The impression one derives from the target article on “The Duty to Disclose Adverse Clinical Trials Results” is that Liao and colleagues (2009) envision a research platform consisting only of a tea...

Since the Nuremberg trials (1947–1949), informed consent has become central for ethical practice in patient care and biomedical research. Codes of ethics emanating from the Nuremberg Code (1947) recognize the importance of protecting patients and research subjects from abuses, manipulation and deception. Informed consent empowers individuals to autonomously and voluntarily accept or reject participation in either clinical treatment or research. In some cases, however, the underlying mental or physical condition of the individual may alter his or her cognitive abilities and (...) compromise the informed consent process. This is particularly true in chronic psychiatric conditions such as Treatment-Resistant Depression (TRD), where individuals may fail to respond to traditional antidepressant treatments (e.g., psychotherapy, pharmacotherapy). Moreover, it may raise further concerns for an individual’s motivation to consent and the level of understanding of the treatment or research procedure. This paper focuses on the informed consent process for Vagus Nerve Stimulation (VNS) in the treatment of individuals diagnosed with TRD. Specifically, the paper addresses how depression may affect the decision-making capacity of an individual and the potential ethical and legal impact of failure to appreciate the seven elements of the consenting process (competence, voluntariness, disclosure, recommendation, understanding, decision, and authorization). To ensure the protection of vulnerable individuals with psychiatric disorders such as TRD and promote ethical behavior in biomedical research and patient care while avoiding potential legal pitfalls, we propose a paradigm that requires a stringent evaluation process of decision-making capacity for informed consent. (shrink)

Standing in front of perhaps the most crucial decade of the future to come, when mankind has just experienced three years of global pandemic, a raging war, extreme climate events and mass extinction of animals and plants, we have arrived at a crossroads. Decisions must be made on whether we charge at full speed to explore alternative social-ecological systems that lead to human well-being and regeneration of nature; or continue down a pathway built on resource extraction, unsustainable and unethical urbanization (...) and destruction of nature and lives. Recently, as countries seek to recover from the pandemic, many are contemplating large-scale infrastructure schemes and projects, which have been tried and proven means to drive extraction-based economic growth. This highlights the importance of environmental justice and resistance – an area from which voices are not often heard loud enough, yet offers fertile ground where radical, sustainable alternatives may emerge among people and communities that refuse to comply with the unjust development imposed on them. Our work seeks to contribute to research studying the potential of such phenomena, by designing a framework to capture key organizational, political and ethical features that make resistance a transformative practice. The outcome of this effort is a Resistance-Based Transformative Alternative (ReBasTA) Framework, which can be employed to inform both desktop-based data collection and analysis on resistance practices, as well as in-depth field research on deep drivers and leverage points for transformation. Moreover, the framework makes longitude study of transformative practice possible, by using a consistent set of criteria. This paper introduces the conceptual and methodological approach underlying our framework and the collaborative process employed in designing it and its key criteria. In the final section, we also discuss possible applications, with particular reference to resistance movements triggered by large-scale infrastructures. (shrink)

The lie detector test has long been treated with suspicion by the law. Recently, several authors have called this suspicion into question. They argue that the lie detector test may have considerable forensic benefits, particularly if we move past the classic, false-positive prone, autonomic nervous system-based (ANS-based) control question test, to the more reliable, brain-based, concealed information test. These authors typically rely on a “comparative advantage” argument to make their case. According to this argument, we should not be so suspicious (...) of lie detection evidence if it has comparative advantages over the epistemic methods currently utilised by the legal system. In this article, I add to this growing support by making a novel comparative advantage argument in favour of brain-based lie detection evidence. The argument focuses on the P300 concealed information test (P300 CIT), which has several unique properties, and on the effect it may have on pre-trial bargaining in criminal cases rather than in-court evidence. The thesis is that P300 CIT could allow for innocent defendants to credibly signal their innocence to investigators and prosecutors during pre-trial bargaining more effectively than current proposed methods for doing the same thing. I defend this argument from a number of objections, and suggest that it opens up an interesting avenue in the ongoing debate about the merits of this technology. Although the argument is presented with the criminal law in mind, it could form part of a more general cumulative case in favour of this technology. (shrink)

