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- (...) class='Hi'>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.

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)

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)

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)

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)

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)

¿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)

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)

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)

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)

The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular (...) institutional role. I examine two types of institutional contexts: (1) public research agencies – agencies or departments of states that fund or conduct clinical research in the public interest; and (2) private-for-profit corporations. I argue that investigators who are employed or have their research sponsored by the former have a distinctive institutional obligation to conduct their research in a way that is consistent with the state's duty of distributive justice to provide its citizens with access to basic health care, and its duty to aid citizens of lower income countries. By contrast, I argue that investigators who are employed or have their research sponsored by private-for-profit corporations do not possess this obligation nor any other institutional obligation that is directly relevant to the ethics of RCTs. My account of the institutional obligations of investigators aims to contribute to the development of a reasonable, distributive justice-based account of standard of care. (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. -/- .

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)

In response to commentators, we argue that whether waiving patent rights will meaningfully improve access to COVID-19 vaccines for low income and middle-income countries (LMICs), particularly in the short term, is an empirical matter. We also reject preferentially allocating vaccines to countries that hosted trials because doing so unethically favours those with research infrastructure, rather than those facing the worst burdens from COVID-19.

Deep Brain Stimulation is currently being investigated as an experimental treatment for patients suffering from treatment-refractory AN, with an increasing number of case reports and small-scale trials published. Although still at an exploratory and experimental stage, initial results have been promising. Despite the risks associated with an invasive neurosurgical procedure and the long-term implantation of a foreign body, DBS has a number of advantageous features for patients with SE-AN. Stimulation can be fine-tuned to the specific needs of the particular patient, (...) is relatively reversible, and the technique also allows for the crucial issue of investigating and comparing the effects of different neural targets. However, at a time when DBS is emerging as a promising investigational treatment modality for AN, lesioning procedures in psychiatry are having a renaissance. Of concern it has been argued that the two kinds of interventions should instead be understood as rivaling, yet “mutually enriching paradigms” despite the fact that lesioning the brain is irreversible and there is no evidence base for an effective target in AN. We argue that lesioning procedures in AN are unethical at this stage of knowledge and seriously problematic for this patient group, for whom self-control is particularly central to wellbeing. They pose a greater risk of major harms that cannot justify ethical equipoise, despite the apparent superiority in reduced short term surgical harms and lower cost. (shrink)

It is a truism to say that we live in a world that has been deeply shaped by imperialism. The history of humanity is, in many ways, a story of the attempted and achieved subjugation of one people by another, and it is unsurprising that such interaction has had profound effects on the contemporary world, affecting cultural understandings of community identity; the composition of, and boundaries between, modern day states; and the distribution of resources between different communities. This chapter addresses (...) the claim that some contemporary states may possess obligations to pay reparations as a result of the lasting effects of a particular form of historic imperialism: colonialism. Claims about the harms and benefits caused by colonialism must make some kind of comparison between the world as it currently is, and a counterfactual state where the injustice which characterised so much of historic interaction between colonisers and the colonised did not occur. Rather than imagining a world where there was no such interaction, this chapter maintains that the appropriate counterfactual is one where relations between different communities were characterized by an absence of domination and exploitation. This means that current day states may possess reparative duties which are much more extensive than is often supposed. (shrink)

