This essay discusses various representations of Eichmann's mind that were fashioned on the occasion of his trial in Jerusalem in 1961. Gideon Hausner the prosecutor presented the defendant as demonic. Hannah Arendt, the German-born American Jewish philosopher portrayed him as banal or thoughtless. Limiting themselves to the issue of mens rea in their judgment, the Israeli Supreme Court justices described Eichmann's mind as controlled by criminal intent. While these views have been widely discussed in the literature, much of this (...) essay focuses on a hitherto little noted perspective on Eichmann's mind that was formulated by the mental health experts who examined Eichmann for the prosecution. As compared to the inclusionist, confictual, and complex picture these experts presented of Eichmann's mind, Arendt's and Hausner's views appear similar in their reductionism, rather than diametrically opposed, while the approach of the Supreme Court justices to Eichmann's mind can be regarded as restrictive. Methodological problems involved in all these different perspectives are discussed, and it is argued that even though the psychological outlook declares itself to be non-judgmental, it does, in fact, entail a dimension of moral judgment. Finally, Eichmann 's recently declassified memoirs are adduced and interpreted as lending some support to the psychological, inclusionist perspective on Eichmann's mind. (shrink)

The eminent philosopher and political theorist Hannah Arendt once attended a similar trial with a similar plea: the 1961 trial of the mid‐level Nazi official Adolf Eichmann. She portrayed him as an exemplar of what she termed the banality of evil. After his capture in 1960, Eichmann was tried on charges including war crimes and crimes against humanity. Eichmann was an exemplary case of the thoughtlessness and lack of self‐reflection that goes into setting unthinkable atrocities into motion. Like (...) Eichmann, Mao doesn't cut the figure of a hardline fanatic, blinded by ideology. Mao's unwillingness to place the cause ahead of his own desires should indicate that he isn't wholly blinded by fanaticism, as Dresden is. In her characterizations of Eichmann, Arendt noted his odd lack of imagination, his inability, in other words, “to think from the standpoint of someone else.”. (shrink)

This article reviews professional mental health publications before and after the Eichmann trial. Psychiatrists rejected the massive denial of survivors' emotional reactions that was prevalent in Israeli society at the time. The Eichmann trial permitted the opening up of survivors' experiences in public. Legal procedure enabled the witnesses to speak about what they had hidden until then. The judge's presence gave legitimacy and power to the accusations, transforming the survivors from outlaws to partners in justice. The audience came (...) to support this stronger survivor identity. Through a slow process, it became a valid issue for psychotherapy, allowing the weaker aspects of the survivors' personalities to be addressed. This article reviews professional mental health publications before and after the Eichmann trial. Psychiatrists rejected the massive denial of survivors' emotional reactions that was prevalent in Israeli society at the time. The Eichmann trial permitted the opening up of survivors' experiences in public. Legal procedure enabled the witnesses to speak about what they had hidden until then. The judge's presence gave legitimacy and power to the accusations, transforming the survivors from outlaws to partners in justice. The audience came to support this stronger survivor identity. Through a slow process, it became a valid issue for psychotherapy, allowing the weaker aspects of the survivors' personalities to be addressed. (shrink)

This article takes as its focus the question, raised by Shoshana Felman and Dori Laub in their 1995 book Testimony: Crises of Witnessing in Literature, Psychoanalysis and History, of what it means for an event to be constituted by the collapse of its witness. The discussion centres on a reading of the moment Yehiel Dinoor, a writer also known as K-Zetnik and one of the few eyewitnesses at the 1961 Eichmann trial in Jerusalem, falls out of the stand and (...) into a coma while attempting to provide his testimony. By rethinking this historical trauma as a ‘collapse of witnessing’, I suggest Felman and Laub shift the focus from a purely cognitive or epistemological question — a problem of knowing and not-knowing — to a question of communicating to others: a problem of address. It is the circumstance of having ‘no one to whom one could say Thou’, as Laub puts it, that constitutes the Holocaust, for the victims, as what the authors call an ‘event without a witness’. (shrink)

The Eichmann trial has been one of the most important formative events in the short history of the State of Israel. The echoes of its impact on how Israelis as individuals and as a public perceive themselves reverberate even today in the most profound and existential of ways. In the public consciousness the trial was, and still is, fundamentally identified with its prosecutor then Attorney General Gideon Hausner. However the trial was not a one-man show as the (...) public tended to perceive it. Behind the scenes were numerous people working and preparing for the trial and influencing the prosecution's case against Eichmann: the investigators in the special police unit Bureau 06 established to conduct the investigation and prepare the criminal file; the Holocaust survivor organizations and institutions; and all echelons of the political sphere. This paper will trace some of the stages in the preparation of the prosecution of Eichmann and the people involved, as well as the matter of the scope of the bill of indictment and of the historical narrative tolls at the trial and the fact that it emerged to he one of the most important trials in the history of the twentieth century. (shrink)

