between studies. (shrink)

Ethics consultation has become an integral part of the fabric of U.S. health care delivery. This article summarizes the second edition of the Core Competencies for Health Care Ethics Consultation report of the American Society for Bioethics and Humanities. The core knowledge and skills competencies identified in the first edition of Core Competencies have been adopted by various ethics consultation services and education programs, providing evidence of their endorsement as health care ethics consultation (HCEC) standards. This revised report was prompted (...) by thinking in the field that has evolved since the original report. Patients, family members, and health care providers who encounter ethical questions or concerns that ethics consultants could help address deserve access to efficient, effective, and accountable HCEC services. All individuals providing such services should be held to the standards of competence and quality described in the revised report. (shrink)

Our aims are to set forth a multiprinciple system for selecting among clinical trials competing for limited space in an immunotherapy production facility that supplies products under investigation by scientific investigators; defend this system by appealing to justice principles; and illustrate our proposal by showing how it might be implemented. Our overarching aim is to assist manufacturers of immunotherapeutic products and other potentially breakthrough experimental therapies with the ethical task of prioritizing requests from scientific investigators when production capacity is limited.

Setting reasonable and fair limits of emergency research acceptability in ethical norms and legal regulations must still adhere to the premise of well-being of the research subject over the interests of science and society. Informed consent of emergency patients to be enrolled in clinical trials is a particularly difficult issue due to impaired competencies of patients’ to give consent, short diagnostic and therapeutic windows, as well as the requirement to provide detailed information to participants. Whereas the Declaration of Helsinki, Good (...) Clinical Practice guideline, Additional Protocol to the European Bioethical Convention concerning Biomedical Research, as well as appropriate regulations adopted by the Food and Drugs Administration (USA) allow waivers from participants’ consent or deferred consent for emergency research, the regulations of most European Community countries following the Clinical Trial Directive (2001/20/EC) do not give space for a deferred consent or a waiver from consent for adult patients (unless surrogate consent is made use of). This is even more confusing in case of Poland, where conflicting regulations on a waiver from a participant’s consent in emergency research exist and the regulations on surrogate consent of temporarily incompetent adults are too restrictive and authorise only the guardianship courts to consent, which is not or hardly feasible in practice. European Community regulations need to be amended to allow for implementation of the deferred consent or waivers from consent for emergency research in order to enable ethical research of emergency conditions that should become a large part of important public health priorities. (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)

Supervised injectable opioid assisted treament prescribes injectable opioids to individuals for whom other forms of addiction treatment have been ineffective. In this article, we examine arguments that opioid-dependent people should be assumed incompetent to voluntarily consent to clinical research on siOAT unless proven otherwise. We agree that concerns about competence and voluntary consent deserve careful attention in this context. But we oppose framing the issue solely as a matter of the competence of opioid-dependent people and emphasize that it (...) should be considered in the context of inequities in access to siOAT as a medical treatment. Consequently, we suggest that bioethics literature on nonexploitation, which focuses on clinical research in low-income countries, is helpful due to locating ethical issues within systemic social conditions. Finally, we consider the implications of our argument for the ethics of clinical research on siOAT. (shrink)

The important question of the legality of the state obliging trial incompetent defendants to receive competency-restoring treatment against their wishes, is one that has received much attention by legal scholars. Surprisingly, however, little attention has been paid to the, in many ways more fundamental, moral question of whether the state ought to administer such treatments. The aim of this paper is to start filling this gap in the literature. I begin by offering some reasons for thinking it morally acceptable (...) to, at least sometimes, oblige trial-incompetent defendants to receive competency-restoring treatments. The paper then discusses whether three prominent arguments (and their variations) offered by legal scholars against using non-consensual treatment to restore trial competence provide grounds for thinking there to be a general moral prohibition against these treatments. I argue that they do not. (shrink)

The recent review by Monrad1 presents several issues about secondary vaccine trials. It lays out the case in which a vaccine has been tested through phases I–III and is being deployed. Subsequently, consideration is being given to conducting ‘trials for another vaccine for the pathogen’. Monrad states: ‘In summary, we may say that researchers have strong prima facie reasons not to conduct a secondary vaccine trial.’ Monrad discusses several factors meriting careful consideration about the need for developing and testing (...) more than one vaccine: relative efficacy, length of immunity, adverse reactions, ease of storage and administration, economic and logistical factors. What is not addressed are the ethical duties that exist when there are competing phase III vaccine candidates for COVID-19. We have serious concerns about potential ethical inadequacies about these ongoing trials and …. (shrink)

BackgroundWe describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512). This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European (...) provisions were evaluated. Descriptive analysis, Wilcoxon Rank-Sum test and General Linear Model analysis were used to determine factors potentially influencing the timelines. The Cluster Analysis procedure was used to identify homogenous groups of cases.ResultThe authorisation process was completed in 7.7 to 53.8 months in European countries and in 17.1 to 27.1 months in non-European countries. The main factors influencing these timelines were the requests for changes/clarifications in European countries and the different national legislations in non-European countries.ConclusionThis work confirms that the procedures and requirements for the clinical trial application of a paediatric trial are different. In the European Union, the timeframes for submission were generally harmonised but longer. In non-European countries, delays were caused by national dispositions but the entire authorisation process resulted faster with less requests from ECs/cas. The upcoming application of Regulation (EU) 536/2014 is expected to harmonise practices in Europe and possibly outside. Networks on paediatric research acting at international level will be crucial in this effort. (shrink)

