In late 1949 the former Soviet Union conducted an open trial of eight Japanese physicians and researchers and four other military servicemen in Khabarovsk, a city in eastern Siberia. Despite its strong ideological tone and many obvious shortcomings such as the lack of international participation, the trial established beyond reasonable doubt that the Japanese army had prepared and deployed bacteriological weapons and that Japanese researchers had conducted cruel experiments on living human beings. However, the trial, together (...) with the evidence presented to the court and its major findings — which have proved remarkably accurate — was dismissed as communist propaganda and totally ignored in the West until the 1980s. This paper reviews the 1949 Khabarovsk trial, examines the West's dismissal of the proceedings as mere propaganda and draws some moral lessons for bioethics today. As an important historical case, set in the unique socio-political context of the Cold War, the West's dismissal of the trial powerfully illustrates some perennial ethical issues such as the ambivalence of evidence and the power of ideology in making (or failing to make) cross-national and cross-cultural factual and moral judgments. (shrink)

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

To monopolize the scientific data gained by Japanese physicians and researchers from vivisections and other barbarous experiments performed on living humans in biological warfare programs such as Unit 731, immediately after the war the United States government secretly granted those involved immunity from war crimes prosecution, withdrew vital information from the International Military Tribunal for the Far East, and publicly denounced otherwise irrefutable evidence from other sources such as the Russian Khabarovsk trial. Acting in “the national interest” and (...) for the security of the US, authorities in the US tramped justice and morality, and engaged in what the English common law tradition clearly defines as “complicity after the fact.” To repair this historical injustice, the US government should issue an official apology and offer appropriate compensation for having covered up Japanese medical war crimes for six decades. To help prevent similar acts of aiding principal offender in the future, international declarations or codes of human rights and medical ethics should include a clause banning any kind of complicity in any unethical medicine—whether before or after the fact—by any state or group for whatever reasons. (shrink)

The classical Athenian philosopher Socrates was tried in 399 BCE on the basis of two notoriously ambiguous charges: corrupting the youth and impiety (in Greek, asebeia). A majority of the 501 dikasts (Athenian citizen-jurors) voted to convict him. Socrates was ultimately sentenced to death by drinking a hemlock-based liquid. This well-known account of the trial is by Plato, one of Socrates' students and a famous philosopher in his own right. Whether Socrates was punished unjustly is a contested issue which (...) to this day inspires discussions about the nature and meaning of justice. (shrink)

The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The authors raise (...) questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region.. (shrink)

"In May 1621 Francis Bacon's political career came to an abrupt end as a consequence of his being impeached from the office of Lord Chancellor of England. Later in the same year he composed his most imaginative political testament, the History of the Reign of King Henry VII. These two events were by no means coincidental. Of his several vocations, politics was the one that mattered most to Bacon, and he did not go willingly into retirement. The History, like so (...) many of his writings, was intended to persuade James I of his redoubtable abilities as a counselor of kings. [The author] fits the story of that year into the pattern of Bacon's life, beginning with a narrative account of the impeachment, an episode testifying to weaknesses both in Bacon's political position as well as in his personal character. [The author] examines Bacon's political career during the preceding years for what they tell us about Bacon's mind. To understand Bacon in politics, [the author] believes, it must be realized how distinctive habits of intellect and sensibility permeate everything he wrote and that virtually everything he wrote was intended to serve his political ambition. Finally, [the author] analyzes the History to show that it must be read not only as a summary portrait of Bacon's civil career but as a justification of his ideas and himself. Setting the History into Bacon's life makes apparent how much of his achievement sprang from his skills as a rhetorician. Words were his greatest gift and one that he always exploited. [The author]'s study demonstrates the extent to which Bacon was also a prisoner of his talent"--. (shrink)

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

As the_number of clinical trials continues to grow, there is an increasing need for education and training in the field. The clinical research climate is less forgiving of errors and oversights and therefore requires more knowledge of regulations and requirements. This brand new edition details new laws and regulations in protecting children participating in clinical trials and how a new focus on privacy of individual health information in the United States has changed how medical records are handled. Includes a manual (...) for investigators, research nurses and study coordinators with minimal experience or who are new to clinical research An easy-to-read and open text design using ‘sidebars’ of examples and information boxes related to the main text Includes a list of Frequently Asked Questions and Glossary Duke Clinical Research Institute is the world’s largest academic clinical research organisation and is well known and respected within the clinical research community. (shrink)

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

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)

