In this article we report the findings of a randomised control clinical trial that assessed the impact of a Philosophy for Children program and replicated a previous study conducted in Scotland by Topping and Trickey. A Cognitive Abilities Test was administered as a pretest and a posttest to randomly selected experimental groups and control groups. The students in the experimental group engaged in philosophy lessons in a setting of structured, collaborative inquiry in their language arts classes for one hour (...) per week for a number of weeks. The control group received the standard language arts curriculum in that one hour. The study found that the seventh grade students who had experienced the P4C program showed significant gains relative to those in the seventh grade control group at a high level of statistical significance, but the eighth grade students in the experimental group did not show such gains over the eighth grade control group. It was discovered that the seventh grade teachers started the program early in the school year and continued it for a period of 22 to 26 weeks, while the eighth grade teachers started much later and used the program for only 4 to 10 weeks. Our findings suggest that the P4C program must involve students in activities for a significant period of time before the program shows results, but that a meaningful impact on students’ cognitive abilities can be achieved in about 24 weeks of lessons, less than half the time evidenced by the study by Topping and Trickey. (shrink)

In this article we report the findings of a randomised control clinical trial that assessed the impact of a Philosophy for Children program and replicated a previous study conducted in Scotland by Topping and Trickey. A Cognitive Abilities Test was administered as a pretest and a posttest to randomly selected experimental groups and control groups. The students in the experimental group engaged in philosophy lessons in a setting of structured, collaborative inquiry in their language arts classes for one hour (...) per week for a number of weeks. The control group received the standard language arts curriculum in that one hour. The study found that the seventh grade students who had experienced the P4C program showed significant gains relative to those in the seventh grade control group at a high level of statistical significance, but the eighth grade students in the experimental group did not show such gains over the eighth grade control group. It was discovered that the seventh grade teachers started the program early in the school year and continued it for a period of 22 to 26 weeks, while the eighth grade teachers started much later and used the program for only 4 to 10 weeks. Our findings suggest that the P4C program must involve students in activities for a significant period of time before the program shows results, but that a meaningful impact on students’ cognitive abilities can be achieved in about 24 weeks of lessons, less than half the time evidenced by the study by Topping and Trickey. (shrink)

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

This review discusses the thesis advanced by Sarah Summers in her recent book. In particular it examines the three radical claims that structure her argument. First, that the commonly used analytical distinction between adversarial and inquisitorial traditions in criminal procedure should be abandoned. Secondly, that since the Continental reforms of the 19th century, criminal procedure can best be understood in terms of a single European procedural tradition. Thirdly, that the European Court of Human Rights has misconstrued the logic of that (...) single European procedural tradition by failing to understand that it involves the rejection of a ‘determinative’ pre-trial phase. Each of Summers’ three arguments is subjected to critical analysis and ultimately rejected as innovative and stimulating but flawed. (shrink)

Allocating scarce organs to transplant candidates is only one stage in the long process of organ transplantation. Before being listed, all candidates must undergo a rigorous assessment by a multidisciplinary transplant team. The Department of Health and NHS Blood and Transplant (NHSBT) are responsible for the development of detailed strategies to ensure a fair and objective assessment experience for all transplant candidates. Difficulties arise when particularly vulnerable candidates, such as candidates with psychiatric illnesses, are assessed. NHSBT has already developed (...) unique assessment guidelines for alcoholic and substance-abusing liver transplant candidates to allow for a more comprehensive evaluation, but candidates with psychiatric illnesses are still assessed against general criteria. Should these candidates be assessed against their own criteria? On what clinical grounds do transplant teams justify excluding such candidates from transplantation? Is redress available for candidates who feel they have been unfairly refused a liver transplant simply because of their psychiatric illness? This essay will critically examine the provisions published by the Department of Health and NHSBT for the assessment of liver transplant candidates with psychiatric illnesses, and will provide a commentary as to whether enough is being done to protect these particularly vulnerable candidates from inconsistent assessment decisions. (shrink)

