The general aim of this article is to give a critical interpretation of post-trial obligations towards individual research participants in the Declaration of Helsinki 2013. Transitioning research participants to the appropriate health care when a research study ends is a global problem. The publication of a new version of the Declaration of Helsinki is a great opportunity to discuss it. In my view, the Declaration of Helsinki 2013 identifies at least two clearly different types of post-trial (...) obligations, specifically, access to care after research and access to information after research. The agents entitled to receive post-trial access are the individual participants in research studies. The Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of post-trial obligations, I first introduce a classification of post-trial obligations and illustrate its application with examples from post-trial ethics literature. I then make a brief reconstruction of the formulations of post-trial obligations of the Declaration of Helsinki from 2000 to 2008 to correlate the changes with some of the most salient ethical arguments. Finally I advance a critical interpretation of the latest formulation of post-trial obligations. I defend the view that paragraph 34 of ‘Post-trial provisions’ is an improved formulation by comparison with earlier versions, especially for identifying responsible agents and abandoning ambiguous ‘fair benefit’ language. However, I criticize the disappearance of ‘access to other appropriate care’ present in the Declaration since 2004 and the narrow scope given to obligations of access to information after research. (shrink)

The paper Post-Trial Acces To Treatment (PTA) offers an insight into current corporate policies and corporate best practices relating to the provision of PTA in low and middle income countries based on company sources. In these countries there is a greater appeal for pharmaceutical companies to take responsibility for providing PTA. However, the practice of providing PTA is the exception rather than the rule.

I. EXECUTIVE SUMMARY The MRCT Center Post-trial Responsibilities: Continued Access to an Investigational Medicine Framework outlines a case-based, principled, stakeholder approach to evaluate and guide ethical responsibilities to provide continued access to an investigational medicine at the conclusion of a patient’s participation in a clinical trial. The Post-trial Responsibilities (PTR) Framework includes this Guidance Document as well as the accompanying Toolkit. A 41-member international multi-stakeholder Workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and (...) Women’s Hospital and Harvard University (MRCT Center) developed this Guidance and Toolkit. Project Motivation A number of international organizations have discussed the responsibilities stakeholders have to provide continued access to investigational medicines. The World Medical Association, for example, addressed post-trial access to medicines in Paragraph 34 of the Declaration of Helsinki (WMA, 2013): “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” This paragraph and other international guidance documents converge on several consensus points: • Post-trial access (hereafter referred to as “continued access” in this Framework [for terminology clarification – see definitions]) is the responsibility of sponsors, researchers, and host country governments; • The plan for continued access should be determined before the trial begins, and before any individual gives their informed consent; • The protocol should delineate continued access plans; and • The plan should be transparent to potential participants and explained during the informed consent process. -/- However, there is no guidance on how to fulfill these responsibilities (i.e., linking specific responsibilities with specific stakeholders, conditions, and duration). To fill this gap, the MRCT Center convened a working group in September of 2014 to develop a framework to guide stakeholders with identified responsibilities. This resultant Framework sets forth applicable principles, approaches, recommendations and ethical rationales for PTR regarding continued access to investigational medicines for research participants. (shrink)

Translation from Spanish to English of ANMAT’s procedure for import of post-trial access provisions. This is a regulatory mechanisim to comply with post-trial provisions requirement in Declaration of Helsinki, paragraph 34. The translation it is based on a selection of the text of ANMAT’s Provision 12792/2016. -/- .

ABSTRACT Many recent articles argue that participants who seroconvert during HIV prevention trials deserve treatment when they develop AIDS, and there is a general consensus that the participants in HIV/aids treatment trials should have continuing post‐trial access. As a result, the primary concern of many ethicists and activists has shifted from justifying an obligation to treat trial participants, to working out mechanisms through which treatment could be provided. In this paper I argue that this shift frequently conceals (...) an important assumption: that if there is an obligation to supply treatment, then any party who could provide it may be prevailed upon to discharge the obligation. This assumption is false. The reasons why trial participants should get ART affect who has the duty to provide it. We should not burden governments with the obligations of sponsors, nor researchers with the obligations of the international community. And we should not deprive a group of treatment because their need is less salient than that of research participants. Insisting otherwise may lead to people being wrongfully deprived of access to antiretrovirals. (shrink)

Care after research is for participants after they have finished the study. Often it is NHS-provided healthcare for the medical condition that the study addresses. Sometimes it includes the study intervention, whether funded and supplied by the study sponsor, NHS or other party. The NHS has the primary responsibility for care after research. However, researchers are responsible at least for explaining and justifying what will happen to participants once they have finished. RECs are responsible for considering the arrangements. There are (...) ethical and practical issues, in particular when participants may wish to continue on the study intervention after the study. There are also various guidelines and legislation. This document presents a framework of questions to help NHS RECs and their applicants. Information on this document’s development is here. (shrink)

