Background The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period. Objectives The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance. Methods An observational study of protocols of randomised (...) trials of chronic therapies for cardiac conditions, approved by the REB of two academic institutions affiliated with the University of Toronto in Canada (University Health Network and Mount Sinai Hospital) from 1995 to 2007. Plans for patient surveillance in the post-trial period described in the protocol or in the consent form before and after REB approval were recorded. Results 42 studies were identified including 18 heart failure and 15 coronary artery disease trials. Only four studies planned a clinical visit after trial termination, and an additional three planned a telephone contact after trial completion. Five trials submitted consent forms to the REB with a discussion of the post-trial period. Conclusions The majority of protocols and consent forms did not discuss plans for post-trial period surveillance. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form. The small number of trial protocols evaluated in the study may impair the degree to which the results can be generalised. (shrink)

The paper seeks to analyse how two domestic courts decided criminal trials under circumstances of emotional mobilisation and political stress. Decisions from Argentina after 1983 and Romania after Ceausescu’s dictatorship illustrate how citizens’ affects influence courts’ choices within penal cases. Both cases show how the judiciary had to enter a dialogue with resentful and indignant claims for redress. However, while the Argentinean court filtered emotions through the strainer of equal respect and thus pushed the cause of democratic justice ahead, the (...) Romanian case serves as a cautionary tale about how not to correct injustices through criminal law. These two cases provide us with important lessons about the obstacles, but also the opportunities associated with public emotions during periods of radical political transformation. (shrink)

One of the ways in which film was used by the communist authorities for propaganda purposes was to present show trials. The aim of the article is an attempt to explain how film was used in Poland to discredit defendants in trials before courts during the Stalinist period. How were the roles of the participants in the court proceedings presented in the film? How were the films from court hearings to be used to depreciate the defendants in the eyes (...) of society, and to legitimise and strengthen the authority of the new government? The article is based on examples of films from show political trials of “enemies of the people” in Poland in the 1940s and 1950s. (shrink)

In the first part of this paper, I shall argue that Apollodorus of Athens, in his Chronica, dated Anaxagoras' arrival at Athens to 456/5, following Demetrius of Phalerum. Rejecting the divergent opinion of others, he also followed Demetrius' estimation of the Athenian period as having lasted 20 years, which makes 437/6 Anaxagoras' last year at Athens 1). In the second part I shall argue that the trial of Anaxagoras, about which no information survives in the remains of Apollodorus (...) but which is reported by several other sources, should probably be dated to 437/6. This second argument is independent of the first; both run counter to the view, still rather popular among historians of ancient philosophy, which favours a date for the trial either immediately preceding or even following upon the beginning of the Peloponnesian War, as well as to the communis opinio according to which the Athenian period lasted 30 years. What is common to both parts of this inquiry is a refusal to study the chronology of Anaxagoras' career in isolation. In part I, which is chiefly concerned with an analysis of the relevant passage in Diogenes Laertius qua specimen of Apollodorean reasoning, the problem is discussed against the background of Apollodorus' synchronistic matrices. In part II, the trial and the decree of Diopeithes which made it possible are studied in connection with the plot against Pericles and certain members of his circle.-A suggestion regarding the date of 'publication' of Anaxagoras' treatise will be appended to part II. (shrink)

When research concludes, post-trial access to the trial intervention or standard healthcare can be crucial for participants who are ill such as those in resource-poor countries with inadequate healthcare, British participants testing ‘last-chance drugs’ unavailable on the National Health Service and underinsured US participants. Yet, many researchers are unclear about their obligations regarding the post-trial period, and many research ethics committees do not know what to require of researchers. Consequences include participants who reasonably expect but lack (...) PTA to the trial intervention, unplanned financial liabilities for NHS Trusts forced to fund this, negative press and potential to undermine public trust.1–3,iOne reason for the lack of clarity is controversy over whether and when participants should have access, after the study, to the study intervention. At one extreme is the view that continued access should be ensured when the intervention has benefited the participant or when it has proven safe and effective for the participant population, irrespective of the cost and burden of ensuring continued access. At the other extreme is the view that continued access need never be provided so long as non-availability of the study intervention post-trial was adequately disclosed when participants were invited to participate.6 There is also disagreement about when poststudy access to the study intervention should be considered beneficial for participants. The spectrum ranges from the view that the intervention should be regarded as beneficial for a proposed use only after the …. (shrink)

Baruch Spinoza is considered one of the great rationalist thinkers of the seventeenth century. His magnum opus, _Ethics_, in which he criticized the dualism of Descartes, solidified his reputation and greatly influenced the Enlightenment thinkers who would build from his work. Born in Amsterdam into a family of Sephardic Jews who had to take refuge there after they were expelled from Portugal, the precocious young scholar imbibed skepticism at an early age. By the time he was twenty-four, he had challenged (...) what he called the “fairy tales” of the Old Testament and was excommunicated by the Synagogue. In this biographical play, Tariq Ali contextualizes Spinoza’s philosophy by linking it to the turbulent politics of the period, in which Spinoza was deeply involved. Ali originally wrote _The Trials of Spinoza_ as part of a series on philosophy for British Channel Four television, and this publication also includes a DVD of that original television production. This work will be welcomed as a testament to the continuing interest in and relevance of Spinoza’s work and as an example of Ali’s eloquent and always politically engaged writing. (shrink)