This article engages with the vogue for predicting the effects of the Human Rights Act 1998 by focusing on the rape prosecution and trial. The specific interest is feminist scrutiny of the right to a fair trial, particularly the concept of ‘fairness’, in light of the increasing use of disclosure rules (in Canada and England) to gain access to medical and counseling records. Transcending the two contemporary narratives of ‘victims’/women’s rights and defendants’ rights in the criminal justice (...) system, the authors argue for the infusion of the legal debate on disclosure with feminist understandings of wider cultural debates. They suggest that an increased reflexivity about intimacy, publicity and power, leading perhaps to the development of a concept of ‘democratic publicity’ (Fraser, 1997, p. 100), might help to revision the meaning of ‘relevant’ evidence in the rape trial. They also suggest that the wide-ranging cultural debate about memory, truth and history, and the emerging commitment to experimentation in responding to massive, institutionalised human rights violations (including apartheid, war crimes and child abuse) might be of use in deepening current thinking about the rape trial and listening to the ‘voice’ of the complainant. (shrink)

In his Rights Forfeiture and Punishment, Christopher Heath Wellman argues that his preferred ‘strong’ version of rights forfeiture theory makes the moral rights of due process and a fair trial null and void for guilty offenders. They may still possess legal rights to due process, but these are not strong pre-institutional moral rights. I explain here why I disagree with Wellman. I also suggest that he is not entitled, by his own lights, to affirm strong forfeiture theory, at (...) least in our social world. (shrink)

This paper seeks to argue that although fair trial standards are commonly portrayed as a set of minimum coherent standards applicable across a range of different legal traditions, there is a tension between those standards that accentuate the importance of individual will and autonomy and those that emphasise the importance of accurate outcome through an effective defence. This tension has been managed for the most part by enabling individuals to be represented by legal counsel who present the defence (...) on the basis of their clients’ instructions. Human rights law has recognised the importance of legal assistance at trial and pre-trial stages of criminal procedures. Despite this certain developments in domestic and international criminal processes have led to a growing number of cases being decided without an effective defence being provided by legal counsel. Such cases have been disposed on the basis of defendants’ ‘consent’ and this supposed autonomy has held sway over any effective defence. The paper begins by tracing different dimensions of the fair trial standards and exposes a tension between the need for defendants to exercise autonomy over their case and the need for an effective defence. The paper then argues that the right to counsel has acted as a bridge between these two competing demands. Recent developments are then reviewed which have served to impede counsel from providing an effective defence in the interests of the client’s freedom to choose how her case should be handled. The examples examined are the growing number of cases that are pleaded or diverted out of court with no real examination of the strength of the prosecution case, the emergence of special advocates who do not take instructions from defendants and the increasing tendency for defendants to represent themselves in certain types of cases. The paper concludes by arguing that we need to make a sharper distinction between individual rights and procedural standards and argues for greater attention to be given to the latter on the design of criminal procedure. (shrink)

Various special investigative methods are more often applied nowadays; their use is unavoidably induced by today’s reality in combating organised crime in the spheres such as corruption, prostitution, drug trafficking, trafficking in persons, money counterfeit and etc. Therefore, special secret investigative methods are more often used and they are very effective in gathering evidence for the purpose of detecting and investigating very well-organised or latent crimes. Both the Convention on the Protection on Human Rights and Fundamental Freedoms itself, i.e. its (...) Article 6, and other international instruments, such as the Council of Europe’s Criminal Law Convention, the Council of Europe’s Convention on Laundering, Search, Seizure and Confiscation of the Proceeds from Crime and others, do not prohibit the use of special investigative methods, provided that their use does not violate human rights. The use of special investigative methods, such as undercover agents or other undercover investigative methods, cannot in itself infringe human rights and the right to a fair trial; however, its use must have clear limits and safeguards. The recent judgements of the European Court of Human Rights regarding the use of undercover agents confirm that the use of undercover agents in certain types of cases is often unavoidable and also very problematic, because the Court imposes on the member states of the Convention increasingly wider obligations. Partly this is determined by the fact that the current jurisprudence of the Court is still in the state of formation, therefore many questions are left unanswered. (shrink)

