Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first propose a categorization (...) of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs. (shrink)

Socrates is one of the most important yet enigmatic philosophers of all time; his fame has endured for centuries despite the fact that he never actually wrote anything. In 399 B.C.E., he was tried on the charge of impiety by the citizens of Athens, convicted by a jury, and sentenced to death (ordered to drink poison derived from hemlock). About these facts there is no disagreement. However, as the sources collected in this book and the scholarly essays that follow them (...) show, several of even the most basic facts about these events were controversial in antiquity, and the questions persist today: How and why was Socrates brought to trial? Why did the jurors, members of the world's first democracy, find him guilty? When he was given an opportunity to escape execution, why did he refuse to do so and instead accept the punishment that he and his friends agreed was unjustly assigned to him? How exactly did Socrates die? Differences of opinion on these and other issues continue to arouse our curiosity and to challenge new generations of students and scholars. The Trial and Execution of Socrates: Sources and Controversies is the first work to collect in one place all of the major ancient sources on Socrates' death--those of both his critics and his defenders--as well as recent scholarly views. Part I includes new translations of Plato's Euthyphro, Apology, Crito, and the death scene from Phaedo, as well as other ancient sources that shed light on Socrates' trial and execution. Part II features some of the most influential recent scholarship on this historically momentous event with work by M. F. Burnyeat, Robert Parker, Mark L. McPherran, Thomas C. Brickhouse and Nicholas D. Smith, Richard Kraut, Christopher Gill, and Enid Bloch (whose essay is published here for the first time). Ideal for undergraduate surveys of ancient Greek philosophy and upper-level courses on Socrates and Socratic philosophy, this unique collection provides an unprecedented look into the many perplexing questions surrounding the trial and execution of this remarkable man. (shrink)

Impossible love -- Between nature and culture -- Surviving, forever foreign -- Cryptic crossing -- Touching transcendence, in the flesh -- The tragedy of Christianity.

Socrates is one of the most important yet enigmatic philosophers of all time; his fame has endured for centuries despite the fact that he never actually wrote anything. In 399 B.C.E., he was tried on the charge of impiety by the citizens of Athens, convicted by a jury, and sentenced to death. About these facts there is no disagreement. However, as the sources collected in this book and the scholarly essays that follow them show, several of even the most basic (...) facts about these events were controversial in antiquity, and the questions persist today: How and why was Socrates brought to trial? Why did the jurors, members of the world's first democracy, find him guilty? When he was given an opportunity to escape execution, why did he refuse to do so and instead accept the punishment that he and his friends agreed was unjustly assigned to him? How exactly did Socrates die? Differences of opinion on these and other issues continue to arouse our curiosity and to challenge new generations of students and scholars. The Trial and Execution of Socrates: Sources and Controversies is the first work to collect in one place all of the major ancient sources on Socrates' death--those of both his critics and his defenders--as well as recent scholarly views. Part I includes new translations of Plato's Euthyphro, Apology, Crito, and the death scene from Phaedo, as well as other ancient sources that shed light on Socrates' trial and execution. Part II features some of the most influential recent scholarship on this historically momentous event with work by M. F. Burnyeat, Robert Parker, Mark L. McPherran, Thomas C. Brickhouse and Nicholas D. Smith, Richard Kraut, Christopher Gill, and Enid Bloch. Ideal for undergraduate surveys of ancient Greek philosophy and upper-level courses on Socrates and Socratic philosophy, this unique collection provides an unprecedented look into the many perplexing questions surrounding the trial and execution of this remarkable man. (shrink)

Suppose one hundred prisoners are in a yard under the supervision of a guard, and at some point, ninety-nine of them collectively kill the guard. If, after the fact, a prisoner is picked at random and tried, the probability of his guilt is 99%. But despite the high probability, the statistical chances, by themselves, seem insufficient to justify a conviction. The question is why. Two arguments are offered. The first, decision-theoretic argument shows that a conviction solely based on the statistics (...) in the prisoner scenario is unacceptable so long as the goal of expected utility maximization is combined with fairness constraints. The second, risk-based argument shows that a conviction solely based on the statistics in the prisoner scenario lets the risk of mistaken conviction surge potentially too high. The same, by contrast, cannot be said of convictions solely based on DNA evidence or eyewitness testimony. A noteworthy feature of the two arguments in the paper is that they are not confined to criminal trials and can in fact be extended to civil trials. (shrink)

The novelties of the contemporary international order require a rethinking of the normative foundations of criminal justice. Although one can understand the relevance of basic principles such as th...