The trial took place at Bristol Crown Court, England, United Kingdom for the murder of Joanna Yeates, and Dr Vincent Tabak was the Defendant. The author attended at court for this trial and this paper notes many of the obvious and unsatisfactory legal and procedural points in this trial. Dr Vincent Tabak was convicted of the murder at this trial. Of course the jury were not to know the finer points of law as the lower court (...) judge did not advise the jury of any such points before they adjourned to make their decision. All but one concluded that Dr Tabak was guilty as charged, although even the charge was vague and all-encompassing as he was charged with ‘murder between Friday 17 December 2010 and Sunday 19 December 2010’. Defence counsel, very eminent barrister-at-law, appeared to be cowed by the other side and let them walk all over this case procedurally. For example, prosecution counsel handed him 1200 pages of evidence on the first day of the trial, as if to FULFIL disclosure obligations. E was stunned and asked the court for time off. But this was never again discussed. -/- The lower court judge appeared as if he had already decided on the case. When Defence Counsel asked him if he had before him a copy of a certain document, he flippantly say he had it but had left it on his desk in his room. When Defence Counsel, of international renown, was ready to present his opening speech and cross-examination of his client, Dr Vincent Tabak, this lower court judge dismissed the jury to their lunch break knowing that counsel was going to speak. Court had to be adjourned and the members of the jury quickly assembles by the court porters as they were leaving the court, which must have hampered their interest in what counsel’s statement said. A photograph of a dead body by a roadside, allegedly, Miss Yeates, was shown by projector slide a dozen irrelevant times during the trial period, thus embedding that photograph in the jury’s mind. The computer evidence leaves much to be desired and could, some suggested, easily have been concocted by the prosecution team, abusing the law of metadata evidence. Te lady who presented it did not give the court her qualifications and her expertise if any- and much more that beggars belief and loses trust in the British Criminal Justice System, such as it is, following ‘form over substance’. -/- . (shrink)

In times of crises, public health leaders may claim that trials of public health interventions are unethical. One reason for this claim can be that equipoise—i.e. a situation of uncertainty and/or disagreement among experts about the evidence regarding an intervention—has been disturbed by a change of collective expert views. Some might claim that equipoise is disturbed if the majority of experts believe that emergency public health interventions are likely to be more beneficial than harmful. However, such beliefs are not always (...) justified: where high quality research has not been conducted, there is often considerable residual uncertainty about whether interventions offer net benefits. In this essay we argue that high-quality research, namely by means of well-designed randomized trials, is ethically obligatory before, during, and after implementing policies in public health emergencies (PHEs). We contend that this standard applies to both pharmaceutical and non-pharmaceutical interventions, and we elaborate an account of equipoise that captures key features of debates in the recent pandemic. We build our case by analyzing research strategies employed during the COVID-19 pandemic regarding drugs, vaccines, and non-pharmaceutical interventions; and by providing responses to possible objections. Finally, we propose a public health policy reform: whenever a policy implemented during a PHE is not grounded in high-quality evidence that expected benefits outweigh harms, there should be a planned approach to generate high-quality evidence, with review of emerging data at preset time points. These preset timepoints guarantee that policymakers pause to review emerging evidence and consider ceasing ineffective or even harmful policies, thereby improving transparency and accountability, as well as permitting the redirection of resources to more effective or beneficial interventions. (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)

The potential for vaccines to prevent the spread of infectious diseases is crucial for vaccination policy and ethics. In this paper, I discuss recent evidence that the current COVID-19 vaccines have only a modest and short-lived effect on reducing SARS-CoV-2 transmission and argue that this has at least four important ethical implications. First, getting vaccinated against COVID-19 should be seen primarily as a self-protective choice for individuals. Second, moral condemnation of unvaccinated people for causing direct harm to others is unjustified. (...) Third, the case for a harm-based moral obligation to get vaccinated against COVID-19 is weak. Finally, and perhaps most significantly, coercive COVID-19 vaccination policies (e.g., measures that exclude unvaccinated people from society) cannot be directly justified by the harm principle. (shrink)

Weighing competing obligations and achieving the “greatest balance” of right over wrong guides an individual, an agency or a country in determining what ought to be done in an ethically challenging situation. Conducting controlled human infection model (CHIM) studies in India is one such situation. The ethical challenge in conducting a CHIM study lies in completing the difficult task of introducing standardised, attenuated strains of micro-organisms into normal healthy volunteers, at the same time ensuring the safety of these healthy (...) individuals from potential and completely informed risks in a fashion that is transparent and accountable. The bar is further raised against the background of already fragile public confidence in biomedical research in India; especially when “deliberate” introduction of microbial agents into healthy individuals is involved, with the larger altruistic objective of gain to society as a whole. -/- This paper discusses the uses of CHIM studies with respect to the larger scientific Indian research enterprise of the 21st century. It further explores etic and emic perspectives in conducting such trials in India and seeks to generate an ethical coherence to the justification for conducting CHIM studies in India. The paper deliberates on ethical issues arising out of conducting CHIM studies and reflects on how developing the capacity for CHIM studies in India is likely to strengthen the health research and development sector in the country. -/- . (shrink)