Commentators often note that there are contradictions, or at least inconsistencies, in Arendt’s work. On the one hand, Arendt is accused of theoretical inconsistencies, insofar as she makes claims in her later work that seem incompatible with claims she made earlier. On the other hand, Arendt has been accused of contradicting herself morally, with some commentators claiming that Arendt should not have written Eichmann in Jerusalem the way she wrote it. Both views place the treatment of the 1961 Eichmann (...) class='Hi'>trial at the center of Arendt’s thought, and cast it as representing a radical shift from Arendt’s earlier work. This article shows that both views fail to acknowledge the importance of what I call the “archetype of non-contradiction” in Arendt’s work. I argue that, viewed in perspective, her treatment of the Eichmann trial is simply another instance of Arendt attempting to follow the archetype of non-contradiction, practicing tentative and fluid thinking, and maintaining her friendship with herself. (shrink)

This paper explores the Eichmann trial in its dimension as a living, powerful event, whose impact is defined and measured by the fact that it is "not the same for all." I examine this legal event from two perspectives: Hannah Arendt's and my own. I pledge my reading against Arendt's, in espousing the State's vision of the trial, but in interpreting the legal meaning of this vision us one that exceeds its own deliberateness and distinct from the State's (...) ideology. I use Nietzsche's terms to contrast "critical history" with "monumental history." Whereas the official State vision of the trial is, I propose, precisely one of "monumental history, " Arendt's vision offers a substitutive "critical history." I analyze, one against the other, what I call the monumental legal vision of the Eichmann trial and the critical vision offered by Arendt. Exploring thus the monumental versus the critical as two opposed but non-exclusive and, in fact, profoundly complementary perspectives, I examine, side by side, the Eichmann trials' monumental focus on the victims and Arendt's critical objections to this focus: her objections, I show, are based in a jurisprudential conservatism coexisting with a historiographical radicalism. The Eichmann trial, in my view, is on the contrary and diametrically, historiographically conservative, but jurisprudentially revolutionary. I argue that Arendt failed to see the way in which the trial in effect did not simply repeat the victim's story, but historically created it for the first time. I submit, in other words, that the Eichmann trial legally created a radically original and new event: not a rehearsal of a given story, but a groundbreaking narrative event that is itself historically and legally unprecedented. Examining the trial's transformation of victims into prosecution witnesses, I analyze the victim-oriented focus of the trial as s legal process of translation of private traumas into public ones and as a public scene of the recovery of language and legal subjecthood by victims who were formerly defined by the oppressor's language and who were, therefore, not just injured, but essentially robbed of a language in which to articulate their injury and name their victimization. I argue that the Eichmann trial expanded the space available for moral deliberation in creating a new legal language: the trial was the victim's trial only insofar as it was now the victims who, against all odds, were precisely writing their own history. To enable such a writing, the Eichmann trial had to enact not simply memory, but memory as change. It had to dramatize upon its legal stage before the audience nothing less than a conceptual revolution in the victim. And this, in fact, is what the trial did This historically unprecedented revolution in the victim that was operated in and by the Eichmann trial is, I suggest, the trial's major contribution not only to Jews, but to history, to law, to culture - to humanity at large. I further argue that as a singular legal event, the Eichmann trial calls for a rethinking - and sets in motion a transvaluation - of the structures and the values of conventional criminal law. I submit that the quintessence of the Eichmann trial is the acquisition of semantic authority by victims. It was the newly acquired semantic and historical authority of this revolutionary story that, for the first time, created what we know today as the Holocaust: a theme of international discussion and world conversation designating the experience of the victims and referring to the crime against the Jewish people independently from the political and military story of the Second World War. (shrink)

