Sociological research on moral panics, long understood as “struggles for cultural power,” has focused on the social groups and media conditions that enable moral panics to emerge, and on the consequences of moral panics for the social control systems of societies. In this article I turn instead to modeling the specific cultural process of how the conditions for a moral panic are turned into an actual moral panic, moving the understanding of moral panic away from its Durkheimian origins and towards (...) a process-relational cultural sociology. Drawing on Roland Barthes’ theory of myth and Kenneth Burke’s dramatism, the paper posits the cultural process of resignification via synecdoche and metanarrative as the driver of the disproportion, concern, hostility, consensus, and volatility of moral panics. This process can be carefully traced in the case of the Salem Witch Trials; a retrospective reading reveals the same process at work in the “Mods and Rockers” panic analyzed by Stanley Cohen. Beyond moral panics, theorizing resignification as a non-exclusive counterpoint to framing and ideational embeddedness enriches the theoretical repertoire of cultural sociology. “Deep culture” and mythological signification can, using the schema proposed here, be understood as practical accomplishments—rhetorical responses to particular situations that, when performed successfully, legitimate violence and other forms of domination. (shrink)

This article examines responses from Lutheran pastors, theologians, and physicians to the arguments given by Johann Weyer in 1563 that those women who confessed to a pact with the devil suffered from melancholy and were thus not responsible for their acts. Weyer’s conception of melancholy was a medical one, yet among Lutheran pastors and theologians the concept of a spiritual form of melancholy emerged that came from religious sources. The article clarifies the difference between the concepts of medical and spiritual (...) melancholy within Lutheranism and reviews the respective roles they played in the debates over Weyer’s arguments. (shrink)

In 1590, after Norway’s most famous witch trial, Anne Pedersdotter was burned alive. Resource scarcity and religious competition transformed an old superstition into a witch craze to which Anne fell victim. Her story became a play in 1908 and a film in 1943. The two adaptations attempt to give Anne’s persecution more modern explanations. In the play Anne Pedersdotter, Anne has psychic powers that make her neighbors think she is a Satanic collaborator. In the film Day of Wrath, (...) Anne embodies humanistic aspirations that would have been delusional in her own era and that are perhaps also poorly adapted to human nature in general. The trial and the two fictional versions of the trial all illustrate how thought patterns that evolved for small groups of foragers can be overstimulated in post-agricultural environments. This article identifies cognitive dispositions that, in periods of crisis, can trigger persecution of outsiders, discusses how those universal mechanisms man­ifest themselves in different cultural contexts, and examines the historically specific beliefs and values that animate the two fictional versions of Anne’s story. The article concludes with reflections on how the evolved cognitive mechanisms that led to beliefs in witchcraft often manifest themselves, in the present, as conspiracy beliefs directed at minorities. (shrink)

While contemporary readers may find what appear to be appealing streaks of liberalism in Montaigne's 'Essays', I argue that a more careful analysis suggests that Montaigne's overall stance is quietistic and conservative. To help support this claim I offer a close reading of 'Essays' III.11 ("Of Cripples"), where Montaigne offers his famous critique of the witch trials of early modern Europe. Once Montaigne's objections to the witch trials are properly understood, we see that Montaigne did not (...) seriously or consistently dispute the church's authority in political matters, though certain undeveloped seeds of liberalism do leave an unresolved tension in his writings. (shrink)

The concept of a witch hunt is frequently invoked, in recent times, to describe a kind of procedure for deciding the guilt of a person against whom an accusation has been made. But what exactly is a witch hunt? In this paper, ten conditions are formulated as a cluster of properties characterizing the witch hunt as a framework in which arguments are used: (1) pressure of social forces, (2) stigmatization, (3) climate of fear, (4) resemblance to a (...) fair trial, (5) use of simulated evidence, (6) simulated expert testimony, (7) nonfalsifiability characteristic of evidence, (8) reversal of polarity, (9) non-openness, and (10) use of the loaded question technique. The witch hunt, as characterized by these criteria, is shown to function as a negative normative structure for evaluating argumentation used in particular cases. (shrink)

The great upsurge of witch trials in early modern Europe remains a historical puzzle. Popularly known as the “witch craze”, this eruption of persecution is puzzling because belief in witchcraft had existed for centuries, but large-scale witch-hunting appeared rather abruptly, spread widely, and was remarkably brutal in comparison with the past. We define a theory of ideational diffusion to describe the general process of the emergence and spread of a new idea along with its prescribed behavioral (...) change, in this case the adoption of witch-hunting. Ideational diffusion distinguishes between the adoption of new ideas, which lead social actors to reinterpret the world and thus to change their behavior, and the adoption of behavior alone. We relate how a new theory of witchcraft appeared in the fifteenth century and show that its widespread propagation, owing to the new technology of printing, matches our description of ideational diffusion. We then analyze the diffusion of witch trials in Central Europe by combining data on the publication of demonological treatises alongside climate, state capacity, religious economy, and city network variables. We find that cities adopted persecution after demonological treatises were printed, and that nearby trials induced neighbors to adopt persecution. Tracing the print vectors and social interdependence spurring witch-hunting helps us understand the general mechanisms behind the spread of persecution. (shrink)