Todos los días se prueban nuevos psicofármacos, tratamientos para el VIH/SIDA o el cáncer, entre otras enfermedades. Algunos de esos tratamientos son lo suficientemente exitosos como para cronificar enfermedades antes consideradas mortales, como los antirretrovirales para el VIH/SIDA o el imatinib para la leucemia mieloide a principios del 2000. No obstante, antes de que puedan ser comercializados o estar disponibles en los sistemas de salud pública, deben pasar por una serie de rigurosas pruebas de calidad, seguridad y eficacia. Estas pruebas (...) implican el testeo de las drogas en animales y su estudio en seres humanos, sanos o enfermos. Estrictas normas de buenas prácticas científicas y éticas regulan todo el proceso de las investigaciones biomédicas. El problema de mi tesis se centra en el momento de la finalización de los estudios en seres humanos. Alguien podría preguntarse qué pasa con las personas si se benefician clínicamente del tratamiento experimental durante el estudio cuando este finaliza. La interrupción abrupta de un tratamiento beneficioso podría poner en peligro la salud de los sujetos. Y en el caso de sujetos de investigación afectados por enfermedades crónicas, es probable que deban continuar con el tratamiento beneficioso u otra atención adecuada por el resto de sus vidas. Un sujeto de investigación estadounidense sin seguro de salud que participó en un estudio de largo plazo de diabetes resume estas preocupaciones: "de repente cortan la cuerda, y uno está solo por su cuenta ... O conseguís trescientos o cuatrocientos dólares por mes para seguir con esto o simplemente seguís adelante y morís". Este tipo de casos me llevaron a preguntar si existe alguna obligación moral de proveer el tratamiento beneficioso a un sujeto de investigación que no puede pagárselo. Muchas personas podrían pensar que interrumpir el tratamiento beneficioso al sujeto de investigación que padece de diabetes y no tiene seguro para cubrir un tratamiento es incorrecto, porque nadie debería morir de una enfermedad o dedicar todos los recursos disponibles para sobrevivir, especialmente cuando se contribuyó a encontrar una cura o a obtener la evidencia científica necesaria para desarrollar un mejor tratamiento que el existente. Otras personas podrían pensar que lo correcto es ofrecer el tratamiento a un "precio justo", y si la persona no puede pagar por la continuidad de tratamiento es su responsabilidad. Mi intuición es que una sociedad democrática justa tiene una obligación moral de establecer un sistema de continuidad de tratamiento beneficioso para los sujetos de investigación. En esta tesis intento justificar filosóficamente esta última intuición básica utilizando el marco teórico de la teoría de la justicia de Rawls. Elijo utilizar la teoría rawlsiana, porque esta teoría me permite ubicar los problemas morales con respecto a la continuidad de tratamiento beneficioso en su contexto social adecuado y en el contexto de la búsqueda general de una sociedad más justa. En particular, la encuentro especialmente adecuada para explicar fenómenos complejos de responsabilidad social como los que creo que subyacen en el problema de la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación. Como mostraré más adelante, es imposible tener en cuenta los aspectos morales de la continuidad de tratamiento beneficioso aislada de la sociedad en la que se realizan los estudios con seres humanos. En el capítulo 1 presento una introducción general al tema de la ética de la investigación y al problema de la continuidad de tratamiento beneficioso. En el capítulo 2 intento determinar el campo de estudio de la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación. Para eso, mi estrategia es la siguiente. Primero, busco identificar los casos de estudios clínicos donde se daría la obligación de continuidad beneficiosa hacia los sujetos de investigación. Segundo, presento el problema de la justificación moral de la obligación de continuidad y la necesidad de discutir las justificaciones basadas en la idea de justicia como reciprocidad. Para esto, en la sección 2, identifico la obligación de continuidad de tratamiento a través de una selección de sus casos paradigmáticos en la literatura. Comienzo con el caso de los estudios clínicos con antirretrovirales llevados a cabo en Sudáfrica en personas con VIH/SIDA. Luego, introduzco el concepto teórico de sistema de continuidad de tratamiento beneficioso. Este concepto me permite evaluar y comparar teóricamente cómo diferentes sociedades hacen frente al problema de proveer la continuidad de tratamiento beneficioso a los sujetos de investigación. Por último, rastreo los casos ejemplares de obligación de continuidad de tratamiento beneficioso hacia los sujetos en países desarrollados, con énfasis especial en los Estados Unidos. En la sección 3, analizo algunos problemas de confusión o ambigüedad más importantes en torno a la obligación. Primero, analizo el nombre de la obligación. Luego, trato de distinguir la obligación de continuidad de tratamiento hacia los sujetos de investigación de la obligación de disponibilidad razonable, una confusión muy común en la literatura de la ética de la investigación. Finalmente, me detengo a analizar una posible ambigüedad en el concepto de "tratamiento beneficioso" y utilizo algunos de los casos paradigmáticos identificados para argumentar a favor de mi interpretación. Atacado el primer problema, en la sección 4 y 5 me vuelco a relevar el problema de la justificación moral de la obligación de continuidad. En la sección 4, reconstruyo lo que llamo la "versión simple" del concepto de obligación a partir de la discusión sobre las fuentes de la obligación de continuidad de tratamiento beneficioso. Luego, planteo la necesidad de investigar las justificaciones basadas en la idea de justicia como reciprocidad debido a las ambigüedades y la falta de un marco teórico claro dentro del campo de la ética de la investigación en seres humanos. Finalmente, en la sección 5, introduzco algunas distinciones clásicas con el fin de complejizar el marco teórico de las obligaciones, el cual será utilizado en la discusión de los próximos dos capítulos. En el capítulo 3 discuto la justificación de la obligación de continuidad de tratamiento que da el modelo económico de Alan Wertheimer. En la sección 1 del capítulo, debido a lo específico del tema y lo poco conocido del autor, introduzco a la persona y el contexto institucional de su obra. En la sección 2 del capítulo, distingo tres interpretaciones del concepto de justicia como reciprocidad e intento mostrar que Wertheimer utiliza una interpretación caracterizada por el uso mutuo y el intercambio de beneficios, a la cual llamo "reciprocidad de mercado". En la sección 3, presento el marco teórico del modelo económico. La pregunta fundamental de Wertheimer es la siguiente: ¿tienen los investigadores o patrocinadores una obligación supercontractual de proporcionar la continuidad de tratamiento u otros beneficios a los sujetos de investigación? Según el autor, el consenso en ética de la investigación responde de manera afirmativa a esta pregunta y como fundamento de esta obligación se encontraría lo que Wertheimer llama "el principio de interacción". Analizo este principio y presento las críticas que hace Wertheimer al mismo. En la sección 4, presento la respuesta a la pregunta fundamental que da Wertheimer mediante su "argumento estratégico". En la sección 5 analizo la solución dada por Wertheimer e intento explicar algunos de los supuestos principales del modelo, a saber, (i) la lógica del argumento estratégico, (ii) la fuerza moral de los conceptos de Pareto y (iii) el compromiso del modelo económico con la restricción de la información. Por último, en la sección 6 presento mis críticas al modelo económico. En el capítulo 4 presento el modelo de reciprocidad democrática, inspirado en la teoría de la justicia de Rawls. Este modelo se presenta como un marco teórico y una interpretación de la justicia como reciprocidad alternativos al modelo económico presentado en el capítulo anterior. En la sección 2 del presente capítulo, explicito los problemas del marco teórico relacionados con el concepto de justicia como reciprocidad que subyacen a la discusión sobre la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación. Para esto, me centro en tres puntos: (i) la relación del principio de justicia como reciprocidad y el concepto de obligación; (ii) el problema del alcance del principio de reciprocidad, y (iii) la relación entre el principio de reciprocidad y el concepto de equidad, o lo que llamo "el problema de la medida de la reciprocidad". En la sección 3, defino con mayor claridad el enfoque rawlsiano de la justicia distributiva y expongo una crítica a los argumentos antirrawlsianos esgrimidos por los defensores del modelo económico que afirman que los principios de justicia política de Rawls no se aplican a los individuos. Si mi respuesta a los defensores del modelo económico es correcta, los principios de justicia política se aplican a los individuos de manera indirecta, mediante la asignación de obligaciones posicionales por parte de la estructura básica de instituciones de una sociedad democrática, y permiten garantizar igual justicia a todos los miembros de la sociedad. En la sección 4, presento mi propuesta original de cómo entender la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación. Esta sería una obligación posicional perfecta correlativa con el derecho a la salud en sociedades democráticas justas o moderadamente injustas. En la sección 5, muestro de manera detallada el mecanismo apropiado para extender los principios de justicia política al caso de la obligación de continuidad de tratamiento beneficioso hacia los sujetos de investigación. Con este objetivo, introduzco la idea de secuencia en cuatro etapas, que permite evaluar y diseñar nuevos esquemas institucionales para dar contenido a la obligación de continuidad de tratamiento. Y presento los principios de obligaciones y deberes individuales, que cierran el sistema rawlsiano brindando razones morales a los individuos para extender los esquemas institucionales justos a nuevas situaciones, reformar los existentes y cumplir con las obligaciones posicionales asignadas por estos nuevos esquemas. Por último, en la sección 6, discuto las objeciones más importantes al modelo de justificación de reciprocidad democrática. Por último, en la conclusión general, hago un intento de aplicación del marco teórico del modelo de reciprocidad democrática al análisis de los sistemas de continuidad de tratamiento para países como Argentina o Brasil y presento las líneas más importantes para la investigación futura. (shrink)

Background: In response to the pandemic caused by COVID-19, World Health Organization (WHO), together with International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), developed research protocols facilitating global collaboration and accelerating the understanding of the disease, to identify the potential symptoms and persistent sequelae in infected individuals, which can be used in different areas of health, that is, in primary care, at a hospital or outpatient level, both public and private. Objective: To describe the International Severe Acute Respiratory and (...) Emerging Infection Consortium (ISARIC) protocol as a new global collaborative platform for global clinical trials targeting post-COVID-19 patients. Methods: The standardized forms were developed from the COVID-19 Clinical Characterization Protocol (PCC) by the ISARIC/WHO working group composed of specialist researchers with experience in clinical research in different areas of medicine and public health, especially outbreaks and infectious diseases. Conclusion: It is expected that the creation of a database composed of different populations from all over the world will help in the characterization of risk factors, in the best form of clinical intervention and in the best prevention strategies for physical, neurological and psychosocial sequelae in the medium and long term in post-COVID-19 patients. (shrink)

This article seeks to identify and analyse the most significant changes regarding parental leave provision in post-communist Romania, as well as the extent to which its legal adjustments that took place after 1990 reveal both old trends inherited from the former political regime as well as new tendencies influenced by EU norms and directives. Consequently, this article has a twofold structure. First, a brief overview of the main concepts and theoretical approaches to parental leave will allow us to proceed (...) to a proper understanding of the epistemological tools underpinning this research object. Second, this article tackles the numerous legislative changes concerning parental leave that occurred after the fall of the communist regime. Although limited to a single category of research sources, this inquiry is indispensable for analysing the extent to which childcare and the gendered division of parental responsibilities have become real political struggles within the post-communist public agenda in Romania. (shrink)

Este artículo considera el problema de justicia en la investigación biomédica en países en desarrollo. En particular se hace foco en la discusión de si el requisito de poner a disposición toda intervención probada efectiva puede ser considerado como una obligación post investigación de los patrocinadores hacia la comunidad anfitriona. Primero, se discuten las concepciones de la Comisión Nacional de Asesoramiento sobre Bioética (NBAC) de los Estados Unidos y de las guías éticas internacionales sobre la obligación post investigación (...) hacia la comunidad. Luego, se examinan las interpretaciones del modelo de disponibilidad razonable y el modelo de beneficios justos sobre la condición de acceso a los beneficios post investigación. Por último, presento y critico el argumento del carácter contraproducente de la obligación post investigación que afirma que la obligación post investigación limita el desarrollo de la investigación y empeora la situación de las poblaciones de los países en desarrollo. [ABSTRACT] This article refers to the problem of justice in biomedical research in developing countries and in particular it focus in the discussion of whether the requirement of making available any effective intervention could be consider a post-trial obligation of the sponsor towards the host community. First, the National Advisory Bioethics Commission’s (NBAC) conception and the international guidelines’ conception of post-trial obligations towards the community are discussed. Second, the interpretation of reasonable availability model and the fair benefits model of the condition of access to post trial benefits are examined. Finally, I present and criticize the moral counterproductive argument which affirms that post trial obligations towards the community prevent new drug research and make population in developing countries worse off. (shrink)

Background If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical - trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. Methods The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the (...) 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as ‘core’, 39 addressing trials of invasive procedures and a 5% sample of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Findings Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. Conclusions The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research. (shrink)