Objectives: To review the performance of research ethics committees in Spain in assessing multicentre clinical trial drug protocols, and to evaluate if they would comply with the requirements of the new EU Directive to be implemented by May 2004.Design and setting: Prospective study of applications of MCT submitted to RECs.Main measurements: Protocol related features and evaluation process dynamics.Results: 187 applications to be performed in 114 centres, were reviewed by 62 RECs. RECs had a median number of 14 members, of (...) which three were lay members. All applications were approved except four which were however approved by the other RECs involved. The median times from submission to approval and from submission to reception at the sponsor’s offices were 48 and 62 days, respectively. In 55% of all applications approved, 41 RECs raised 307 queries, 40% of these were protocol related issues, and 38% related to the patients’ information sheets. RECs charging an evaluation fee in advance and applications with no queries raised were statistically significantly associated with shorter evaluation times. However, there is a gap of at least 1.5 weeks between the date of the meeting and the reception of the approval letter in the sponsor’s office.Conclusions: Evaluating MCT protocols by RECs is a time consuming process. Needing 1.5 weeks for communicating the decision taken by RECs to the sponsor suggests serious administrative shortcomings within most RECs. By significantly reducing the time for communication of their decisions, the majority of RECs would comply with the Directive requirement of a maximum 60 day period for the assessment of MCT. (shrink)

Background. Informed consent (IC) is not only a regulatory but also an ethical requirement to participate in any clinical trial. It is essential to determine that research participants understand what they consent to. Studies that evaluate participants’ understanding of IC conclude that recall and understanding of IC is often low, and researchers recommend that interactive multimedia interventions should be implemented to optimise understanding. Objectives. To assess participants’ understanding of IC of the research trial that they agreed to participate (...) in.Methods. A descriptive survey design, within a quantitative research approach, was used to conduct the study at two government hospitals in the Eastern Cape Province. A semi-structured, self-administered questionnaire was used to collect information from 170 participants in research studies. Descriptive statistics were used to analyse the results.Results. Participants were recruited from among women who enrolled in any of the three studies that were ongoing at the two sites during the recruitment period. The study participants had a mean age of 25.9 years. Nearly one-third (30%) could not recall the purpose of the original trial that they consented to. The concept of randomisation was not understood by any of the participants.Conclusion. Regardless of extensive efforts to ensure that participants understood their participation, this study unveiled poor recall of essential information on IC. It is proposed that IC should be short and only address essential components such as purpose, procedure, possible risks or benefits, alternative options if not participating and explaining the concept of voluntary participation. (shrink)

Some National Health Service healthcare boards in the UK will approve a request for female sterilisation only if the patient first accepts a trial period of 1 year with an intrauterine device (IUD), a form of long-acting reversible contraception. In this article, I argue that this requirement is not justified by appeal to any of (or any combination of) promotion of informed consent, paternalistic concerns regarding patient regret in later life and health service budgetary considerations. Informed consent and (...) patient autonomy may be promoted by a mandatory waiting period, but the concomitant imposition of an IUD trial during this period cannot be justified on these grounds. As long as elective vasectomy is offered by the healthcare system, elective female sterilisation should be accessible under reasonably similar—even if not identical—conditions. (shrink)

The need for continuing provision of beneficial experimental interventions after research is concluded remains a controversial topic in bioethics for research. Based on the principle of beneficence, justice as reciprocity, concerns about exploitation and fair benefits, participants should be able to have continuing access to benefits beyond the research period. However, there is no consensus about whether or not post-trial provision of beneficial interventions should be mandatory for participants from developing countries. This paper summarises recommendations from international and (...) national guidelines. Ethical principles and practical issues relating to post-trial provision are also discussed. In conclusion, post-trial provision is not necessary in all situations and a set of criteria are proposed to identify the situations that beneficial interventions should be provided beyond the research period. However, mandatory post-trial supply of beneficial experimental interventions should be assured for those who still need and are able to benefit from them but have no alternative access. Mandatory provision is based on universal bioethical principles such as beneficence and justice. Furthermore, difficulties associated with implementation of post-trial provision are not unmanageable. Careful advanced planning and a comprehensive partnership among relevant parties would be very helpful in solving these difficulties in practice, which therefore should not be taken as an excuse to escape post-trial responsibility. (shrink)

Transitional justice is broadly understood to refer to formal efforts to deal with past wrongs in the midst of a transition from an extended period of conflict or repression to democracy. In this paper, I consider the role of international criminal trials in transitional justice. I argue that such trials may contribute to transitional justice, but such contributions are conditional on two main factors. The first factor is time. The second factor is what other transitional justice responses are adopted (...) domestically. (shrink)

Kafka's novel The Trial, written from 1914 to 1915 and published in 1925, is a multi-faceted, notoriously difficult manifestation of European literary modernism, and one of the most emblematic books of the 20th Century. It tells the story of Josef K., a man accused of a crime he has no recollection of committing and whose nature is never revealed to him. The novel is often interpreted theologically as an expression of radical nihilism and a world abandoned by God. It (...) is also read as a parable of the cold, inhumane rationality of modern bureaucratization. Like many other novels of this turbulent period, it offers a tragic quest-narrative in which the hero searches for truth and clarity, only to fall into greater and greater confusion. This collection of nine new essays and an editor's introduction brings together Kafka experts, intellectual historians, literary scholars, and philosophers in order to explore the novel's philosophical and theological significance. Authors pursue the novel's central concerns of justice, law, resistance, ethics, alienation, and subjectivity. Few novels display human uncertainty and skepticism in the face of rapid modernization, or the metaphysical as it intersects with the most mundane aspects of everyday life, more insistently than The Trial. Ultimately, the essays in this collection focus on how Kafka's text is in fact philosophical in the ways in which it achieves its literary aims. Rather than considering ideas as externally related to the text, the text is considered philosophical at the very level of literary form and technique. (shrink)

The history of drug/vaccine development has included major advances guided primarily by risk/benefit analyses concerning the innovative agent, not by evidence-based clinical trials (Phase I–IV). Because the approval for new drugs is hindered under the present process, the system requires restructuring. The Phase I/II study period should be more flexible, using the “environment of knowledge” about the new agent, plus risk/benefit assessments. Phase III, as presently constructed, does not add new adverse events data, it provides a narrower profile of (...) drug efficacy than properly done Phase II studies, and placebo-controlled trials continue to raise unresolved ethical and social issues. Phase III studies should be abandoned for most drugs, and substituted with properly powered Phase II doseranging studies plus careful post-marketing surveillance. Phase III should be a penalty for poor drug development, not a regulatory requirement. (shrink)