A world in which atheism has replaced religion is the dream of Oxford evolutionary biologist and “New Atheist” activist, Richard Dawkins. He thinks that religious belief is irrational superstition that leads to violence (like the inquisition), intolerance (like homophobia), ignorance (like creationism), and corruption (like red hot Catholic love). In fact, in the episode “Go God Go,” it is the cartoon version of Dawkins himself who pioneered the efforts culminating in religion's demise. First, one has to understand what science is. (...) Science is a method for discovering the truth about the world. Many philosophers argue that science and religion are perfectly compatible. Religion is about ethics and meaning, but science is about explaining the way the world works. Religion has led to a lot of violence—the Crusades, the Spanish Inquisition, witch trials, 9/11, and more. And it's certain that the end of religion wouldn't eliminate all violence. (shrink)

An exploration of the untamed crossroads where 'the feline' and 'the feminine' mingle and make magic. From ancient Egypt to early modern Venice to Edo Japan, the witch trials to the Women's March, Catwoman to cat ladies, kitten play to cat conventions, this book tracks the cat's circuitous connection to women and femininity through a magical lens. By combining historical research, pop culture and art analyses, and original interviews, this book uncovers what the 'feral feminine' might mean to (...) witches, sluts, feminists, artists, historians, philosophers, cat ladies, and cat lovers today. (shrink)

The following article begins with my recollection of the only academic conference on Zdziechowski that was organised still under the communist regime in the autumn of 1984 at the Jagiellonian University and ends with a description of the discussion on the genesis and power of evil, with the participation of Czesław Miłosz and Leszek Kołakowski, which was triggered in Poland immediately after the publication of the last edition of On Cruelty in 1993. On Cruelty was first published in 1928 in (...) the journal Przegla̧d Współczesny [Contemporary Review] in Krakow, a second time in 1938 in the volume of articles In the Face of the End, Krakow 1938, and a third – and so far last – time also in Krakow in 1993. On Cruelty, published three times but so far only in Polish, has never been thoroughly analysed or even discussed, which is why this article focuses on discussing it and related questions about the origins and nature of evil, mainly in Europe and Asia, from the earliest times to the present. Zdziechowski was particularly outraged when the cruelty he condemned was justified by religion, especially Christianity (Catholic and Protestant). From these condemnations, he described the activities of the Inquisition, the witch trials, cruelty to animals, and – in the introduction – the “psychology of cruelty.” At the same time, however, he meticulously listed the names of those political and spiritual leaders in Europe and Asia, theologians and thinkers, who, over many centuries, up to the present day, have resolutely spoken out against evil, including cruelty, within and outside the Church. A separate and important issue is Zdziechowski’s attitude to Tsarist Russia and Bolshevism, as outlined in his work On Cruelty. On the one hand, he pointed out that at least two rulers of Russia before 1917 – Ivan the Terrible and Peter the Great – had made major contributions to the history of cruelty in Europe and Asia. But Bolshevism, which Zdziechowski condemned in the strongest terms, was in his eyes not a continuation of pre-1917 Russian despotism, but emanated from the depths of Asia. (shrink)

A thorough and careful report on the variety and extent of offenses prosecuted by the Puritan churches from colonial times into the nineteenth century, with some asides on civil cases, such as the Salem witch trials. The text is lively with verbatim testimony. A large bibliography frankly notes the various reasons why some records are "unavailable."--E. T.