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)

Objectives To analyse the perspective of clinical research stakeholders concerning post-trial access to study medication. Methods Questionnaires and informed consents were sent through e-mail to 599 ethics committee (EC) members, 290 clinical investigators (HIV/AIDS and Diabetes) and 53 sponsors in Brazil. Investigators were also asked to submit the questionnaire to their research patients. Two reminders were sent to participants. Results The response rate was 21%, 20% and 45% in EC, investigators and sponsors’ groups, respectively. 54 patients answered the questionnaire (...) through their doctors. The least informative item in the consent form was how to obtain the study medication after trial. If a benefit were demonstrated in the study, 60% of research participants and 35% of EC answered that all patients should continue receiving study medication after trial; 43% of investigators believed the medication should be given to participants, and 40% to subjects who participated and benefited from treatment. For 50% of the sponsors, study medication should be assured to participants who had benefited from treatment. The majority of responders answered that medication should be provided free by sponsors; investigators and sponsors believed the medication should be kept until available in the public health sector; EC members said that the patient should keep the benefit; patients answered that benefits should be assured for life. Conclusions Due to the study limitations, the results cannot be generalised; however, the data can contribute to discussion of this complex topic through analysing the views of stakeholders in clinical research in Brazil. (shrink)

This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not (...) yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. (shrink)

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

Mounting evidence suggests that participation in clinical trials confers neither advantage nor disadvantage on those enrolled. Narrow focus on the question of a “trial effect,” however, distracts from a broader mechanism by which patients may benefit from ongoing clinical research. We hypothesize that the existence of clinical trials infrastructure—the organizational culture, systems, and expertise that develop as a product of sustained participation in cooperative clinical trials research—may function as a quality improvement lever, improving the quality of care and outcomes (...) of all patients within an institution or region independent of their individual participation in trials. We further contend that this “infrastructure effect” can yield particular benefits for patients in low- and middle-income countries. The hypothesis of an infrastructure effect as a quality improvement intervention, if correct, justifies enhanced research capacity in LMIC as a pillar of health system development. (shrink)

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

How can a system of criminal punishment be justified? In particular can it be justified if the moral demand that we respect each other as autonomous moral agents is taken seriously? Traditional attempts to justify punishment as a deterrent or as retribution fail, but Duff suggests that punishment can be understood as a communicative attempt to bring a wrong-doer to repent her crime. This account is supported by discussions of moral blame, of penance, of the nature of the law's demands, (...) and of the proper meaning and purpose of the criminal process of trial and verdict: it deals both with the ideals that should inform a system of criminal law and the extent to which those ideals are actualised in existing institutions and practices. The conclusion is pessimistic: punishment cannot be justified within our legal system; and this gap between the ideal and the actual presents us with serious moral dilemmas. (shrink)

Randomized controlled trials (RCTs) are widely taken as the gold standard for establishing causal conclusions. Ideally conducted they ensure that the treatment ‘causes’ the outcome—in the experiment. But where else? This is the venerable question of external validity. I point out that the question comes in two importantly different forms: Is the specific causal conclusion warranted by the experiment true in a target situation? What will be the result of implementing the treatment there? This paper explains how the probabilistic theory (...) of causality implies that RCTs can establish causal conclusions and thereby provides an account of what exactly that causal conclusion is. Clarifying the exact form of the conclusion shows just what is necessary for it to hold in a new setting and also how much more is needed to see what the actual outcome would be there were the treatment implemented. (shrink)

In this paper, Isuggest that placebo effects, as we know them today, should be understood as experimental phenomena, low-level regularities whose causal structure is grasped through particular experimental designs with little theoretical guidance. Focusing on placebo interventions with needles for pain reduction -one of the few placebo regularities that seems to arise in meta-analytical studies- I discuss the extent to which it is possible to decompose the different factors at play through more fine-grained randomized clinical trials. My sceptical argument is (...) twofold. On the one hand, I argue that experiments alone are not enough to standardize interventions, and that it is necessary to include theories. On the other hand, I argue that the social interactions that seem to be part of placebo effects are difficult, if not impossible, to blind. Therefore, the measurement biases arising from the participants’ reactivity to the experimental setup cannot be controlled for. Further decomposition of placebo effects requires a theoretical account of the existing experimental regularities that may guide further tests. (shrink)