Resources for Feminist Research, Vol. 3, No. 4, pp. 44-45, 1985 In this brief article, written in 1984 and published the following year, Lucinda Vandervort sets out a comprehensive agenda for enforcement of sexual assault laws in Canada. Those familiar with her subsequent writing are aware that the legal implications of the distinction between the “social” and “legal” definitions of sexual assault, identified here as crucial for interpretation and implementation of the law of sexual assault, are analyzed at length in (...) “Mistake of Law and Sexual Assault: Consent and Mens Rea” (1986), published at (1987-88) 2(2) Canadian Journal of Women and the Law, 233 309. In that article the author argued that most mistakes about consent are not mistakes about a “fact” that may sometimes negative mens rea, but are actually mistakes about the law that afford accused no excuse under either Canadian common law or statutory criminal law. She argued further that consent must be interpreted as “voluntary agreement” and must be affirmatively and unequivocally communicated in order to operate as an effective waiver of a person’s legal right to be free from interference with his or her bodily integrity. That article was a central reference point in the consultations leading to the 1992 amendments to the sexual assault provisions in the Canadian Criminal Code and in some key decisions by the Supreme Court of Canada in sexual assault cases in the 1990’s. As a result of a gradual transformation of theoretical analysis of the law of mens rea and consent in Canada, culpable awareness is now understood by many jurists and criminal law theorists quite differently than it was twenty-five years ago. As Vandervort acknowledged in her 1984 Agenda for Action, however, clarity in legal theory and legal doctrine is no guarantee of how sexual assault laws will operate in practice. Theory and practice, doctrine and its implementation, often diverge. This phenomenon is still seen in some decisions taken at the trial, pre-trial, and pre-charge stages in sexual assault cases. Police, prosecutors, and many trial judges, like accused, may often be influenced by traditional attitudes about sexual consent and mistaken about the law of consent. Accordingly, in her recent work Vandervort re-visits and re-examines the exercise of discretion by police, prosecutors, and the judiciary. An example is her 2009 article “Legal Subversion of the Criminal Justice Process? Judicial, Prosecutorial and Police Discretion in R. v. Edmondson, Kindrat and Brown” in Sexual Assault Law, Practice & Activism in a Post-Jane Doe Era, edited by Elizabeth Sheehy (Ottawa: University of Ottawa Press, 2012). In this and some of her other recent work, the distinctions between social and legal norms and questions of fact and law, previously analyzed with the objective of clarifying the law, are used to control the effects of social ignorance and partiality in the handling of sexual assault complaints by decision-makers in the criminal justice system at trial and pre-trial. Lucinda Vandervort’s published and unpublished legal and philosophical writings on sexual assault and sexual assault law illustrate the development of a socio-legal scholar’s “Agenda for Action” into a principled, pragmatic, open-ended exercise in “institutional design.” Across two centuries, from the revolutionary era of the 18th century to the present, other radical egalitarians would recognize both the impetus for the project and many features of the political and cultural resistance to it. (shrink)

The paper suggests that Samuel Taylor Coleridge’s arguments against sympathy after the French Revolution, Walter Benjamin’s claims against empathy following the traumatic shock of Modernity and the First World War, and Hannah Arendt’s critical take on compassion. after the Holocaust are similar responses to singular historical crises. Reconsidering Arendt’s On Revolution (1963) and its evocation of Hermann Melville’s novella Billy Budd (1891), I show first that the novella bears the traces of an essay by Samuel Taylor Coleridge, “The Appeal to (...) Law” (1809). Then, drawing on Walter Benjamin’s writings on trauma in Illuminations (1968, edited by Arendt), I discuss the political importance Arendt attaches to the proper way of telling a story, at a time when “the communicability of experience is decreasing” (Benjamin, Illuminations, 86). Through the analysis of Benjamin’s “The Storyteller” and Arendt’s “heartless” report on the Eichmann trial (1963), I equally show that, according to Arendt, testimonies must be narrated, or rather performed, in a dispassionate, dry, and compact manner so that they can be historically and politically relevant. (shrink)

Objectives. The purpose of this study was to conduct the first randomized controlled trial (RCT) to evaluate the effectiveness of a second-generation mindfulness-based intervention (SG-MBI) for treating fibromyalgia syndrome (FMS). Compared to first generation mindfulness-based interventions, SG-MBIs are more acknowledging of the spiritual aspect of mindfulness. Design. A RCT employing intent-to-treat analysis. Methods. Adults with FMS received an 8-week SG-MBI known as meditation awareness training (MAT; n = 74) or an active control intervention known as cognitive behaviour theory for (...) groups (n = 74). Assessments were performed at pre-, post-, and 6-month follow-up phases. Results. Meditation awareness training participants demonstrated significant and sustained improvements over control group participants in FMS symptomatology, pain perception, sleep quality, psychological distress, non-attachment (to self, symptoms, and environment), and civic engagement. A mediation analysis found that (1) civic engagement partially mediated treatment effects for all outcome variables, (2) non-attachment partially mediated treatment effects for psychological distress and sleep quality, and (3) non-attachment almost fully mediated treatment effects for FMS symptomatology and pain perception. Average daily time spent in meditation was found to be a significant predictor of changes in all outcome variables. Conclusions. Meditation awareness training may be a suitable treatment for adults with FMS and appears to ameliorate FMS symptomatology and pain perception by reducing attachment to self. (shrink)

El objetivo del presente trabajo es analizar la nueva formulación del principio de acceso posinvestigación en la más reciente (2008) revisión de la Declaración de Helsinki. Se identifican los artículos relevantes de la Declaración y se presentan dos interpretaciones posibles del principio de acceso posinvestigación: una interpretación robusta y otra permisiva, inspiradas cada una por modelos de justicia distintos. Luego, se hace una evaluación crítica de dichas interpretaciones y se intenta avanzar argumentos en contra de la interpretación permisiva. [The objective (...) of this study is to critically analyze the new formulation of the principle of post-trial access in the most recent (2008) revision of the Helsinki Declaration. The relevant articles of the declaration are identified and two possible interpretations of the principle of post-trial access are set out; one robust and one permissive, inspired by different models of distributive justice. A critical evaluation of both interpretations is presented and arguments against the permissive one advanced.]. (shrink)

El problema de la transición de los participantes desde una investigación hacia la atención de la salud apropiada es un problema global. La publicación de una nueva versión de la Declaración de Helsinki es una excelente oportunidad para repensar este problema. Según mi interpretación, la Declaración de Helsinki 2013 introduce dos tipos diferentes de obligaciones posinvestigación, a saber, (1) obligaciones de acceso a atención de la salud y (2) obligaciones de acceso a información. Los beneficiarios pretendidos de estas obligaciones son (...) los participantes individuales de estudios de investigación. Y la Declaración identifica a los patrocinadores, investigadores y gobiernos de los países anfitriones como los principales agentes responsables de cumplir con las obligaciones posinvestigación. Para justificar esta interpretación de los tipos, agentes y beneficiarios de las obligaciones posinvestigación, presento primero una clasificación tentativa de las obligaciones posinvestigación. Luego hago una breve reconstrucción conceptual de las formulaciones de las obligaciones posinvestigación en las versiones anteriores de la Declaración y reviso las principales críticas. Finalmente presento un análisis crítico de la nueva formulación de las obligaciones posinvestigación basándome en la discusión de las secciones anteriores. [ABSTRACT] The problem of transitioning research participants when the study is concluded to the appropriate health care is a global problem. The publication of a new version of the Declaration of Helsinki and its public discussion is a great opportunity to rethink this problem. According to my interpretation, the Declaration of Helsinki 2013 identifies two different types of post-trial obligations, namely, (1) obligations of access to health care and (2) the obligations of access to information. The intended beneficiaries of these obligations are individual participants of research studies. And the Declaration identifies the sponsors, researchers and host country governments as the main agents responsible for complying with the post-trial obligations mentioned above. To justify this interpretation of the types, agents and beneficiaries of post-trial obligations, I first introduce a tentative classification of post-trial obligations. Then I make a brief conceptual reconstruction of formulations of post-trial obligations in earlier versions of the Declaration and revise the main critiques. Finally I advance a critical analysis of the new formulation of post-trial obligations based on the discussion in the previous sections. (shrink)

¿Qué ocurre con la continuidad del tratamiento de los sujetos de investigación después de que realizan la última visita del ensayo en el que participan? En algunos casos, la falta de continuidad de atención de la salud apropiada podría poner en peligro la salud de estas personas. Por lo tanto, es probable que los sujetos de investigación que al terminar su participación en un ensayo todavía se encuentran enfermos, necesiten continuar con el tratamiento en estudio u otra atención de la (...) salud adecuada por el resto de sus vidas, sean unos pocos meses o muchos años. No obstante, no todas las sociedades cuentan con los recursos e instituciones para resolver el problema de la continuidad de tratamiento beneficioso. La opinión de un sujeto de investigación norteamericano, al que llamaremos Pedro, sin seguro de salud que participó en un ensayo de largo plazo sobre diabetes ejemplifica el problema de la continuidad de tratamiento beneficioso: “de repente [ellos] simplemente cortan la cuerda, y uno está solo por su cuenta, ya sabes. O consigues trescientos o cuatrocientos dólares al mes para seguir con esto o simplemente sigues adelante y mueres”. En este trabajo intentaré dar un panorama de la reciente discusión en torno al problema de la continuidad de tratamiento beneficioso en la ética de la investigación. Por tratamiento beneficioso hago referencia a dos cosas. En primer lugar, el tratamiento beneficioso puede ser (1) el tratamiento en estudio, p. e. el tratamiento o intervención en investigación que estaba recibiendo Pedro para su diabetes en el ejemplo anterior. Una droga o un producto biológico es un tratamiento en estudio para un uso propuesto (indicación) desde el primer ensayo con seres humanos hasta el momento en que es aprobado para su comercialización por las autoridades reguladoras de fármacos. El segundo lugar, el tratamiento beneficioso también puede ser (2) otra atención de la salud apropiada para el sujeto de investigación distinta del tratamiento en estudio, p. e. si existiera un tratamiento alternativo disponible para la enfermedad o condición de Pedro, distinto del tratamiento en estudio, y se justificara hacer la transición a ese otro tratamiento por razones de un mejor perfil de efectividad, seguridad y/o toxicidad. En la sección 1 de este trabajo introduciré una taxonomía de las obligaciones éticas de acceso posinvestigación (1.1.), realizaré un relevamiento histórico del concepto basado en las guías éticas internacionales (1.2) y analizaré el surgimiento del término “continuidad de tratamiento beneficioso hacia los sujetos de investigación” y otros términos análogos como “atención después de la investigación” (1.3). En la sección 2 presentaré los casos ejemplares en la bibliografía: continuidad de tratamiento en investigación en VIH/SIDA (2.1), continuidad de tratamiento en investigación en cáncer (2.2.) y otros casos de continuidad de tratamiento (2.3). (shrink)