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:Benedict XVI: A Life. Volume 2, Professor and Prefect to Pope and Pope Emeritus 1966–The Present by Peter SeewaldEmil AntonBenedict XVI: A Life. Volume 2, Professor and Prefect to Pope and Pope Emeritus 1966–The Present by Peter Seewald, translated by Dinah Livingstone (London: Bloomsbury Continuum, 2021), viii + 568 pp.What better way to spend Pope Benedict XVI's ninety-fifth birthday (which turned out to be his last) than by (...) visiting his birth house in Marktl am Inn at his birth minute—4.15 AM! In addition to five Finnish pilgrims, twenty or so local grandmas and grandpas attended the now-traditional early morning prayer, which this year fell on Holy Saturday, the very liturgical day on which Joseph Ratzinger was born and baptized. Other destinations on a do-it-yourself Ratzinger pilgrimage included Freising (studies and ordination), Regensburg (professorial years), Altötting (favorite Marian sanctuary), childhood villages and towns (Tittmoning, Aschau am Inn, Hufschlag, Traunstein), and of course Munich (seminary and episcopal years), with beer, good food, and Apfelstrudel at the Augustiner Klosterwirt.Such a trip is highly recommended, even though there were no Ratzinger books in the "Theology" section of University of Regensburg's bookshop, reflecting his persona non grata status in German academia. In Altötting, however, Peter Seewald's magnificent biography was on offer, as well as icon-like pictures of Pope Benedict and candles with his image on them—good for both admirers and critics!In English, Seewald's biography is divided into two volumes (for my review of volume 1, see Nova et Vetera [English] 20, no. 3), the second one comprising three parts: (1) professor, (2) prefect, and (3) Pope. The book was certainly worth the wait and does not disappoint: the research and analysis are excellent, the style is enjoyable, and interesting new details are revealed, such as the "endless outbursts of crying" and "violent quarrels with cardinals" of "popess" (as the housekeeper was called in the curia) Ingrid Stampa, who "kept Ratzinger's diary, edited official speeches and even decided who could meet the Holy Father" (351).As a journalist, Seewald is especially strong on the German press coverage [End Page 285] of Ratzinger. During his time as archbishop of Munich, "Ratzinger took part so frequently in the public debate that the Süddeutsche Zeitung feared that it would be a 'big shock' for millions of Upper Bavarian Catholics if his name did not appear in any edition of the four Munich daily papers" (109). Ratzinger's predominantly negative media image seems to stem to a great extent from the actions of Hans Küng. Asked about the cancellation of Küng's missio canonica at a youth event in 1979, Ratzinger said off the cuff that it was right, since Küng was actively disputing essential doctrines of the Catholic Church (128). The comments were published without authorization, which led to Küng accusing Ratzinger of "falling back on pre-conciliar customs of heresy-hunting, insinuation and defamation" (129). After the publication of Vittorio Messori's The Ratzinger Report in 1985, Küng "crashed in with a sweeping blow in the Hamburg weekly Die Zeit" (170), not failing to bring up his "litany of complaints: the 'case of Galileo,' the 'Chinese rites controversy,' 'putting all the most important European thinkers on the Index (Descartes, Kant, Sartre etc.),' '9 million victims of witch trials'" (171). According to Seewald, this momentous article, ending with the claim that Ratzinger was "afraid of the truth more than anything else," provided the endlessly reproduced media image of the prefect.Seewald singles out the Bild journalist Andreas Englisch as a striking example of the kind of deliberate manipulation typical of so-called expert reporters. After Benedict XVI's election, Englisch admitted with apparent remorse that, in previous reporting, in order to make John Paul II's "light shine more brightly," he had "needed an enemy to make the story more dramatic" (192). Seewald continues: "However, Englisch had no scruples about later applying his business model to books about Pope Francis, whom he raised almost to heaven, in order finally to shove the retired Benedict XVI down to hell" (192... (shrink)