There are certain moments, such as the American founding or the Civil Rights Movement, that we revisit again and again as instances of democratic triumph, and there are other moments that haunt us as instances of democratic failure. How should we view moments of democratic failure, when both the law and citizens forsake justice? Do such moments reveal a wholesale failure of democracy or a more contested failing, pointing to what could have been, and still might be? Public Trials reveals (...) the considerable stakes of how we understand democratic failure. Maxwell argues against a tendency in the thinking of Plato, Rousseau and contemporary theorists to view moments of democratic failure as indicative of the failure of democracy, insomuch as such thinking leads to a deference to authority that unintentionally encourages complicity in elite and legal failures to assure justice. In contrast, what Maxwell calls "lost cause narratives" of democratic failure reveal the contingency of democratic failure by showing that things "could have been" otherwise-and, with public action and response, might yet be. A politics of lost causes calls for democratic responsiveness to failure via practices of resistance, theatrical claims-making, and re-narration. Maxwell makes a powerful case for the politics of lost causes by examining public controversies over trials. She focuses on the dilemmas and diagnoses of democratic failure in four instances: Edmund Burke's speeches and writings on the Warren Hastings trial in late 18th century Britain, Emile Zola's writings on the Dreyfus Affair in late 19th century France, Hannah Arendt's writings on the Eichmann trial in 1960's Israel, and Kathryn Bigelow's recent narration of (the lack of) trials of alleged terrorist detainees in Zero Dark Thirty. Maxwell marshals her subtle, historically grounded readings of these texts to show the dangers of despairing of democracy altogether, as well as the necessity of re-narrating instances of democratic failure so as to cultivate public responsiveness to such failures in the future. (shrink)

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)

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)

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

The 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)

Theater requires artifice, justice demands truth. Are these demands as irreconcilable as the pejorative term “show trials” suggests? After the Second World War, canonical directors and playwrights sought to claim a new public role for theater by restaging the era’s great trials as shows. The Nuremberg trials, the Eichmann trial, and the Auschwitz trials were all performed multiple times, first in courts and then in theaters. Does justice require both courtrooms and stages? In Staged, Minou Arjomand draws on a (...) rich archive of postwar German and American rehearsals and performances to reveal how theater can become a place for forms of storytelling and judgment that are inadmissible in a court of law but indispensable for public life. She unveils the affinities between dramatists like Bertolt Brecht, Erwin Piscator, and Peter Weiss and philosophers such as Hannah Arendt and Walter Benjamin, showing how they responded to the rise of fascism with a new politics of performance. Linking performance with theories of aesthetics, history, and politics, Arjomand argues that it is not subject matter that makes theater political but rather the act of judging a performance in the company of others. Staged weaves together theater history and political philosophy into a powerful and timely case for the importance of theaters as public institutions. (shrink)

This article describes our efforts to screen and enrol clinical trial participants conscientiously in the COVID-19 pandemic setting. We present the standard screening and enrolment process prior to, and our process of adapting to, the pandemic. Our goal was to develop a way to screen and enrol people for clinical trials that was both equitable and effective. In addition, we outline the steps our research department took to ensure that ethical, clinical and logistical factors were considered when matching a (...) patient to a clinical trial. (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)

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)

Responsibilities of the data monitoring committee and motivating illustrations -- Composition of a data monitoring committee -- Independence of the data monitoring committee : avoiding conflicts of interest -- Confidentiality issues relating to the data monitoring committee -- Data monitoring committee meetings -- Data monitoring committee interactions with other trial components or related groups -- Statistical, philosophical and ethical issues in data monitoring -- Determining when a data monitoring committee is needed -- Regulatory considerations for the operation of data (...) monitoring committees -- Legal considerations for DMCs. (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)

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)

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)

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)

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

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)

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)

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)

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)

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)

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.

Existing justifications for exclusionary rules and stays of proceedings in response to pre-trial wrongdoing by police officers and prosecutors are often thought to be counter-productive or disproportionate in their consequences. This article begins to explore whether the concept of standing to blame can provide a fresh justification for such responses. It focuses on a vice related to standing—hypocrisy—and a related vice concerning inconsistent blame. It takes seriously the point that criminal justice agencies, although all part of the State, are (...) in real terms separated from each other, and analyses the so-called separation thesis (or theses). It concludes that hypocrisy and inconsistent blame arguments could plausibly justify exclusion and stays only in relation to lower-level offending, and even there only indirectly. This is in the sense that exclusion and stays are expressions of judicial frustration with other bodies for their failure to take pre-trial wrongdoing seriously. (shrink)

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)

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)

This paper is part of a project that is based on the notion of a dialectical system, introduced by Magari as a way of capturing trial and error mathematics. In Amidei et al. (2016, Rev. Symb. Logic, 9, 1–26) and Amidei et al. (2016, Rev. Symb. Logic, 9, 299–324), we investigated the expressive and computational power of dialectical systems, and we compared them to a new class of systems, that of quasi-dialectical systems, that enrich Magari’s systems with a natural (...) mechanism of revision. In the present paper we consider a third class of systems, that of p-dialectical systems, that naturally combine features coming from the two other cases. We prove several results about p-dialectical systems and the sets that they represent. Then we focus on the completions of first-order theories. In doing so, we consider systems with connectives, i.e. systems that encode the rules of classical logic. We show that any consistent system with connectives represents the completion of a given theory. We prove that dialectical and q-dialectical systems coincide with respect to the completions that they can represent. Yet, p-dialectical systems are more powerful; we exhibit a p-dialectical system representing a completion of Peano Arithmetic that is neither dialectical nor q-dialectical. (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)