This book begins the discourse on post-trial access to drugs in developing countries. Underlying ethical issues in global health inequalities and global health research serve as the context of the debate. Due to rampant allegations of violations of rights of research participants, especially in developing countries, it discusses the regulatory infrastructure and ethical oversight of international clinical research, thus emphasizing the priority of safeguarding the rights of research participants and host populations as desiderata in conducting clinical trials in developing (...) countries. This is the first book that analyzes the major obstacles of affordable access to drugs in developing countries - patent and non-patent factors and how they can be overcome through a middle ground approach and a new paradigm to establish global health justice which includes national and global health responsibilities. The book also deals extensively with all complex aspects of the discourse on affordable access to drugs in developing countries, including intellectual property law, international regulations, political and cultural systems, international trade agreements. Furthermore it contains a robust ethical debate and in-depth analysis. The book crafts a paradigm of global health justice involving a sliding scale of national and global responsibilities for the realization of the right to health in general and access to drugs in particular. (shrink)

A persistent theme in the Vitae of Aesop, Archilochus, and Homer, and in Plato's Apology, is the righteous poet brought to trial by a corrupt society that has found him and his poetry intolerable. As society condemns the poet, it condemns itself, and is punished following the poet's punishment ; often the society then grants a hero cult to the poet.

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

How can a system of criminal punishment be justified? In particular can it be justified if the moral demand that we respect each other as autonomous moral agents is taken seriously? Traditional attempts to justify punishment as a deterrent or as retribution fail, but Duff suggests that punishment can be understood as a communicative attempt to bring a wrong-doer to repent her crime. This account is supported by discussions of moral blame, of penance, of the nature of the law's demands, (...) and of the proper meaning and purpose of the criminal process of trial and verdict: it deals both with the ideals that should inform a system of criminal law and the extent to which those ideals are actualised in existing institutions and practices. The conclusion is pessimistic: punishment cannot be justified within our legal system; and this gap between the ideal and the actual presents us with serious moral dilemmas. (shrink)

Substituted judgment has increasingly become the accepted standard for rendering decisions for incapacitated adults in the USA. A broad exception exists with regard to patients with diminished capacity secondary to depressive disorders, as such patients’ previous wishes are generally not honoured when seeking to turn down life-preserving care or pursue aid-in-dying. The result is that physicians often force involuntary treatment on patients with poor medical prognoses and/or low quality of life as a result of their depressive symptoms when similarly situated (...) incapacitated patients without such depressive symptoms would have their previous wishes honoured via substituted judgment. This commentary argues for reconsidering this approach and for using a substituted judgment standard for a subset of EMP/LQL patients seeking death. (shrink)

We distinguish dynamical and statistical interpretations of evolutionary theory. We argue that only the statistical interpretation preserves the presumed relation between natural selection and drift. On these grounds we claim that the dynamical conception of evolutionary theory as a theory of forces is mistaken. Selection and drift are not forces. Nor do selection and drift explanations appeal to the (sub-population-level) causes of population level change. Instead they explain by appeal to the statistical structure of populations. We briefly discuss the implications (...) of the statistical interpretation of selection for various debates within the philosophy of biologythe `explananda of selection' debate and the `units of selection' debate. (shrink)

Employing the National Institute of Mental Health-funded Prevention of Suicide in Primary Care Elderly Collaborative Trial as a case study, we discuss 2 sets of ethical issues: obtaining informed consent for a clinic-based intervention study and using treatment as usual (TAU) as the control condition. We then address these ethical issues in the context of the debate about the quality improvement efforts of health care organizations. Our analysis reveals the tension between ethics and scientific integrity involved with using TAU (...) as a control condition and the difficulty in designing high-quality research in a community-based setting. (shrink)