Dotted throughout the records of the turbulent last decades of fourth-century Athens are reports—often frustratingly vague—of prosecutions, many of intellectuals on the charge of . Most belong to the period of Macedonian domination: Theophrastus was one targeted at this time, and we hear also of actions against Demetrius of Phalerum, Theodorus the atheist, and Stilpo of Megara. Even before the Athenian capitulation to Macedon, in the immediate aftermath of the death of Alexander, prosecutions were launched against Demades and Aristotle. (...) These two early prosecutions are generally accepted to have had a political purpose, being attacks aimed at Macedonian sympathizers by the more staunchly pro-democratic Athenian elements; the later trials, however, are poorly attested in the sources and have received less scholarly attention, particularly for their political aspects. (shrink)

The purpose of den trials is to assess innate ability and preparedness of dachshunds and terriers to work in natural beds in order to control fox numbers. International earthdog trials within the period 2009–2018 were evaluated in Slovakia, in which 1812 dogs participated, of which terriers represented 61.36% and dachshunds 38.64%. Depending on the way of work, dogs of these breeds work as bayer, bolter or hard dog. The test rules were compared in terms of animal protection, principles of (...) ethics and welfare requirements in the Visegrad countries. We investigated the extent to which animals used in trials are exposed to suffering in the countries under review. During the den trials in Slovakia, there is a direct physical contact between the dog and the fox, where the foxes are unnecessarily exposed to excessive stress, injury and pain and violated by Five Animal Welfare Needs, in particular the need to protect against pain, injury and disease. Due to non-compliance with the welfare, we propose a change in the examination rules in the earthdog work in Slovakia. Non-parametric Chi square statistic to analyse group differences when the dependent variable is measured at nominal level was used. (shrink)

The literary sources for the Flavian and Antonine periods of Roman history, it is a notorious and unhappy fact, where they exist at all, are infuriatingly fragmentary, frequently obscure, too frequently inaccurate or mendacious. Significant gaps still linger even in chronology; hence it can hardly occasion surprise that we are rarely permitted a glimpse of the political activity which preoccupied the emperors and Senate.

Les femmes ont-elles été jugées pour des crimes perpétrés pendant la période nazie? Pour tenter de répondre à cette question, il convient de faire la distinction entre les procès qui se sont déroulés très vite après la capitulation allemande, dans les diverses zones d’occupation et ceux qui se font à Nuremberg, selon un nouveau droit international. Les seconds visent des criminels ayant un degré de responsabilité dans les divers appareils de l’État nazi, responsabilité alors interdite aux femmes. Les premiers, qui (...) se font selon le droit déjà établi, concernent ceux qui ont commis de leurs propres mains des violences meurtrières. On apprendra donc par cet article que de très jeunes femmes furent condamnées à mort et exécutées pour les crimes qu’elles ont commis dans les camps. (shrink)

One way to test vaccines is through human challenge trials in which participants are intentionally infected with a contagious organism to expedite the process of assessing the vaccine’s effectiveness. Some experts believe challenge trials may play an important role in fighting COVID-19, especially if the vaccines under current study do not demonstrate sufficient efficacy, if spread of COVID-19 is controlled to a point that radically slows down traditional trials, or if new vaccines need to be rapidly developed for specific subpopulations.1 (...) Challenge trials involve significant time, burden and risk, requiring participants to spend 3–6 weeks in legal quarantine for 24 hours a day in a high-security facility. During this time, no inperson visitors will be allowed, except for very limited inperson contact from researchers collecting necessary data and checks. Following the quarantine period, participants will be asked to attend numerous outpatient follow-up visits over the course of months, to further monitor their response to the vaccine. Participation involves being away from family who may themselves become sick during the global pandemic, as well as potential fear and mental anguish around being a ‘first’ subject. Because there is no definitive treatment for COVID-19, participants could experience serious illness. But even with milder illness, medical experts know very little about the long-term consequences of COVID-19 infection. This raises the question of how much people should be paid for their participation in COVID-19 challenge trials. Most think participants should be paid something, but many contend that we should be …. (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)

This paper looks at the thread throughout Nancy’s work on the notion of the decision and judgment. In a period when we must rethink not only the sovereign decision but all manner of traditional jurisprudential and ethical modes of thinking the decision, Nancy’s considerations of freedom help us reflect on thinking the decision otherwise and thus could prove revolutionary for how we think crime and punishment and calculating with the incalculable of each and every trauma we dub a crime. (...) At a time when the geographies of the prison–industrial complex overtake the West, perhaps no other thinking is more central to undoing its practices and sovereignty. (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)

BackgroundInformed consent as stipulated in regulatory human research guidelines requires that a volunteer is well-informed about what will happen to them in a trial. However researchers are faced with a challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. We conducted a qualitative study among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent and their perceptions of the (...) class='Hi'>trial procedures, study information and interactions with the research team.MethodsBetween January and December 2012, 23 volunteers who had been in the two trials for over 6 months, consented to be interviewed about their experience in the trial three times over a period of nine months. They also took part in focus group discussions. Themes informed by study research questions and emerging findings were used for content analysis.ResultsVolunteers defined the informed consent process in terms of their individual welfare. Only two of the volunteers reported having referred during the trial to the participant information sheets given at the start of the trial. Volunteers remembered the information they had been given at the start of the trial on procedures that involved drawing blood and urine samples but not information about study design and randomisation. Volunteers said that they had understood the purpose of the trial. They said that signing a consent form showed that they had consented to take part in the trial but they also described it as being done to protect the researcher in case a volunteer later experienced side effects.ConclusionVolunteers pay more attention during the consent process to procedures requiring biological tests than to study design issues. Trust built between volunteers and the research team could enhance the successful conduct of clinical trials by allowing for informal discussions to identify and review volunteers’ perceptions. These results point to the need for researchers to view informed consent as a process rather than an event. (shrink)