The European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout the different (...) steps including the registration of the trial in the European database; the preparation of documents to be submitted and their contents; the preparation of documents related to the information and consent process; the submission to competent bodies. Specific issues related to paediatric research and trials involving non EU/EEA countries have been addressed as well. Results reveal that the European legislation offers a well defined set of European rules covering different aspects of a Clinical Trial Application. However, these are not suitable to meet the challenges from multicentre and multinational clinical studies. A stronger set of rules, such as is available in a composite European Regulation has been adopted and is expected to harmonise practices and enable sponsors to carry out well conducted trials. But will the new regulation overcome the existing criticisms of Directive 2001/20/EC? (shrink)

In this article, the concept of competence is studied from the point of view of the semiotics of education. It will be claimed that it is a central key concept when we are trying to analyse the meaning of education. Educational action can be reasonably understood as an insecure and complicatedly mediated trial to affect another person's competence. First, the recent discussion about the concept of competence and its relatives is shortly reviewed. Then, competence is (...) analysed and defined according to Greimassian semiotic theory as a basic determining character of an acting subject. At the same time as competence is indispensably central for understanding the subjects of action, it is problematically empirically ineffable. This ineffability has a special meaning in education, where we must try to both plan our own educative action and evaluate the learning of the student according to these invisible features. It is proposed that in the recent discourse of education, the very popular use of the concept of competence is misguided and problematically mixed with its conceptual counterpart performance. From this viewpoint, the concept of competence should rather be connected to the ontological concept of disposition. The problem of multi-dimensionality of competence is considered with the help of the Greimassian conception of modalities to create a richer and more detailed picture of the role of competence in action, and especially in education. (shrink)

Successful clinical trials are important for all of us, but they can be extremely complicated to design and run, so work must be done to consider what commonly goes wrong and how these issues can be addressed. Gelinas et al suggest an ethical argument for institutional prioritisation of clinical trials conducted among limited populations. This is to ensure successful recruitment and prevent competing trials rendering each other irrelevant through lack of statistical power. But they overlook the fact that effective prioritisation (...) already occurs, and their suggestion produces yet another hurdle for researchers to overcome. Their argument hinges around the claim that allocation of participants to trials represents an inevitable rationing scenario and, like all rationing scenarios, the best methods should be used for objectively determining how limited resources are distributed to achieve the end goal.1 Although they acknowledge that both individuals and clinicians may have preferences as to which trial a patient participates in, trial interventions are by definition experimental, and therefore choosing between trials is not really analogous to choosing between alternative clinical interventions. Here it seems that although clinical instinct is important when determining treatment options, a clinical trial is a specific attempt to create systematic justified knowledge and thus individual patient/clinician autonomy …. (shrink)

Background Researchers are required to determine whether a person has capacity to consent to a research study before they are able to participate. The Mental Capacity Act and accompanying Code of Practice for England and Wales provide some guidance on this process, but researchers have identified that it can be difficult to determine capacity to consent when a person has complex cognitive or communication needs. This study aimed to understand the experiences and opinions of researchers who recruit people with dementia (...) to research projects, to inform the future development of training resources. Methods A mixed method, cross-sectional, electronic survey was circulated via social media and research networks in England and Wales. The survey remained open for ten weeks and included open and closed questions exploring respondents’ confidence in determining capacity in the context of recruiting people with dementia to consent, their views on training and support they have experienced and their suggestions for future training and support needs. Results 60 respondents completed the survey from across England and Wales. Although 75% of respondents had experience of determining capacity to consent with people with dementia to research, only 13% rated themselves as feeling ‘very confident’ in this. Qualitative content analysis of open responses led to the generation of six themes, explaining researchers’ confidence, competence and future training needs in this area: (1) Researcher uncertainties, (2) Lack of time, (3) Balancing information complexity with accessibility, (4) Gatekeepers, (5) Existing enablers and (6) Envisioning future training. Conclusions Researchers would benefit from specific training in undertaking conversations around consent with people with dementia. People with dementia may have fluctuating capacity, and despite support from caregivers, researchers have little practical guidance on methods of determining a person’s ability to understand or appreciate the information they have provided during the consent process. Given the development of large complex trials within dementia research, there is an urgency to develop specific and practical guidance and training for researchers working with people with dementia and their families. (shrink)

English law gives the competent patient the right to refuse life-saving medical treatment, either contemporaneously or in an advance directive, and a physician commits a battery when treating a patient who validly refused treatment. However, with regard to the details of a physician's liability, many questions remain unanswered, and it is not at all clear under what circumstances a patient's tort action for unwanted life-saving treatment will succeed, and what remedies would be available to the patient. The article suggests that (...) a physician should be liable in battery for administering life-saving treatment, even if he/she had doubts about the validity of the patient's treatment refusal, unless a defence of reasonable mistake can be established. Furthermore, in case of a battery which resulted in keeping the patient alive, the patient should not only be able to claim nominal damages, but general and special damages, including mental and physical pain and suffering caused by the prolongation of the patient's life, should equally be available. (shrink)