A SECOND COMPLETELY REVISED EDITION OF THIS TEXTBOOK ON INTERDISCIPLINARY RESEARCH WAS PUBLISHED WITH AMSTERDAM UNIVERSITY PRESS IN 2022. Check out that version here and a PDF of its ToC and Introduction, as this first edition (AUP 2016) is no longer available. [This book (128 pp.) serves as an introduction and manual to guide students through the interdisciplinary research process. We are becoming increasingly aware that, as a result of technological developments and globalisation, problems are becoming so complex that they (...) can only be solved through cooperation between multiple disciplines. Healthcare, climate change, food security, energy, financial markets and quality of life are just a few examples of issues that require scientists and academics to work in a crossdisciplinary way. As a result of these developments, an interdisciplinary approach is becoming increasingly popular in higher education and must be considered an absolute necessity. Young academics are being called on to step beyond the boundaries of traditional disciplines in order to contribute to addressing fundamental problems and solving challenges facing society. There is a need for people who are not afraid to ask critical questions, who can work together well and can look beyond the boundaries of their own field. This means students need to learn more about how they can integrate and apply knowledge, methods and skills from different fields. Interdisciplinary research projects and practical training courses offer students more than one perspective on the same subject. Comparing and contrasting, connecting, adding and adapting concepts, theories and methodologies from different disciplines ultimately results in new insights and better answers to complex problems.]. (shrink)

Resumen Ésta es la primera traducción al español de las guías “Atención después de la investigación: un marco para los comités de ética de investigación del National Health Service (NHS) (borrador versión 8.0)”. El documento afirma que existe una fuerte obligación moral de garantizar que los participantes enfermos de un estudio clínico hagan una transición después del estudio hacia una atención de la salud apropiada. Con “atención de la salud apropiada” se hace referencia al acceso para los participantes a la (...) atención de la salud, proporcionada principalmente por el National Health Service (en adelante NHS), el sistema de salud del Reino Unido, y/o a la intervención en estudio, también llamada producto o tratamiento en investigación. Las guías “Atención después de la investigación” están dirigidas principalmente a los miembros de los 79 comités de ética de investigación del NHS y a quienes presentan sus estudios de investigación ante estos comités. Se trata de un documento borrador muy avanzado, trabajado en numerosas reuniones, durante más de 3 años, que ha sido discutido por participantes de estudios y miembros de la comunidad, miembros y presidentes de comités de ética de investigación del Reino Unido, especialistas internacionales en ética de la investigación, representantes de la industria y otras partes interesadas. La redacción de las guías es producto de la colaboración de Neema Sofaer y Penney Lewis, ambas investigadoras del King’s College London, en el Centre of Medical Law and Ethics del Dickson Poon School of Law, y Hugh Davies, Asesor en Ética de la Investigación de la Health Research Authority (HRA) del NHS. El traductor del presente documento, Ignacio Mastroleo, participó del workshop en la Fundación Brocher (Ginebra, Suiza, diciembre de 2011) donde se revisó el borrador versión 7.0 y contribuyó en la revisión del borrador de la versión 8.0 durante el 2012. -/- Abstract This is the first Spanish translation of the guidelines “Care after research: a framework for NHS RECs (8th draft)”. The document states that there is a strong moral obligation to ensure that participants in a clinical study who are ill transition after the study to appropriate healthcare. The terms "appropriate healthcare" refer to participants’ access to health care, mainly provided by the National Health Service (NHS), the health system in the UK, and/or to the intervention study also named investigational treatment or product. The guides "Care after research" are mainly directed to members of the 79 NHS committees of research ethics (RECs) and to those who submit their research to these committees. This is a very advanced draft document, worked in several meetings, for more than three years, that has been discussed with study participants and community members, members and chairs of RECs in the UK, international specialists in research ethics, industry representatives and other stakeholders. The drafting of the guidelines is the result of the collaboration of Neema Sofaer and Penney Lewis, both researchers at King's College London, at the Centre of Medical Law and Ethics of Dickson Poon School of Law, and Hugh Davies, Research Ethics Advisor of the Health Research Authority (HRA) of the NHS. The translator of this document, Ignacio Mastroleo, attended the workshop at the Brocher Foundation (Geneva, Switzerland, December 2011) where draft version 7.0 was revised and contributed in the revision of draft version 8.0 during 2012. (shrink)

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

Este trabajo es un comentario sobre la primera traducción al español de las guías del Reino Unido “Atención después de la investigación: un marco para los comités de ética de investigación del NHS (borrador versión 8.0)”. El comentario se divide en tres partes. En la primera parte, se busca resumir la información básica necesaria para mejorar la lectura comprensiva de la traducción de las guías. En la segunda parte, se analiza una selección de la normativa argentina que trata sobre atención (...) después de la investigación. En la tercera parte, se presentan las principales limitaciones del borrador de las guías y su traducción. El propósito de este comentario es que los futuros lectores y lectoras puedan hacer un uso crítico y deliberado de las guías, en la evaluación de estudios clínicos o como base para la redacción de guías propias sobre atención después de la investigación. ***This work is a commentary on the first Spanish translation of the UK guidelines “Care after research: a framework for NHS research ethics committees (draft version 8.0)”. The commentary is divided into three parts. The first part seeks to summarize the basic information needed to improve reading comprehension of the translation of the guidelines. The second part analyzes a selection of Argentinean regulations dealing with care after research. The third part presents the main limitations of the guidelines draft and its translation. The purpose of this commentary is that future readers can make a critical and deliberate use of guidelines in the assessment of clinical studies or as a basis for drafting their own guidelines on care after research. (shrink)

Experimental balance is usually understood as the control for the value of the conditions, other than the one under study, which are liable to affect the result of a test. We will discuss three different approaches to balance. ‘Millean balance’ requires to identify and equalize ex ante the value of these conditions in order to conduct solid causal inferences. ‘Fisherian balance’ measures ex post the influence of uncontrolled conditions through the analysis of variance. In ‘efficiency balance’ the value of (...) the antecedent conditions is decided ex ante according to the efficiency they yield in the estimation of the treatment outcome. Against some old arguments by John Worrall, we will show that in both Fisherian and efficiency balance there are good reasons to randomize the allocation of treatments, in particular when there is no agreement among experimenters as to the antecedent conditions to be controlled for. (shrink)