Patients have received experimental pharmaceuticals outside of clinical trials for decades. There are no industry-wide best practices, and many companies that have granted compassionate use, or ‘preapproval’, access to their investigational products have done so without fanfare and without divulging the process or grounds on which decisions were made. The number of compassionate use requests has increased over time. Driving the demand are new treatments for serious unmet medical needs; patient advocacy groups pressing for access to emerging treatments; internet platforms (...) enabling broad awareness of compelling cases or novel drugs and a lack of trust among some that the pharmaceutical industry and/or the FDA have patients’ best interests in mind. High-profile cases in the media have highlighted the gap between patient expectations for compassionate use and company utilisation of fair processes to adjudicate requests. With many pharmaceutical manufacturers, patient groups, healthcare providers and policy analysts unhappy with the inequities of the status quo, fairer and more ethical management of compassionate use requests was needed. This paper reports on a novel collaboration between a pharmaceutical company and an academic medical ethics department that led to the formation of the Compassionate Use Advisory Committee. Comprising medical experts, bioethicists and patient representatives, CompAC established an ethical framework for the allocation of a scarce investigational oncology agent to single patients requesting non-trial access. This is the first account of how the committee was formed and how it built an ethical framework and put it into practice. (shrink)

Clinical trials emerged in rapid succession as the COVID-19 pandemic created an unprecedented need for life-saving therapies. Fair and equitable subject selection in clinical trials offering investigational therapies ought to be an urgent moral concern. Subject selection determines the distribution of risks and benefits, and impacts the applicability of the study results for the larger population. While Research Ethics Committees monitor fair subject selection within each trial, no standard oversight exists for subject selection across multiple trials for (...) the same disease. Drawing on the experience of multiple clinical trials at a single academic medical centre in the USA, we posit that concurrent COVID-19 trials are liable to unfair and inequitable subject selection on account of scientific uncertainty, lack of transparency, scarcity and, lastly, structural barriers to equity compounded by implicit bias. To address the critical gap in the current literature and international regulation, we propose new ethical guidelines for research design and conduct that bolsters fair and equitable subject selection. Although the proposed guidelines are tailored to the research design and protocol of concurrent trials in the COVID-19 pandemic, they may have broader relevance to single COVID-19 trials. (shrink)

Randomised clinical trials provide the most valid means of establishing the efficacy of clinical therapeutics. Ethical standards dictate that patients and clinicians should not consent to randomisation unless there is uncertainty about whether any of the treatment options is superior to the others ("equipoise"). However, true equipoise is rarely present; most randomised trials, therefore, present challenging ethical dilemmas. Minimising the tension between science and ethics is an obligation of investigators and clinicians. This article briefly reviews several techniques for addressing this (...) issue and suggests that unbalanced randomisation, a technique rarely employed in current clinical trial practice, may be useful for enhancing the ethical design of human experimentation. (shrink)

Cluster randomized controlled trials (cluster RCTs) randomize whole clusters of individuals in testing two or more competing interventions. Here we will present the ethical problems raised by cluster RCTs concerning their effect on inequality. We argue that some inequalities generated by cluster RCTs are larger in scope than those generated from individual RCTs. We also argue that any cluster RCT-generated inequalities, which divide groups rather than individuals, are more problematic in type than the inequalities created in individual RCTs. These concerns (...) should be taken into consideration when designing research at the cluster level, and those conducting the research should consider modified research design strategies in cases where they believe the risk of generating inequalities is large. (shrink)

Despite legitimate concerns, Saddam Hussein has received an appropriate and fair trial, both in light of the specific details of the judicial proceedings and in light of the political nature of war crimes justice in an anarchic system of states.

This book addresses the European Court of Human Rights’ fairness standards in criminal appeal, filling a gap in this less researched area of studies. Based on a fair trial immediacy requirement, the Court has found several violations of Article 6 of the European Convention on Human Rights at the appellate level by at least eighteen States of the Council of Europe in a vast array of cases, particularly in contexts of first instance acquittals overturning and of sentences increasing (...) on appeal. -/- On the one hand, the book critically engages this case-law with the law revisions it has recently inspired in European countries, as well as with the critiques and difficulties that it continues to raise. On the other hand, it interweaves insight from criminal procedure theory with new discoveries in the field of cognitive sciences (neuroscience of memory, philosophy of knowledge, AI), shedding an interdisciplinary light on the (in)adequacy and limits of the Strasbourg Court’s jurisprudence. (shrink)