This essay examines the Kastner trial and the Eichmann trial as constitutive moments in the development of Israeli collective identity. This aspect of the trials is explored by comparing the intervention of two intellectuals, Nathan Alterman and Hannah Arendt, in the two trials respectively. Both social critics challenged the terms of the collective identity that was reinforced by the trials. During the Kastner trial, the Israeli poet Alterman set out to challenge the "two paths" conception of heroism (...) and cowardice that shaped the court's - and society's - understanding of the Holocaust. The first part of the essay examines Alterman's critical intervention and the public controversy that followed in its wake. In the second part, I examine Arendt's criticism of the Eichmann trial as an attempt to construct Israeli collective identity around opposition to the demonic Nazi In this context, I discuss the famous controversy between Arendt and Gershom Scholem over the terms of her criticism. The two episodes come together in the third part of the essay, where I discuss the surprising continuities and affinities between the controversies. The two controversies offer a fascinating tale about the role of the law in the construction of collective identities and the role of the social critic in the development of a liberal society. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Eichmann, Empathy, and LolitaLeland de la DurantayeISometime in late 1960 or early 1961 Adolf Eichmann, jailed and awaiting trial in Jerusalem, was given by his guard a copy of Vladimir Nabokov's recently published Lolita, as Hannah Arendt puts it, "for relaxation." After two days Eichmann returned it, visibly indignant: "Quite an unwholesome book"—Das ist aber ein sehr unerfreuliches Buch—he told his guard. 1 Though we are not privy (...) to, and nor does Arendt speculate upon this officer's intentions, it is difficult to imagine that they were limited to procuring Eichmann a little "relaxation." The tale of a homicidal madman writing under observation and awaiting a trial that will consign him either to death or prolonged imprisonment—which fate spares him by felling him with a heart attack—could hardly have been very relaxing for someone at that moment writing his own memoirs and himself awaiting a trial with similar stakes.We might imagine other intentions on the part of Eichmann's guard. Could the gesture have been ironic? Or was it motivated by a dark curiosity—something of the order of an experiment? The sulphurous halo of Nabokov's book was still burning brightly in the popular consciousness of 1960. 2 Might Eichmann's guard have seen Lolita as a sort of litmus test for radical evil, and wanted to see whether the real-life villain—he who impassively organized the transport towards certain death of countless innocents—would coldly, even gleefully, approve the various and vile machinations of Nabokov's creation?This is all only speculation. In Arendt's account, she congratulates Eichmann for his indignation and moves on to other matters. In any event, given Eichmann's radical conventionality one could hardly imagine him liking—or even very well understanding—much of the book. As [End Page 311] Eichmann himself avowed, during his adult life he had read only two books, one of them being Theodor Herzl's The Jewish State. But whatever the motivations of Eichmann's guard, whatever Eichmann's degree of comprehension, and whatever congratulations Eichmann might have deserved for his disgust, the incident raises a question for the study of Nabokov's finest work which has yet to be answered.IIBefore turning to this question, let us remain with Arendt and her notorious reader for a moment. Arendt notes elsewhere that it appeared to her that Eichmann was nearly "aphasic." She comments that, "when he did succeed in constructing a sentence of his own, he repeated it until it became a cliché," and that, "his inability to speak was closely connected with an inability to think, namely, to think from the standpoint of somebody else." Arendt offers here nothing less than a definition of thought itself. "To think" is glossed ("... namely") by Arendt as, "to think from the standpoint of someone else." Though as a definition of thought, it is hardly impressive, it nevertheless expresses something essential about Arendt's conception of thought and thinking. (3) In her view, thought is to be placed under the sign of intellectual empathy, under the sign of living in the strangeness and wonder of another's world. (Though Arendt does not mention the connection, both the language she wrote Eichmann in—English—and her native one—German—make special provision for such a sense, as he or she who is "thoughtless" is not her or she who is incapable of some form of cognition or calculation, as "thoughtless" people can indeed be very clever and very clever people have been capable of great "thoughtlessness.")Thought is thus a communal, not individualistic, thing. 4 This point is important as, though Adolf Eichmann was unlikely to have seen much of himself in the irreverent and urbane genius of Nabokov's Humbert Humbert, nor in the latter's strange eloquence, Eichmann the man and Humbert the character of the first part of the novel (to leave the repenting Humbert of the book's last pages out for the moment), share an essential trait. What Eichmann the man shares with Nabokov's literary creation is the inability or unwillingness "to think from the standpoint of somebody else." The evil they share is the... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Eichmann, Empathy, and LolitaLeland de la DurantayeISometime in late 1960 or early 1961 Adolf Eichmann, jailed and awaiting trial in Jerusalem, was given by his guard a copy of Vladimir Nabokov's recently published Lolita, as Hannah Arendt puts it, "for relaxation." After two days Eichmann returned it, visibly indignant: "Quite an unwholesome book"—Das ist aber ein sehr unerfreuliches Buch—he told his guard. 1 Though we are not privy (...) to, and nor does Arendt speculate upon this officer's intentions, it is difficult to imagine that they were limited to procuring Eichmann a little "relaxation." The tale of a homicidal madman writing under observation and awaiting a trial that will consign him either to death or prolonged imprisonment—which fate spares him by felling him with a heart attack—could hardly have been very relaxing for someone at that moment writing his own memoirs and himself awaiting a trial with similar stakes.We might imagine other intentions on the part of Eichmann's guard. Could the gesture have been ironic? Or was it motivated by a dark curiosity—something of the order of an experiment? The sulphurous halo of Nabokov's book was still burning brightly in the popular consciousness of 1960. 2 Might Eichmann's guard have seen Lolita as a sort of litmus test for radical evil, and wanted to see whether the real-life villain—he who impassively organized the transport towards certain death of countless innocents—would coldly, even gleefully, approve the various and vile machinations of Nabokov's creation?This is all only speculation. In Arendt's account, she congratulates Eichmann for his indignation and moves on to other matters. In any event, given Eichmann's radical conventionality one could hardly imagine him liking—or even very well understanding—much of the book. As [End Page 311] Eichmann himself avowed, during his adult life he had read only two books, one of them being Theodor Herzl's The Jewish State. But whatever the motivations of Eichmann's guard, whatever Eichmann's degree of comprehension, and whatever congratulations Eichmann might have deserved for his disgust, the incident raises a question for the study of Nabokov's finest work which has yet to be answered.IIBefore turning to this question, let us remain with Arendt and her notorious reader for a moment. Arendt notes elsewhere that it appeared to her that Eichmann was nearly "aphasic." She comments that, "when he did succeed in constructing a sentence of his own, he repeated it until it became a cliché," and that, "his inability to speak was closely connected with an inability to think, namely, to think from the standpoint of somebody else." Arendt offers here nothing less than a definition of thought itself. "To think" is glossed ("... namely") by Arendt as, "to think from the standpoint of someone else." Though as a definition of thought, it is hardly impressive, it nevertheless expresses something essential about Arendt's conception of thought and thinking. (3) In her view, thought is to be placed under the sign of intellectual empathy, under the sign of living in the strangeness and wonder of another's world. (Though Arendt does not mention the connection, both the language she wrote Eichmann in—English—and her native one—German—make special provision for such a sense, as he or she who is "thoughtless" is not her or she who is incapable of some form of cognition or calculation, as "thoughtless" people can indeed be very clever and very clever people have been capable of great "thoughtlessness.")Thought is thus a communal, not individualistic, thing. 4 This point is important as, though Adolf Eichmann was unlikely to have seen much of himself in the irreverent and urbane genius of Nabokov's Humbert Humbert, nor in the latter's strange eloquence, Eichmann the man and Humbert the character of the first part of the novel (to leave the repenting Humbert of the book's last pages out for the moment), share an essential trait. What Eichmann the man shares with Nabokov's literary creation is the inability or unwillingness "to think from the standpoint of somebody else." The evil they share is the... (shrink)