The routine practice of clinical research involving patient-subjects without informed consent prior to 1966 unquestionably was unethical. Does it follow that all clinical research involving competent adult patient-subjects is unethical without informed consent?In his landmark 1966 paper, Henry Beecher noted that of the 50 example studies he had originally compiled in preparation for that paper, only two even mentioned consent, and he observed further that mention of consent is “meaningless unless one knows how fully the patient was informed”. Some of (...) the studies in Beecher’s paper, such as one comparing sulfadiazine with no treatment to assess the complications of streptococcal pharyngitis (when the... (shrink)

To address the burden of maternal morbidity and mortality in low‐ and middle‐income countries (LMICs), research with pregnant women in these settings is increasingly common. Pregnant women in LMIC‐context may experience vulnerability related to giving consent to participate in a clinical trial. To recognize possible layers of vulnerability this study aims to identify factors that influence the decision process towards clinical trial participation of pregnant women in an urban middle‐income setting. This qualitative research used participant observation, in‐depth interviews, (...) and focus group discussion with medical staff and pregnant women eligible for trial participation, at a regional hospital in Accra, Ghana. Besides lack of familiarity with modern scientific concepts, specific factors influencing the decision‐making process were identified. These include a wide power difference between health provider and patient, and a different perception of risk through externalization of responsibility of risk management within a religious context as well as a context shaped by authority. Also, therapeutic misconception was observed. The combination of these factors ensued women to rely on the opinion of the medical professional, rather than being guided by their own motivation to participation. Although being a (pregnant) woman per se should not render the label of being vulnerable, this study shows there are factors that influence the decision process of pregnant woman towards trial participation in a LMIC context that can result in vulnerability. The identification of context‐specific factors that can create vulnerability facilitates adaptation of the design and conduct of research in a culturally competent manner. (shrink)

This article offers a justification for the continued use of jury trials. I shall critically examine the ability of juries to render just verdicts, judicial impartiality, and judicial transparency. My contention is that the judicial system that best satisfies these values is most preferable. Of course, these three values are not the only factors relevant for consideration. Empirical evidence demonstrates that juries foster both democratic participation and public legitimation of legal decisions regarding the most serious cases. Nevertheless, juries are costly (...) and, therefore, economically less efficient than competing modes of trial. I do not argue that all human beings possess an inalienable legal right to be tried by a jury. However, it is my hope that this analysis will make clear what we might gain or lose when we propose jury reforms. (shrink)

This systematic review identifies and critically evaluates instruments that have been developed to measure clinical trial informed consent comprehension in non-cognitively-impaired adults.Literature searches were carried out on Medline (Ovid), PsycInfo, CINHAL, ERIC, ScienceDirect, and Cochrane Library for English language articles published between January 1980 and September 2008. Instruments were excluded if they focused on consent onto paediatric trials, the construct under study was primarily capacity or competency, or the instrument was developed specifically for psychiatric or cognitively-impaired populations. Instruments selected (...) for review were evaluated against the following criteria: (1) method of item generation; (2) type and format of test items; (3) administration and interpretation of test results; and (4) psychometric properties.Three instruments met our defined inclusion criteria: the Deaconess Informed Consent Comprehension Test (DICCT), the Quality of Informed Consent (QuIC) questionnaire and the Brief Informed Consent Protocol (BICEP). Each instrument varied in terms of content measured. Significantly, these are the first standardized instruments developed to assess comprehension in non-cognitively-impaired adults. Yet, each instrument had its own set of limitations such as the lack of generalizability and the absence of details pertaining to how test results should be used to guide clinical decision-making.Standardized clinical trial informed consent comprehension assessments have been developed to identify gaps in research participants' understanding and ensure that respect for patient autonomy is satisfied. (shrink)

A dearth of clinical research involving children has resulted in off-licence and sometimes inappropriate medications being prescribed to the paediatric population. In this environment, recent years have seen the introduction of a raft of regulation aimed at increasing the involvement of children in clinical trials research and generating evidence-based medicinal preparations for their use. However, this regulation pays scant attention to the autonomy of competent minors. In particular, it makes no provision for the ability of competent minors to consent to (...) participate in medical research and is therefore at odds with best ethical practice. This article explores the tensions between law and ethics in relation to clinical research involving minors and concludes that greater respect should be given to the autonomy of those minors who are competent to decide for themselves. (shrink)