Kafka's work provoked more than three decades of interpretations before Wagenbach provided information showing that Kafka was quite familiar with the work of Brentano and his Prague followers, including their unique conceptions of natural law, ethical concepts, and human acquaintance with them. Kafka took a lively interest in discussions in this Prague circle, and The Trial may without violence be read as a deliberate illustration for issues in philosophy of law as they would have been understood within this circle. (...) This does not require that it be read as a reflection of Kafka's personality, nor does it require that he accepted Brentano's views. Wagenbach demonstrated Kafka's familiarity with unique conceptions, in the work of Brentano and his Prague followers, of natural law and ethics. Issues involved in these conceptions are cogently illustrated in The Trial. K. is tried for violating a law which is no positive law but a necessary condition for all positive law since all positive laws imply that they ought to be obeyed. Brentano adamantly rejected all forms of nativism. The opposite of 'natural' in the phrase 'natural law' is not 'acquired' but 'conventional.' Acquaintance with natural norms is entirely acquired: persons having no such acquaintance can exist; K. is such a person. Natural norms, have a cognizable inherent correctness; any other norms oblige only through being authoritatively decreed. Conventional guilt or innocence is subject to influence. K.'s quest for a person to exert such influence on his behalf is evidence of his guilt. K. is unaware that absolute guilt is possible. In the Prometheus myth related by Plato's Protagoras, a sense of justice and right is necessary for politically organized society. Without insight into the natural sanction for correct positive laws, citizens cannot fulfill the duty rationally to choose positive laws: citizens will wrong one another, cities perish, humankind will be threatened. The myth gives important clues to the imagery of the parable "Before the Law." Every authentic act of willing requires that something be desired for its own sake. Since there is a plurality of intrinsic goods, authentic action requires recognizing the chosen action to be better than its alternatives. Acquaintance with good, evil, better, and worse is acquired, Brentano insisted, only by perceiving certain affects to be correct. Like judgments, affects are either blind or evident. Basic moral concepts arise like all others from perception. K. could become innocent by acquiring the lacking concepts. Then, actual acquittal would be just despite his guilt when arrested. His trial tests whether he is likely to experience intrinsically correct emotions. Guilt would be objective, independent of any finding by the Court. K.'s guilt entails his lacking any such concept of absolute guilt. He is convinced that guilt depends entirely on the Court, is altogether a matter of authority. This is K.'s delusion concerning his relation to the Court and the Law, the delusion illustrated by the legend, "Before the Law.". (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)

American Muslims increasingly negotiate their relation to a government that is suspicious of Islam, yet which is legally obligated to recognize them as rights-bearing citizens. To better understand how the post-9/11 state is reshaping American Islam, I examine the case of Muslim American dissident Tarek Mehanna, sentenced to seventeen years in prison for providing material support for terrorism, on the basis of his controversial words (USA v. Mehanna et al, 2012). I situate Mehanna’s writing and reflections within a long (...) history of American activism, in particular the traditions represented by Henry David Thoreau and John Brown. -/- . (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)

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)

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)

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)

The field of bioethics is replete with applications of moral theories such as utilitarianism and Kantianism. For a given dilemma, even if it is not clear how one of these western philosophical principles of right (and wrong) action would resolve it, one can identify many of the considerations that each would conclude is relevant. The field is, in contrast, largely unaware of an African account of what all right (and wrong) actions have in common and of the sorts of factors (...) that for it are germane to developing a sound response to a given bioethical problem. My aim is to help rectify this deficiency by first spelling out a moral theory grounded in the mores of many sub-Saharan peoples, and then applying it to some major bioethical issues, namely, the point of medical treatment, free and informed consent, standards of care and animal experimentation. For each of these four issues, I compare and contrast the implications of the African moral theory with utilitarianism and Kantianism, my overall purposes being to highlight respects in which the African moral theory is distinct and to demonstrate that the field should take it at least as seriously as it does the Western theories. (shrink)