Denounced by neighbors and scrutinized by demonologists, the early modern French witch also confessed, self-identified as a witch and as the author of horrific deeds. What led her to this point? Despair, solitude, perhaps even physical pain, but most decisively, demonology's two-pronged prosecutorial and truth-seeking confessional apparatus. This book examines the systematic and well-oiled machinery that served to extract, interpret, and disseminate witches' confessions in early modern France. For the demonologist, confession was the only way to find out (...) the truth about the clandestine activities of witches. For the witch, however, trial confessions opened new horizons of selfhood. In this book, Virginia Krause unravels the threads that wove together the demonologist's will to know and the witch's subjectivity. By examining textual and visual evidence, Krause shows how confession not only generated demonological theory but also brought forth a specific kind of self, which we now recognize as the modern subject. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:Bleed: Destroying Mythsand Misogyny in Endometriosis Care by Tracey LindemanSarah Seabrook (bio)Bleed: Destroying Myths and Misogyny in Endometriosis Care by Tracey Lindeman. Toronto: ECW Press, 2023Endometriosis—a complex and painful health condition in which tissue similar to the endometrium tissue that normally lines the inside of a person's uterus grows outside—has gained considerable attention over the last few years. Because endometriosis patients' concerns about their reproductive health and menstrual (...) experiences are often dismissed by healthcare professionals (Wahl 2021; Alberta Women's Health Foundation 2022), there has been a groundswell of conversations about abnormal menstruation and endometriosis, not by government or medical professionals but rather by patients who validate each other's experiences and relate to one another's struggles in seeking access to care (EndoAct Canada 2024). Experiences about the trials and tribulations endometriosis patients endure seeking medical care and diagnosis are shared through op-eds and Facebook support groups and have appeared on special feature segments on the local news. With increased attention around endometriosis, there remains a lot of work to do around dispelling what endometriosis truly is and why people are not being adequately treated.In BLEED: Destroying Myths and Misogyny in Endometriosis Care, author and endometriosis patient Tracey Lindeman (2023), takes on the work of that dispelling. With a focus on the North American context (largely Canada and the United States), Lindeman shines a light on the deeply embedded systemic discrimination that shapes experiences of endometriosis and other gendered health conditions that prevent women, trans, and non-binary people from receiving a diagnosis and/or adequate treatment. This compelling part memoir, part investigation of the systemic barriers to care for endometriosis patients, reveals the long-standing and ongoing history of misogyny in contemporary gynecology and healthcare (Davis-Floyd 1997; Wetherell, Taylor, and Yates 2001; Young, Fisher, and Krikman 2019), including how pharmaceutical funding and interests are prioritized at the expense of endometriosis patients' health and well-being, and how sexism and racism, among other markers of discrimination, are [End Page 181] institutionalized features in healthcare systems that strip women, trans, and non-binary people of their agency over their bodies and decision-making capacity.BLEED is a particularly timely and important contribution to feminist health scholarship because it offers an intimate account of how the historical medicalization of female-specific health issues has normalized power asymmetries between patients and medical professionals. She demonstrates how the contemporary dynamics in healthcare settings leave women and gender-nonconforming people to navigate the intersections of misogyny and myths surrounding endometriosis. Lindeman does so by discussing her own experiences, including being asked by medical professionals to provide a written letter of support from her male partner indicating his approval of her requested hysterectomy.As both a researcher and someone with endometriosis, Lindeman is able to take the narrative of BLEED in several directions. She offers readers the intimacy of her perspective and experiences with endometriosis in Canada's health system while also offering readers a broader view of how age, race, gender identity, sexual orientation, and geography inform the experiences of others who have endometriosis. Her ability to situate her experiences as a cis-white woman as the focal point of her analysis provides readers with a strong reference point to recognize and understand the heightened systemic discrimination experienced by her nonwhite, non-cis interviewees. In particular, the contrast between Lindeman's experiences of being prescribed sixty-tablet refills of the painkiller naproxen for endometriosis pain and the experiences of her interviewee, Denise, a black cis-woman who was only given five naproxen pills a month provides insight into racialized dimensions of endometriosis care (39).Recognizing that a history unlearned results in history being repeated, Lindeman opens BLEED by situating the painfully paternalistic and misogynistic experiences of endometriosis patients in the healthcare system in the context of the evolution of gynecology as a subfield. Lindeman highlights how the medicalization of endometriosis as a condition went hand in hand with the professionalization of gynecology, which has since created and perpetuated a power asymmetry between patients and their care providers. Whereas gynecological care was historically provided by women—witches, midwives, and healers—the long male-dominated... (shrink)

Various historical sources from the Renaissance--including transcripts of trials for witchcraft, writings on demonology and textbooks of pharmaceutical botany--describe vegetal ointments prepared by women accused of witchcraft and endowed with marked psychoactive properties. Here, we examine the botanical composition and the possible pharmacological actions of these ointments. The results of our study suggest that recipes for narcotic and mind-altering salves were known to Renaissance folk healers, and were in part distinct from homologous preparations of educated medicine. In addition, our (...) study reveals an unexpected connection of these vegetal psychotropes with archaic chtonic beliefs, confirming the tight association between rituals and cults entered on the Underworld and the image of the Medieval witch. (shrink)

A case study is presented of the development of computer-based support tools for power engineers in the electricity supply industry. The objective was to develop an expert system to support witching schedule production. A user-centred approach was followed which led the user community to conclude that a switching schedule production assistant (SSPA) was required which would leave control with the power engineer. Prototype systems were developed and evaluated in user trials which revealed that a significant and more general purpose (...) tool would be a computer generated electricity network display that the engineers could manipulate. The paper concludes that the process of enabling users to evaluate alternative forms of technology can facilitate the development systems that are useful, acceptable and usable. (shrink)

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

Clinicians have good moral and professional reasons to contribute to pragmatic clinical trials (PCTs). We argue that clinicians have a defeasible duty to participate in this research that takes place in usual care settings and does not involve substantive deviation from their ordinary care practices. However, a variety of countervailing reasons may excuse clinicians from this duty in particular cases. Yet because there is a moral default in favor of participating, clinicians who wish to opt out of this research (...) must justify their refusal. Reasons to refuse include that the trial is badly designed in some way, that the trial activities will violate the clinician’s conscience, or that the trial will impose excessive burdens on the clinician. (shrink)