BACKGROUND: There is a need for interdisciplinary research to better understand how pedagogical approaches in primary physical education (PE) can support the linked development of physical, cognitive and affective aspects of physical literacy and physical activity behaviours in young children. The Skill Acquisition Methods fostering Physical Literacy in Early-Physical Education (SAMPLE-PE) study aims to examine the efficacy of two different pedagogies for PE, underpinned by theories of motor learning, to foster physical literacy, especially for children living in disadvantaged areas. METHODS: (...) SAMPLE-PE will be evaluated through a cluster-randomised controlled trial targeting 5-6 year old children from schools located in areas of high deprivation in Merseyside, North-West England. Schools will be randomly allocated to one of three conditions: Linear Pedagogy, Nonlinear Pedagogy or Control. Nonlinear and Linear Pedagogy intervention primary schools will receive a PE curriculum delivered by trained coaches over 15 weeks, while control schools will follow their usual practice. Data will be collected at baseline (T0), immediately post-intervention (T1) and six months after the intervention has finished (T2). Children’s movement competence is the primary outcome in this trial. Secondary outcomes include physical activity, perceived competence, motivation, executive functions, and self-regulation. An extensive process evaluation will also examine implementation factors such as intervention context, reach, dose, fidelity and acceptability. DISCUSSION: The SAMPLE-PE project will enable better understanding surrounding how to operationalise physical literacy through enrichment of PE practices in early PE. The study will provide robust scientific evidence regarding the efficacy of underpinning PE pedagogy with theories of motor learning to promote the development of physical literacy. (shrink)

Reason Curve, Jury Competence, and the English Criminal Justice System, a cross-jurisdictional and cross-disciplinary book, seeks to stimulate discussion and extend the debate in the area of criminal trials in light of the absence of an articulated explanation for a verdict. The book traces the history and development of the jury, from the Carolingian kings, its advancement in the English Courts following papal intervention, the impact of the Magna Carta, to its general use, current curtailment in England and Wales, (...) and re-emergence in Continental Europe. Central to the book's submission is the dictum that the jurors' franchise to deliver a cryptic verdict is 'a matter between them and their conscience... (shrink)

A document discovered in the Roman archives of the Jesuits sheds new light on the involvement of the Jesuit mathematician Christoph Scheiner in the trial of Galileo. The document suggests that Scheiner did not initiate the 1632–33 proceedings against Galileo, despite a long suspicion of his role in the events leading to Galileo’s condemnation, abjuration, and house arrest. An exploration of the contrasting conceptions of the scientific enterprise competing for hegemony within the Society of Jesus at the time of (...) the trial leads to the development of a model of scientific exchange based on money rather than gift giving. (shrink)

Individual and institutional conflict of interests in biomedical research have becomes matters of increasing concern in recent years. In the United States, the growth in relationships — sponsored research agreements, consultancies, memberships on boards, licensing agreements, and equity ownership — between for-profit corporations and research universities and their scientists has made the problem of conflicts, particularly financial conflicts, more acute. Conflicts can interfere with or compromise important principles and obligations of researchers and their institutions, e.g., adherence to accepted research norms, (...) duty of care to patients, and open exchange of information. Disclosure is a key component of a successful conflict policy. Commitments which conflict with a faculty member's primary obligations to teaching, research, administrative responsibilities, or patient care also need attention. Institutional conflict of interests present different problems, some of which are discussed in an analysis of an actual problem posed by two proposed clinical trials. (shrink)

The charge of treason and the judgment of insanity have left questions that invariably intrude on an assessment of Pound’s life and work. Critics frequently adopt a strategy of separating the life and the work, but tactical review is often necessary. There is a lightness in Pound’s writing that speaks of a being detached from the concerns of the world. Yet with his economic theory of social credit, his political and racial views, as well as his concern for other writers, (...) he is of the world—in the world and part of it. He was decidedly not tied to geography. He had no region or period, and he was as comfortable in Confucian China as in Dante’s Florence or twentieth-century Rome. He could work anywhere. He wrote The Pisan Cantos while jailed in Italy. The Cantos were published while he was in a mental wart at St. Elizabeths, yet a court found that he could not understand the charges against him. Can such an impairment and such achievement occur at the same time? If you say no, then what of the treason? Did he feign madness to escape punishment? Could Pound have been convicted of treason?In this paper, I intend to examine what has been loosely referred to as “the trial of Ezra Pound” and to show that Pound’s case should have been brought to trial within one or two years after his commitment to St. Elizabeths because he had a reasonable chance of being found not guilty of treason; even if found guilty, the circumstances in mitigation of a long prison term would have been so evident that he would have likely spent considerably less time in prison than he spent locked up at the mental institution. I will do this, in part, by reviewing the similarities and differences between Pound’s case and three other treason cases that came to trial within the first years after World War II. The English case, Rex v. Joyce, was tried shortly after the close of the war and well before Pound’s competency hearing on 13 February 1945.3 The law applied in Joyce would have led Pound’s lawyer to seek some postponement of trial until the American courts decided whether to follow the English lead. The other two cases involve the Americans, Douglas Chandler and Robert Best, employees of German radio, who were indicted with Pound in 1943. 3. William Joyce was an American who came to be known as “Lord Haw Haw.” He was hanged at Wandsworth, England, 3 Jan. 1946. He was the best known of the “radio traitors.” He began his programs, “This is Jairmany calling,” and would then prophesy the destruction of English towns and cities. The name “Lord Haw Haw” was created by the English journalist, Jonah Barrington, to ridicule Joyce and to make him appear idiotic. Conrad L. Rushing is a Superior Court Judge in California and an occasional lecturer in law at the University of California, Berkeley. He teaches a course in law and literature at the California Judges College and is a founder of the Sane Jose Poetry Center. (shrink)

