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)

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)

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)

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.

When discussing the safety of research subjects, including their exploitation and vulnerability as well as failures in clinical research, recent commentators have focused mostly on countries with low or middle-income economies. High-income countries are seen as relatively safe and well-regulated. This article presents irregularities in clinical trials in an EU member state, Poland, which were revealed by the Supreme Audit Office of Poland (the NIK). Despite adopting many European Union regulations, including European Commission directives concerning Good Clinical Practice, these (...) irregularities occurred. Causes as well as potential solutions to make clinical trials more ethical and safer are discussed. (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)

Some placebo-controlled trials can continue ethically after a candidate vaccine is found to be safe and efficacious.

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

I will open the first part of this paper by trying to elucidate the frequentist foundations of RCTs. I will then present a number of methodological objections against the viability of these inferential principles in the conduct of actual clinical trials. In the following section, I will explore the main ethical issues in frequentist trials, namely those related to randomisation and the use of stopping rules. In the final section of the first part, I will analyse why RCTs (...) were accepted for regulatory purposes. I contend that their main virtue, from a regulatory viewpoint, is their impartiality, which is grounded in randomisation and fixed rules for the interpretation of the experiment. Thus the question will be whether Bayesian trials can match or exceed the achievements of frequentist RCTs in all these respects. In the second part of the paper, I will first present a quick glimpse of the introduction of Bayesianism in the field of medical experiments, followed by a summary presentation of the basic tenets of a Bayesian trial. The point here is to show that there is no such thing as “a” Bayesian trial. Bayesianism can ground many different approaches to medical experiments and we should assess their respective virtues separately. Thus I present two actual trials, planned with different goals in mind, and assess their respective epistemic, ethical and regulatory merits. In a tentative conclusion, I contend that, given the constraints imposed by our current regulatory framework, impartiality should preside over the design of clinical trials, even at the expense of many of their inferential and ethical virtues. (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)

The transferability problem—whether the results of an experiment will transfer to a treatment population—affects not only Randomized Controlled Trials but any type of study. The problem for any given type of study can also, potentially, be addressed to some degree through many different types of study. The transferability problem for a given RCT can be investigated further through another RCT, but the variables to use in the further experiment must be discovered. This suggests we could do better on the (...) epistemological problem of transferability by promoting, in the repeated process of formulating public health guidelines, feedback loops of information from the implementation setting back to researchers who are defining new studies. (shrink)

How, if at all, should race figure in criminal trials with a jury? How far should attorneys be allowed or encouraged to probe the racial sensitivities of jurors and what does this mean for the appropriate way to present cases which involve racial profiling and, therefore, are likely to pit the words and actions of a white policeman against those of a young black man?

Introduction and Discussion of a Special Issue in philosophy of law "Philosophical Dimensions of the Trial" -/- .

Our goal in this paper is to articulate a precise concept of at least a certain kind of disease-mongering, showing how pharmaceutical marketing can commercially exploit certain diseases when their best definition is given through the success of a treatment in a clinical trial. We distinguish two types of disease-mongering according to the way they exploit the definition of the trial population for marketing purposes. We argue that behind these two forms of disease-mongering there are two well-known problems in the (...) statistical methodology of clinical trials (the reference class problem and the distinction between statistical and clinical significance). Overcoming them is far from simple. (shrink)

The current study is a pilot trial to examine the effects of a nonelective, classroom-based, teacher-implemented, mindfulness meditation intervention on standard clinical measures of mental health and affect in middle school children. A total of 101 healthy sixth-grade students (55 boys, 46 girls) were randomized to either an Asian history course with daily mindfulness meditation practice (intervention group) or an African history course with a matched experiential activity (active control group). Self-reported measures included the Youth Self Report (YSR), a modified (...) Spielberger State-Trait Anxiety Inventory, and the Cognitive and Affective Mindfulness Measure –Revised. Both groups decreased significantly on clinical syndrome subscales and affect but did not differ in the extent of their improvements. Meditators were significantly less likely to develop suicidal ideation or thoughts of self-harm than controls. These results suggest that mindfulness training may yield both unique and non-specific benefits that are shared by other novel activities. (shrink)

Patient-funded trials are gaining traction as a means of accelerating clinical translation. However, such trials sidestep mechanisms that promote rigor, relevance, efficiency, and fairness. We recommend that funding bodies or research institutions establish mechanisms for merit review of patient-funded trials, and we offer some basic criteria for evaluating PFT protocols.