Why you have the right to resist unjust government The economist Albert O. Hirschman famously argued that citizens of democracies have only three possible responses to injustice or wrongdoing by their governments: we may leave, complain, or comply. But in When All Else Fails, Jason Brennan argues that there is a fourth option. When governments violate our rights, we may resist. We may even have a moral duty to do so. For centuries, almost everyone has believed that we must allow (...) the government and its representatives to act without interference, no matter how they behave. We may complain, protest, sue, or vote officials out, but we can’t fight back. But Brennan makes the case that we have no duty to allow the state or its agents to commit injustice. We have every right to react with acts of “uncivil disobedience.” We may resist arrest for violation of unjust laws. We may disobey orders, sabotage government property, or reveal classified information. We may deceive ignorant, irrational, or malicious voters. We may even use force in self-defense or to defend others. The result is a provocative challenge to long-held beliefs about how citizens may respond when government officials behave unjustly or abuse their power. (shrink)

Two experiments were conducted to examine whether the resistance to extinction obtained in evaluative conditioning (EC) studies implies that EC is a qualitatively distinct form of classical conditioning (Baeyens, Eelen, & Crombez, 1995 Baeyens, F, Eelen, P, and Crombez, G, (1995a). Pavlovian associations are forever: On classical conditioning and extinction, Journal of Psychophysiology 9 ((1995a)), pp. 127–141.[Web of Science ®], [Google Scholar]a) or whether it is the result of an nonassociative artefact (Field & Davey, 1997 Field, AP, and Davey, (...) GCL, (1997). Conceptual conditioning: Evidence for an artifactual account of evaluative learning, Learning and Motivation 25 ((1997)), pp. 446–464.[Crossref], [Web of Science ®], [Google Scholar], 1998 Field, AP, and Davey, GCL, (1998). Evaluative conditioning: Arti‐fact or ‐fiction?‐ A reply to Baeyens, De Houwer, Vansteenwegen, and Eelen (1998), Learning and Motivation 29 ((1998)), pp. 475–491.[Crossref], [Web of Science ®], [Google Scholar], 1999 Field, AP, and Davey, GCL, (1999). Reevaluating evaluative conditioning: A nonassociative explanation of conditioning effects in the visual evaluative conditioning paradigm, Journal of Experimental Psychology: Animal Behavior Processes 25 ((1999)), pp. 211–224.[Crossref], [PubMed], [Web of Science ®], [Google Scholar]). Both experiments included between‐subjects control groups in addition to standard within‐subjects control conditions. In Experiment 1, only verbal ratings were measured in order to evaluate the effect of postacquisition CS‐only exposures on EC whereas in Experiment 2, verbal ratings and postextinction priming effects were measured. The results showed that the EC effects are demonstrable in a between‐subjects design and that the extinction procedure did not have any influence on the acquired evaluative value of CSs regardless of whether the verbal ratings or the priming effects were used as dependent variables. The present results provide evidence that EC is resistant to extinction and suggest an interpretation of EC as a qualitatively distinct form of associative learning. (shrink)

Davey suggests that increased resistance to extinction of CRs conditioned to fear-relevant stimuli may be due to more persistent expectancies of the UCS following these stimuli. However, this viewpoint is contradicted by existing empirical evidence that fear-relevant CRs survive an extinction trials series producing extinction of expectancies whereas CRs conditioned to non-fear-relevant CSs do not.

The purpose of the article is to study the influence of Nazi experiments on the formation of ideas about the ethos of science in the field of biomedicine. It is shown that the idea of discrediting a value-neutral science was often confronted with the resistance of the scientists themselves, who, in different contexts of condemning Nazi crimes, appealed to the fact that they acted for the good of science, and even of all mankind. The article discusses the strategy of (...) American lawyers adopted at the Nuremberg Trials aimed at demonstrating the perversity of Nazi crimes in the field of biomedicine both ethically and scientifically. In addition, an analysis of individual materials of the Nuremberg process was carried out, which made it possible to give an idea of the scientific and linguistic design of the human body (name correction strategy) as a “correct” scientific object with desired properties. The article considers the influence of the data obtained on Nazi crimes on the formation of the content of the Nuremberg Code and the design of the principle of informed consent in biomedicine. Ethical aspects related to the further use of Nazi scientific data are also considered. In conclusion, the problem of the formation of scientific knowledge in non-violence mode is articulated. (shrink)