BackgroundInternational guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned.MethodsIt was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National (...) Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety.ResultsIn total, 106 clinical trial protocols were identified from 2173 protocols seen in the archive and 104 included for review. Seventy six trials did not include the surveillance of adverse events as part of their objective. A total of 91 protocols did not budget for adverse event surveillance, 76 did not have a data safety management board, 11 included insurance for participants, 47 did not include a case definition for serious adverse events, 33 described procedures to detect adverse events, 33 described procedure for reporting and 22 described procedure for investigating adverse events.DiscussionsMost clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols.ConclusionClinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee. (shrink)

Decision-making by a Data and Safety Monitoring Board (DSMB) regarding clinical trial conduct and termination is intricate and largely limited by cases and rules. Decision-making by legal jury is also intricate and largely constrained by cases and rules. In this paper, I argue by analogy that legal decision-making, which strives for a balance between competing demands of conservatism and innovation, supplies a good basis to the logic behind DSMB decision-making. Using the doctrine of precedents in legal reasoning as my (...) central analog will lead us to a decision-theoretic analogy for much more systematic documentation of decisions in clinical trials. My conclusion is twofold: every DSMB decision should articulate a clear general principle (a ratio decidendi) that gives reason for the decision; and all such decisions should be made public. I use Bartha’s (2010) theory of analogical arguments to both frame and assess my argument by analogy. (shrink)

Background: Understanding is an important goal of the informed consent process in research. We sought to assess the interrater reliability (IRR) and concurrent validity of two measures of understanding in child and young adult subjects and their parents. Methods: We conducted a cross-sectional survey and interview-based study of children and young adults participating in a clinical trial for cancer, along with one parent per child or young adult subject. We estimated the IRR of the Semi-Structured Comprehension Interview (SSCI) and (...) the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). We also estimated concordance between the SSCI, the MacCAT-CR, and the Quality of Informed Consent (QuIC). Results: For our sample of 32 subjects (16 parent–child pairs), IRR estimates were high for total score on the SSCI (intraclass correlation coefficient [ICC] = 0.88, 95% confidence interval [CI] = 0.76–0.94), as well as on the understanding (ICC = 0.93, 95% CI = 0.86–0.97) and reasoning (ICC = 0.97, 95% CI = 0.94–0.98) subscales of the MacCAT-CR. IRR was lower for the appreciation subscale of the MacCAT-CR (ICC = 0.70, 95% CI = 0.47–0.84). Scores on the SSCI were strongly correlated with scores on the understanding subscale of the MacCAT-CR (Spearman's rho = 0.72, 95% CI = 0.48–0.85) and the QuIC (Spearman's rho = 0.66, 95% CI = 0.24–0.87). Mean administration time for the SSCI was 3.1 minutes (95% CI = 2.7–3.5 minutes). Conclusions: The SSCI is a valid and reliable measure of understanding for use with both pediatric and adult research participants. It is easy to administer and score consistently, even by nonprofessional raters. The SSCI is a promising tool for use by clinician-investigators to study, detect, and correct deficiencies in understanding among children, adolescents, and adults making decisions about research participation. (shrink)

Until about thirty years ago, the extent of disclosure about and consent-seeking for medical interventions was influenced by a beneficence model of professional behaviour. Informed consent shifted attention to a duty to respect the autonomy of patients. The new requirement arrived on the American scene in two separate contexts: for daily practice in 1957, and for clinical study in 1966. A confusing double standard has been established. 'Daily consent' is reviewed, if at all, only in retrospect. Doctors are merely exhorted (...) to obtain informed consent; they often minimise uncertainties about 'best' treatment and they feel duty-bound to provide patients with an unequivocal recommendation for action. 'Study consent' in a clinical trial is reviewed prospectively, and doctors are compelled by regulation to point out that there is insufficient evidence to make a rational choice between two compared treatments. It has been impossible to devise informed consent practices that satisfy, in full, the competing moral imperatives of respect for autonomy, concern for beneficence with emphasis on the value of health, and a vigil for justice. A way must be found to experiment with various discretionary approaches that would strike a realistic balance among competing interests. (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)

Objective: To assess whether continuous consent, a process in which information is given to research participants at different stages in a trial, and clinician training in that process were effective when used by clinicians while gaining consent to the Total Body Hypothermia (TOBY) trial. The TOBY trial is a randomised controlled trial (RCT) investigating the use of whole-body cooling for neonates with evidence of perinatal asphyxia. Obtaining valid informed consent for the TOBY trial is difficult, (...) but is a good test of the effectiveness of continuous consent. Methods: Semistructured interviews were conducted with 30 sets of parents who consented to the TOBY trial and with 10 clinicians who sought it by the continuous consent process. Analysis was focused on the validity of parental consent based on the consent components of competence, information, understanding and voluntariness. Results: No marked problems with consent validity at the point of signature were observed in 19 of 27 (70%) couples. Problems were found mainly to lie with the competence and understanding of the parents: mothers, particularly, had problems with competence in the early stages of consent. Problems in understanding were primarily to do with side effects. Problems in both competence and understanding were observed to reduce markedly, particularly for mothers, in the post-signature phase, when further discussion took place. Randomisation was generally understood but unpopular. Information was not always given by clinicians in stages during the short period available before parents gave consent. Most clinicians, however, were able to give follow-up information. Discussion: Consent validity was found to compare favourably with similar trials examined in the Euricon study. Conclusion: Adopting the elements of the continuous consent process and clinician training in RCTs should be considered by researchers, particularly when they have concerns about the quality of consent they are likely to obtain by using a conventional process. (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)