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

Those researching HIV prevention measures for people who inject drugs face a dilemma. Regions where baseline HIV prevalence and onward transmission via injecting is sufficiently high to power HIV prevention trials are also those where repressive laws, policies and practices raise concerns about the ethics of research subject protection. Dawson et al, outlining criteria to address ethical challenges in HIV prevention research among PWID, recommend that all trial participants be offered sterile injecting equipment and urge additional strategies to limit (...) research and background risks.1 In light of ethical questions opened by recent clinical trials involving PWID, including several the authors cite favourably, these cautions are timely. Dawson et al urge weighing of costs and benefits of PWID participation in research trials as an essential part of the ethical calculus. Overdose is a particular risk in any trial that uses abstinence from opioids as a precondition for participation or as an outcome of interest, and a risk that institutional review boards and researchers frequently ignore. Given the increased likelihood of fatal overdose for those who return to injection following a period of abstinence, provision to all trial participants of naloxone—the overdose antidote …. (shrink)

ObjectiveThis study aimed to describe how parents and physicians experienced the informed consent interview and to investigate the aspects of the relationship that influenced parents’ decision during the consent process for a randomised clinical trial in a tertiary neonatal intensive care unit. The secondary objective was to describe the perspectives of parents and physicians in the specific situation of prenatal informed consent.SettingSingle centre study in NICU of the Centre Hospitalier Intercommunal de Créteil, France, using a convenience period from (...) February to May 2016.DesignAncillary study to a randomised clinical trial: Prettineo. Records of interviews for consent. Population: parents and physicians. Mixed study including qualitative and quantitative interview data about participants’ recall and feelings about the consent process. Interviews were reviewed using thematic discourse analysis.ResultsParents’ recall and understanding of the study’s main goal and design was good. Parents and physicians had a positive experience, and trust was one of the main reasons for parents to consent. Misunderstanding was the main reason for refusal.Before birth, three situations can compromise parents’ consent: the mother already consented to participate in other studies, the absence of the father during the interview and the feeling that the baby’s birth is not an imminent possibility.ConclusionsConfronting parents and physicians’ perspectives in research can help us reach answers to sensitive issues such as content and timing of information. Each different types of study raises different ethical dilemmas for consent that might be discussed in a more individual way. (shrink)

This paper seeks to contribute to the field of transitional justice by adding new insights about the role that trials of victimizers can play within democratization processes. The main argument is that criminal proceedings affirming the value of equal respect and concern for both victims and abusers can contribute to the socialization of citizens’ politically relevant emotions. More precisely, using law constructively to engage public resentment and indignation can be successful to the extent that legality is not sacrificed. In order (...) to locate this argument within the rich literature on the pedagogical functions of transitional trials this paper enters a dialogue with three emblematic texts. Lawrence Douglas’s narrative jurisprudence approach, Judith Shklar’s critique of the limits of legalism, and Marc Osiel’s interest in ‘discursive solidarity’ represent starting points for a more complex conceptualization of the relationship between democracy, law and emotional education within transformational periods. (shrink)

Background: It is acknowledged that publishers now require all primary research papers to demonstrate that they have obtained ethical approval for their research. Objectives: To assess the rate of reporting of ethical approval in clinical trials in core nursing journals in mainland China. Research design: A retrospective observational study. Participants: All clinical trials published in all of the 12 core nursing periodicals from 2016 edition China Science and Technology Journal Citation Report (core version) between 2013 and 2016 were retrieved by (...) hand to explicate rate of reporting ethical approval and informed consent. Ethical considerations: The study did not require approval from the research ethics committee as it did not involve human subjects or records. Results: In total, 40,278 papers were published in 12 nursing periodicals between 2013 and 2016. Out of these, 9488 (23.6%) focused on clinical trials. Informed consent obtained from patients or the legally authorized representative was reported in 51.8% of clinical trials. Notably, only 27.4% of clinical trials reported that they had obtained written consent. Furthermore, 25.9% of clinical trials described ethical approval; however, the rate of reporting informed consent and ethical approval in these 12 nursing journals in China during 4 years from 2013 to 2016 improved markedly, with 38.1%, 44.0%, 59.0% and 66.6%, respectively ( p < 0.001), and 17.6%, 21.9%, 28.6% and 35.8%, respectively ( p < 0.001). In addition, both reporting informed consent and reporting written informed consent had a positive significant correlation with the reporting ethical approval ( p < 0.05 or < 0.01). Conclusion: Chinese scientific nursing journals have improved the rate of reporting informed consent and ethical approval in clinical trials during the last 4 years. However, it should be noted that nearly half of clinical trials still did not report either ethical approval or whether informed consent was obtained. Efforts from editors, researchers, sponsors and authors are needed to ensure the transparency of ethical scrutiny and adherence to ethical guidelines in publishing clinical trials in Chinese nursing journals. (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)

In this paper, I have analyzed the right to trial by jury in civil cases as reflected in decisions of the Michigan Supreme Court over approximately a 20 year period dealing with three areas affecting the right to trial by jury in civil cases: (1) entitlement to a jury trial; (2) summary disposition; and (3) directed verdicts. The study was constructed to cover cases over a substantial period of time, so that it would be possible (...) to analyze whether the changing composition of the Michigan Supreme Court, beginning in the late 1990's, impacted on the Court's decisions in these three areas.The conclusion that emerges from the is that the Court, as currently constituted, has diminished the right to trial by jury in civil cases in Michigan. The Court is more inclined than it was prior to 1999 to hold in more cases that there is no genuine issue of material fact, justifying summary disposition, and has now heard cases in which it has held that the defendant is entitled to a directed verdict. And the fact that the Court is more inclined to uphold the granting of summary disposition and directed verdicts is likely to have a demonstrable impact on these kinds cases when they are presented to the Court of Appeals and the trial courts. These courts, following the precedents of the Supreme Court and the results of the cases coming before that Court, will be more likely to rule in favor of granting motions for summary disposition and motions for directed verdicts.Given the Court's view of the diminished role of the jury in resolving factual disputes in civil cases, litigating lawyers must make the best of a bad situation and do everything that they can in order to protect the right to trial by jury in civil cases. They must try to ensure in the early stages of the litigation that their cases are strong enough to survive a motion for summary disposition and get to the jury, and at the trial they must make a determined effort to present sufficient evidence to survive a directed verdict. Hopefully the Court's view of the diminished role of the jury will not have dealt a fatal blow to the right to trial by jury in civil cases in Michigan. Time will tell how well the lawyers of Michigan have succeeded in preserving this fundamental constitutional right. (shrink)