One important ethical issue in randomised controlled trials is randomisation. Relatively little is known about how participating individuals and communities understand and perceive central aspects of randomisation such as equality, fairness, transparency and accountability in community-based trials. The aim of this study was to understand and explore study communities’ perspectives of the randomisation process in a cluster RCT in rural Zambia studying the effectiveness of different support packages for adolescent girls on early childbearing. In this explorative study, in-depth semi-structured interviews (...) were carried out in 2018 with 14 individuals who took part in the randomisation process of the Research Initiative to Support the Empowerment of Girls project in 2016 and two traditional leaders. Two of the districts where the trial is implemented were purposively selected. Interviews were audio recorded and fully transcribed. Data were analysed by coding and describing emergent themes. The understanding of the randomisation process varied. Some respondents understood that randomisation was conducted for research purposes, but most of them did not. They had trouble distinguishing research and aid. Generally, respondents perceived the randomisation process as transparent and fair. However, people thought that there should not have been a “lottery” because they wanted all schools to receive equal or balanced benefits of the interventions. Randomisation was misunderstood by most respondents. Perceived procedural fairness was easier to realize than substantive fairness. Researchers working on Cluster Randomised Controlled Trials should consider carefully how to explain randomisation. (shrink)

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

Clinical investigators must engage in just subject recruitment and selection and avoid unduly influencing research participation. There may be tension between the practice of keeping payments to participants low to avoid undue influence and the requirements of justice when recruiting normal healthy volunteers for phase 1 drug studies. By intentionally keeping payments low to avoid unduly influenced participation, investigators, on the recommendation or insistence of institutional review boards, may be targeting or systematically recruiting healthy adult members of lower socio-economic groups (...) for participation in phase 1 studies. Investigators are at risk of routinely failing to fulfill the obligation of justice, which prohibits the systematic targeting and recruiting of subjects for reasons unrelated to the nature of the study. Insofar as we take seriously the obligation to engage in just subject recruitment and selection, I argue that we must acknowledge the implications low payments might have for subject recruitment and selection and examine the effect of low payments. If low payments de facto target the less well-off for phase 1 studies, we must defend the priority ranking of the obligation to avoid undue influence over the obligation of justice or adopt an alternative recruitment approach. This paper identifies a number of alternatives to the current system of low-value payments to research participants. (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)

Volume 20, Issue 2, February 2020, Page 35-38.

In 2004 Emanuel et al. published an influential account of exploitation in international research, which has become known as the 'fair benefits account'. In this paper I argue that the thin definition of fairness presented by Emanuel et al, and subsequently endorsed by Gbadegesin and Wendler, does not provide a notion of fairness that is adequately robust to support a fair benefits account of exploitation. The authors present a procedural notion of fairness – the fair distribution of (...) the benefits of research is to be determined on a case-by-case basis by the parties involved in each study. The fairness of the distribution of benefits is not assessed against an independent normative standard. Emanuel et al.'s account of fairness provides a framework for objecting only to transactions that occur without the fully informed consent of the weaker party. As a result, a debate about exploitation collapses into a debate about consent. This is problematic because, as the proponents of the fair benefits framework acknowledge, neither the trial participants' consent nor the host community's consent preclude exploitation. Attempts to stipulate normative standards of fairness to protect research subjects in developing countries have been controversial and divisive, and it is therefore understandable that bioethicists would be tempted to develop accounts of exploitation that are independent of such prescriptive principles. I conclude, however, that the utility of the fair benefits model of exploitation as a policy tool will ultimately depend on whether a substantive principle of fairness can be developed to underpin it. (shrink)

According to the JUSTIFIED FAIR COINS principle, if I know that a coin is fair, and I lack justification for believing that it won’t be flipped, then I lack justification for believing that it won’t land tails. What this principle says, in effect, is that the only way to have justification for believing that a fair coin won’t land tails, is by having justification for believing that it won’t be flipped at all. Although this seems a plausible (...) and innocuous principle, in a recent paper Dorr, Goodman and Hawthorne use it in devising an intriguing puzzle which places all justified beliefs about the future in jeopardy. They point out, further, that one very widespread theory of justification predicts that JUSTIFIED FAIR COINS is false, giving us additional reason to reject it. In this paper, I will attempt to turn this dialectic around. I will argue that JUSTIFIED FAIR COINS does not inevitably lead to scepticism about the future, and the fact that it is incompatible with a widespread theory of justifi... (shrink)