OBJECTIVE: (a) To measure the effect of a guideline-based training on the performance of ontology developers compared with the performance after unspecific training by a competency question based evaluation; and (b) to provide empirical evidence for the applicability of competency questions in formal ontology evaluation in general. BACKGROUND: A close connection between ontology development and ontology evaluation as quality management procedure can been attained with the use of competency questions. Competency questions are often used as a semi-formal specification of requirements (...) for an ontology under development. Hence they can also be used as evaluation instruments, in order to check how far an ontology fulfills these requirements. METHODS: A randomized controlled trial was conducted with two groups of 12 students each. The intervention consisted in a differential guideline-based training on ontology development vs. unspecific training. After a group-specific training focusing on three topics per group, performance of students was assessed with 12 exercises (2 exercises per topic), in which the students had to apply their skills. Different types of competency questions were elaborated for the analysis of the students' ontologies. We used the proportion of correct answers as a measure of ontology quality. RESULTS: On single topic level, the performance of ontology developers increased after guideline-based training for two out of the six topics: it increased from a proportion of 0.46 to 0.63 for the topic Process \& Participation and from 0.44 to 0.53 for the topic Collective Material Entity. In regression analysis, a positive correlation was shown between the performance of students on untrained topics and the performance after specific guideline-based training. Moreover, in multiple regression analysis an overall effect of specific training of 0.09 was calculated (p < 0.1). CONCLUSION: The results show an effect of a specific guideline-based training on the performance of ontology developers compared to the performance after unspecific training by an increase of about 10 \% on the rate of correct competency questions. In addition, this study has shown the general applicability of competency questions in a formal ontology evaluation scenario. However, the study also shows that the training of ontology developers and their performance evaluation is a tedious task. The resulting performance of ontology developers is more dependent on the a priori individual competencies than on the specific acquired skills after training. (shrink)

Many opponents of BIG programs believe that receiving guaranteed subsistence income would act as a strong disincentive to work. In contrast, various areas of empirical research in psychology suggest that a BIG would not lead to meaningful reductions in work. To test these competing predictions, a comprehensive review of BIG outcome studies reporting data on adult labor responses was conducted. The results indicate that 93 % of reported outcomes support the prediction of no meaningful work reductions when the criterion for (...) support is set at less than a 5 % decrease in either average hours worked per week or the rate of labor participation. Overall, these results indicate that adult labor responses would show no substantial impact following a BIG intervention. (shrink)

Hundreds of clinical trials of potential treatments and vaccines for the “coronavirus 19 disease” have been set up in record time. This is a remarkable reaction to the global pandemic, but the absence of a global coordination of clinical research efforts raises serious ethical concerns. Some COVID-19 patients might carry the burden of clinical trial involvement even though their trial cannot be completed as researchers are competing for patients. A shortage of medicines can occur when existing drugs are (...) diverted for clinical trials. Research ethics committees are overburdened with multiple applications. A multitude of trials can also overstretch medical staff and risk neglecting non-COVID-19 patients. And finally, conflicting conclusions from a multitude of heterogeneous trials might lead to delays in public health decisions about life-saving issues. These challenges are made worse by the unpredictable evolution of epidemics, the active involvement of political decision-makers in scientific issues and the pressure of social media globally. While freedom to conduct research must be safeguarded, global health emergency situations would greatly benefit from effective international coordination mechanisms for clinical research. (shrink)

Direct brain intervention based mental capacity restoration techniques-for instance, psycho-active drugs-are sometimes used in criminal cases to promote the aims of justice. For instance, they might be used to restore a person's competence to stand trial in order to assess the degree of their responsibility for what they did, or to restore their competence for punishment so that we can hold them responsible for it. Some also suggest that such interventions might be used for therapy or reform (...) in criminal legal contexts-i.e. to make non-responsible and irresponsible people more responsible. However, I argue that such interventions may at least sometimes fail to promote these responsibility-related legal aims. This is because responsibility hinges on other factors than just what mental capacities a person has-in particular, it also hinges on such things as authenticity, personal identity, and mental capacity ownership-and some ways of restoring mental capacity may adversely affect these other factors. Put one way, my claim is that what might suffice for the restoration of competence need not necessarily suffice for the restoration of responsibility, or, put another way, that although responsibility indeed tracks mental capacity it may not always track restored mental capacities. (shrink)