This essay examines a challenge to common literary representations of female mental illness in the Early Modern period—the hysterical woman—in a collection of French short stories contemporary to Vesalius's De Fabrica: Jeanne Flore's Tales and Trials of Love. Jeanne Flore's tales depict several mentally disturbed female protagonists, young women prone to paroxysms of madness and self-mutilation. This study maintains that while Tales and Trials of Love superficially participates in the literary tradition that grew out of those accepted social and (...) medical beliefs, it also questions the long-accepted paradigm of female hysteria and points to a shift in the socio-medical climate. Jeanne Flore's fictional narratives suggest that mental illness no longer consists in the realignment of a uterine imbalance, but rather in the telling of personal stories, a precursor to psychoanalysis and narrative medicine. (shrink)

This article analyzes the bioethical implications of using a control/placebo group when conducting clinical trials (CTs) investigating the treatment of periodontitis. For this, the deductive method was used, proposing the interrelation of values, and a scoping systematic review was carried out. A total of 53% of the CTs reviewed were performed in low- and middle-income (LMI) countries, and 92% used a control/placebo group as a comparison group. Although there is a gold standard for the adjunctive treatment of periodontitis, the research (...) ethics committees of most of the analyzed studies approved the use of control/placebo groups for the performance of CTs that did not explore new therapeutic alternatives. In some cases, the CT protocols were not approved by ethics committees, nor was informed consent used. In the LMI countries, a shorter period of recruitment was observed for patients who attended universities and public hospitals. Likewise, most of the CTs reviewed had public funding, a significant amount of which came from the pharmaceutical industry. Only one CT reported the low economic and educational level of its participants. Furthermore, none of the authors of the reviewed CTs declared conflicts of interest. Although the axiology of techno-science always takes into account at least the epistemic, technical and economic value systems, the hegemony of the economic values imposed by the pharmaceutical industry is evident in the performance of CTs investigating the treatment of periodontitis in LMI countries. (shrink)

Introduction: Falls are the leading cause of fatal and nonfatal injuries among older adults. Studies showed that older adults can reduce the risk of falls after participation in an unexpected perturbation-based balance training, a relatively novel approach that challenged reactive balance control. This study aims to investigate the effect of the practice schedule on reactive balance function and its transfer to proactive balance function. Our primary hypothesis is that improvements in reactive balance control following block PBBT will be not inferior (...) to the improvements following random PBBT.Methods and Analysis: This is a double-blind randomized controlled trial. Fifty community-dwelling older adults will be recruited and randomly allocated to a random PBBT group or a block PBBT group. The random PBBT group will receive eight training sessions over 4 weeks that include unexpected machine-induced perturbations of balance during hands-free treadmill walking. The block PBBT group will be trained by the same perturbation treadmill system, but only one direction will be trained in each training session, and the direction of the external perturbations will be announced. Both PBBT groups will receive a similar perturbation intensity during training, the same training period, and the same concurrent cognitive tasks during training. The generalization and transfer of learning effects will be measured by assessing the reactive and proactive balance control during standing and walking before and after 1 month of PBBT, for example, step and multiple steps and fall thresholds, Berg balance test, and fear of falls. The dependent variable will be rank transformed prior to conducting the analysis of covariance to allow for nonparametric analysis.Discussion: This research will explore which of the balance retraining paradigms is more effective to improve reactive balance and proactive balance control in older adults over 1 month. The research will address key issues concerning balance retraining: older adults’ neuromotor capacities to optimize training responses and their applicability to real-life challenges.Clinical Trial Registration: Helsinki research ethics approval has been received. (shrink)

BackgroundAccurate reporting on sex and gender in health research is integral to ensuring that health interventions are safe and effective. In Canada and internationally, governments, research organizations, journal editors, and health agencies have called for more inclusive research, provision of sex-disaggregated data, and the integration of sex and gender analysis throughout the research process. Sex and gender analysis is generally defined as an approach for considering how and why different subpopulations (e.g., of diverse genders, ages, and social locations) may experience (...) health conditions and interventions in different or similar ways.The objective of this study was to assess the extent and nature of reporting about sex and/or gender, including whether sex and gender analysis (SGA) was carried out in a sample of Canadian randomized controlled trials (RCTs) with human participants.MethodsWe searched MEDLINE from 01 January 2013 to 23 July 2014 using a validated filter for identification of RCTs, combined with terms related to Canada. Two reviewers screened the search results to identify the first 100 RCTs that were either identified in the trial publication as funded by a Canadian organization or which had a first or last author based in Canada. Data were independently extracted by two people from 10% of the RCTs during an initial training period; once agreement was reached on this sample, the remainder of the data extraction was completed by one person and verified by a second.ResultsThe search yielded 1433 records. We screened 256 records to identify 100 RCTs which met our eligibility criteria. The median sample size of the RCTs was 107 participants (range 12–6085). While 98% of studies described the demographic composition of their participants by sex, only 6% conducted a subgroup analysis across sex and 4% reported sex-disaggregated data. No article defined “sex” and/or “gender.” No publication carried out a comprehensive sex and gender analysis.ConclusionsFindings highlight poor uptake of sex and gender considerations in the Canadian RCT context and underscore the need for better articulated guidance on sex and gender analysis to improve reporting of evidence, inform policy development, and guide future research. (shrink)