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

Prevailing ethical thinking about informed consent to clinical research is characterized by theoretical confidence and practical disquiet. On the one hand, bioethicists are confident that informed consent is a fundamental norm. And, for the most part, they are confident that what makes consent to research valid is that it constitutes an autonomous authorization by the research participant. On the other hand, bioethicists are uneasy about the quality of consent in practice. One major source of this disquiet is substantial evidence of (...) the “therapeutic misconception”—the tendency of patient-subjects in clinical trials to confuse participating in research with receiving personalized medical care. This .. (shrink)

In recent years, there has been a surge of high-profile publications on applications of artificial intelligence (AI) systems for medical diagnosis and prognosis. While AI provides various opportunities for medical practice, there is an emerging consensus that the existing studies show considerable deficits and are unable to establish the clinical benefit of AI systems. Hence, the view that the clinical benefit of AI systems needs to be studied in clinical trials—particularly randomised controlled trials (RCTs)—is gaining ground. However, an issue that (...) has been overlooked so far in the debate is that, compared with drug RCTs, AI RCTs require methodological adjustments, which entail ethical challenges. This paper sets out to develop a systematic account of the ethics of AI RCTs by focusing on the moral principles of clinical equipoise, informed consent and fairness. This way, the objective is to animate further debate on the (research) ethics of medical AI. (shrink)

It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for participants. There is evidence that such a competition is a predictor of low study accrual, with increased competition tied to increased recruitment shortfalls. But there is no consensus on what steps, if any, institutions should take to approach this issue. In this article, we argue (...) that an institutional policy that prioritises some trials for recruitment ahead of others is ethically permissible and indeed prima facie preferable to alternative means of addressing recruitment competition. We motivate this view by appeal to the ethical importance of minimising the number of studies that begin but do not complete, thereby exposing their participants to unnecessary risks and burdens in the process. We then argue that a policy of prioritisation can be fair to relevant stakeholders, including participants, investigators and funders. Finally, by way of encouraging and helping to frame future debate, we propose some questions that would need to be addressed when identifying substantive ethical criteria for prioritising between studies. (shrink)

Discussions of fairness in the workplace are built on assumptions about the organization of work and about fairness. Writers on business ethics have not appreciated that work is often organized differently in different stages of the life cycle of a firm. In this paper it is argued that the conceptions of fairness applied to a mature firm are often not applicable to a fledgling one. In a mature firm authority and responsibility are typically delegated and divided into specific jobs with (...) relatively rigid boundaries. Thus, it has been argued that fairness in hiring requires specific job descriptions, fairness in remuneration requires standardized and graded salaries, and fairness in due process requires peer review. However, in the formative stages of a corporation, there may be very little differentiation or specialization. There is a continual re-definition of individual tasks through interaction with others as knowledge about products, production, and consumer demand are acquired by trial and error in the marketplace. Fairness takes a different form in this firm. The principle that similar people are to be treated similarly and different people differently can be operationalized in two ways. The mature firm typically focuses on differences; a fledgling, entrepreneurial one on similarities. How some of the issues of fairness in hiring, pay, and due process need to be reformulated once they are placed within the context of an entrepreneurial firm with its emphasis on similarity are then discussed. (shrink)

The need for continuing provision of beneficial experimental interventions after research is concluded remains a controversial topic in bioethics for research. Based on the principle of beneficence, justice as reciprocity, concerns about exploitation and fair benefits, participants should be able to have continuing access to benefits beyond the research period. However, there is no consensus about whether or not post-trial provision of beneficial interventions should be mandatory for participants from developing countries. This paper summarises recommendations from international and (...) national guidelines. Ethical principles and practical issues relating to post-trial provision are also discussed. In conclusion, post-trial provision is not necessary in all situations and a set of criteria are proposed to identify the situations that beneficial interventions should be provided beyond the research period. However, mandatory post-trial supply of beneficial experimental interventions should be assured for those who still need and are able to benefit from them but have no alternative access. Mandatory provision is based on universal bioethical principles such as beneficence and justice. Furthermore, difficulties associated with implementation of post-trial provision are not unmanageable. Careful advanced planning and a comprehensive partnership among relevant parties would be very helpful in solving these difficulties in practice, which therefore should not be taken as an excuse to escape post-trial responsibility. (shrink)