Commentaries on Eichmann in Jerusalem are of two kinds. The first confronts the historical relevance of Arendt's `report' and attempts to ascertain whether her ironical presentation of Eichmann's trial matches reality, namely, the incommensurable suffering of the Jewish people. The second focuses on the meaning of her expression `the banality of evil', and places Arendt in a long tradition of moral and political philosophy concerned with the problem of evil and, accordingly, of judging evil. The argument of this paper (...) is that both paths of research miss Arendt's intention, and that her `report' has to be read in light of Walter Benjamin's conceptions of history and storytelling. On the one hand, Eichmann in Jerusalem was not intended to reflect reality objectively because, as Arendt claimed, the objectivity of scientific historiography may serve only to condone the genocide. Throughout her entire work, Arendt aimed at avoiding the neutrality of historicism, the `tradition of sine ira et studio', which, according to her, represents a renunciation of responsibility. On the other hand, Arendt emphasized that she did not attempt to write about the nature of evil but to faithfully describe a phenomenon. Therefore the questions to be answered are: What did Arendt mean by a `report'? What does it mean to describe Eichmann's trial non-objectively but faithfully? In this paper, I show that her report should be understood in the light of a new methodological experiment inherited from Benjamin, which can be broken down into two steps: 1. To reveal the truth of history in stories rather than seek historical `objectivity' through theories; and 2. To look at events from forgotten standpoints, which are assumed to represent the experienced `inside' of history. (shrink)

What happens at the end of a clinical trial for an investigational neural implant? It may be surprising to learn how difficult it is to answer this question. While new trials are initiated with increasing regularity, relatively little consensus exists on how best to conduct them, and even less on how to ethically end them. The landscape of recent neural implant trials demonstrates wide variability of what happens to research participants after an neural implant trial ends. Some former (...) research participants continue to receive support for their devices (e.g., battery and component replacements, software updates, etc.). Others, when safe, have their neural implants removed through surgical explantation. Still others continue to live with a deactivated neural implant embedded in their body. In the United States, there are no uniform requirements to provide services, of any kind, after an neural implant study ends, and other nations are similarly facing this challenge. The existence of a post-trial gap in an expanding neural implant research ecosystem invites obvious questions: What is owed to neural implant research participants post-trial, and why has providing it been so difficult to accomplish in practice? To take a step forward on this difficult issue, we assembled one group of stakeholders – researchers funded for neuroethics grants by the National Institutes of Health – to explore possible starting points on one topic: ethical guidance for post-trial care of research participants in neural implant trials. Based on shared concerns discussed in the expert workshop the current paper is a call to action. It reports the key areas of convergence from the meeting and highlights important next steps towards developing much needed guidance. (shrink)