ObjectivesMany older adults with visual impairment also have significant hearing loss. The aim was to investigate the effectiveness of a newly developed Dual Sensory Loss protocol on communication and wellbeing of older persons with DSL and their communication partners in the Netherlands and Belgium.MethodsParticipants and their communication partners were randomized in the “DSL-protocol” intervention group or a waiting-list control group. The intervention took 3 to 5 weeks. Occupational therapists focused on optimal use of hearing aids, home-environment modifications and effective communication (...) strategies. The primary outcome was the Communication Strategies domain of the Communication Profile for the Hearing Impaired. Secondary outcomes measured in participants were the Low Vision Quality Of Life Adjustment subscale, the Center for Epidemiological Studies - Depression Scale, De Jong Gierveld Loneliness Scale and the Fatigue Assessment Scale. The Hearing Handicap and Disability Inventory - Reaction of Others subscale and the Care-related Quality of Life - 7 Dimensions was measured in communication partners. Measurements were taken at baseline and 3-month follow-up. Linear mixed models were used to analyze effects between groups over time for every outcome measure.ResultsIntention-to-treat analyses showed a significant effect of the DSL-protocol on the use of verbal strategies in favor of the control group, however, this effect was non-significant after adjustment for confounding. Effect sizes of other outcomes varied between −0.23 [−0.57, 0.12] and 0.30 [−0.05, 0.64]. The LMM showed a significant effect on the HHDI-Reaction of others scale in favor of communication partners in the treatment group, however, the effect did not remain significant at a 0.01 significance level and the effect size was very small and non-significant 0.12, 95% CI [−0.27 to 0.51]. Adjusted analyses did not reveal treatment effects.ConclusionThe DSL-protocol did not clearly contribute to the enhancement of communication and wellbeing in DSL-patients. Possible reasons for the lack of effects are OTs not being comfortable giving advice on communication and psychosocial issues or the short-term treatment and follow-up period. Further study is warranted to find out how the protocol may be adapted or whether it is necessary to involve mental healthcare professionals.Clinical Trial Registrationwww.ClinicalTrials.gov, identifier NTR2843. (shrink)

This paper examines the role of mathematical instrument makers in establishing a public culture of precision measurement in early-modern England. I argue that this culture was promoted through trials and demonstrations, in the context of which artisans held a privileged position. The trials described here cover land surveying, the measurement of magnetic variation, and standards of measurement for customs and excise. These trials were decisive moments in the ‘cultural biographies’ of precision instruments. I ask how it was that instrument makers (...) were able to assume positions of authority, and what this means for our understanding of the socio-material system of precision measurement in the early-modern period, and the contemporary rise of ‘experimental’ and ‘philosophical’ trials. Because practical mathematics was a self-consciously economic activity – motivated by trade, commerce, exploration and colonization – direct connections to natural philosophy are significant, a point explored in my conclusion. (shrink)

Objectives—To assess the relationship between the approval of trials by a research ethics committee and the fact that informed consent from participants was obtained, with the quality of study design and methods.Design—Systematic review using a standardised checklist.Main measures—Methodological and ethical issues of all trials published between 1993 and 1995 in the New England Journal of Medicine, the Lancet, the Journal of the American Medical Association and the British Medical Journal were studied. In addition, clinical trials conducted in Spain and published (...) by at least one Spanish author during the same period in any other journal were also included.Results—We studied the published articles of 767 trials and found the following indicators of lower methodological quality to be independent predictors for failure to disclose REC approval or ICP: absence of concealment of allocation, lack of justification for unblinded trials, not using a treatment for the patients in the control group, absent information on statistical methods, not including sample size estimation, not establishing the rules to stop the trial, and omitting the presentation of a baseline comparison of groupsConclusion—Trials of higher methodological and scientific quality were more likely to provide information about their ethical aspects. (shrink)

Did you know that insects could be tried for criminal acts in pre-industrial Europe, that the dead could be executed, that statues could be subjected to public humiliation, or that it was widely accepted that corpses could return to life? What made reasonable, educated men and women behave in ways that seem utterly nonsensical to us today? Strange Histories presents for the first time a serious account of some of the most extraordinary occurrences of European history. Throughout the ages, people (...) have held ideas and events have taken place which have baffled later societies. Religious disbelievers were thought deserving of death, insects were occasionally excommunicated, studying the biology of angels was a legitimate activity, and the pursuit of personal happiness was considered rather misguided as a life strategy. Using case studies from the Middle Ages and the early modern period with some from the more recent past, this book provides fascinating insights into the world-view through the ages, and shows how such goings-on fitted in quite naturally with the "common sense" of the time. Explanations of these phenomena, riveting and ultimately rational, encourage further reflection on what really shapes our beliefs. In the light of history, can we be sure of the validity of our own ideas? How many of our own beliefs might no longer "make sense" a few centuries from now? (shrink)

PURPOSE/OBJECTIVES: To examine differences in nursing care received by patients with breast cancer enrolled in clinical trials and those not enrolled in clinical trials. DESIGN: Retrospective review of clinic charts. SETTING: Oncology outpatient department of a tertiary-care hospital. SAMPLE: 90 women with early stage breast cancer. The mean age of the women was 53 years. More than half of the women (51 of 90) were treated in a clinical trial. METHODS: Retrospective chart review of all the nurse-patient clinic encounters (...) for a six-month period from date of cancer diagnosis. The content of each encounter was coded using a modified version of the Nursing Action Classification System. MAIN RESEARCH VARIABLES: Nursing interventions (i.e., assessment, medical scheduling, psychosocial scheduling, reassurance, and teaching) and phone calls. FINDINGS: Women enrolled in clinical trials had more phone interactions with nursing staff (p = 0.003) and received teaching (p < 0.001) and reassurance (p = 0.005) from nursing staff more often than women not enrolled in clinical trials. Controlling for age and stage of disease, teaching (p < 0.001), and reassurance (p = 0.10) were the primary differences in nursing care between the patients enrolled in clinical trials and those not enrolled. CONCLUSION: Differences in nursing care received exist between patients with breast cancer enrolled in clinical trials and those not enrolled. IMPLICATIONS FOR NURSING PRACTICE: Both teaching and reassurance are important components of caring for patients with cancer and are associated with treatment compliance. If the results of this study are confirmed, measures must be employed to ensure that all patients receive optimal care. (shrink)