This article analyzes the origins of the “responsible corporate officer” doctrine: the trial of Joseph Dotterweich. That doctrine holds that an officer may be personally liable for the criminal act of a subordinate if the officer was, in some indefinite way, able to prevent the violation. Applying this doctrine, the prosecution of Dotterweich entailed strict liability for a strict liability offense. The underlying offenses—the interstate sale of one misbranded and adulterated drug and one misbranded drug—were said to be strict (...) liability offenses. And then, with respect to Dotterweich as the corporation’s general manager, the government argued that he was strictly liable because he stood in “responsible relation” to the company’s acts. The government never tried to prove that the company, Buffalo Pharmacal, was negligent, nor did it try to prove that Dotterweich was negligent in his supervision of the employees of Buffalo Pharmacal. The prosecutor and judge were candid about this theory throughout the trial, although the judge conceded that it seemed bizarre and unfair. The defense lawyer repeatedly sought to inject what became known throughout the trial as the “question of good faith,” but was circumvented at almost every turn. What would thus seem to be the crux of any criminal trial—the personal fault of the defendant—was carefully shorn from the jury’s consideration. The government’s theory was so at odds with intuitive notions of liability and blame that, as one probes into the case, and looks at the language used in the government’s appellate briefs, imputations of moral fault inevitably crept in. Yet the government was not entitled to make such accusations, as it had pruned moral considerations from the trial. The article argues that the responsible corporate officer doctrine can never enjoy a secure place in our legal system. First, the doctrine is at a minimum in tension with, and often in direct opposition to, basic principles of the criminal law; and second, the doctrine fails, when followed to its logical conclusions, to accord with basic notions of fair play. The article concludes that the responsible corporate officer doctrine is either unnecessary, in cases in which the evidence establishes personal fault, or unjust, in cases in which it creates liability in the absence of personal fault through the unspecified notion of “responsibility.” The Dotterweich case illustrates what is contemplated by the latter possibility, and why it is problematic in any judicial system that purports, in the words of the Model Penal Code, “to safeguard conduct that is without fault from condemnation as criminal.”. (shrink)

For a significant number of patients, there exists no, or only little, interest in developing a treatment for their disease or condition. Especially with regard to rare diseases, the lack of commercial interest in drug development is a burning issue. Several interventions have been made in the regulatory field in order to address the commercial disinterest in these conditions. However, existing regulations mainly focus on the provision of incentives to the sponsors of clinical trials of orphan drugs, and leave unanswered (...) the overarching question about the rightful place of orphan drugs in resource allocation systems. In this article, we analyse the ethical aspects of funding research and development in the field of rare diseases. We then propose an ethical framework that can help health policy makers move forward in the difficult matter of fairly allocating resources for the prevention, diagnosis and treatment of rare diseases. (shrink)

Many in the international development community have embraced the randomized controlled field experiment, akin to a biomedical clinical trial for social interventions, as the new “gold evidential standard” in program impact evaluation. In response, critics have called upon the method’s advocates to consider the moral dimensions of randomization, leading to a debate about the method’s ethics. My research intervenes in this debate by empirically investigating how researchers manage the perception of randomization in the field. Without the possibility of a (...) placebo, researchers rhetorically and materially frame the experiment differently for the control and treatment groups. Three technologies allow for this differential framing: geographic separation, temporal delay, and public randomization ceremonies. Geographic separation is a “technology of opacity” designed to obscure unequal resource distribution by disentangling the intervention and research components of the experiment for the control group. The latter two are technologies of transparency designed to expose the element of randomization but downplay conditions that may affect participant buy in. All three technologies work to preclude collective definitions of fair resource allocation, yet they are not fully successful in preventing modes of confrontation and resistance that lie outside of the experiment’s framing. (shrink)

Trial participation in the proposed HIV Vaccine Trials in South Africa is discussed in the context of the ethical tension that exists between international ethical research standards and local standards of care and cultural norms in the Third World. The important concepts of informed consent, risk-benefit ratio and fair treatment of trial participants are interpreted differently in traditional, rural African communities, where a moderate form of communitarianism referred to as "Ubuntu" or "communalism" is still prevalent. Research is (...) an altruistic endeavor that benefits communities and societies as a result of risks taken by individuals. Universal ethical guidelines that are highly individualistic and fail to emphasize communalism may represent serious problems for the sort of research needed in Africa today. (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.