In 2018, the Chinese scientist He Jiankui presented his research at the Second International Summit on Human Genome Editing in Hong Kong. While it was intended that he facilitate a workshop, he was instead called on to present his research in heritable human genome editing, where he made the announcement that he had taken great strides in advancement of his research, to the extent that he had gene-edited human embryos and that this had resulted in the live births of two (...) children. While his research ethic and methodology was interrogated, he insisted that two children, twin girls, had been born healthy and that there was another pregnancy (at the time) where birth of a third gene edited child would be imminent. This announcement generated a ripple effect in the scientific community and exposed the gaps in regulation and absence of law relating to the technology. This resulted in a flurry of activity and conversation around regulation of the technology, which scientists stated was not ready for human trials. This article reviews the Third Summit which was held in London in March 2023 and comments on the latest developments in the regulation of heritable human genome editing. (shrink)

Following promulgation of the Nuremberg code in 1947, the ethics of research on human subjects has been a challenging and often contentious topic of debate. Escalation in the use of research participants in low-income countries over recent decades , has intensified the debate on the ethics of international research and led to increasing attention both to exploitation of vulnerable subjects and to considerations of how the 10:90 gap in health and medical research could be narrowed. In 2000, prompted by the (...) discussions over several years that led to the US NIH launching a capacity building programme on research ethics for members of research ethics committees in developing countries, we advanced a ‘new look’ for the ethics of international research.1 Since then progress has been made on several fronts.First, our ideas—considered somewhat radical and impractical at the time—have been provocatively addressed by scholars who have either contested them or advanced similar conceptions of what obligations international researchers have to research participants and communities in low income countries before, during and after clinical trials. Second, those researchers who have been sympathetic to our ideas have either endeavoured to put these into practice or have investigated the feasibility of doing so. Third, the intractability of the 10/90 gap and the escalation of interest in global health have sensitised many to the need to amplify the uptake of these ideas in practice.Here, we briefly review the conceptual and practical developments in international research ethics. While much conceptual progress has been made (and the concepts are now appearing …. (shrink)

Participants in some clinical trials are at risk of being harmed and sometimes are seriously harmed as a result of not being provided with available, relevant risk information. We argue that this situation is unacceptable and that there is a moral duty to disclose all adverse clinical trial results to participants in clinical trials. This duty is grounded in the human right not to be placed at risk of harm without informed consent. We consider objections to disclosure grounded in (...) considerations of commercial interest, and we argue that these concerns are insufficient to override the moral duty to disclose adverse clinical trial results. However, we also develop a proposal that enables commercial interests to be protected, while promoting the duty to disclose adverse clinical trial results. (shrink)

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

Conventional and well-established guidelines for the ethical conduct of clinical research are necessary but not sufficient for addressing research dilemmas related to public health research. There is a particular need for a public health ethics framework when, in the face of an epidemic, research is urgently needed to promote the common good. While there is limited experience in the use of a public health ethics framework, the value and potential of such an approach is increasingly being appreciated. Here we use (...) two examples of adolescent women as potential candidates for participation in microbicide trials to illustrate how ethical decisions for public health research can be enhanced by drawing on both traditional research ethics guidance, and the emerging framework for public health ethics. (shrink)

As we aggressively pursue research to cure and prevent Alzheimer’s disease, we encounter important ethical challenges. None of these challenges, if handled thoughtfully, would pose insurmountable barriers to research. But if they are ignored, they could slow the research process, alienate potential study subjects and do damage to research recruits and others. These challenges are the necessity of very large cohorts of research subjects, recruited for lengthy studies, probably ending only in the subjects’ death; the creation of cohorts of ’study (...) ready' volunteers, many of whom will be competent to consent at the beginning of the process, but move into cognitive impairment later; reliance on adaptive trial design, creating challenges for informed consent, equipoise and justice; the use of biomarkers and predictive tests that describe risk rather than certainty, and that can threaten participants’ welfare if the information is obtained by insurance companies or long-term care providers; the use of study partners that creates unique risks of harm to the relationship of subject and study partner. We need greater attention, at all levels, to these complex ethical issues. Work on these issues should be included in research plans, from the federal to the local, and should be supported through NIH in the same way that it supported work on the ethical, legal and social implications of genetic research. (shrink)