PREFACE WORD The Tanzimat period, which was the starting point of reform movements in many areas such as social, political, economic, military, etc., in which steps were taken towards Westernization, is considered to be an important milestone in drawing the fate of the Ottoman Empire. In this longest century of the empire, when many things were rushed, education partially received its share of change and reform. However, since the field of education was under the control of religious institutions such as (...) the Şeyhülislâmlık and the Nezâresi Evkâf-ı Hümâyun, the changes and reforms in this field remained limited. Regarding philosophy, which is the subject of our study, we can say in advance that philosophical movements in the West, the ideas of philosophers and philosophical education in the Western sense began to enter our country in the post-Tanzimat period. It is noteworthy that during this period when the Ottoman Empire became acquainted with Western philosophy, philosophy in the West experienced a period of crisis. In the period preceding this acquaintance, philosophy education in our country was carried out in a style loyal to the tradition of Islamic philosophy, and the break in this tradition occurred with the Tanzimat. One of the most widely debated issues from the Tanzimat to the present day has been whether or not a philosophical tradition unique to us can be established. Issues such as whether a philosophy built on our own culture and values can provide us with the opportunity to raise philosophers who are considered philosophers in the Western sense, and the level of competence and proficiency of Turkish in terms of creating a philosophical language on the way to realizing this opportunity, and efforts to establish a deep-rooted tradition continue to stand before us. In this study, from a holistic perspective, the changes in philosophical paradigms in certain periods from Tanzimat to the present day have been tried to be determined chronologically and problematically. The fact that the movements that emerged with Tanzimat were broken in certain periods, such as 1915, 1933 and 1960, and left their place to different movements, and the changes in our country in parallel with the change in the perception of philosophy in the world have been tried to be revealed in this study, and as a result of the study, results that have not been expressed so far have been reached. Again, whether the perception of philosophy has changed in society along with the change in philosophy in higher education is among the topics investigated in this study. For example, the fact that professors such as Mehmet İzzet, Niyazi Berkes and Necati Öner, who studied philosophy, regretfully admitted that it was embarrassing to say "I am studying philosophy", and instead took refuge in evasive answers such as "I am studying at the Faculty of Literature, I am studying at the Faculty of Language and History", clearly shows how the difficulty of doing philosophy in Turkey is at a high level with these prejudices. From the times when philosophy was identified with irreligion and atheism, and philosophers were seen as useless people who only criticized and did not produce solutions, to the present situation, the paths taken and the obstacles overcome make us hopeful for the bright future of philosophy in Turkey. In the Dârülfünun, which was de facto established in 1863 and opened and closed many times, philosophy courses were able to find a wide place in the curriculum after 1900 and especially after 1916. However, the contribution of philosophy courses and departments, which have been a significant part of the academy since 1916 both as a field of research and education, to the establishment and development of the longed-for original philosophical thought is currently the subject of a separate discussion. Indeed, philosophy departments have never escaped the criticism that they teach Western thought, transfer Western intellectual currents, ignore social values, and provide an exclusively Western and unproductive education. Our study, which deals with the processes of change and transition in philosophy education in Turkey and the debates on these processes, consists of three chapters and three appendices. In the first part, the studies in the field of philosophy from Tanzimat to the Republic are discussed theoretically and a general framework is tried to be drawn about the establishment of philosophy in Turkey. The topics covered in this section are mainly philosophy education until the establishment of the first university in 1863 under the name Dârülfünun and its closure and reopening in 1900 under the name Dârülfünun-ı Şâhâne. As is known, after a long period of trial and error, Dârülfünun was reformed under the name "Dârülfünun-ı Osmânî" in 1908 during the Second Constitutional Monarchy. Reforms in the field of education continued unabated, and with the university reforms in 1915 and 1933, philosophy departments also underwent significant change and transformation. Especially German faculty members, who were influential in these reforms, played an active role in the restructuring of the philosophy department. Apart from universities, philosophical activities were also carried out in non-governmental organizations, newspapers and journals. In particular, the philosophers who tried to become an association under the name of the Turkish Philosophical Society are today actively working under the name of the Philosophical Society of Turkey and the Turkish Philosophical Association. In this part of our study, in addition to these issues, the philosophers of the Republican period, which we have identified as four generations, and their philosophical attitudes and behaviors are evaluated together with the aspects reflected and not reflected in their works, and the interaction between the similarities and differences between the general characteristics of the generations and the philosophical atmosphere in the country is tried to be analyzed. The similarities and differences between the generations are analyzed since they are the main factors that determine and govern the course of philosophy in Turkey. The second chapter is devoted to "Philosophical Disciplines in Purgatory in the Republican Era". In this section, the disciplines of history of science, logic, Islamic philosophy and philosophy of religion, which we characterize as disciplines in limbo because their place in philosophy departments has always been controversial, are analyzed. In the third and final chapter, under the title "Philosophical Problems and Movements in the Republican Era", the problem of establishing the practical implications of the philosophical issues discussed in the first two chapters on the theoretical level, the question of whether Turkish can be the language of philosophy, Western philosophical movements in Turkey and their representatives are discussed. This chapter concludes with the main purpose of the study, which is to discuss the problems of philosophy in Turkey, suggestions for solutions and future perspectives. We have tried to enrich our research with three appendices that are considered to be complementary to these three chapters. The first appendix contains interviews with twelve senior professors who retired after teaching philosophy in Turkey for many years. These senior professors were asked questions about the changes in the view of philosophy in Turkey, philosophy education in higher education, their perceptions of philosophy, etc., and an important historical note was made with their answers based on their experiences. In this respect, we believe that these interviews will serve as an important source and reference for future generations and the social sciences community. Although the speeches of these professors contain many important discourses, messages and references, we have chosen one motto phrase to carry in the title. On this occasion, we would like to express our gratitude to our esteemed professors for sharing their vast knowledge and experience in the field of philosophy with us. In the second appendix, the short life stories and works of about a hundred professors in the field of philosophy in the Republican period are included. Although this information is sometimes easily obtained through the internet, biographical books or the works of the professors themselves, sometimes, after a very long and laborious work, original information has been reached, which is expressed for the first time in this study. Sometimes the capture of a very small detail required great efforts. In the third and final appendix, the names and periods of the senior philosophers of the Republican period are listed chronologically. (shrink)

Contrary to the widely accepted consensus, Christopher Heath Wellman argues that there are no pre-institutional judicial procedural rights. Thus commonly affirmed rights like the right to a fair trial cannot be assumed in the literature on punishment and legal philosophy as they usually are. Wellman canvasses and rejects a variety of grounds proposed for such rights. I answer his skepticism by proposing two novel grounds for procedural rights. First, a general right against unreasonable risk of punishment grounds rights to (...) an institutionalized system of punishment. Second, to complement and extend the first ground, I more controversially propose a right to provision of the robust good of security. People have a right to others' protecting for avoiding wrongfully harming them: when I take an action that is reasonably expected to threaten the protected interests of others, I must take appropriate care to avoid setting back those interests. Inflicting punishment on someone--intentionally harming them in response to a violation--is prima facie wrongful, so I can only count as taking appropriate care in punishing when I follow familiar procedures that reliably and redundantly test whether they are liable to such punishment, i.e. whether they have forfeited their right against punishment through a culpable act. (shrink)

Harms of medical interventions are systematically underestimated in clinical research. Numerous factors—conceptual, methodological, and social—contribute to this underestimation. I articulate the depth of such underestimation by describing these factors at the various stages of clinical research. Before any evidence is gathered, the ways harms are operationalized in clinical research contributes to their underestimation. Medical interventions are first tested in phase 1 ‘first in human’ trials, but evidence from these trials is rarely published, despite the fact that such trials provide the (...) foundation for assessing the harm profile of medical interventions. If a medical intervention is deemed safe in a phase 1 trial, it is tested in larger phase 2 and 3 clinical trials. One way to think about the problem of underestimating harms is in terms of the statistical ‘power’ of a clinical trial—the ability of a trial to detect a difference of a certain effect size between the experimental group and the control group. Power is normally thought to be pertinent to detecting benefits of medical interventions. It is important, though, to distinguish between the ability of a trial to detect benefits and the ability of a trial to detect harms. I refer to the former as power-B and the latter as power-H. I identify several factors that maximize power-B by sacrificing powerH in phase 3 clinical trials. If a medical intervention is approved for general use, it is evaluated by phase 4 post-market surveillance. Phase 4 surveillance of harms further contributes to underestimating the harm profile of medical interventions. At every stage of clinical research the hunt for harms is shrouded in secrecy, which further contributes to the underestimation of the harm profiles of medical interventions. (shrink)

Methadone maintenance therapy is a cost-effective, evidence-based treatment for heroin dependence. In the USA, a majority of heroin-dependent offenders are forced to detox from methadone when incarcerated. Recent research published in The Lancet has demonstrated the negative health and economic outcomes associated with such policies. Methadone Continuation Versus Forced Withdrawal on Incarceration in a Combined US Prison and Jail: A Randomised, Open Label Trial. The Lancet, 386, 350–359). This novel evidence raises questions as to the justification for current policies (...) of forced detox in American prisons. Opponents of methadone provision in prisons might offer arguments from retributivism, resource allocation and curative effectiveness to justify their position. This article contends that these arguments do not stand up to ethical scrutiny. In light of this, we hold that American policymakers should reform criminal justice policies to allow the initiation and continuation of methadone treatment in correctional settings. This would be consistent with both international recommendations and the example set by a number of other Western countries. (shrink)

In 2001, three non-Aboriginal men in their twenties were charged with the sexual assault of a twelve year old Aboriginal girl in rural Saskatchewan. Legal proceedings lasted almost seven years and included two preliminary hearings, two jury trials, two retrials with juries, and appeals to the provincial appeal court and the Supreme Court of Canada. One accused was convicted. The case raises questions about the administration of justice in sexual assault cases in Saskatchewan. Based on observation and analysis of the (...) record, this paper: (1) examines relationships between legal errors dealing with availability of the defence of “belief in consent” and interpretation of the “all reasonable steps” provision, the need for retrials, and apprehended race-gender-age bias and discrimination; and 2) proposes incremental and systemic remedies to address the weaknesses in police, prosecutorial and judicial policy and practice highlighted by this case. (shrink)

The availability of the defence of belief in consent under section 265(4) is a question of law, subject to review on appeal. The statutory provision is based on the common law rule that applies to all defences. Consideration of the defence when it is unavailable in law and failure to consider it when it is available are both incorrect. A judge is most likely to avoid error when ruling on availability of the defence if the ruling: (1) is grounded on (...) sound analysis of the substantive basis for the defence and its relationship to the principles of criminal responsibility; and (2) uses precise legal criteria to govern practical application of section 265(4) to the evidence in specific cases. The guidelines proposed in Part I are based on analyses of the substantive defence and culpable awareness and were developed to ensure that appropriate criteria are properly used when section 265(4) is applied. When a trial judge rules that the defence is available in law, the trier of fact must determine whether the defence is available on the facts as found, based on the evidence in the case. The model jury instructions proposed in Part II are designed to ensure that deliberations by the trier of fact are also guided and shaped by appropriate legal criteria. At both stages, the objective is to ground the deliberation process on fact, not fiction, and to regulate the exculpatory effect of the defence by using legal norms to exclude excuses based on extra-legal considerations such as sexual/racial fantasy, stereotype and myth, or community attitudes and custom. (shrink)