Inquiries concerning the theory of imperatives and norms prosecuted in Poland in the 20th century covered practically the whole scope of this theory. In a uniform conceptual scheme, the paper shows main results of this research done mostly within the Lvov-Warsaw School tradition. It begins with presenting the Polish theoreticians’ approach to three correlated theoretical situations containing our preferences (opposed to impulses, decisions and tendencies), accepted values and imposed obligations. The second step is discussing their views on means of (...) verbalising these situations, i.e. by help of imperatives, evaluations and norms (opposed to consultatives, instructions and optatives) correspondingly. The paper is closed with examining the Polish logicians’ trials of reconstruction of imperative-normative argumentation. (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)

Optogenetics is an invasive neuromodulation technology involving the use of light to control the activity of individual neurons. Even though optogenetics is a relatively new neuromodulation tool whose various implications have not yet been scrutinized, it has already been approved for its first clinical trials in humans. As optogenetics is being intensively investigated in animal models with the aim of developing novel brain stimulation treatments for various neurological and psychiatric disorders, it appears crucial to consider both the opportunities and dangers (...) such therapies may offer. In this review, we focus on the memory-modifying potential of optogenetics, investigating what it is capable of and how it differs from other memory modification technologies. We then outline the safety challenges that need to be addressed before optogenetics can be used in humans. Finally, we re-examine crucial neuroethical concerns expressed in regard to other MMTs in the light of optogenetics and address those that appear to be unique to the memory-modifying potential of optogenetic technology. (shrink)

Legal theorists have characterized physical evidence of brain dysfunction as a double-edged sword, wherein the very quality that reduces the defendant’s responsibility for his transgression could simultaneously increase motivations to punish him by virtue of his apparently increased dangerousness. However, empirical evidence of this pattern has been elusive, perhaps owing to a heavy reliance on singular measures that fail to distinguish between plural, often competing internal motivations for punishment. The present study employed a test of the theorized double-edge pattern using (...) a novel approach designed to separate such motivations. We asked a large sample of participants (N = 330) to render criminal sentencing judgments under varying conditions of the defendant’s mental health status (Healthy, Neurobiological Disorder, Psychological Disorder) and the disorder’s treatability (Treatable, Untreatable). As predicted, neurobiological evidence simultaneously elicited shorter prison sentences (i.e., mitigating) and longer terms of involuntary hospitalization (i.e., aggravating) than equivalent psychological evidence. However, these effects were not well explained by motivations to restore treatable defendants to health or to protect society from dangerous persons but instead by deontological motivations pertaining to the defendant’s level of deservingness and possible obligation to provide medical care. This is the first study of its kind to quantitatively demonstrate the paradoxical effect of neuroscientific trial evidence and raises implications for how such evidence is presented and evaluated. (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)

Bernard Williams thought that philosophy should address real human concerns felt beyond academic philosophy. But what wider concerns are addressed by Ethics and the Limits of Philosophy, a book he introduces as being ‘principally about how things are in moral philosophy’? In this article, we argue that Williams responded to the concerns of his day indirectly, refraining from explicitly claiming wider cultural relevance, but hinting at it in the pair of epigraphs that opens the main text. This was Williams’s solution (...) to what he perceived as the stylistic problem of how to pursue philosophy as cultural critique. Taking the epigraphs as interpretative keys to the wider resonances of the book, we show how they reveal Williams’s philosophical concerns – with the primacy of character over method, the obligation to follow orders, and the possibility of combining truth, truthfulness, and a meaningful life in a disillusioned world – to be recognisably rooted in the cultural concerns of post-war Britain. In the light of its epigraphs, the book emerges as the critique of a philosophical tradition’s inadequacies to the special difficulties of its cultural moment. (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)

This essay engages with Bernard Stiegler’s discussion with Martin Heidegger in The ordeal of Truth, published in Foundations of Science 2020. It appreciates Stiegler’s progressive reading of Heidegger’s work but critically reflects on several elements in his work. A first element is the methodological aspect of Heidegger’s being historical thinking, which is missed by Stiegler and confirms the indifference towards philosophical method that can be found in the work of many contemporary philosophers. A second element concerns Heidegger’s and Stiegler’s remaining (...) humanism and the necessity to move beyond humanism and post-humanism in the era of global warming. A third element of reflection concerns Stiegler’s idea of the obligation of making our being-in-default come true, which shows a hidden metaphysical orientation in his work. (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)