The attitudes of women patients with cancer were explored when they were invited to participate in one of three randomised trials that included chemotherapy at two university centres and a satellite centre. Fourteen patients participating in and 15 patients declining trials were interviewed. Analysis was based on the constant comparative method. Most patients voiced positive attitudes towards clinical research, believing that trials are necessary for further medical development, and most spontaneously argued that participation is a moral obligation. Most trial (...) decliners, however, described a radical change in focus as they faced the actual personal choice. Almost no one got an impression of clinical equipoise between treatments in the trials, and most patients expressed discomfort with randomisation. A patient’s choice to participate was mainly determined by whether the primary focus was on treatment effect or on adverse effects. Both knowledge about and feelings towards trials originated mostly from the media, although paradoxically the media were largely seen as untrustworthy. Mistrust was shown towards the pharmaceutical industry, and although most patients originally trusted that doctors primarily pursued the interest of patients, they did not trust the adequacy of doctors or industry in maintaining self-regulation. Thus, public control measures were judged to be essential. (shrink)

Many drugs used in paediatric medicine are off-label. There is a rising call for the use of adaptive clinical trial designs in responding to the need for safe and effective drugs given their potential to offer efficiency and cost-effective benefits compared with traditional clinical trials. ADs have a strong appeal in paediatric clinical trials given the small number of available participants, limited understanding of age-related variability and the desire to limit exposure to futile or unsafe interventions. Although the ethical (...) value of adaptive trials has increasingly come under scrutiny, there is a paucity of literature on the ethical dilemmas that may be associated with paediatric adaptive designs. This paper highlights some of these ethical concerns around safety, scientific/social value and caregiver/guardian comprehension of the trial design. Against this background, the paper develops a non-static conceptual lens for understanding PADs. It shows that ADs are epistemically open and reduce some of the knowledge-associated uncertainties inherent in clinical trials as well as fast-track the time to draw conclusions about the value of evaluated drugs/treatments. On this note, the authors argue that PADs are ethically justifiable given they have multiple layers of safety, exposing enrolled children to lesser potential risks, create social/scientific value generally and for paediatric populations in particular, specifically foster the flourishing of paediatric populations and can significantly improve paediatric trial efficiency when properly designed and implemented. However, because PADs are relatively new and their regulatory, ethical and logistical characteristics are yet to be clarified in some jurisdictions, the cooperation of various public and private stakeholders is required to ensure that the interests of children, their caregivers and parents/guardians are best served while exposing paediatric research subjects to the most minimal of risks when they are enrolled in paediatric trials that use ADs. Data sharing not applicable as no datasets generated and/or analysed for this study. Not applicable. (shrink)

Norman Kretzmann's recent analysis of the natural law slogan ``lex iniusta non est lex'' (an unjust law is not a law) demonstrates the coherence of the slogan and makes a case for its practical value, but I shall argue that it also ends up showing that the slogan fails to mark any interesting conceptual or practical division between natural law and legal positivist views about the nature of law. I argue that this is a happy result. The non-est-lex slogan has (...) been used to exaggerate the extent of disagreement about the nature of law and has diverted critics of natural law theory from recognizing that the main disagreement between natural lawyers and legal positivists centres on theories of practical reason and how they affect our understanding of the relationship between law and morality. This extends the debate about the nature of law somewhat beyond the traditional boundaries of philosophy of law, but these boundaries are due in part to the diversion created by debate over the non-est-lex slogan. Recognizing that the non-est-lex slogan fails on its own to mark any interesting practical or conceptual division between natural law theories and legal positivism should therefore focus and encourage debate on matters of genuine substance between these outlooks. The disagreement, however, may turn out to be primarily metaphysical and explanatory and not normative in nature. (shrink)

Participants in some clinical trials are at risk of being harmed and sometimes are seriously harmed as a result of not being provided with available, relevant risk information. We argue that this situation is unacceptable and that there is a moral duty to disclose all adverse clinical trial results to participants in clinical trials. This duty is grounded in the human right not to be placed at risk of harm without informed consent. We consider objections to disclosure grounded in (...) considerations of commercial interest, and we argue that these concerns are insufficient to override the moral duty to disclose adverse clinical trial results. However, we also develop a proposal that enables commercial interests to be protected, while promoting the duty to disclose adverse clinical trial results. (shrink)

The number of women living with HIV/AIDS is increasing worldwide, and there is an urgent public health need to develop new user-initiated HIV prevention methods, including microbicides. Although funding for microbicide development has increased since 2000, financial support is provided predominantly by governmental agencies and private foundations. Many donors, including the US Agency for International Development (USAID) and the US National Institutes of Health (NIH), have policies that restrict how research funds may be used. Among these are the now-rescinded Mexico (...) City Policy, elements of the US Foreign Assistance Act, and restrictions on non-study-related care. The effect of these restrictions on the design and conduct of clinical research is poorly understood. As part of a recent mapping exercise conducted by the Global Campaign for Microbicides, we reviewed the impact of donor restrictions on seven HIV prevention trials. We found considerable confusion within the HIV prevention field as to whether and how Mexico City and other policies affect the use of research funds. We also found that these donor-imposed policies limited the level of care provided to trial participants and the types of capacity building projects undertaken. (shrink)