Phase I clinical trials are the first stage of testing new pharmaceuticals in humans. The majority of these studies are conducted under controlled, inpatient conditions using healthy volunteers who are paid for their participation. This article draws on an ethnographic study of six phase I clinics in the United States, including 268 semistructured interviews with research staff and healthy volunteers. In it, I argue that an institutional banalization of risk structures the perceptions of research staff and healthy volunteers participating (...) in the studies. For research staff, there are three mechanisms by which risk becomes banal: a perceived homogeneity of studies, Fordist work regimes, and data-centric discourse. For healthy volunteers, repeat study participation contributes to the institutional banalization of risk both through the process of desensitization to risk and the formation of trust in the clinics. I argue that the institutional banalization of risk also renders invisible ethical concerns about exploitation of underprivileged groups in pharmaceutical research. (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)

As interest in comparative effectiveness research grows, questions have emerged regarding whether it is ever acceptable to alter informed consent requirements for research when patients are randomly assigned to widely-used therapies. This paper reports on interviews with Institutional Review Board members and researchers and on focus groups with patients from Geisinger and Johns Hopkins health systems. The objective was to elicit participants' views of the acceptability of four different disclosure and authorization models for low-risk pragmatic comparative effectiveness trials of (...) widely-used therapies. Results suggest that although participants valued autonomous choice, many also believed that it was acceptable to streamline information disclosure and to use an opt-out process for eligible individuals who would prefer not to participate. This provides some preliminary evidence that relevant stakeholders find alternatives to traditional informed consent acceptable for low-risk pragmatic comparative effectiveness trials of widely-used therapies as long as a sufficient amount of choice is preserved. (shrink)

Placebo-controlled surgical trials can provide important information about the efficacy of surgical interventions. However, they are ethically contentious as placebo surgery entails the risk of harms to recipients, such as pain, scarring or anaesthetic misadventure. This has led to claims that placebo-controlled surgical trials are inherently unethical. On the other hand, without placebo-controlled surgical trials, it may be impossible to know whether an apparent benefit from surgery is due to the intervention itself or to the placebo effect.

Those researching HIV prevention measures for people who inject drugs face a dilemma. Regions where baseline HIV prevalence and onward transmission via injecting is sufficiently high to power HIV prevention trials are also those where repressive laws, policies and practices raise concerns about the ethics of research subject protection. Dawson et al, outlining criteria to address ethical challenges in HIV prevention research among PWID, recommend that all trial participants be offered sterile injecting equipment and urge additional strategies to limit (...) research and background risks.1 In light of ethical questions opened by recent clinical trials involving PWID, including several the authors cite favourably, these cautions are timely. Dawson et al urge weighing of costs and benefits of PWID participation in research trials as an essential part of the ethical calculus. Overdose is a particular risk in any trial that uses abstinence from opioids as a precondition for participation or as an outcome of interest, and a risk that institutional review boards and researchers frequently ignore. Given the increased likelihood of fatal overdose for those who return to injection following a period of abstinence, provision to all trial participants of naloxone—the overdose antidote …. (shrink)

One way to test vaccines is through human challenge trials in which participants are intentionally infected with a contagious organism to expedite the process of assessing the vaccine’s effectiveness. Some experts believe challenge trials may play an important role in fighting COVID-19, especially if the vaccines under current study do not demonstrate sufficient efficacy, if spread of COVID-19 is controlled to a point that radically slows down traditional trials, or if new vaccines need to be rapidly developed (...) for specific subpopulations.1 Challenge trials involve significant time, burden and risk, requiring participants to spend 3–6 weeks in legal quarantine for 24 hours a day in a high-security facility. During this time, no inperson visitors will be allowed, except for very limited inperson contact from researchers collecting necessary data and checks. Following the quarantine period, participants will be asked to attend numerous outpatient follow-up visits over the course of months, to further monitor their response to the vaccine. Participation involves being away from family who may themselves become sick during the global pandemic, as well as potential fear and mental anguish around being a ‘first’ subject. Because there is no definitive treatment for COVID-19, participants could experience serious illness. But even with milder illness, medical experts know very little about the long-term consequences of COVID-19 infection. This raises the question of how much people should be paid for their participation in COVID-19 challenge trials. Most think participants should be paid something, but many contend that we should be …. (shrink)