Exploratory experiments are widely characterized as experiments that do not test hypotheses. Experiments that do test hypotheses are characterized as confirmatory experiments. Philosophers have pointed out that research programmes can be both confirmatory and exploratory. However, these definitions preclude single experiments being characterized as both exploratory and confirmatory; how can an experiment test and not test a hypothesis? Given the intuition that some experiments are exploratory, some are confirmatory, and some are both, a recharacterization of the relationship between exploratory and (...) confirmatory experimentation is needed. I discuss ‘phase IV’ trials to show what this recharacterization could look like. Phase IV trials can be exploratory and confirmatory insofar as they concurrently test hypotheses and explore for unforeseen phenomena. Even if it is uncontroversial that a single experiment can have multiple aims, the recharacterization of the relationship between exploratory and confirmatory experimentation is still required for these aims to be held together coherently. I offer an alternative characterization of the relationship between exploratory and confirmatory experimentation where the former remains a distinct kind of experimentation but is not characterized as non-hypothesis-testing. (shrink)

ABSTRACT“Evidence-based” methods, which most prominently include randomized controlled trials, have gained increasing purchase as the “gold standard” for assessing the effect of public policies. But the enthusiasm for evidence-based research overlooks questions about the reliability and applicability of experimental findings to diverse real-world settings. Perhaps surprisingly, a qualitative study of British educators suggests that they are aware of these limitations and therefore take evidence-based findings with a much larger grain of salt than do policy makers. Their experience suggests that (...) the real world is more heterogeneous than the world imagined by evidence-based policy enthusiasts. (shrink)

Did the impartiality of clinical trials play any role in their acceptance as regulatory standards for the safety and efficacy of drugs? According to the standard account of early British trials in the 1930s and 1940s, their impartiality was just rhetorical: the public demanded fair tests and statistical devices such as randomization created an appearance of neutrality. In fact, the design of the experiment was difficult to understand and the British authorities took advantage of it to promote their (...) own particular interests. I claim that this account is based on a poorly defined concept of experimental fairness . I present an alternative approach in which a test would be impartial if it incorporates warrants of non-manipulability. With this concept, I reconstruct the history of British trials showing that they were indeed fair and this fairness played a role in their acceptance as regulatory yardsticks. (shrink)

The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (...) (4) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial last two cases. This article sets out key considerations relevant to considering whether methodological reasons for a placebo control are compelling. (shrink)

This paper discusses the so-called non-interference assumption (NIA) grounding causal inference in trials in both medicine and the social sciences. It states that for each participant in the experiment, the value of the potential outcome depends only upon whether she or he gets the treatment. Drawing on methodological discussion in clinical trials and laboratory experiments in economics, I defend the necessity of partial forms of blinding as a warrant of the NIA, to control the participants’ expectations and their (...) strategic interactions with the experimenter. (shrink)

At the height of the Covid pandemic, there was much discussion in the literature about using human challenge trials (HCTs) to expedite the development of effective Covid-19 vaccines. Historically, reluctance to fully accept HCTs has largely been due to potential conflicts with the principle of nonmaleficence in bioethics. Only a few commentators have explored this topic in depth. In this paper, we claim that to address ethical concerns regarding HCTs, two types of ethical reasons should be identified and investigated: (...) first-order reasons that can be given to claim that a practice in itself is in direct conflict with the principles of bioethics; and second-order reasons that take into consideration how a practice is carried out and its consequences. We argue that understanding these ethical reasons is crucial for guiding the implementation of HCTs. We investigate a first-order reason against HCTs when the practice is in conflict with the principle of nonmaleficence, and when it is not. Following this argument and assuming there is no first-order reason based on nonmaleficence that hinders using HCTs, we argue there may be second-order reasons to guide implementation of this practice, such as difficulty in obtaining informed consent; protection of the weaker party; and trust in the scientific enterprise. (shrink)

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

The principle of clinical equipoise has been variously characterized by ethicists and clinicians as fundamentally flawed, a myth, and even a moral balm. Yet, the principle continues to be treated as the de facto gold standard for conducting randomized control trials in an ethical manner. Why do we hold on to clinical equipoise, despite its shortcomings being widely known and well-advertised? This paper reviews the most important arguments criticizing clinical equipoise as well as what the most prominent proposed alternatives (...) are. In the process, it evaluates the justification for continuing to use clinical equipoise as the gold standard for randomized control trials. (shrink)