This study examines the relation of language use to a person’s ability to perform categorization tasks and to assess their own abilities in those categorization tasks. A silent rhyming task was used to confirm that a group of people with post-stroke aphasia (PWA) had corresponding covert language production (or “inner speech”) impairments. The performance of the PWA was then compared to that of age- and education-matched healthy controls on three kinds of categorization tasks and on metacognitive self-assessments of their (...) performance on those tasks. The PWA showed no deficits in their ability to categorize objects for any of the three trial types (visual, thematic, and categorial). However, on the categorial trials, their metacognitive assessments of whether they had categorized correctly were less reliable than those of the control group. The categorial trials were distinguished from the others by the fact that the categorization could not be based on some immediately perceptible feature or on the objects’ being found together in a type of scenario or setting. This result offers preliminary evidence for a link between covert language use and a specific form of metacognition. (shrink)

Medical ghostwriting is the practice in which pharmaceutical companies engage an outside writer to draft a manuscript submitted for publication in the names of “honorary authors,” typically academic key opinion leaders. Using newly-posted documents from paroxetine litigation, we show how the use of ghostwriters and key opinion leaders contributed to the publication of a medical journal article containing manipulated outcome data to favor the proprietary medication. The article was ghostwritten and managed by SmithKline Beecham, now GlaxoSmithKline (GSK) and Scientific Therapeutics (...) Information, Inc. without acknowledging their contribution in the published article. The named authors with financial ties to GSK, had little or no direct involvement in the paroxetine 352 bipolar trial results and most had not reviewed any of the manuscript drafts. The manuscript was originally rejected by peer review; however, its ultimate acceptance to the American Journal of Psychiatry was facilitated by the journal editor who also had financial ties to GSK. Thus, GSK was able to take an under-powered and non-informative trial with negative results and present it as a positive marketing vehicle for off-label promotion of paroxetine for bipolar depression. In addition to the commercial spin of paroxetine efficacy, important protocol-designated safety data were unreported that may have shown paroxetine to produce potentially harmful adverse events. (shrink)

Social work is a contested tradition, torn between the demands of social governance and autonomy. Today, this struggle is reflected in the division between the dominant, neoliberal agenda of service provision and the resistance offered by various critical perspectives employed by disparate groups of practitioners serving diverse communities. Critical social work challenges oppressive conditions and discourses, in addition to addressing their consequences in individuals’ lives. However, very few recent critical theorists informing critical social work have advocated revolution. A challenging exception (...) can be found in the work of Cornelius Castoriadis (1922–97), whose explication of ontological underdetermination and creation evades the pitfalls of both structural determinism and post-structural relativism, enabling an understanding of society as the contested creation of collective imaginaries in action and a politics of radical transformation. On this basis, we argue that Castoriadis’s radical-democratic revisioning of revolutionary praxis can help in reimagining critical social work’s emancipatory potential. (shrink)

A clear and provocative introduction to the ethics of COVID-19, suitable for university-level students, academics, and policymakers, as well as the general reader. It is also an original contribution to the emerging literature on this important topic. The author has made it available Open Access, so that it can be downloaded and read for free by all those who are interested in these issues. Key features include: -/- A neat organisation of the ethical issues raised by the pandemic. An exploration (...) of the many complex interconnections between these issues. A succinct case for a continued lockdown until we develop a vaccine. An original account of the Deep Moral Problem of the Pandemic, and a Revolutionary Argument for how we should change society post-pandemic. References to, and engagement with, many of the best writings on the pandemic so far (both in popular media and academic journals). -/- ISBN: 978-0-6489016-0-0. (shrink)

This article advances a critical analysis of John Rawls’s justification of liberal democratic nuclear deterrence in the post-Cold War era as found in The Law of Peoples. Rawls’s justification overlooked how nuclear-armed liberal democracies are ensnared in two intransigent ethical dilemmas: one in which the mandate to secure liberal constitutionalism requires both the preservation and violation of important constitutional provisions in domestic affairs, and the other in which this same mandate requires both the preservation and violation of the (...) liberal commitment to international legal arrangements and to the rule of law generally. On this view, the choice to violate constitutional provisions and international legal arrangements is evidence of nuclear despotism. Moreover, this choice does not imply that the ethical foreign policy dilemmas were resolved. Instead, it implies that the dilemmas force liberal democratic governments into implementing ethically paradoxical policy outcomes. (shrink)

According to an editor of The Economist, the world produced, in the years since World War II, seven times more goods than throughout all history. This is well appreciated by lay people, but has hardly affected social scientists. They do not have the conceptual apparatus for understanding accelerated material-technical change and its meaning for people's personal lives, for their ways of relating to them-selves and to the outside world. Of course, a great deal of speculation about emerging life forms in (...) industrialised societies exists and social scientists with a futuristic bend have projected their diverse visions upon public debates, ranging from thc Efficient Hedonism of "post-industrialist' society a la Daniel Bell to the “Responsible Convivialism” of 'post-materialist" critics such as Fritz Schumacher. Competing images of the coming "services society" or "self-service society" share a central concern: the ongoing relation between tile spheres of large organisations and personal lifestyles, between salaried work arid private consumption. They also share a eel-tau' implausibility: few people recognize themselves in either projection. And they sham ubiquitous reference to "technology", without accounting for it in real terms. A good diagnostic of what is actually happening seems to me to be Jonathan Gershuny, who sees a drift toward a particular type of self-service economy: a quite radical shift in the mode of provision of social services, as he calls it, based on new kinds of consumer technologies. Industrialization used to be partial, but is becoming total fast. This process obviously has many facets, the one I am interested in here is the intrusion of modern technology into spheres of life which in the past have been relatively little dependent on it. (shrink)

The anti-counterfeiting trade agreement was originally meant to harmonise and enforce intellectual property rights provisions in existing trade agreements within a wider group of countries. This was commendable in itself, so ACTA’s failure was all the more disappointing. In this article, I wish to contribute to the post-ACTA debate by proposing a specific analysis of the ethical reasons why ACTA failed, and what we can learn from them. I argue that five kinds of objections—namely, secret negotiations, lack of (...) consultation, vagueness of formulation, negotiations outside any international body, and the creation of a new governing body outside already existing forums—had only indirect ethical implications. This takes nothing away from their seriousness but it does make them less compelling, because agreements should be evaluated, ethically, for what they are, rather than for the alleged reasons why they are being proposed. I then argue that ACTA would have caused three ethical problems: an excessive and misplaced kind of responsibility, a radical decrease in freedom of expression, and a severe reduction in information privacy. I conclude by indicating three lessons that can help us in shaping a potential ACTA 2.0. First, we should acknowledge the increasingly vital importance of the framework of implicit expectations, attitudes, and practices that can facilitate and promote morally good decisions and actions. ACTA failed to perceive that it would have undermined the very framework that it was supposed to foster, namely one promoting some of the best and most successful aspects of our information society. Second, we should realise that, in advanced information societies, any regulation affecting how people deal with information is now bound to influence the whole ‘onlife’ habitat within which they live. So enforcing IPR becomes an environmental problem. Third, since legal documents, such as ACTA, emerge from within the infosphere that they affect, we should apply to the process itself, which one day may lead to a post-ACTA treaty, the very framework and ethical values that we would like to see promoted by it. (shrink)

It is sometimes thought that the normative justification for responding to large-scale violations of human rights via the judicial appararatus of trial and punishment is undermined by the desirability of reconciliation between conflicting parties as part of the process of conflict resolution. I take there to be philosophical, as well as practical and psychological issues involved here: on some conceptions of punishment and reconciliation, the attitudes that they involve conflict with one another on rational grounds. But I shall argue (...) that there is a conception of political reconciliation available which does not involve forgiveness and this forms of reconciliation may be the best we can hope for in many conflicts. Reconciliation is nevertheless likely to require the expression of what Darrell Moellendorf has called 'political regret' and the denunciatory role aspect of punishment makes it particularly well-suited to this role. (shrink)

Criminal law theory made a significant advance roughly thirty years ago when George Fletcher popularized the important conceptual distinction between justifications and excuses. In the intervening years, however, very little progress has been made in exploring the structure and function of justification defenses. The reason for this failure, I suggest, is a widely shared misconception about their place within the criminal law’s institutional structure. Contrary to what is generally believed, it is not up to trial courts to decide ex (...) post facto what conduct is justified and what is not. This determination is made ex ante by other institutional actors such as private fiduciaries, public officials, and sometimes, ordinary citizens caught in extraordinary circumstances. The court’s role is simply to review the validity of that prior exercise of decision-making discretion. More broadly, my study is intended to serve as a reminder of the importance of institutional structure in criminal law. It is almost always misleading to address issues in criminal law by way of abstract moral theorizing, as is often done, because this leaves out the crucial question of institutional division of labor. Before addressing the substantive aspect of particular questions—what conduct should be prohibited, justified, or excused—we must first address ourselves to the institutional questions that I have called the problems of authority, discretion, and legality. These institutional questions receive their most thorough treatment in two other areas of law: the private law of fiduciaries and public administrative law. If we wish to make progress in understanding justification defenses—and the institutional structure of criminal law more generally—I argue that it is to these areas of law that we should attend. (shrink)