American bioethics has served as a safety net for the rich and powerful, often failing to protect minorities and the economically disadvantaged. For example, minorities and the economically disadvantaged are often unduly influenced into participating in clinical trials that promise monetary gain or access to health care. This is a violation of the bioethical principle of “respect for persons,” which requires that informed consent for participation in clinical trials is voluntary and free of undue influence. Promises of access (...) to health care invalidate the voluntariness of informed consent not only because it unduly induces minorities and the economically disadvantaged to participate in clinical trials to obtain access to potentially life saving health care, but it is also manipulative because some times the clinical trial is conducted by the very institutions that are denying minorities and the economically disadvantaged access to health care. To measure whether consent is voluntary and free of undue influence, federal agencies should require researchers to use the Vulnerability and Equity Impact Assessment tool, which I have created based on the Health Equity Impact Assessment tool, to determine whether minorities and the economically disadvantaged are being unduly influenced into participating in clinical trials in violation of the “respect for persons” principle. (shrink)

Opioid use disorder can encompass a number of behavioral, psychological, physiological, and interpersonal symptoms which collectively impair one’s functioning to different degrees. Of all the personal and societal problems associated with OUD, the most destructive and absolute is death. Given the caustic effects of OUD on quality of life and mortality, evidence-based pharmacotherapy and psychosocial interventions are necessary. It is the collective potential for buprenorphine to increase safety and concurrent cognitive-behavioral group therapy to address substance use triggers as well as (...) comorbid psychiatric conditions, which makes this combination particularly promising for RCT of effectiveness. The purposes of this article are to identify specific ethical issues which may hinder community partners from collaborating with clinical trialist wishing to conduct CBGT buprenorphine efficacy-effectiveness trials at their agency and provide some basic guidelines and methods for addressing these community partner ethical concerns. The purpose of the manuscript is to facilitate university and substance use/mental health center community collaborations that will result in ethical clinical trial methodology and findings that meaningfully translate to efficacious, effective, and generalizable CBGT and buprenorphine hybrid interventions for OUD. (shrink)

This afterword extends and refines the arguments presented in Cohen and Jacobs . The main point made by the authors is that the antidepressant randomized controlled trial world is a make-believe world in which researchers act as if a bona fide medical experiment is being conducted. From the assumed existence of the “disorder” and the assumed homogeneity of the treatment groups, through the validity of rating scales and the meaning of their scores, to the presentations of researchers’ ratings as the (...) genuine outcome of interest — all aspects of such trials are make-believe. The continued acceptance of randomized controlled trials as appropriate mechanisms to ascertain the actual effects of psychoactive drugs on human beings in distress confirms that researchers are inextricably dependent on large-scale organizational and financial interests that require the sustained production of make-believe results about psychoactive drugs. (shrink)

Recruitment processes for clinical trials are governed by guidelines and regulatory systems intended to ensure participation is informed and voluntary. Although the guidelines and systems provide some protection to potential participants, current recruitment processes often result in limited understanding and experiences of inadequate decision support. Many trials also have high drop-out rates among participants, which are ethically troubling because they can be indicative of poor experiences and they limit the usefulness of the knowledge the trials were designed (...) to generate. Drawing on recent social-psychological and philosophical-ethical research on trial recruitment and patient participation in treatment decision-making, this paper identifies possibilities for improving communicative support for both initial decisions and ongoing participation in clinical trials. It highlights the potential of a shift in thinking about ‘voluntariness’, underpinned by relational understandings of autonomy, to encourage more nuanced judgements about the ethics of communication between trial staff and (potential) participants. The paper suggests that the idea of responsively enabling people to consider invitations or requests to participate in particular trials could serve as a general guide to communication. This might help ensure decisions about trial participation are meaningfully informed and voluntary, and that relationships between trial staff and participants contribute to positive experiences of trial participation and ultimately to the generation of the robust knowledge. (shrink)

Migrant workers in dormitories are an attractive source of clinical trial participants. However, they are a vulnerable population that has been disproportionately affected by the COVID-19 pandemic. Guidelines on recruiting vulnerable populations for clinical trials have long been established, but ethical considerations for migrant workers have been neglected. This article aims to highlight and explain what researchers recruiting migrant workers must be cognizant of, and offers recommendations to address potential concerns. The considerations raised in this article include: three types (...) of illiteracy, power dynamics, the risks associated with communal living and potential benefits to the migrant workers as well as researchers. No data are available. This article does not include original data. (shrink)