Mood disorders, including major depressive disorder and bipolar disorder, are highly prevalent, frequently disabling, and sometimes deadly. Additional research and more effective medications are desperately needed, but clinical trials research in mood disorders is fraught with ethical issues. Although many authors have discussed these issues, most do so from a theoretical viewpoint. This manuscript uses available empirical data to inform a discussion of the primary ethical issues raised in mood disorders research. These include issues of consent and decision-making capacity, including (...) patients’ motivations for participating in research. We also address drug withdrawals, placebo controls, and the overall safety of research. Finally, we examine the extant literature for studies discussing potential indirect benefits of clinical trials research to participants. Taken together, the evidence suggests that clinical trials research incorporating drug withdrawals and placebo controls can be conducted safely and ethically, even in patients with severe or treatment-resistant mood disorders. In fact, given the dearth of effective treatment options for this population, it is our opinion that a moral imperative exists to extend the offer of research participation to severely ill or treatment-resistant groups. (shrink)

Recently, there has been increasing interest in the use of heavily restricted randomization designs which enforce balance on observed covariates in randomized controlled trials. However, when restrictions are strict, there is a risk that the treatment effect estimator will have a very high mean squared error. In this article, we formalize this risk and propose a novel combinatoric-based approach to describe and address this issue. First, we validate our new approach by re-proving some known properties of complete randomization and (...) restricted randomization. Second, we propose a novel diagnostic measure for restricted designs that only use the information embedded in the combinatorics of the design. Third, we show that the variance of the MSE of the difference-in-means estimator in a randomized experiment is a linear function of this diagnostic measure. Finally, we identify situations in which restricted designs can lead to an increased risk of getting a high MSE and discuss how our diagnostic measure can be used to detect such designs. Our results have implications for any restricted randomization design and can be used to evaluate the trade-off between enforcing balance on observed covariates and avoiding too restrictive designs. (shrink)

Background: No studies have examined the underlying structure or predictive validity of the Cognitive Therapy Adherence and Competence Scale. Examining the structure of the CTACS is of great relevance because it could provide information on what constitutes competence in CBT, and whether some underlying factors are more important for predicting treatment outcomes than others. This study investigates the psychometric properties of the Norwegian version of CTACS and its associations with treatment outcomes in a sample of primary care clients who (...) received CBT for anxiety and/or depression.Method: Independent assessors rated audiotaped therapy sessions in a sample of 132 primary care clients, participating in the Prompt Mental Health Care trial. Outcomes were symptoms of anxiety and depression assessed by patient self-report questionnaires. Structural validity was examined by means of confirmatory and exploratory factor analyses, whereas longitudinal associations with treatment outcome were explored by adopting multilevel modeling.Results: No evidence was found for the divergent validity of the constructs competence and adherence as indicated by a very high correlation between these two subscales in CTACS. Regarding reliability, ICCs for the mean score of the full competence scale and its associated subscales were generally good to excellent, although the subscale measuring the quality of the therapeutic relationship was relatively low. Internal consistency was overall acceptable, but our CFA models did not provide an acceptable fit for the pre-specified one-factor and four-factor solutions. EFA results were difficult to interpret, with a sub-optimal three-factor solution providing best model fit and only two meaningful factors [CBT specific skills and session structure ]. Overall, the results indicated no evidence for the scales' predictive validity.Conclusion: Our findings point to several psychometric problems of the CTACS that may limit both its research and clinical utility. The importance of providing empirical evidence for both reliability and validity aspects of scales are discussed and suggestions for future research are provided. (shrink)

Mosquito‐borne diseases take a tremendous toll on human populations, especially in developing nations. In the last decade, scientists have developed mosquitoes that have been genetically modified to prevent transmission of mosquito‐borne diseases, and field trials have been conducted. Some mosquitoes have been rendered infertile, some have been equipped with a vaccine they transmit to humans, and some have been designed to resist diseases. This article focuses on ethical issues raised by field trials of disease‐resistant, genetically modified mosquitoes. Some of these (...) issues include: protecting the public and the environment from harm, balancing benefits and risks, collaborating with the local community, avoiding exploitation, and safeguarding the rights and welfare of research subjects. One of the most difficult problems involves protecting the welfare of community members who will be impacted by the release of mosquitoes but who are not enrolled in the study as research subjects. To address this concern, field trials should take place only when the targeted disease is a significant public health problem in an isolated area, the benefits of the trial for the community are likely to outweigh the risks, community leaders approve of the trial, and there are measures in place to protect the welfare of un‐enrolled community members, such as informing the community about the study and offering free treatment to people who contract mosquito‐borne diseases. Since the justification of any field trial depends on a careful examination of the scientific and ethical issues, proposed studies should be evaluated on a case‐by‐case basis. (shrink)