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)

Many oppose the use of profile evidence against defendants at trial, even when the statistical correlations are reliable and the jury is free from prejudice. The literature has struggled to justify this opposition. We argue that admitting profile evidence is objectionable because it violates what we call “equal protection”—that is, a right of innocent defendants not to be exposed to higher ex ante risks of mistaken conviction compared to other innocent defendants facing similar charges. We also show why admitting (...) other forms of evidence, such as eyewitness, trace, and motive evidence, does not violate equal protection. (shrink)

Accused persons who are subjected to a saturation level of negative media coverage may be denied an impartial hearing, which is perhaps the most important aspect of the right to a fair hearing. Despite this, the courts have generally held that the social imperative of prosecuting accused trumps the interests of the accused. The justification for an impartial hearing stems from the repugnance of convicting the innocent. Viewed dispassionately, this imperative is not absolute, given that every legal system condones (...) procedures which result in the conviction of some innocent people. While the importance of guarding against wrongful convictions has been overstated, the imperative to bring to trial all accused has been even more exaggerated. The legal system has displayed a capacity to deal with cases where the guilty walk free. The institutional integrity of the criminal justice system would be significantly compromised by convictions that are tarnished by pre-judgment. Confidence in the criminal justice system is more important than individual criminal accountability. The inability to receive an impartial hearing should result in a permanent stay. The only exception is where the alleged crime has the capacity to cause widespread fear or social unrest. This only applies in relation to serious acts of terrorism. This article focuses on recent legal fair trial developments in Australia, however, the analysis, reasoning and conclusion applies in relation to all jurisdictions where juries determine guilt and innocence. (shrink)

This article explores the “fair trial” as a good practice for the construction of public proof. If proof signifies closure on matter at hand, and publicness is taken to signify both “access to” and “participation in” the construction of proof by the publics concerned, the authors contend that the “fair trial” is a good example of building public proof and that its backbone constraints can be of great interest to the defenders and advocates of participative Technology (...) Assessment, especially citizens' juries. (shrink)

Future economic game research should include: (1) within-culture comparisons between individuals exposed and not exposed to market integration; (2) use of a game (such as the “Sharing Game”) that enables subjects to maximize their earnings while also maximizing those of the other participant; and (3) assessment of performance in a repeated-trials format that might encourage sensitivity to the games' economic contingencies.

The concept of Homo economicus, one of the major foundations of neoclassical economics and a subset of the ideology of laisser-faire capitalism. was recently charged and tried in the island high court. Using the island’s virtual jury system for the first time, the accused was tried before a jury of three — Plato, Schopenhauer and feminist economists — chosen by him while under a veil of ignorance of the charge. All three returned guilty verdicts. Plato’s was prescriptive: ‘One ought not (...) to be like Homo economicus’. Schopenhauer’s verdict was descriptive: ‘Human nature is not Homo economicus’. The feminist verdict was both. Following the trial — described as a thought experiment — the island’s resident philosopher put forward two claims: (a) Neoclassical economists base their theories on a deficient depiction of humankind (descriptive misconception) a claim supported by a witness expert in experimental economics; (b) The depiction holds a dominant but unjustified position in various discourses such as welfare state debates because it is promoted by a small but highly influential group of economically privileged, universityeducated whites, namely graduates of economics, a claim supported by the sociology expert witness. (shrink)

Government agencies and nonprofit organizations have increasingly turned to randomized controlled trials (RCTs) to evaluate public policy interventions. Random assignment is widely understood to be fair when there is equipoise; however, some scholars and practitioners argue that random assignment is also permissible when an intervention is reasonably expected to be superior to other trial arms. For example, some argue that random assignment to such an intervention is fair when the intervention is scarce, for it is sometimes (...) class='Hi'>fair to use a lottery to allocate scarce goods. We investigate the permissibility of randomization in public policy RCTs when there is no equipoise, identifying two sets of conditions under which it is fair to allocate access to a superior intervention via random assignment. We also reject oft-made claims that alternative study designs, including stepped-wedge designs and uneven randomization, offer fair ways to allocate beneficial interventions. (shrink)