The paper investigates how field experimentation of genetically modified crops became central to the French controversy on genetically modified organisms in recent years. Initially constructed in the 1980s as a cognitive endeavor to be preserved from lay interference, field trials of genetically modified crops were reconceived as “an intrusion in the social space,” which had to be negotiated with actors from that space. In order to analyze this transformation, the authors suggest that it is necessary to develop an interpretive (...) framework that combines theoretical perspectives from science and technology studies and the sociology of social problems, and emphasizes the importance of the way in which actors compete in a heterogeneous public space, to put forward alternative framings of problems. The authors present a detailed analysis of the interactions and conflicts between actors in diverse social arenas in order to better understand the dynamics of this sociotechnical controversy. (shrink)

It is common for drug trials to exclude older people, usually over 65 or 70. Many of the drugs which are successfully tested are then registered and become available either on prescription or over the counter. Healthcare professionals are left in a bind: either they do not prescribe the medications to those in the excluded age groups because of the lack of age-relevant data, or they prescribe, off-label, despite the lack of systematic collection of age-relevant data. Alternatively, if the (...) pharmaceutical is available without prescription, older people may be buying without any inkling or warning that the drug was never tried on people of their own age. Either way, our older fellow citizens are not getting the same ethical treatment as younger adults. Compounding the questionable ethics involved is the fact that as age increases, the ratio of women to men increases. Amplified by the fact that women consume more pharmaceuticals than do men, the discrimination takes on a distinctly sexist slant as well as an ageist one.Two other groups often excluded from trials are (a) minors and (b) pregnant or lactating women. But the rationale for their exclusion is different from that for the exclusion of seniors. A major reason for these two groups’ exclusion is the legal incapacity of the young to consent and the concomitant flow-on liability for injuries and damages to the youngsters. The potential exposure to later legal claims may be a strong motivating force for pharmaceutical companies to exclude from their trials people without legal capacity to consent. But the third group of people, seniors, is excluded by reference to their seniority not their inability to give informed consent. While the other two exclusions can be explained in terms of moral, social and legal conventions, seniority alone is based on two practical concerns: firstly, whether seniors are likely to die before the end of the trial, and secondly, the compounding effects of the so-called diseases of old age. Together, these concerns are thought to justify seniority exclusion in the interests of clean science. This paper explores some of the ethical issues, the implicit ageism and sexism in the exclusion of seniors. The discussion considers the ethical consequences of the exclusion, where seniors are either taking drugs in the absence of evidence-based trials on their age groups, or are denied drugs because they are untried on the age groups. (shrink)

Pragmatic clinical trials offer important benefits, such as generating evidence that is suited to inform real-world health care decisions and increasing research efficiency. However, PCTs also present ethical challenges. One such challenge involves the management of information that emerges in a PCT that is unrelated to the primary research question, yet may have implications for the individual patients, clinicians, or health care systems from whom or within which research data were collected. We term these findings as?pragmatic clinical trial collateral (...) findings,? or?PCT-CFs?. In this article, we explore the ethical considerations associated with the identification, assessment, and management of PCT-CFs, and how these considerations may vary based upon the attributes of a specific PCT. Our purpose is to map the terrain of PCT-CFs to serve as a foundation for future scholarship as well as policy-making and to facilitate careful deliberation about actual cases as they occur in practice. (shrink)

What kinds of evidence reliably support predictions of effectiveness for health and social care interventions? There is increasing reliance, not only for health care policy and practice but also for more general social and economic policy deliberation, on evidence that comes from studies whose basic logic is that of JS Mill's method of difference. These include randomized controlled trials, case–control studies, cohort studies, and some uses of causal Bayes nets and counterfactual-licensing models like ones commonly developed in econometrics. The (...) topic of this paper is the 'external validity' of causal conclusions from these kinds of studies. We shall argue two claims. Claim, negative: external validity is the wrong idea; claim, positive: 'capacities' are almost always the right idea, if there is a right idea to be had. If we are right about these claims, it makes big problems for policy decisions. Many advice guides for grading policy predictions give top grades to a proposed policy if it has two good Mill's-method-of difference studies that support it. But if capacities are to serve as the conduit for support from a method-of-difference study to an effectiveness prediction, much more evidence, and much different in kind, is required. We will illustrate the complexities involved with the case of multisystemic therapy, an internationally adopted intervention to try to diminish antisocial behaviour in young people. (shrink)

The treatment of the control group in externally sponsored clinical trials is the issue of one of the most heated debates in international research ethics. The paradigmatic cases are the mother-to-child HIV-transmission trials that took place in 16 developing countries in 1997, where the control group received a placebo while proven treatment was available in industrialized countries. From this circumstance results the controversy as to whether the sponsor and researchers of externally sponsored trials have to supply a (...) treatment that is usually not available in the host country. From the beginning of the debate the controversial level of treatment has been called “standard of care”. However, besides the disagreement about the quality of the care that has to be supplied, there is as yet no widely accepted clear meaning of this concept. This article examines the fundamental ambiguity of the term and its formal function as an ethical criterion including suggestions on its further use. (shrink)