What kind of patients may be recruited to early clinical trials of xenotransplantation? This is discussed under the assumption that the risk of viral infection to the public is non-negligible. Furthermore, the conditions imposed by the Helsinki declaration are analysed. The conclusion is that only patients at risk of dying and with no alternative treatment available should be recruited to xenotransplantation trials in the early phase. For some of the less dangerous cell or islet cell xenotransplantation other categories might be (...) recruited. The risk of cell and islet cell xenotransplantation should, however, be weighted against the development of other technologies.In order to safeguard the public, the opt-out clause in the Helsinki declaration should not be fully applied. Legally binding rules on obligatory monitoring and restrictions should be imposed—before clinical trials start. Journal of Medical Ethics. (shrink)

Two of the most important concepts in medicine are “curing” and “caring”. Patients should enter clinical trials with the understanding that they benefit from the treatment or that there may be some benefit to others. In many cancer trials, for example, the best that can be hoped for is a prolongation of life. Whether or not life is prolonged, we argue that there exists an obligation which can be termed a “bond of responsibility” to provide appropriate palliative care within the (...) patient’s own cultural context.The Declaration of Helsinki,1 the principal code governing the conduct of medical research, shows this “bond of responsibility” to be at its core. A number of statements stand out: “the health of my patient will be my first consideration”2 and “a physician shall only act in a patient’s best interest when providing medical care which might have the effect of weakening the physical and mental …. (shrink)

The issue of aftercare for participants in clinical research was explored in the context of an asthma drug trial. Although there may be financial constraints and practical difficulties with implementation, the results show that it may be feasible for clinical investigators and commercial sponsors to take on some limited responsibility for the medical care of research subjects after clinical trials. However, the ethical implications for this practice remain unclear. On the one hand, society may have a moral obligation to (...) compensate and reward some of its members who assume the risk of research subjects for the benefit of society as a whole. On the other hand, the promise of aftercare may provide an inducement to volunteers which, under certain conditions may be considered morally wrong and scientifically unsound. (shrink)

BackgroundAccurate reporting on sex and gender in health research is integral to ensuring that health interventions are safe and effective. In Canada and internationally, governments, research organizations, journal editors, and health agencies have called for more inclusive research, provision of sex-disaggregated data, and the integration of sex and gender analysis throughout the research process. Sex and gender analysis is generally defined as an approach for considering how and why different subpopulations (e.g., of diverse genders, ages, and social locations) may experience (...) health conditions and interventions in different or similar ways.The objective of this study was to assess the extent and nature of reporting about sex and/or gender, including whether sex and gender analysis (SGA) was carried out in a sample of Canadian randomized controlled trials (RCTs) with human participants.MethodsWe searched MEDLINE from 01 January 2013 to 23 July 2014 using a validated filter for identification of RCTs, combined with terms related to Canada. Two reviewers screened the search results to identify the first 100 RCTs that were either identified in the trial publication as funded by a Canadian organization or which had a first or last author based in Canada. Data were independently extracted by two people from 10% of the RCTs during an initial training period; once agreement was reached on this sample, the remainder of the data extraction was completed by one person and verified by a second.ResultsThe search yielded 1433 records. We screened 256 records to identify 100 RCTs which met our eligibility criteria. The median sample size of the RCTs was 107 participants (range 12–6085). While 98% of studies described the demographic composition of their participants by sex, only 6% conducted a subgroup analysis across sex and 4% reported sex-disaggregated data. No article defined “sex” and/or “gender.” No publication carried out a comprehensive sex and gender analysis.ConclusionsFindings highlight poor uptake of sex and gender considerations in the Canadian RCT context and underscore the need for better articulated guidance on sex and gender analysis to improve reporting of evidence, inform policy development, and guide future research. (shrink)

Background This article describes the issues encountered when designing a study to evaluate recruitment of minority ethnic groups into clinical cancer research in order to monitor adherence to the principles for good practice set out in the Department of Health, Research Governance Framework, England. Methods (i) A review of routine data sources to determine whether their usefulness as a source of data on prevalence of cancer in the population by ethnic category. (ii) A local case study at one hospital trust (...) to ascertain whether the ethnicity of cancer trial participants was representative of admitted cancer patients. Results (i) The lack of a comparator population makes it problematic to assess recruitment levels by ethnic group in clinical research. (ii) The odds of being in a trial were 30% lower for a member of a minority ethnic group compared to a white cancer patient after adjusting for disease, age and gender, OR 0.70 (0.53 to 0.94). These results differed for each ethnic group; Asian patients did not appear under-represented while Black and Chinese did so. However, there are important caveats to the findings based on the limited recording of ethnicity. Conclusions The lack of available data on the ethnicity of participants in clinical research and the prevalence of cancer in the population according to ethnicity makes it difficult to design a study to monitor representation of minority ethnic groups. This information is necessary to assess adherence to the Research Governance Framework principle that research evidence reflects the diversity of the population. (shrink)

Morain and Largent’s (2023) thorough and thoughtful article concludes that the partial-entrustment model of medical researchers’ ancillary-care obligations (Richardson and Belsky 2004; Belsky and R...