Regulators rely on clinical trials for drug approval and labeling decisions. Health systems and clinicians rely on the evidence from trials to determine treatment, and patients rely on it to decide which courses of care to undertake. Many of these stakeholders presume that the careful review of individual studies is enough to address the ethical and scientific questions that arise in clinical trials. In what follows, however, we demonstrate that explicit consideration of trial portfolios—series of trials that are interrelated (...) by a common set of objectives—is crucial. the ethical acceptability and evidentiary probity of individual trials can change depending on the characteristics of the portfolios in which they are embedded. Second, how trial portfolios are composed, how well they are coordinated, and how efficiently they use information determines the balance of risks and benefits they present as well as their different prospects for generating socially valuable information; these three factors also raise distinct questions of justice. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Cynthia B. Cohen THE TRIALS OF SOCRATES AND JOSEPH K. No two trials could have been more unlike than those of Socrates and Joseph K. As portrayed in Plato's Apology,' Socrates was the conscience of Athens, a thoughtful and courageous man whose life was devoted to the pursuit of wisdom. He challenged others to examine themselves and to transform themselves into lovers of truth and goodness. This gadfly of (...) Athens was put on trial by those whom he had stung and was dispatched with a final slap. He died the bravest, wisest, and most upright man of his time. By contrast, Joseph K., the protagonist of Kafka's novel, The Trial, was an ordinary bank clerk locked into a life of unreflective routine. His arrest one day by the agents of a Court he could not comprehend failed to change his rote approach. Like a fly stuck fast to flypaper, he was glued to the details of his immediate experience, and would not rise above these to find meaning in his dreary life, or even in his shameful death. Socrates was an original and constructive thinker who died rather than deny the purpose that he found in human life; Joseph K. was a leaden bureaucrat whose life was one long moment of guilty hesitation before a broader vision of things. Or is it that Socrates was an arrogant, peculiar, conniving failure who was engaged in an insidious attempt to undermine the moral and political values of Athens? And is it that Joseph K. was a successful young businessman who had established himself as a conscientious, decent, and eminently reasonable man struggling bravely for justice against an alien and capricious authority? Or perhaps these two trials should be seen as very similar. Each man was tried on charges of which he claimed to be innocent; each wanted to restore order and meaning to a disintegrating world; each led a life that became the cause of his death; and each was condemned for claiming that the unexamined life was not worth living. Or is it that Joseph K. was condemned for maintaining that it was the examined life that was not worth living...? 212 Cynthia B. Cohen213 Difficulties in the interpretation of works of literature are to be expected when their subjects are complex and subtle individuals set in an atmosphere in which basic questions of human significance are raised. Both the Apology and The Trial are such works. Socrates initially seems a model of clarity to the interpreter. He responds to his accusers in a form of direct discourse that can be taken at face value. He presents his arguments openly and cogently. There can be no doubt that his general position is coherent, consistent, and reasonable. Yet the interpreter 's initial satisfaction fades as Socrates' irony creates confusion about what Socrates professes to know. His lines of reasoning seem to intersect in paradox; his answers to questions about the meaning and purpose of human life curve around to miss each other. The interpreter emerges confused and perplexed. These transformations of perspective and significance are repeated in The Trial. Joseph K., too, is described in a straightforward manner that is clear and quite detailed. His reactions and arguments appear sensible and well-reasoned. Yet on closer examination, his simple statements turn out to have hidden meanings; his responses often contradict one another; his logical arguments appear pointless. His answers to questions about the meaning and purpose of human life are immediately challenged by a horde of competitors. To the interpreter, The Trial metamorphizes into a model of intentional obscurity. The problem of interpretation is compounded in the case of Socrates by the question of the accuracy of our information about him. The "Socratic problem" is well known. Each of the four major sources about his life and thought, Xenophon, Aristophanes, Plato, and Aristotle, presents a somewhat different person. There has been strong support for the view that the portrayal of Socrates in the earlier dialogues of Plato is essentially sound, even though this earlier Socrates seems at variance with the later one. The resolution of this problem is irrelevant to this endeavor. Our purpose is to consider the life and... (shrink)