There has been little previous research regarding the effectiveness of ethics education interventions for residential care‐givers. The Researching Interventions to Promote Ethics in social care project responded to the question: Which is the most effective ethics education intervention for care‐givers in residential social care? A pragmatic cluster trial explored the impact of three ethics education interventions for: (a) interactive face‐to‐face ethics teaching; (b) reflective ethics discussion groups; and (c) an immersive simulation experience. There was also a control arm (d). (...) 144 trial participants were recruited from 39 residential care homes for older people in southern England. Change scores compared across intervention arms showed a significant reduction in work‐related moral stress in the teaching arm compared with control group (p =.03); there were no significant differences between control and intervention arms in change scores for moral sensitivity, interpersonal reactivity (empathy) or ethical leadership. Qualitative data themes were as follows: ethical care; care challenges; and ethical care inhibitors. Overall findings stimulate reflection on the value of three different ethics education interventions and the most appropriate means to evaluate their impact. Findings suggest the complexity and diverse nature of ethical competence in care. We suggest a way forward for research evaluating ethics education. (shrink)

Background: No studies have examined the underlying structure or predictive validity of the Cognitive Therapy Adherence and Competence Scale. Examining the structure of the CTACS is of great relevance because it could provide information on what constitutes competence in CBT, and whether some underlying factors are more important for predicting treatment outcomes than others. This study investigates the psychometric properties of the Norwegian version of CTACS and its associations with treatment outcomes in a sample of primary care clients (...) who received CBT for anxiety and/or depression.Method: Independent assessors rated audiotaped therapy sessions in a sample of 132 primary care clients, participating in the Prompt Mental Health Care trial. Outcomes were symptoms of anxiety and depression assessed by patient self-report questionnaires. Structural validity was examined by means of confirmatory and exploratory factor analyses, whereas longitudinal associations with treatment outcome were explored by adopting multilevel modeling.Results: No evidence was found for the divergent validity of the constructs competence and adherence as indicated by a very high correlation between these two subscales in CTACS. Regarding reliability, ICCs for the mean score of the full competence scale and its associated subscales were generally good to excellent, although the subscale measuring the quality of the therapeutic relationship was relatively low. Internal consistency was overall acceptable, but our CFA models did not provide an acceptable fit for the pre-specified one-factor and four-factor solutions. EFA results were difficult to interpret, with a sub-optimal three-factor solution providing best model fit and only two meaningful factors [CBT specific skills and session structure ]. Overall, the results indicated no evidence for the scales' predictive validity.Conclusion: Our findings point to several psychometric problems of the CTACS that may limit both its research and clinical utility. The importance of providing empirical evidence for both reliability and validity aspects of scales are discussed and suggestions for future research are provided. (shrink)

On September 15, 2003, the US. Court of Appeals for the Eleventh Circuit held that agreements between pharmaceutical and generic companies not to compete are not per se unlawful if these agreements do not expand the existing exclusionary right of a patent. The Valley DrugCo.v.Geneva Pharmaceuticals decision emphasizes that the nature of a patent gives the patent holder exclusive rights, and if an agreement merely confirms that exclusivity, then it is not per se unlawful. With this holding, the appeals court (...) reversed the decision of the trial court, which held that agreements under which competitors are paid to stay out of the market are per se violations of the antitrust laws. An examination of the Valley Drugtrial and appeals court decisions sheds light on the two sides of an emerging legal debate concerning the validity of pay-not-to-compete agreements, and more broadly, on the appropriate balance between the seemingly competing interests of patent and antitrust laws. (shrink)

Because corporate social responsibility can be beneficial to both companies and its stakeholders, interest in factors that support CSR performance has grown in recent years. A thorough integration of CSR in core business processes is particularly important for achieving effective long-term CSR practices. Here, we explored the individual CSR-related competencies that support CSR implementation in a corporate context. First, a systematic literature review was performed in which relevant scientific articles were identified and analyzed. Next, 28 CSR directors and managers were (...) interviewed. The literature review complemented with interview data resulted in the following eight distinct CSR-related competencies: Anticipating CSR challenges; Understanding CSR-relevant systems and subsystems; Understanding CSR-relevant standards; CSR management competencies, including Leading CSR programs, Managing CSR programs, and Identifying and realizing CSR-related business opportunities; Realizing CSR-supportive interpersonal processes; Employing CSR-supportive personal characteristics and attitudes; Personal value-driven competencies, including Ethical normative competencies, Balancing personal ethical values and business objectives, and Realizing self-regulated CSR-related behaviors and active involvement; and Reflecting on personal CSR views and experiences. Based on these results, implications for further research on this topic, as well as implications for practitioners, are discussed. (shrink)

There are competing ethical concerns when it comes to designing any clinical research study. Clinical trials of possible treatments for Ebola virus are no exception. If anything, the competing ethical concerns are exacerbated in trying to find answers to a deadly, rapidly spreading, infectious disease. The primary goal of current research is to identify experimental therapies that can cure Ebola or cure it with reasonable probability in infected individuals. Pursuit of that goal must be methodologically sound, practical and consistent with (...) prevailing norms governing human subjects research. Some maintain that only randomized controlled trials with a placebo or standard-of-care arm can meet these conditions. We maintain that there are alternative trial designs that can do so as well and that sometimes these are preferable to RCTs. (shrink)