The objective of this research programme is to contribute to the establishment of the emerging science of Formal Ontology in Information Systems via a collaborative project involving researchers from a range of disciplines including philosophy, logic, computer science, linguistics, and the medical sciences. The re­searchers will work together on the construction of a unified formal ontology, which means: a general framework for the construction of ontological theories in specific domains. The framework will be constructed using the axiomatic-deductive method of modern (...) formal ontology. It will be tested via a series of applications relating to on-going work in Leipzig on medical taxonomies and data dictionaries in the context of clinical trials. This will lead to the production of a domain-specific ontology which is designed to serve as a basis for applications in the medical field. (shrink)

The world’s first COVID-19 human challenge trial using the D614G strain of SARS-CoV-2 is underway in the United Kingdom. The Wellcome Trust is funding challenge stock preparation of the Beta variant (B.1.351) for a follow-up human challenge trial, and researchers at Imperial College London are considering conducting that trial. However, little has been written thus far about the ethical justifiability of human challenge trials with SARS-CoV-2 variants of concern. While vaccine resistance as such does not increase risks for volunteers (...) in COVID-19 challenge trials, we explore two specific characteristics of some variants that may initially be thought to make such trials unethical and conclude that SARS-CoV-2 variant challenge trials can remain ethical. (shrink)

Decision-making by a Data and Safety Monitoring Board (DSMB) regarding clinical trial conduct and termination is intricate and largely limited by cases and rules. Decision-making by legal jury is also intricate and largely constrained by cases and rules. In this paper, I argue by analogy that legal decision-making, which strives for a balance between competing demands of conservatism and innovation, supplies a good basis to the logic behind DSMB decision-making. Using the doctrine of precedents in legal reasoning as my central (...) analog will lead us to a decision-theoretic analogy for much more systematic documentation of decisions in clinical trials. My conclusion is twofold: every DSMB decision should articulate a clear general principle (a ratio decidendi) that gives reason for the decision; and all such decisions should be made public. I use Bartha’s (2010) theory of analogical arguments to both frame and assess my argument by analogy. (shrink)

My dissertation argues that Plato composed the figure of Socrates as a three- dimensional literary character who experiences and confronts emotions in ways that other studies have overlooked. By adopting a dramatic, non-dogmatic mode of reading the dialogues and emphasizing the literary elements of the texts and their dramatic connections, this dissertation offers a new and compelling portrait of Socrates in the dialogues that relate his finals weeks of life: Theaetetus, Euthyphro, Apology, Crito, and Phaedo. This study in turn provides (...) new insights into the genre of Plato’s texts and demonstrates how he exploited the dramatic nature of the prose dialogue to capture social-historical realities surrounding the trial and execution of Socrates. By emphasizing emotional and interpersonal aspects of Plato’s texts, my dissertation shows that Plato’s dialogues are profitably read through a literary lens to recover their complex reconstruction of Socrates’ place and time in history. (shrink)

The article presents the advantages and limitations of adaptive clinical trials for assessing the effectiveness of medical interventions and specifies the conditions that contributed to their development and implementation in clinical practice. I advance two arguments by discussing different cases of adaptive trials. The normative argument is that responsible adaptation should be taken seriously as a new way of doing clinical research insofar as a valid justification, sufficient understanding, and adequate operational conditions are provided. The second argument is (...) historical. The development of adaptive trials can be related to lessons learned from research in cases of urgency and to the decades-long efforts to end the productivity crisis of pharmaceutical research, which led to the emergence of translational, personalized, and, recently, precision medicine movements. (shrink)

Against a backdrop of rapidly expanding health artificial intelligence (AI) development, this paper examines how the European Union’s (EU) stringent digital regulations may incentivise the outsourcing of personal health data collection to low- and middle-income countries (LMICs), fuelling a new form of AI ethics dumping. Drawing on parallels with the historical offshoring of clinical trials, we argue that current EU instruments, such as the General Data Protection Regulation (GDPR), Artificial Intelligence Act (AI Act) and Medical Devices Regulation, impose robust (...) internal safeguards but do not prevent the use of health data collected unethically beyond EU borders. This regulatory gap enables data colonialism, whereby commercial actors exploit weaker legal environments abroad without equitable benefit-sharing. Building on earlier EU responses to ethics dumping in clinical trials, we propose legal and policy pathways to prevent similar harms in the context of AI. (shrink)