In its early periods, pesantren as a type of Islamic educational institution focused merely on religious teachings. Socio-political pressures and the need to carry out Islamic outreach have pushed kiai as pesantren leaders to negotiate their idealism according to the circumstances in different historical periods. Historical accounts from the Dutch colonial period to Indonesian independence show that kiai leadership becomes the decisive factor as well as the legitimation for pesantren to take certain actions during precarious situations. To examine the (...) institutional development of pesantren in the post-reformation era, a recent ethnographic fieldwork has been carried out in three pesantren in Madura, Java, and Lombok. This paper discusses the development and transformation of pesantren as an institution from the Dutch Ethical Policy Period until today. It demonstrates pesantren’s involvement in anti-Western campaigns and trials of affiliation with oppositions in the colonial period. This paper shows how Islamic virtues remain the heart of pesantren education and examines how innovation in contemporary pesantren regarding pedagogies and values translated in seemingly non-religious areas is substantially based on religious values. (shrink)

Diabetes self-management is a crucial part in the management of diabetic patients. Most randomized controlled clinical trials reported significant benefits by diabetes self-management education on DSM behaviors and metabolic control. Although the randomized clinical trials are the gold standard method in assessing the effectiveness of any intervention, including DSME interventions, the outcomes of these studies may reflect exaggerated effects; because in most of these studies, subjects in control group receive usual care with no any DSME. The lack of such education (...) in the control group had many drawbacks: make blindness impossible; at which non blinded studies may result in false-positive findings; it may be unethical to recruit patients for participation in DSME studies as control subjects, most of these studies with long periods of follow up, without any direct benefit to them during the study period; the lack of direct benefit to control subjects in any clinical trial may results in high attrition rate. The high attrition rate in clinical trials especially in the control group can lower the statistical power of the study results; thus, the DSME program would appear to have positive effects even if the program had no real benefit. This problem of the DSME exaggerated effects can be solved partially through providing control subjects with education about some DSM behaviors or comparing the effect of DSME through different educational approaches. (shrink)

_Background:_ Literature has documented the role of family in the outcome of chronic schizophrenia. In the light of this, family interventions (FIs) are becoming an integral component of treatment for psychosis. The First Episode of Psychosis (FEP) is the period when most of the changes in family atmosphere are observed; unfortunately, few studies on the relatives are available. _Objective:_ To explore burden of care and emotional distress at baseline and at 9-month follow-up and the levels of service satisfaction at (...) follow-up in the two groups of relatives (experimental treatment EXP vs. treatment as usual TAU) recruited in the cluster-randomized controlled GET UP PIANO trial. _Methods:_ The experimental treatment was provided by routine public Community Mental Health Centers (Italian National Health Service) and consisted of Treatment as Usual plus evidence-based additional treatment (Cognitive Behavioral Therapy for psychosis for patients, Family Intervention for psychosis, and Case Management). TAU consisted of personalized outpatient psychopharmacological treatment, combined with non-specific supportive clinical management and informal support/educational sessions for families. The outcomes on relatives were assessed by the Involvement Evaluation Questionnaire (IEQ-EU), the General Health Questionnaire (GHQ-12), and the Verona Service Satisfaction Scale (VSSS-EU). Differences within and between groups were evaluated. _Results:_ At baseline, 75 TAU and 185 EXP caregivers were assessed. In the experimental group 92% of relatives participated in at least 1 family session. At follow-up both groups experienced improvement in all IEQ and GHQ items, but caregivers belonging to the EXP arm experienced a significantly greater change in 10 IEQ items (mainly pertaining to the “Tension” dimension) and in GHQ items. Due to the low sample size, a significant effectiveness was only observed for 2 IEQ items and 1 GHQ-12 item. With respect to VSSS data at follow-up, caregivers in the EXP arm experienced significantly greater satisfaction in 8 items, almost all pertaining to the dimensions “Relatives' Involvement” and “Professionals' Skills and Behavior.” _Conclusions:_ The Family intervention for psychosis delivered in the GET UP PIANO trial reduced family burden of illness and improved emotional distress and satisfaction with services. These results should encourage to promote FIs on caregivers of first-episode psychosis patients. (shrink)

BackgroundVast sums are distributed based on grant peer review, but studies show that interrater reliability is often low. In this study, we tested the effect of receiving two short individual feedback reports compared to one short general feedback report on the agreement between reviewers.MethodsA total of 42 reviewers at the Norwegian Foundation Dam were randomly assigned to receive either a general feedback report or an individual feedback report. The general feedback group received one report before the start of the reviews (...) that contained general information about the previous call in which the reviewers participated. In the individual feedback group, the reviewers received two reports, one before the review period and one during the period. In the individual feedback group, the reviewers were presented with detailed information on their scoring compared with the review committee as a whole, both before and during the review period. The main outcomes were the proportion of agreement in the eligibility assessment and the average difference in scores between pairs of reviewers assessing the same proposal. The outcomes were measured in 2017 and after the feedback was provided in 2018.ResultsA total of 2398 paired reviews were included in the analysis. There was a significant difference between the two groups in the proportion of absolute agreement on whether the proposal was eligible for the funding programme, with the general feedback group demonstrating a higher rate of agreement. There was no difference between the two groups in terms of the average score difference. However, the agreement regarding the proposal score remained critically low for both groups.ConclusionsWe did not observe changes in proposal score agreement between 2017 and 2018 in reviewers receiving different feedback. The low levels of agreement remain a major concern in grant peer review, and research to identify contributing factors as well as the development and testing of interventions to increase agreement rates are still needed.Trial registrationThe study was preregistered at OSF.io/n4fq3. (shrink)