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)

Research on the use of propranolol as a pharmacological memory dampening treatment for post-traumatic stress disorder is continuing and justifies a second look at the legal and ethical issues raised in the past. We summarize the general ethical and legal issues raised in the literature so far, and we select two for in-depth reconsideration. We address the concern that a traumatized witness may be less effective in a prosecution emerging from the traumatic event after memory dampening treatment. We analyze (...) this issue in relation to sexual assault, where the suggestion that corroborating evidence may remedy any memory defects is less likely to be helpful. We also consider the clinical ethical question about a physician's obligation to discuss potential legal consequences of memory dampening treatment. We conclude that this latter question reflects a general problem related to novel medical treatments where the broader socio-legal consequences may be poorly understood, and suggest that issues of this sort could usefully be addressed through the promulgation of practice guidelines. (shrink)

My aim is to extend and complement the arguments that others have already made for the claim that women who are citizens of economically disadvantaged states and who have been trafficked into sex work in economically advantaged states should be considered candidates for asylum. Familiar arguments cite the sexual violence and forced labor that trafficked women are subjected to along with their well-founded fear of persecution if they’re repatriated. What hasn’t been considered is that reproductive rights are also at stake. (...) I explain how reproductive rights are implicated in sex trafficking. Moreover, I contend that sex traffickers’ abuse of women’s reproductive rights is persecutory and that that this persecutory abuse obliges destination states to offer asylum to transnational sex trafficking victims. I start by sketching reproductive human rights doctrine. I then examine studies of women who are in post-trafficking recovery programs in order to ascertain the impact of their past experience of forced sex work on their reproductive freedom and health. On the basis of these findings, I maintain that, among other outrages, sex trafficking systematically violates victims’ reproductive human rights. In view of this abuse, women trafficked into sex work might seem to be prime candidates for asylum in destination states. Yet, economically well-off destination states are not particularly receptive to this idea, and international law provides some justification for their chilliness. Preliminary to challenging them, I explicate four ways in which international anti-trafficking law and international refugee law interfere with viewing women trafficked into sex work as refugees and approving their applications for asylum. The second half of my paper aims to overcome those legal obstacles. In the interest of parsimony and because there are many continuities between U.S. refugee law and anti-trafficking law and the policies of similar destination states, I focus mainly on the U.S. in this part of the paper. To anchor my argument, I spotlight two precedents in refugee law for taking reproductive human rights seriously and several precedents for treating trafficked women as members of a distinct social group as required by refugee law. I then urge that a law enforcement gestalt has gained undue influence over U.S. legal practices where anti-trafficking law intersects with refugee protection law. A human rights gestalt is needed as a counterweight, for otherwise victims of sex trafficking and the reproductive abuse they’ve suffered are erased. Taking up a human rights perspective and mobilizing the precedents I’ve identified, I show that respecting the reproductive human rights of women who have been trafficked into sex work entails that affluent destination states must recognize their right to asylum. (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)