Patriarchal institutions govern all aspects of women's lives: their minds, their bodies, and their souls. Additionally, they govern the ways in which women are perceived by others and the ways in which women perceive themselves. (Re) Interpretations: The Shapes of Justice in Women's Experience, is a collection of essays on language, religion, war, sex trafficking, and medicine-the patriarchal structures that form the basis of western society and, thus, are in many ways inherently unjust. The essays illustrate the multitude of ways (...) that women have found to work within and without these structures to create justice. Traditional theories of justice cast it as a cardinal virtue, unbiased and impartial. The essays in this book, however, remove justice from the abstract and return it to the specific: most of the essays use personal narratives to highlight the connections all people share. The women discussed here are challenging the authority of existing patriarchal narratives by telling their versions, and, thus, calling attention to and challenging their own political and social realities. Reflecting a focus on global connectedness and interdisciplinarity, the writers of these essays aim not only to raise questions, but also to show ways in which women are creating new pathways for themselves. Only by exploring solutions will women reclaim justice. From L.A. to Zimbwabe, women have stories to tell about their experiences of justice in the inherently patriarchal institutions of Language, Religion, War, Sex Trafficking, and Medicine. This relevant and thought-provoking collection captures the trials that women across the world face and the hope they create through their courageous actions. Through both personal narrative and factual overview, these essays emphasize that as people committed to justice, women must not simply raise the questions, but they must also explore solutions in order to reclaim justice for themselves, their daughters, their sisters, and their mothers. Contributors: Yifat Bitton, Stephany Ryan Cate, Jo Scott-Coe, Susan Dewey, Carmela Epright, Carmen Faymonville, Adam Gaynor, Pauline Greenhill, Denise Handlarski, Alison Jobe, Marc J.W. de Jong, Jodie M. Lawston, Jody Lisberger, Kristy Maher, Susan Maloney, Mickias Musiyiwa, Ruben Murillo, Annemarie Profanter, Natalie Wilson, and J. Carter Wood. (shrink)

This article investigates the potential of fMRI to test assumptions about different components in models of complex cognitive tasks. If the components of a model can be associated with specific brain regions, one can make predictions for the temporal course of the BOLD response in these regions. An event‐locked procedure is described for dealing with temporal variability and bringing model runs and individual data trials into alignment. Statistical methods for testing the model are described that deal with the scan‐to‐scan correlations (...) in the errors of measurement of the BOLD signal. This approach is illustrated using a “sacrificial” ACT‐R model that involves mapping 6 modules onto 6 brain regions in an experiment from Ravizza, Anderson, and Carter (in press) concerned with equation solving. The model's visual encoding predicted the BOLD response in the fusiform gyrus, its controlled retrieval predicted the BOLD response in the lateral inferior prefrontal cortex, and its subgoal setting predicted the BOLD response in the anterior cingulate cortex. On the other hand, its motor programming failed to predict anticipatory activation in the motor cortex, its representational changes failed to predicted the pattern of activity in the posterior parietal cortex, and its procedural component failed to predict an initial spike in caudate. The results illustrate the power of such data to direct the development of a theory of complex problem solving, both at the level of a specific task model as well as at the level of the cognitive architecture. (shrink)

Background: Authors are required to describe in their manuscripts ethical approval from an appropriate committee and how consent was obtained from participants when research involves human participants.Objective: To assess the reporting of these protections for several study designs in general medical journals.Design: A consecutive series of research papers published in the Annals of Internal Medicine, BMJ, JAMA, Lancet and The New England Journal of Medicine between February and May 2003 were reviewed for the reporting of ethical approval and patient consent. (...) Ethical approval, name of approving committee, type of consent, data source and whether the study used data collected as part of a study reported elsewhere were recorded. Differences in failure to report approval and consent by study design, journal and vulnerable study population were evaluated using multivariable logistic regression.Results: Ethical approval and consent were not mentioned in 31% and 47% of manuscripts, respectively. 88 papers failed to report both approval and consent. Failure to mention ethical approval or consent was significantly more likely in all study designs than in randomised controlled trials . Failure to mention approval was most common in the BMJ and was significantly more likely than in The New England Journal of Medicine. Failure to mention consent was most common in the BMJ and was significantly more likely than in all other journals. No significant differences in approval or consent were found when comparing studies of vulnerable and non-vulnerable participants.Conclusion: The reporting of ethical approval and consent in RCTs has improved, but journals are less good at reporting this information for other study designs. Journals should publish this information for all research on human participants. (shrink)