Jury science is fraught with difficulty. Since legal and institutional hurdles render it all but impossible to study live criminal jury deliberation, researchers make use of various indirect methods to evaluate jury performance. But each of these methods are open to methodological criticism and, strikingly, some of the highest-profile jury research programmes in recent years have reached opposing conclusions. Uncertainty about jury performance is an obstacle for legal reform—ongoing debates about the ‘justice gap’ for complainants of sexual offences has rendered (...) these problems stark. This paper proposes a way to advance the debate. (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 the beginning of the COVID pandemic, researchers and bioethicists called for human challenge trials to hasten the development of a vaccine for COVID. However, the fact that we lacked a specific, highly effective treatment for COVID led many to argue that a COVID challenge trial would be unethical and we ought to pursue traditional phase III testing instead. These ethical objections to challenge trials may have slowed the progress of a COVID vaccine, so it is important to (...) evaluate their merit. One common way of doing so is to make an analogy to other social practices that are relevantly similar and which we currently sanction. We submit that non-directed live organ donation (NDLOD) is a promising analogy. After arguing that the risks to volunteers for each activity appear similar, we explore potential disanalogies that would undermine the comparison. We note that there are differences in both the kind and certainty of benefit secured by NDLOD compared to challenge trials. We conclude these differences are insufficient to make NDLOD permissible and challenge trials impermissible. Ultimately, if we think the risks associated with NDLOD are ethically permissible, then we should think the same of the risks associated with COVID challenge trials. (shrink)

It is sometimes thought that randomized study group allocation is uniquely proficient at producing comparison groups that are evenly balanced for all confounding causes. Philosophers have argued that in real randomized controlled trials this balance assumption typically fails. But is the balance assumption an important ideal? I run a thought experiment, the CONFOUND study, to answer this question. I then suggest a new account of causal inference in ideal and real comparative group studies that helps clarify the roles of (...) confounding variables and randomization. 1Confounders and Causes2The Balance Assumption3The CONFOUND Study 3.1CONFOUND 13.2CONFOUND 24Disjunction C and the Ideal Study 4.1The ultimate ‘other cause’: C4.2The ideal comparative group study4.3Required conditions for causal inference5Confounders as Causes, Confounders as Correlates6Summary. (shrink)

During the recent Ebola epidemic, some commentators and stakeholders argued that it would be unethical to carry out a study that withheld a potential treatment from affected individuals with such a serious, untreatable disease. As a result, the initial trials of experimental treatments did not have control arms, despite important scientific reasons for their inclusion. In this paper, we consider whether the duty to rescue entails that it would be unethical to withhold an experimental treatment from patient-participants with serious (...) diseases for which there are no effective treatments, even when doing so is scientifically necessary to test the effectiveness of the treatment. We argue that the duty to rescue will rarely apply. The context of medical research also throws new light on the content of the duty to rescue, since the interests of future patients—who stand to benefit from the fruits of medical research—are relevant to whether the duty applies. (shrink)

This paper focuses on an important yet underexplored idea of existential trial, expressed by the notion of Anfægtelse, in Kierkegaard’s account of the human self. I argue that there are three kinds of existential trials, corresponding to the three major existential spheres: the esthetic, the ethical, and the Christian-religious. Each existential trial involves an essential conflict between two constitutive elements of the relevant sphere, and thereby reveals the problem inherent to one’s relation to a certain “other” in that sphere. (...) The possibility of existential trials highlights the Kierkegaardian idea that the human self is not self-grounding or self-sufficient, which in turn points to the need for divine assistance in one’s self-development. Furthermore, I show that the religious Anfægtelse can mean two different but closely related things. It sometimes refers to a spiritual temptation that distracts one from engaging in an absolute God-relationship, and sometimes a spiritual trial to which the spiritual temptation pertains only as a part. (shrink)

We raise a problem of applicability of RCTs to validate nuclear diagnostic imaging tests. In spite of the wide application of PET and other similar techniques that use radiopharmaceuticals for diagnostic purposes, RCT-based evidence on their validity is sparse. We claim that this is due to a general conceptual problem that we call Prevalence of Treatment, which arises in connection with designing RCTs for testing any diagnostic procedure in the present context of medical research, and is particularly apparent in this (...) case. We also identify three practical reasons why RCTs do not qualify as the best option for PET validation, which have to do with specific characteristics of nuclear diagnostic imaging, and of radiopharmaceuticals. The paper is meant to contribute both to the philosophical discussion on the EBM hierarchy of evidence, and on the specific debate on radiopharmaceuticals in nuclear medicine. (shrink)

Discusses who should decide the result of legal trials, focusing on the jury system.