Interpretation -- Introduction -- Interpreting Plato -- The political culture of Plato's early dialogues -- Dialogue -- Character and history -- The mouthpiece principle -- Forms of evidence -- Desire -- Socrates and eros -- The subjectivist conception of desire -- Instrumental and terminal desire -- Rational and irrational desires -- Desire in the critique of Akrasia -- Interpreting Lysis -- The deficiency conception of desire -- Inauthentic friendship -- Platonic desire -- Antiphilosophical desires -- Knowledge -- Excellence as wisdom (...) -- The epistemic unity of excellence -- Dunamis and technê -- Goodness and form -- The epistemological priority of definitional knowledge -- Ordinary ethical knowledge -- Method -- The Socratic fallacy -- Socrates' pursuit of definitions -- Hupothesis -- Two postulates -- The geometrical illustration -- Geometrical analysis -- The method of reasoning from a postulate -- Elenchus and hupothesis -- Knowledge and aitia -- F-conditions -- Cognitive security -- Aporia -- Forms of aporia -- Dramatic aporia -- The example of Charmides -- Charmides as autobiography -- The politics of Sôphrosunê -- Critias' Philotimia -- Self-knowledge and the knowledge of knowledge -- Knowledge of knowledge and knowledge of the good -- Philosophy and the polis. (shrink)

Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under “ideal” conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under “usual” conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some (...) of the challenges inherent in attempts to enhance knowledge translation and encourage evidence-based practice. The situation is more than simply frustrating, however; it is potentially unethical. Clinical trials must be socially valuable in order to (1) warrant the risks they impose on human research subjects and (2) fairly and efficiently assess new clinical interventions. Most bioethicists would agree that trials that have no social value, for instance, because their results do not have the potential to advance clinical care, should not be performed. What is less widely appreciated is that given limited research resources, trials that are more socially valuable should be preferred to trials that are less socially valuable when all else is equal. With respect to clinical trial design, I argue that while explanatory trials often have some social value, many have less social value than their pragmatic counterparts. On the basis of this general ethical assessment, I provide a preliminary defense of the position that clinical researchers should aim to conduct pragmatic trials, that is, that researchers face a burden of justification related to any idealizing elements added to trial designs. (shrink)

Throughout the sixteenth century, learned physicians across Europe performed a diverse array of “trials” of phenomena and published reports about them. This essay traces the phrase “periculum facere” (“to make a trial”) and related terms through natural history investigations, drug testing, chymical analysis, and anatomical discoveries. Physicians used ancient precedents, their learned expertise, and pedagogical authority to anchor the epistemic status of their trials and incorporated the historical narratives of their trial-making within arguments to factual and causal knowledge, (...) even philosophical scientia. Developed from engagement with things, ancient texts, other healers, and students, this lively tradition of contrived, first-person empirical trials flourished in some academic institutions, especially the University of Padua. The frequency and visibility of sixteenth-century medical trials, especially in the education of hundreds of students annually, is essential evidence for understanding how experimentation came to be widespread in early modern Europe. (shrink)

Decisions by industry sponsors to end clinical trials early for commercial reasons have been the subject of controversy. I argue that the principal consideration in assessing these decisions ought to be the way in which the termination would affect the trial’s risk–benefit relationship. If there is not yet sufficient benefit to be gained from the study to offset the risks to which participants were exposed and it is expected that important scientific information would be obtained if the trial (...) were continued, early termination constitutes an unethical alteration of the risk−benefit relationship. This violates the grounds on which permission is given to conduct human research, patients consent to participate, and investigators agree to conduct studies. These knowable and avoidable changes in risk–benefit relationship should generally be seen as impermissible. (shrink)

In the opening of the article, the author briefly assesses the existing legal regulations of criminal procedure in the Czech Republic adopted as far back as in 1961. He points out to specific imperfections, which justify the need for their recodification. The mainstay of the article is devoted to the very pre-trial proceedings, i.e. checking and investigation. The existing legal regulations are analysed, and selected application problems are mentioned in relation to the recodification under preparation.