The monograph is an English, expanded and revised version of the book Cheshko, V. T., Ivanitskaya, L.V., & Glazko, V.I. (2018). Anthropocene. Philosophy of Biotechnology. Moscow, Course. The manuscript was completed by me on November 15, 2019. It is a study devoted to the development of the concept of a stable evolutionary human strategy as a unique phenomenon of global evolution. The name “An Evolutionary Metaphysics (Cheshko, 2012; Glazko et al., 2016). With equal rights, this study could be entitled “Biotechnology (...) as a result and factor of the evolutionary processˮ. The choice in favor of used “The Evolutionary Metaphysics of Human Enhancement Technologiesˮ was made in accordance with the basic principle of modern post-academician and human-sized science, a classic example of which is biotechnology. The “Metaphysics of Evolution” and “Evolutionary Metaphysics” concepts are used in several ways in modern philosophical discourse. In any case, the values contain a logical or associative reference to the teleological nature of the evolutionary process (Hull, 1967, 1989; Apel, 1995; Faye, 2016; Dupre, 2017; Rose, 2018, etc). In our study, the “evolutionary metaphysics” serves to denote the thesis of the rationalization and technologization of global evolution and anthropogenesis, in particular. At the same time, the postulate of an open future remains relevant in relation to the results of the evolutionary process. The theory of evolution of complex, including the humans system and algorithm for its constructing are а synthesis of evolutionary epistemology, philosophical anthropology and concrete scientific empirical basis in modern science. ln other words, natural philosophy is regaining the status bar element theoretical science in the era of technology-driven evolution. The co-evolutionary concept of 3-modal stable evolutionary strategy of Homo sapiens is developed. The concept based оn the principle of evolutionary complementarity of anthropogenesis: value of evolutionary risk and evolutionary path of human evolution are defined bу descriptive (evolutionary efficiency) and creative-teleological (evolutionary correctness) parameters simultaneously, that cannot bе instrumental reduced to others ones. Resulting volume of both parameters define the vectors of blological, social, cultural and techno-rationalistic human evolution Ьу two gear mechanism genetic and cultural co-evolution and techno-humanitarian balance. The resultant each of them сап estimated Ьу the ratio of socio-psychological predispositions of humanization / dehumanization in mentality. Explanatory model and methodology of evaluation of creatively teleological evolutionary risk component of NBIC technological complex is proposed. Integral part of the model is evolutionary semantics (time-varying semantic code, the compliance of the blological, socio-cultural and techno-rationalist adaptive modules of human stable evolutionary strategy). It is seem necessary to make three clarifications. First, logical construct, “evolutionary metaphysics” contains an internal contradiction, because it unites two alternative explanatory models. “Metaphysics”, as a subject, implies deducibility of the process from the initial general abstract principle, and, consequently, the outcome of the development of the object is uniquely determined by the initial conditions. Predicate, “evolutionary”, means stochastic mechanism of realizing the same principle by memorizing and replicating random choices in all variants of the post-Darwin paradigm. In philosophy, random choice corresponds to the category of “free will” of a reasonable agent. In evolutionary theory, the same phenomenon is reflected in the concept of “covariant replication”. Authors will attempt to synthesize both of these models in a single transdisciplinary theoretical framework. Secondly, the interpretation of the term “evolutionary (adaptive) strategyˮ is different from the classical definition. The difference is that the adaptive strategy in this context is equivalent to the survival, i.e. it includes the adaptation to the environment and the transformation (construction) of the medium in accordance with the objectives of survival. To emphasize this difference authors used verbal construction “adaptiveˮ (rather than “evolutionaryˮ) strategy as more adequate. In all other cases, the two terms may be regarded as synonymous. Thirdly, the initial two essays of this series were published in one book in 2012. Their main goal was the development of the logically consistent methodological concept of stable adaptive (evolutionary) strategy of hominines and the argumentation of its heuristic possibilities as a transdisciplinary scientific paradigm of modern anthropology. The task was to demonstrate the possibilities of the SESH concept in describing and explaining the evolutionary prospects for the interaction of social organization and technology (techno-humanitarian balance) and the associated biological and cultural mechanisms of the genesis of religion (gene-cultural co-evolution). In other words, it was related to the sphere of cultural and philosophical anthropology, i.e. to the axiological component of any theoretical constructions describing the behavior of self-organizing systems with human participation. In contrast, the present work is an attempt to introduce this concept into the sphere of biological anthropology and, consequently, its main goal is to demonstrate the possibility of verification of its main provisions by means of procedures developed by natural science, i.e. refers to the descriptive component of the same theoretical constructions. The result of this in the future should be methods for assessing, calculating and predicting the risk of loss of biological and cultural identity of a person, associated with a permanent and continuously deepening process of development of science and technology. (shrink)

The high number of Dengue Hemorrhagic Fever (DHF) cases from year to year and the endemic status of DHF in Kutaraja District, Banda Aceh City encourages us to always make efforts to reduce the morbidity rate of DHF. The involvement of elementary school teachers is very important to participate in DHF control which will teach their students. This study was conducted to assess the effect of before and after administration of the DHF learning module on the average knowledge score of (...) 90 grade IV and V elementary school students in the Kutaraja District, Banda Aceh City. The quasi-experimental method and Focus Group Discussions involving schools and Puskesmas when designing DHF learning modules were conducted. One-group pretest-posttest design, consisting of 25 questions that were analyzed using the Wilcoxon Signed Ranks Test. The study results obtained an average pre-test score of 76.6% and a post-test average value of 90.6%. The DHF learning module was able to increase elementary school students' knowledge. The provision of DHF material by elementary school teachers through modules can be done to students to increase students' knowledge so that they can participate in reducing the incidence of dengue hemorrhagic fever. (shrink)

Available reports provide an account of academic staff’s poor job performance in higher education institutions and universities in particular. Consequently, a growing body of research has been attracted to this area, including those seeking ways to understand the problem and others aimed at proffering solutions. This study contributes to the literature by investigating the influence of occupational stress on the job performance of academic staff in universities. Three null hypotheses directed the study in line with the quantitative ex-post facto (...) research design. A sample of 150 respondents was obtained using the systematic random sampling technique from a population of 400 lecturers in the Faculty of Education from two public universities in Nigeria. A 31-item questionnaire was used for data collection. The null hypotheses were tested at the .05 alpha level using simple linear regression analysis. It was revealed that remuneration is a significant positive predictor of academic staff job performance. The prediction of workload was negatively non-significant on the job performance of academics. The provision of institutional amenities has a positive but non-significant prediction on academic staff job performance in the two public universities. It was concluded that occupational stress significantly influences the job performance of lecturers in universities. The study recommended that the government constantly pay lecturers’ salaries as and when due. Institutional managers should reward lecturers with outstanding performance to boost their morale for effective service delivery. (shrink)

The literature on the history of electricity production have studied the evolution of electricity in both developed and developing countries and its impact on their economies. Some have laid foundations upon which other works are carried out. A close examination of historiography and multidisciplinary research on electricity production in Ghana shows that more efforts are required to improve the electric power landscape in Ghana. From the colonial era, the increasing demand for electricity has been the biggest challenge plaguing the energy (...) sector. Respective governments have made significant strides in ensuring reliable and universal access to electricity throughout Ghana, yet such efforts have been accompanied by different levels of challenges. The study uses a qualitative and exploratory research approach to trace the activities that helped, in many other ways to the creation of a sustainable electric power provision to household and industry in Ghana, particularly in two of Ghana’s cities; Accra and Kumasi, within the period 1900 to the1960s. The work focused mainly on archival sources in its quest to arrive at how indigenous Ghanaians provided power for industrial activities and for household purposes. Results from the study show that local and cottage industries relied predominantly on wood, fuel, and biomass for their operations even before the introduction of the more sophisticated means of power generation. Also, the study revealed that in finding solutions to the challenges of electricity production, policymakers have focused more on current issues with little or no effort to trace the historical foundation of electricity production. This notwithstanding, the little efforts that have been made examined the history of energy production, with a limited focus on the immediate post-independence era. (shrink)

The paper deals with the basic concepts and key problems of creating financial stability, as well as the role of central banks in its provision. The role of central banks in providing financial stability is extremely important and has a double manifestation - is the maintenance of the stability of the national currency and the responsibility for the stability of commercial banks and the banking system. The central element of any financial system is always banks, so the emergence of systemic (...) instability in the banking sector always has a negative impact on financial stability in general and has extremely negative socio - economic implications for the country as a whole. The present study provides a thorough analysis of the essence of financial stability, the main challenges faced by central banks in monitoring financial sector and examines the global experience of central banks of different countries to ensure financial stability and their role in these processes. This paper highlights the common and distinctive features of the activities of the central banks of the most developed and developing countries towards the achievement of financial stability. Our paper focuses on the activities of the National Bank of Ukraine. In particular, its role in ensuring financial stability of the country is described and directions of its consolidation are indicated. The major task of the National Bank of Ukraine on the way to financial stability in the post -crisis period selected, the maximum possible mitigation Ukrainian banks consequences of the global financial crisis; increase of financial stability of banking institutions; strengthening of public confidence in banks and the banking system. As a result of the conducted, the key factors of achievement of the set tasks, as well as the main directions of application of monetary instruments of the National Bank of Ukraine in the activities aimed at increasing the stability of banks and ensuring financial stability, were determined. (shrink)