Family members can provide crucial support to individuals participating in clinical trials. In research on the “newest frontier” of Deep Brain Stimulation (DBS)—the use of DBS for psychiatric conditions—family member support is frequently listed as a criterion for trial enrollment. Despite the significance of family members, qualitative ethics research on DBS for psychiatric conditions has focused almost exclusively on the perspectives and experiences of DBS recipients. This qualitative study is one of the first to include both DBS recipients and (...) their family members as interview participants. Using dyadic thematic analysis—an approach that takes both the individuals and the relationship as units of analyses—this study analyzes the complex ways in which family relationships can affect DBS trial participation, and how DBS trial participation in turn influences family relationships. Based on these findings, we propose ways to improve study designs to better take family relationships into account, and better support family members in taking on the complex, essential roles that they play in DBS trials for psychiatric conditions. (shrink)

In this article, I seek to answer the following cluster of questions: What would a characteristically African, and specifically relational, conception of a criminal trial’s final end look like? What would the Afro-relational approach prescribe for sentencing? Would its implications for this matter forcefully rival the kinds of penalties that judges in South Africa and similar jurisdictions typically mete out? After pointing out how the southern African ethic of ubuntu is well understood as a relational ethic, I draw out of (...) it a certain conception of reconciliation that I advance as a strong candidate for being the proper final end of a criminal trial. I argue that, far from requiring forgiveness, seeking reconciliation can provide strong reason to punish offenders. Specifically, a reconciliatory sentence is one that roughly has offenders reform their characters and compensate their victims in ways the offenders find burdensome, thereby disavowing the crime and tending to foster cooperation and mutual aid. I argue that this novel account of punishment is a prima facie attractive alternative to more familiar retributive and deterrence rationales, and that it entails that widespread practices such as imprisonment and mandatory minimum sentences are unjust. (shrink)

The oft-told story of Leibniz’s doctrine of the best world, or optimism, is that it enjoyed a great deal of popularity in the eighteenth century until the massive earthquake that struck Lisbon on 1 November 1755 destroyed its support. Despite its long history, this story is nothing more than a commentators’ fiction that has become accepted wisdom not through sheer weight of evidence but through sheer frequency of repetition. In this paper we shall examine the reception of Leibniz’s doctrine of (...) the best world in the eighteenth century in order to get a clearer understanding of what its fate really was. As we shall see, while Leibniz’s doctrine did win a good number of adherents in the 1720s and 1730s, especially in Germany, support for it had largely dried up by the mid-1740s; moreover, while opponents of Leibniz’s doctrine were few and far between in the 1710s and 1720s, they became increasing vocal in the 1730s and afterwards, between them producing an array of objections that served to make Leibnizian optimism both philosophically and theologically toxic years before the Lisbon earthquake struck. (shrink)