In its essence, post-trial obligations describe a duty by research sponsors to provide a successfully tested drug to research participants who took part in the relevant clinical trials after the trial has been concluded. In some instances,this duty is extended beyond the research participants. This article is divided into three main parts. The first part outlines the legal basis for post-trial obligations by looking at international guidelines, including those issued by the World Medical Association. National legislation is (...) exemplified through resolutions and guidelines issued by Brazil and South Africa respectively. The second part analyses the ethical foundation for post-trial obligations, in particular the attempt to minimize exploitation of research subjects. The third part raises obstacles and challenges for the implementation of post-trial obligations. The jury is still out on whether post-trial obligations in the form of access to drugs for clinical trial participants is the best, or even a good way, to avoid exploitation in medical research. (shrink)

If, as is alleged, challenge trials of vaccines against COVID-19 are likely to save thousands of lives and vastly diminish the economic and social harms of the pandemic while subjecting volunteers to risks that are comparable to kidney donation, then it would seem that the only sensible objection to such trials would be to deny that they have low risks or can be expected to have immense benefits. This essay searches for a philosophical rationale for rejecting challenge trials while supposing (...) that they have huge benefits and relatively low risks. Although it finds some force in objections to challenge trials grounded in the obligations of researchers to limit the harms imposed on some individuals for the benefit of others, it argues that there is no compelling objection to challenge trials of vaccines for COVID-19—if they have the benefits and risks that have been claimed. (shrink)

Subjective probabilities play a significant role in the assessment of evidence: in other words, our background knowledge, or pre-trial beliefs, cannot be set aside when new evidence is being evaluated. Focusing on homeopathy, this paper investigates the nature of pre-trial beliefs in clinical trials. It asks whether pre-trial beliefs of the sort normally held only by those who are sympathetic to homeopathy can legitimately be disregarded in those trials. The paper addresses several surprisingly unsuccessful attempts to provide (...) a satisfactory justification for ignoring the pre-trial beliefs of the homeopathic community. The ensuing diagnosis of the difficulties here emphasizes that the reason the arguments for choosing the pre-trial beliefs of the conventional community seem insufficient is not the arguments per se. It is rather that there is no cogent argument for choosing the conventional stance which would at the same time rationally persuade a member of the homeopathic community. The paper concludes that, once we understand that this is the predicament, there is no genuine reason to doubt the reasoning that leads us to reject the pre-trial beliefs of the homeopathic community. (shrink)

ABSTRACTSpiritual trial is indeed ‘spiritual’ – it is possible only in someone who is not utterly spiritless as Kierkegaard means the word – but it is not true, as Kierkegaard’s pseudonyms occasionally maintain, that it makes sense only as a religious category, unless religious is redefined in radically general terms, as Kierkegaard in fact does, along with the ideas of offense, anxiety, inwardness, and desire. Every existing individual has some minimal acquaintance with spiritual trial, if only as an (...) anxiety about a continual imminent possibility. I argue that spiritual trial, as Kierkegaard and his pseudonyms intend it – although they do not of course put it in these Levinasian terms – is inseparable from a certain phenomenology of the subject that begins with Kierkegaard and that turns spiritual trial into something essential to becoming a self, the result of one’s vulnerability to alterity, one’s anxiety to defend one’s autonomy against the experience of the other as other. Spiritual trial, in Kierkegaard’s strict sense, is therefore best understood as a special form of a very ordinary, basic experience, a kind of primordial trauma, of which Emmanuel Levinas has so far given us the most complete phenomenological description. (shrink)

Xenotransplantation pits clinical research ethics against public health needs because recipients must undergo long-term, perhaps life-long, surveillance for infectious diseases. This surveillance requirement is effectively an abrogation of the right to withdraw from a clinical trial. Ulysses contracts, which are advance directives for future care, may be an ethical mechanism by which to balance public health needs against limitation of individual rights.

Xenotransplantation is defined as “any procedure that involves the transplantation, implantation, or infusion into a human recipient of either live cells, tissues, or organs from a nonhuman animal source, or human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.” Xenotransplantation has been viewed by desperate patients and their surgeons as a solution to the problem of the paucity of human organs available for transplantation. Foes of xenotransplantation argue that (...) the use of animal organs degrades the human race and should be avoided.In this paper, we briefly review the cultural context of xenotransplantation and explore the infectious disease risk of xenotransplantation. The United States Code of Federal Regulations requires life-long surveillance of a xenotransplantation recipient due to the largely unknown risk of novel infectious disease transmitted across species, known as xenogeneic infectious disease. We argue that despite being in the interest of protecting the public health, the imposition of lifelong surveillance requirements on xenotransplant recipients effectively abrogates the right to withdraw from a clinical trial after the transplantation has taken place. Moreover, we argue that a waiver of the right to withdraw should be made explicit in the interest of full disclosure, out of respect for the research subject’s right of self-determination. (shrink)