BackgroundCommunity Advisory Boards (CAB) have become essential organs of involving communities in HIV clinical trials especially in developing countries. However, limited empirical evidence exists on the role of CABs in low and middle-income countries including Tanzania. This study aims at exploring the role of CABs in community-based HIV clinical trials conducted in Tanzania.MethodologyWe adopted a phenomenological approach to purposefully select HIV clinical trial stakeholders. These included CAB members, researchers and Institutional Review Board (IRB) members in Tanzania. We conducted (...) In-depth Interviews (IDIs) with ten participants and three Focus Group Discussions (FGDs) with eighteen participants. The data were thematically analyzed with the aid of MAXQDA software version 20.2.1.ResultsThe findings indicate that at every stage of implementation of a community-based HIV clinical trial, a functioning CAB is important for its success. This importance is based on contextualization of the informed consent process and protocol, managing rumours in the community, weighing trial risks and benefits, sensitizing the community, assisting participant recruitment, tracing and retention. However, being perceived as financial beneficiaries than community representatives emerged as a challenge to CAB members. ConclusionThe study empirically indicates the need for functioning CABs in every stage of implementation of community-based HIV clinical trials. The roles of which are interwoven in serving research goals and protecting the interests of the community and that of trial participants. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include (...) the short-term and long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

Much has changed in maternal-fetal medicine since the early 2000s, when the previous ethical frameworks for fetal therapy trials were established. We applaud Hendriks and colleagues for taking on t...

George P. Fletcher, With Justice for Some: Victims? Rights in Criminal Trials Reading, MA: Addison?Wesley Publishing Co., 1995, xi + 304 pp.

Research that is initiated, designed or funded by sponsor agencies based in countries with relatively high social and economic development, and conducted in countries that are relatively less developed, gives rise to many important ethical challenges. Although clinical trials of HIV vaccines began ten years ago in the US and Europe, an increasing number of trials are now being conducted or planned in other countries, including several that are considered “developing” countries. Safeguarding the rights and welfare of individuals (...) participating as research subjects in developing countries is a priority. In September, 1997, the Joint United Nations Programme on HIV/AIDS embarked on a process of international consultation; its purpose was further to define the important ethical issues and to formulate guidance that might facilitate the ethical design and conduct of HIV vaccine trials in international contexts. This paper summarises the major outcomes of the UNAIDS consultative process. (shrink)

BackgroundEarly in the COVID-19 pandemic, the urgent need to discover effective therapies for COVID-19 prompted questions about the ethical problem of randomization along with its widely accepted solution: equipoise. In this scoping review, uses of equipoise in discussions of randomized controlled trials of COVID-19 therapies are evaluated to answer three questions. First, how has equipoise been applied to COVID-19 research? Second, has equipoise been employed accurately? And third, do concerns about equipoise pose a barrier to the ethical conduct of (...) COVID-19 RCTs?MethodsGoogle Scholar and Pubmed were searched for articles containing substantial discussion about equipoise and COVID-19 RCTs. 347 article titles were screened, 91 full text articles were assessed, and 48 articles were included. Uses of equipoise were analyzed and abstracted into seven categories.Results and discussionApproximately two-thirds of articles used equipoise in a way that is consistent with the concept. They invoked equipoise to support RCTs of specific therapies, RCTs in general, and the early termination of RCTs after achieving the primary outcome. Approximately one-third of articles used equipoise in a manner that is inconsistent with the concept. These articles argued that physician preference, widespread use of unproven therapies, patient preference, or expectation of therapeutic benefit may undermine equipoise and render RCTs unethical. In each case, the purported ethical problem can be resolved by correcting the use of equipoise.ConclusionsOur findings highlight the continued relevance of equipoise as it supports the conduct of well-conceived RCTs and provides moral guidance to physicians and researchers as they search for effective therapies for COVID-19. (shrink)

The central dilemma concerning randomized clinical trials (RCTs) arises out of some simple facts about causal methodology (RCTs are the best way to generate the reliable causal knowledge necessary for optimally-informed action) and a prima facie plausible principle concerning how physicians should treat their patients (always do what it is most reasonable to believe will be best for the patient). A number of arguments related to this in the literature are considered. Attempts to avoid the dilemma fail. Appeals to (...) informed consent and mechanisms for minimizing the resulting harm are important for policy, but informed consent is problematic and mechanisms for minimization of harm do not address the dilemma. Appeals to some sort of contract model of justification are promising and illuminating. Keywords: randomized clinical trials, ethics CiteULike Connotea Del.icio.us What's this? (shrink)