Based on an interdisciplinary perspective integrating astrophysics, evolutionary biology, civilizational sociology, and ethics, this paper constructs a progressive empowering model of the "cosmos-planet-civilization" three-level death mechanism. It breaks through the traditional cognition that "death is opposed to civilization" and demonstrates that death is not the ultimate destiny of the universe and civilizations, but an underlying empowering system running through material circulation, biological evolution, and civilizational advancement: The death of stars and planets drives the matter-energy coupling cycle through heavy element synthesis (...) and celestial iteration, laying the material foundation for the birth of life; The death of individual terrestrial organisms maintains the low-entropy equilibrium of ecosystems, promoting the evolutionary emergence of intelligent life through species iteration; The demise of early civilizations constitutes the trial-and-error threshold of civilizational evolution, providing empirical lessons for the ethical revision of mature civilizations through costly practices. Combined with cases of ancient civilization disappearance, this paper clarifies the dialectical relationship between "the empowering nature of death mechanisms" and "the autonomy of civilizational survival" for the first time. It proposes that ethical revision is the core paradigm for civilizations to break through the trial-and-error fate and master cosmic laws. Ultimately, this research provides an interdisciplinary theoretical framework with scientific rigor and practical guidance for human civilization to achieve long-term survival through ethical adjustment, and to undertake the mission of delaying local heat death in the universe. (For the English version, please click the DOI link below.) -/- 本文立足天体物理学、演化生物学、文明社会学与伦理学的跨学科融合视角，构建“宇宙-行星-文明”三级死亡机制的递进赋能模型，系统论证死亡并非宇宙与文明的终极宿命，而是贯穿物质循环、生命演化与文明进阶的底层 赋能机制。研究表明：恒星与行星的死亡是宇宙物质-能量耦合循环的核心引擎，通过重元素合成与天体迭代，为生命诞生奠定物质基础；地球生命个体的死亡是行星生态系统维持低熵平衡的刚性环节，通过物种迭代推动智慧生 命的演化涌现；早期文明的消亡是文明演化的试错阈值，通过代价性实践为成熟文明的伦理修正提供实证镜鉴。本文结合古文明消亡的实证案例，首次明确“死亡机制的赋能性”与“文明存续的自主性”的辩证关系，提出“伦理 修正是文明突破试错宿命、驾驭宇宙规律的核心范式”。研究的创新价值在于，打破“死亡与文明对立”的传统认知，将死亡机制重构为文明演化的前置赋能系统，为人类文明通过伦理修正实现长期存续、最终承接宇宙延迟或逆 转局部热寂的使命，提供了兼具科学严谨性与实践指导性的跨学科理论框架。. (shrink)

The United Kingdom's Parliamentary Bill 'Fraud Trials (Without a Jury) 2007', failed. Nevertheless, fraud trials without a jury do take place and there is much evidence to support this. Today the UK still does not support fraud trials without a jury, even though fraud in the UK today is the highest amount of fraud globally. The longer version of this paper is submitted here since it has become urgent that UK fraud trials be examined as a (...) matter of urgency. On page 87 of this complete paper (cut down for The Criminal Lawyer in 2008) a U.S study of 46 corporate fraud trials revealed that the defendants were CEOs, President, Chairman, Senior Vice Presidents, Chief Financial Officers, but only one entity reach trial stage. After the ce Arthur Anderson LLP v. United States, 544 U.S. 696 (2005), and the Lehman Brothers SEC case and the SEC v. Bank of America Corp., 653 F. Supp. 2d 507 (S.D.N.Y. 2009, and the Report by the U.S. Financial Crisis Inquiry on the 2008 financial crash, a global financial disaster was predicted and George Osborne, UK Chancellor pleaded for leniency for HSBC Bank frauds, threatening a global meltdown. The U.S. judiciary increased its volume of Deferred Prosecution Agreements and the UK followed suit. So, in year 2022, there is global financial meltdown and the UK has the highest rate of fraud in the world with few successful convictions. This paper is very relevant today as we must stop using deferred prosecution agreements and seek more convictions and harsh jail sentences for those financial fraudsters who have created this meltdown. -/- *When this paper was written, UK fraud was estimated at £40 million and some experts suspected twice that amount. Today UK fraud is in the billions of pounds annually. (shrink)

Content note: This paper discusses rape throughout.Abstract. In this paper, I consider arguments in favor of jury trials. While I find these generally persuasive, I argue that there can be cases where juries are not fit for purpose. In those cases, I argue that they should be replaced by judge-only trials. In doing so, I propose a framework for determining whether a type of case is unsuitable for jury trials. Partly in response to low conviction rates, there (...) have been recent suggestions that rape trials should be conducted without juries. I suggest that there is strong evidence that these offences qualify under the criteria I have described. As a result, I argue that judge-only trials should be adopted for trying rape cases. (shrink)

Moral anti-theodicists have posed a consequentialist argument against the theodical enterprise: that theodicies lead to harmful consequences in reality and that this should be sufficient reason to motivate abandoning the practise of theodicising altogether. In this paper, I examine variants of this argument and discuss several prominent responses from theodicists, including the separation thesis. I argue that while these responses are effective in resisting the global conclusion by the anti-theodicist, it still leaves the theodical enterprise vulnerable to a weaker version (...) of the consequentialist critique. In response, I develop an account of ‘theodicies-of-embrace-protest’ which is able to preserve the meaningful strides made in traditional theodicies while taking seriously the criticisms of the moral anti-theodicists. I suggest that sceptical theism fits this bill. (shrink)