The purpose of the article is to analyze aspects of organizational culture of professional ethics in the travel and hospitality industry and to work out recommendations for improvement in the context of the transition to sustainable tourism. The methodological basis of the study is: a) a systematic approach that allowed to consider professional ethics not only its structural components, but also with functional connections and relationships; b) professiographic approach, which discovered the specifics of professional work in the tourism industry; c) (...) statistical approach, that allowed to assess performance of the branch. The article reviews the principles, elements and features of tourism industry and organizational culture of professional ethics at certain stages of production and/or services provision process; contains the author’s definition of professional ethics in terms of sustainable (ethical, socially responsible) tourism; proposes recommendations for the implementation of an ethical approach to the relevant industry companies operations. Tourism is important both in terms of ensuring economic development and social well-being. In recent years, as international experience argues, the competitiveness of the industry increasingly depends on human factors, including professional ethics. It promotes mutual understanding between (among) individuals, people, cultures; serves as a source of tolerance, new knowledge, respect and differences understanding. On the one hand, such a situation is explained by the requirements of society troubled with vulnerability of clients, national traditions and the environment caused by companies irresponsibility; on the other hand, the interest of the business community is to reduce costs, to increase longterm profits, confidence in sustainability of the business relationship, to implement the right choice of the alternatives to encourage such behavior in others. At the same time, ignoring the basic principles of ethical professional conduct by the organization is accompanied with unforeseen losses; causes an uncontrolled flow of trials, applying civil and criminal sanctions by regulators, losses of employees’ loyalty, customers and business partners, chaos in relationships, staff turnover, etc. All abovementioned determines the practical significance of the research. (shrink)

With the passage and implementation of the “first-to-file” provisions of the America Invents Act of 2011, the U.S. patent system must rely more than ever before on patent documents for its own ontological commitments concerning the existence of claimed kinds of useful objects and processes. This Article provides a comprehensive description of the previously unrecognized function of the patent document in incurring and securing warrants to these ontological commitments, and the respective roles of legal doctrines and practices in the (...) patent system’s ontological project. Among other contributions, the resulting metaphysical account serves to reconcile competing interpretations of the written description requirement that have emerged from the Federal Circuit’s recent jurisprudence, and to explain why the patent system is willing and able to examine, grant and enforce claims reciting theoretical entities. While this Article is entirely descriptive, it concludes by identifying promising normative and prescriptive implications of this work, including the formulation of an appropriate test for the patent-eligibility of software-implemented inventions in the post-Bilski era. (shrink)

Introduction: Liposomal bupivacaine (LB) is a long-acting analgesic that, due to its liposomal formulation, purportedly extends its analgesic effect up to 72 hours. However, the clinical efficacy of LB appears mixed. This systematic review seeks to evaluate the effectiveness of liposomal bupivacaine in improving postoperative outcomes compared to ropivacaine (ROPI), another commonly used long-acting analgesic. -/- Materials and Methods: Prospective and randomized controlled trials (RCTs) evaluating the efficacy of LB compared to ROPI were selected for review. Primary outcomes included hospital (...) length of stay (LOS) and postoperative opioid consumption measured in oral morphine equivalents (OME). Secondary outcomes included analgesic cost. -/- Results: 14 studies met the review criteria. We found that LB and ROPI are equivalent in managing postoperative pain. 8 of the 14 trials reported equal efficacy between LB and ROPI as determined by OME post-procedure and 10 of the 14 trials reported similar LOS after surgery. These findings remained consistent across multiple surgical procedures and multiple drug administrative modalities. -/- Conclusion: Our systematic review found that LB was not superior to ROPI in reducing postoperative OME use and hospital LOS. The only consistent finding was the significantly increased cost of LB compared to that of ROPI. Therefore, the use of LB over ROPI cannot be justified. (shrink)

This is a trend study of School Size, Location and Enrolment Figures of Junior secondary schools in Akwa Ibom State of Nigeria covering 2008 – 2016 with implications on sustainable development. The study was tailored to follow the ex-post facto research design. This study was a census, hence the entire population of 227 public secondary schools were used. Secondary quantitative data were obtained using “School Size, Location and Enrolment Figures Checklist (SSLEFC)” were analysed using descriptive statistics, while line graphs (...) and bar charts were used to illustrate the statistical trends. The hypotheses were tested using the independent t-test statistical approach. Findings showed that higher rates of enrolment were recorded in large and urban schools than in small schools and rural schools respectively. The mean differences in the enrolment trend among urban and provincial schools were factually huge. It was presumed that there is an upward pattern in enrolment in all the schools from 2008 – 2013 and a descending pattern from 2015– 2016. Based on this conclusion, implications were discussed, while it was recommended, among others, that infrastructural provisions and adequate supply of qualified personnel be allocated to urban and rural schools evenly, to discourage rural-urban migration but promote active rural participation in Education, as well as foster sustainability in schools. (shrink)

This study assessed two motivational strategies and their respective ties to the service delivery in public universities in Cross River State. In achieving the central and specific targets of this research, four research questions and two null hypotheses were answered and tested in the study. The entire population of 440 security personnel in two public universities was studied, based on the census approach and following the ex-post facto research design. Three sets of expert-validated questionnaires, with Cronbach reliability estimates of (...) 0.80, 0.79 and 0.83 respectively, were used for data collection. Collected data were analysed using descriptive statistics and inferential statistics such as Pearson Product Moment Correlation and the One-way ANOVA. The level of incentives provision and security service delivery in universities was moderate. There were notable disparities between promotion, provision of incentives and security service delivery in universities. Security personnel discharged, on average, services beyond the extent of promotion and incentives provided to them. Provision of incentives did not relate significantly to security service delivery; however, staff promotion significantly influences security service delivery in universities. It was concluded that there are loopholes in the motivational practices of universities for security personnel. The service delivery of security personnel at universities in Cross River State is yet to be at an acceptable point that can promote institutional safety and goal attainment in the short- and long run. It was recommended, among other things, that security personnel who are due for promotion should not be denied such an opportunity, as it represents one of the strongest motivational factors in universities. (shrink)

Many anthropologists interpret neoliberalism as a radical break from and dangerous rupture in post-war societies that featured Keynesian economic policies and welfare provision. The allure of a mythic welfare state has boosted John Maynard Keynes’s popularity to many who embrace certain facets of socialism. Many critical social scientists have embraced Keynesianism in ways that overlook how the US used Keynesian policies to reengineer and redeploy state power. Keynes’s liberal synthesis inspired managers in the US Treasury Department to understand depression-era (...) problems of unemployment and poverty in ways that were consonant with the expansion of corporate power. For understanding Keynesianism, as it actually existed during the Cold War, we must analyse how the US Treasury and State Departments used Keynesian principles to rebuild the social reproductive capacities necessary for capitalist accumulation both domestically and in Western Europe. I focus on how the architects of postwar capitalism used full employment policies, labour laws and welfare provision to renovate the nexus of political practices and institutional structures in ways that formed a benevolent and caring image of ‘the state’ and the myth of a class compromise. Through these reforms, governmental planners and administrators used the ‘state idea’ to reorganize capital accumulation as if the post-war economy would represent ordinary people’s best interests. In the process, these sophisticated practices of power became reified as the ‘welfare state’ and the ‘Keynesian compromise’ in ways that endow these institutions and policies with a character divorced from practices of power. The post-war state embodied a dialectic of repression and reform that combined criminalizing dissent with full employment policies and welfare provision. Taking these aspects of power into account, we can see post-war Keynesianism in ways that inspire a robust and far-reaching criticism of the contemporary predicament of economic uncertainty, political instability and environmental degradation. (shrink)

Diversity in Indonesia raises the tolerance problem. The research goal to find guidance and counseling services right to develop character tolerance. The goals of this research is developing of models group gudance with folklore methode as alternative developing tolerance character. This research use Research and development as an approach. Research and development steps include preliminary study, development hypothetical group guidance model-based folklore, validation of expert judgment and expert practitioners, experimental test form group guidance model- based folklore on a limited basis (...) — descriptive qualitative and descriptive quantitative in research analysis. Group guidance services consisted of 8-9 students from Yogyakarta City, Bantul Regency, Sleman Regency, Kulonpogo Regency, and Gunungkidul Regency (Indonesia Country The result from this research that group guidance with folklore methode can incrase the tolerance character of students. The result of the limited trial appears that there was a change of condition before pre-test with an average of 109 and an increase of 117.9 after post-test in implementation of group guidance service with folklore method. The T-test results also reveal significant changes from before to after the significance of 0.000 (<0.05). (shrink)

We simulate trial data to test speculative claims about research methods, such as the impact of publication bias.