This study offers a proposal about which competencies should be fostered in organizations to promote a culture in favor of sustainability in line with Pope Francis' encyclical letter Laudato Si. As a result, seven main competencies are proposed, with their interpretation in the light of the encyclical letter, and some suggestions on how to implement them in organizations are presented. The competencies are systemic vision, critical thinking, capacity for dialog, inclusion, proper use of goods, creativity, and spirituality. In addition, the (...) study offers a discussion of the relevance of these competencies in today's business context. This study offers a novelty with respect to other theoretical proposals on competencies for sustainability since it includes competencies that require an authentic concern for other people and for a vision of the human being open to transcendence, thus breaking with instrumentalism and technocratic paradigm that underlies other proposals. In this way, it also offers a new key to interpreting the integral ecology proposed by Pope Francis, which goes beyond other approaches to sustainability in that it includes not only the person–nature relationship but also the person–person and person–transcendence or person–God relationships. The conclusions of this theoretical research can be especially useful for those who intend to promote a culture of sustainability inspired by the Catholic Social Teaching, also making use of the knowledge and good practices of competency-based management. (shrink)

Science is sometimes depicted, both in scholarly and lay accounts, as a consensual and orderly progression in the direction of truth; at other times, it is portrayed as an arena in which lone geniuses struggle against rivals and authorities to impose unconventional interpretations of reality. The paper introduces the concept of ‘order-conflict dichotomy’ to stabilize the content of these definitions. It then shows, through an in-depth analysis of the Irving trial, an English libel suit involving historical knowledge about World (...) War II and the Holocaust, how these definitions can be used as rhetorical devices to promote professional and situational goals. Six couples of opposing sub-definitions of science are identified by analyzing court records. As a tentative hypothesis derived from the case, it is argued that the conception of science actors deploy in this kind of controversies reflect the overall structure of the market for knowledge about nature and society rather than disciplinary culture. (shrink)

Crucible experiences are essential in the development of leaders. Crucibles refer to trials and challenges that test and mold the character, values and behavior of leaders. Through in-depth interviews with 32 public relations leaders, we examined how crucible experiences specifically shaped them to practice servant leadership. Through the narratives they constructed about these experiences, we were able to learn specific details about these experiences, the lessons they gleaned and how they shaped and transformed their character, virtues and leadership style. These (...) insights matter, because public relations leaders have the potential to serve as ethical role models for their employees and colleagues. (shrink)

This paper outlines the approaches of two apparently competing schools of statistics. The criticisms made by supporters of Bayesian statistics about conventional Frequentist statistics are explained, and the Bayesian claim that their method enables research into new treatments without the need for clinical trials is examined in detail. Several further important issues are considered, including: the use of historical controls and data routinely collected on patients; balance in randomised trials; the possibility of giving information to patients; patient choice and patient (...) autonomy; and how widely the results of clinical trials can be used. It is concluded that good statistical techniques in the design and analysis of medical studies are essential, but the statistical school used in developing such techniques is relatively unimportant. (shrink)

The American Society for Bioethics and the Humanities (ASBH) issued its Core Competencies for Health Care Ethics Consultation just as it is becoming ever clearer that secular ethics is intractably plural and without foundations in any reality that is not a social–historical construction (ASBH Core Competencies for Health Care Ethics Consultation , 2nd edn. American Society for Bioethics and Humanities, Glenview, IL, 2011 ). Core Competencies fails to recognize that the ethics of health care ethics consultants is not ethics in (...) the usual sense of a morally canonical ethics. Its ethics is the ethics established at law and in enforceable health care public policy in a particular jurisdiction. Its normativity is a legal normativity, so that the wrongness of violating this ethics is simply the legal penalties involved and the likelihood of their being imposed. That the ethics of ethics consultation is that ethics legally established accounts for the circumstance that the major role of hospital ethics consultants is as quasi-lawyers giving legal advice, aiding in risk management, and engaging in mediation. It also indicates why this collage of roles has succeeded so well. This article shows how moral philosophy as it was reborn in the 13th century West led to the ethics of modernity and then finally to the ethics of hospital ethics consultation. It provides a brief history of the emergence of an ethics that is after morality. Against this background, the significance of Core Competencies must be critically reconsidered. (shrink)

Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one (...) that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research. (shrink)

An issue of ongoing concern to clinical investigators, medical ethicists, and institutional review board members is the problem of obtaining informed consent in research that involves people with mental illness as research participants. Although the presence of a mental disorder per se does not render a person incapable of giving informed consent, some individuals afflicted with significant cognitive impairment, formal thought disorder, substantial anxiety or depression, or a variety of other symptoms may be impaired in their capacity to comprehend consent (...) disclosures and therefore to exercise consent to research participation in a competent manner.The stakes surrounding this informed consent issue are significant. On the one hand, the inclusion in research of participants who are not capable of giving informed consent may result in their exposure to unwarranted risks and significant harm. These concerns may be exacerbated in certain clinical trials in which patients are required to discontinue their medications during “washout periods” at the onset of a study, or are randomly assigned to a placebo treatment and remain off medication for extended periods. (shrink)