Placebo-trials on HIV-infected pregnant women in developing countries like Thailand and Uganda have provoked recent controversy. Such experiments aim to find a treatment that will cut the rate of vertical transmission more efficiently than existing treatments like zidovudine. This scenario is first stated as generally as possible, before three ethical principles found in the Belmont Report, itself a sharpening of the Helsinki Declaration, are stated. These three principles are the Principle of Utility, the Principle of Autonomy and the Principle (...) of Justice. These are taken as voices of moral imperative. But although each has intuitive appeal, it can be shown that there are possible scenarios in which they give conflicting prescriptions. To achieve consistency, one must be subordinate to the others. The voice of utility is taken as subordinate to those of justice and autonomy and it is shown that given plausible assumptions about the level of poverty and education in the developing country targeted, the experiment is ruled morally wrong in the name of both justice and autonomy. Moreover, it is argued that no justification can be found for the inclusion of a placebo group, when strictly defined. By contrast, a ‘no- treatment’ control arm might be justified, but only when the demands of autonomy are satisfied, demands that are more stringent than they might appear. A utilitarian defence of the experiment is examined, namely that the would-be participants are in a no-loss situation, and it is shown that this defence is seriously flawed. Finally, it is concluded that there is no justification for amending the Declaration of Helsinki. (shrink)

Much recent work in feminist philosophy of language and epistemology has focused on how power constrains speech and testimony. This paper aims to highlight the flip side of silencing by looking at the productive power of sexist ideology in the context of the Italian gender-based violence crime trial. Building on José Medina’s performative account of epistemic injustice (2013; 2021), I argue that when sexist conceptual resources are used by the judge as an epistemic lens, they do ideological work by setting (...) unfair constraints on the communicative and epistemic agency of the complainant in the obtaining of her testimony. Moreover, I argue that the very same hermeneutical insensitivities and distorting concepts that shape patterns of silence can give rise to forms of agential testimonial injustice (Lackey 2023) in which the only witness statements believed by the Court are those elicited through oppressive questions that obscure, deny, or minimize the reported violence, constituting a form of extracted speech (McKinney 2016). In practical terms, this paper intends to offer a possible theoretical tool to detect and counteract those unjust discursive practices that prevent an unbiased constitution of testimonial evidence. (shrink)

The volume of clinical research is increasing exponentially—far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees should prohibit all other, (...) lower-quality research, even when it might appear to meet some minimal ethical standard. Following a close analysis of the social-value requirement of ethical clinical research, I argue that this proposal is defensible. The problem identified in this paper has two parts, quantity and quality, and some clarification is needed about the latter because “quality” is a highly contested term in the medical literature. When some scholars advocate for high-quality trials, they mean large-scale, simple, explanatory randomized controlled trials. Others, including myself, have defended a different characterization of high-quality research that tends more toward pragmatic trial design and the use of methods other than RCTs. Pragmatic trials aim to provide evidence that directly supports clinical decision-making in “usual” care settings. Unlike explanatory trials, which aim to abstract away from particular settings and patients, in the hopes of creating ideal conditions for the success of an intervention, pragmatic trials deliberately pursue knowledge of high applicability, through the use of representative subjects, clinically important questions, flexible treatment protocols, patient-oriented outcome measures, and so on. I see applicability as a marker of high-quality research. The context in which research is meant to be applied should be the context in which new interventions are evaluated. (shrink)

Over the past several decades, we devoted much energy to generating, reviewing and summarizing evidence. We have given far less attention to the issue of how to thoughtfully apply the evidence once we have it. That’s fine if all we care about is that our clinical decisions are evidence-based, but not so good if we also want them to be well-reasoned. Let us not forget that evidence based medicine (EBM) grew out of an interest in making medicine ‘rational’, with the (...) idea that rational clinical evaluations should be evidence-based. I agree with the uncontroversial statement that the best decision is supported, at least in part, by the best available evidence. Rationality, however, is constituted by reasoning, not evidence. Complete arguments are necessary for rational evaluations, arguments that begin with general evidence and end in a conclusion about a particular patient. In order to traverse these inferential gaps, medicine must address the issue of how to establish, as an intermediate premise, what the evidence has to say about the efficacy of an intervention for particular patients in a particular practice setting. (shrink)