This study appeared in full in the last issue of Research Ethics Review (2009; 5(1): 26). SB, a 21-year-old healthy male, volunteered to take part in a phase I randomized, double-blind, placebo-controlled drug interaction study. The trial compound was a CNS-active drug currently under development for a range of CNS indications. The trial–which was not ‘first in class’ or ‘first in man’ –comprised two residential seven-day study periods with a washout period in between. Three days after the (...) end of the first study period the volunteer developed an acute, severe psychosis that warranted hospitalization. (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)

Background Previous reports have described that simple cognitive training using reading aloud and solving simple arithmetic calculations, so-called “learning therapy”, can improve executive functions and processing speed in the older adults. Nevertheless, it is not well-known whether learning therapy improve a wide range of cognitive functions or not. We investigated the beneficial effects of learning therapy on various cognitive functions in healthy older adults. Methods We used a single-blinded intervention with two groups (learning therapy group: LT and waiting list control (...) group: WL). Sixty-four elderly were randomly assigned to LT or WL. In LT, participants performed reading Japanese aloud and solving simple calculations training tasks for 6 months. WL did not participate in the intervention. We measured several cognitive functions before and after 6 months intervention periods. Results Compared to WL, results revealed that LT improved inhibition performance in executive functions (Stroop: LT (Mean = 3.88) vs. WL (Mean = 1.22), adjusted p =.013 and reverse Stroop LT (Mean = 3.22) vs. WL (Mean = 1.59), adjusted p =.015), verbal episodic memory (logical memory: LT (Mean = 4.59) vs. WL (Mean = 2.47), adjusted p =.015), focus attention(D-CAT: LT (Mean = 2.09) vs. WL (Mean = -0.59), adjusted p =.010) and processing speed compared to the waiting list control group (digit symbol coding: LT (Mean = 5.00) vs. WL (Mean = 1.13), adjusted p =.015 and symbol search: LT (Mean = 3.47) vs. WL (Mean = 1.81), adjusted p =.014). Discussion This RCT can showed the benefit of learning therapy on inhibition of executive functions, verbal episodic memory, focus attention, and processing speed in healthy elderly people. Our results were discussed under overlapping hypothesis. Trial registration “This trial was registered in The University Hospital Medical Information Network Clinical Trials Registry (UMIN000006998).”. (shrink)

Data gathered by investigators are used to test the validity of a specific scientific hypothesis. When the hypothesis relates to the biology of a disease or its treatment, then data sets may contain specific and identifiable medical information. Since the information in a clinical data set was gathered to test a specific hypothesis and there is usually a sponsor interested in the outcome, the issue of who owns the data is a critical one. In my opinion, data from both publicly (...) and privately funded research should be made available, in a format that protects confidentiality and intellectual property rights, to interested and responsible parties within a reasonable period of time after publication. (shrink)

The purpose of this study was to examine the effectiveness of a neuro-meditation program to support nurses during the COVID-19 pandemic. Forty-five nurses were classified into three groups based on their systolic blood pressure: normotensive, hypertensive and control. Using a parallel, randomly controlled design across a 4-week period, 10 × 30-min sessions using the Rebalance© Impulse were completed. Sleep was assessed by wrist actigraphy and subjective sleep questionnaires; perceived sleep quality, Ford Insomnia Response to Stress Test questionnaire and the (...) Spiegel Sleep Quality questionnaire. Blood pressure, resting heart rate, mean heart rate, heart rate variability index, cortisol, and alpha-amylase were also measured. Statistical analysis was completed using factorial ANOVA. Sleep improved in the G-hyp group; SSQ ; perceived sleep quality ; sleep efficiency and fragmentation index. In the G-nor group, sleep was improved to a lesser extent; perceived sleep quality. A significant time–group interaction was reported in resting heart rate, systolic blood pressure, and diastolic blood pressure with these measures being significantly reduced in the G-hyp group. RMSSD increased in the G-nor group. This initial evidence suggests that neuro-meditation reduces excessive sympathetic activity, promoting enhanced sleep quality and autonomic control during periods of increased work-related stress.Clinical Trial RegistrationThe study was conducted at Bioesterel, Sophia-Antipolis, France as a clinical trial: Neuro-meditation improves sleep quality, https://www.drks.de/ui_data_web/DrksUI.html?locale=en, DRKS00025731. (shrink)

In 1590, after Norway’s most famous witch trial, Anne Pedersdotter was burned alive. Resource scarcity and religious competition transformed an old superstition into a witch craze to which Anne fell victim. Her story became a play in 1908 and a film in 1943. The two adaptations attempt to give Anne’s persecution more modern explanations. In the play Anne Pedersdotter, Anne has psychic powers that make her neighbors think she is a Satanic collaborator. In the film Day of Wrath, Anne (...) embodies humanistic aspirations that would have been delusional in her own era and that are perhaps also poorly adapted to human nature in general. The trial and the two fictional versions of the trial all illustrate how thought patterns that evolved for small groups of foragers can be overstimulated in post-agricultural environments. This article identifies cognitive dispositions that, in periods of crisis, can trigger persecution of outsiders, discusses how those universal mechanisms man­ifest themselves in different cultural contexts, and examines the historically specific beliefs and values that animate the two fictional versions of Anne’s story. The article concludes with reflections on how the evolved cognitive mechanisms that led to beliefs in witchcraft often manifest themselves, in the present, as conspiracy beliefs directed at minorities. (shrink)