The central concern of this paper is to explore the efforts of Schiller's post-Kantian idealism and Marcuse's critical theory to develop a new conception of free human experience. That conception is built on the notion of play. Play is said to combine the human capacities for physical pleasure and reason, capacities which the modern world has dualized. Analysis of their respective accounts of play reveals its ambivalent form in the work of both philosophers. Play supports the ideal of ‘freedom (...) from necessity’, understood as a release from all external constraint. But it also appears to serve as a model for ‘freedom as a higher necessity’. In the case of Schiller, the ambivalence encompasses idle play and an obligation to make ourselves worthy of freedom. For Marcuse, play represents a kind of libidinal idleness while also underpinning a non-alienated conception of labour. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Journal of the History of Ideas 61.3 (2000) 453-471 [Access article in PDF] Liberty, Authority, and Trust in Burke's Idea of Empire Richard Bourke When Edmund Burke first embarked upon a parliamentary career, British political life was in the process of adapting to a series of critical reorientations in both the dynamics of party affiliation and the direction of imperial policy. During the period of the Seven Years' War, (...) a reconstituted militia became a focus for patriotic enthusiasm, uniting national sentiment against France and effectively eradicating the remnants of Jacobite rhetoric and aspiration. Traditional opposition between Tory and Whig became irrelevant, while Court and Country jointly came to the support of the Pitt-Newcastle ministry. However, in due course the Old Corps disintegrated as George III succeeded to the throne with the promise of an end to factional strife and the beginning of a patriotic alliance in government. But while competing ideologies and interests on the domestic political scene were undergoing comprehensive realignment, the pursuit of a blue-water policy in tandem with strategic continental campaigns brought Britain's struggle against France into North America, the Caribbean, and India. Trade continued to expand into Asia and West Africa, but the principles of commercial advantage were continually brought into open conflict with the exigencies of war. The division of power in Europe became embroiled in a substantial redivision of empire, and by 1763 British territorial expansion had reached its zenith.When Burke was appointed private secretary to the Marquis of Rockingham, with the national debt standing at an all time high and the demands of imperial defense unlikely to diminish, the politics of empire called for urgent attention from all sections of the political establishment. In particular the Rockinghamites, adopting a posture of aloofness from venality and petty interest, were obliged to advance policies for imperial government on the solid basis of political principle. 1 Coming into parliament as a member for Wendover in the wake of [End Page 453] Grenville's Stamp Act, at a time when the East India Company was assuming control of the revenue in Bengal, Burke set about formulating a doctrine of imperial sovereignty which would be serviceable to the party either in power or in opposition and which would be adequate to the complex reality of detached and extensive empire. The immediate reception of that inquiry, both in Britain and on the Continent, into the fraught world of post-Revolutionary political debate has had the long-term effect of distorting the order of emphasis in terms of which his career as a whole ought properly to be understood.The vigorous elaboration, in opposition to the Jacobin experiment in France, of the conditions under which moderate government could be exercised within the context of an absolute sovereignty was expressed in terms which had originally been invoked as part of a sustained attempt to reconcile civility with empire. As we shall see, that attempt involved a process of delicate coordination by means of which the interests of freedom would be brought into harmony with the demands of public power. In that sense the effort to make liberty and authority mutually responsible can be said to constitute the core ambition of Burke's political rhetoric. In this context responsibility defines the optimally beneficial relation between government and people on the one hand and national sovereignty and the extended empire on the other. This article outlines the practical and theoretical exploration of those relations within the frame of Burke's intervention in the world of eighteenth-century political discourse.Burke was of course well placed in 1765 to evolve a theory of imperial government that was at once ideologically compelling and politically viable. In his capacity as secretary to William Gerard Hamilton in the early 1760s he had already examined the corruption of legitimate empire as represented by the introduction of penal legislation into Ireland after 1694. The Tracts Relating to Popery Laws set out to convict the Irish Parliament in Dublin of flagrant misrule. A subordinate legislature within the empire is charged with having employed... (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)

Our sense in editing this book is that the years since 2014 have shown that, however unpalatable, incoherent, and internally contradictory illiberal democracy may be, it is a political choice that is available at the ballot box in many countries. As critical scholars committed to democracy we have an obligation to understand its socio-historical construction, its emotional appeal, and its rhetorical force, to more effectively combat it. Ultimately, we believe that the difficulty many have had of admitting the political efficacy (...) of illiberal democracy as a term is due to an underlying crisis within liberalism itself: this is the fissured terrain that the phenomenon exploits. Examining illiberalism, liberalism, or democracy as static concepts is just as barren an approach as examining them in one country in isolation from their interactions with others. It is above all to the dynamic, comparative, and interdisciplinary approach to the study of liberalism and its alternatives that this collection aims to contribute. (shrink)

I argue that campus closures and shifts to online instruction in the early stages of the COVID-19 pandemic created an obligation to offer courses asynchronously. This is because some students could not have reasonably foreseen circumstances making continued synchronous participation impossible. Offering synchronous participation options to students who could continue to participate thusly would have been unfair to students who could not participate synchronously. I also discuss why ex post facto consideration of this decision is warranted, noting that similar (...) actions may be necessary in the future and that other tough pedagogical cases share important similarities with this case. (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)