Research Report: A Link between Sertraline Treatment and Susceptibility to (Mis)information.

Recent research revealed that several psycho-cognitive processes, such as insensitivity to positive and negative feedback, cognitive rigidity, pessimistic judgment bias, and anxiety, are involved in susceptibility to fake news. All of these processes have been previously associated with depressive disorder and are sensitive to serotoninergic manipulations. In the current study, a link between chronic treatment with the selective serotonin reuptake inhibitor (SSRI) sertraline and susceptibility to true and fake news was examined. Herein, a sample of 1162 participants was recruited via Prolific Academic for an online study. Half of the sample reported taking sertraline (Zoloft) for at least 8 weeks (sertraline group), and the other half confirmed not taking any psychiatric medication (control group). The sertraline group was further divided according to their daily dosage (50, 100, 150, and 200 mg/day). All participants completed a susceptibility to misinformation scale, wherein they were asked to determine the veracity of the presented true and fake news and their willingness to behaviorally engage with the news. The results were compared between those of the sertraline groups and the control group. The results showed that sertraline groups did not differ significantly in the assessment of the truthfulness of information or their ability to discern the truth. However, those taking sertraline appeared to have a significantly increased likelihood of behavioral engagement with the information, and this effect was observed for both true and fake news. The research presented here represents the initial endeavor to comprehend the neurochemical foundation of the susceptibility to misinformation. The association between sertraline treatment and increased behavioral engagement with information observed in this study can be explained in light of previous studies showing positive correlations between serotonin (5-HT) system activity and the inclination to engage in social behaviors. It can also be attributed to the anxiolytic effects of sertraline treatment, which mitigate the fear of social judgment. The heightened behavioral engagement with information in people taking sertraline may, as part of a general phenomenon, also shape their interactions with fake news. Future longitudinal studies should reveal the specificity and exact causality of these interactions.

The role of perceived minority-group status in the conspiracy beliefs of factual majority groups.

Research suggests that minority-group members sometimes are more susceptible to misinformation. Two complementary studies examined the influence of perceived minority status on susceptibility to misinformation and conspiracy beliefs. In study 1 (n = 2140), the perception of belonging to a minority group, rather than factually belonging to it, was most consistently related with an increased susceptibility to COVID-19 misinformation across national samples from the USA, the UK, Germany and Poland. Specifically, perceiving that one belongs to a gender minority group particularly predicted susceptibility to misinformation when participants factually did not belong to it. In pre-registered study 2 (n = 1823), an experiment aiming to manipulate the minority perceptions of men failed to influence conspiracy beliefs in the predicted direction. However, pre-registered correlational analyses showed that men who view themselves as a gender minority were more prone to gender conspiracy beliefs and exhibited a heightened conspiracy mentality. This effect was correlationally mediated by increased feelings of system identity threat, collective narcissism, group relative deprivation and actively open-minded thinking. Especially, the perception of being a minority in terms of power and influence (as compared to numerically) was linked to these outcomes. We discuss limitations and practical implications for countering misinformation.

Are we willing to share what we believe is true? Factors influencing susceptibility to fake news.

Background: The contemporary media landscape is saturated with the ubiquitous presence of misinformation. One can point to several factors that amplify the spread and dissemination of false information, such as blurring the line between expert and layman's opinions, economic incentives promoting the publication of sensational information, the zero cost of sharing false information, and many more. In this study, we investigate some of the mechanisms of fake news dissemination that have eluded scientific scrutiny: the evaluation of veracity and behavioral engagement with information in light of its factual truthfulness (either true or false), cognitive utility (either enforcing or questioning participants' beliefs), and presentation style (either sober or populistic). Results: Two main results emerge from our experiment. We find that the evaluation of veracity is mostly related to the objective truthfulness of a news item. However, the probability of engagement is more related to the congruence of the information with the participants' preconceived beliefs than to objective truthfulness or information presentation style. Conclusion: We conclude a common notion that the spread of fake news can be limited by fact-checking and educating people might not be entirely true, as people will share fake information as long as it reduces the entropy of their mental models of the world. We also find support for the Trojan Horse hypothesis of fake news dissemination.

Informed Consent and Debriefing When Deceiving Participants: A Systematic Review of Research Ethics Guidelines.

Informed consent and debriefing of research participants in studies that use deception are ethical safeguards for which existing scholarly work on their implementation remains variable and insufficiently clear. A systematic review of research ethics guidelines was conducted to sketch a picture of whether, why and how informed consent and debriefing are recommended when using deception. Documents roughly agreed on several general principles, but varied significantly in the specifics of why and whether these safeguards are necessary, in which conditions and how they should be implemented. Various aspects that appear in the literature could not be found in the guidelines. In our review, guidance was integrated and showed a variation of implementation strategies that could help in contextualizing these safeguards.

Assessing the acceptability of individual studies that use deception: A systematic review of normative guidance documents.

Research participants are often deceived for methodological reasons. However, assessing the ethical acceptability of an individual study that uses deception is not straightforward. The academic literature is scattered on the subject and several aspects of the acceptability assessment are only scarcely addressed, which parallels reports of inconsistent ethics review. Therefore, we aimed to investigate where normative guidance documents agree and disagree about this assessment. A PRISMA-Ethics-guided systematic review of normative guidance documents that discuss deception of research participants was conducted. Our search strategy resulted in 55 documents that were subsequently analyzed through abductive thematic analysis. While guidance documents mention little about specific risks and opportunities of deception, our analysis describes a rich picture of the thresholds for acceptability of the risks and benefits of deception and their integration, the comparison with the risk-benefit analysis of alternative non-deceptive methods, and the bodies of people who are positioned to do the review. Our review reveals an agreement on the general process of assessing the acceptability of studies that use deception, although significant variability remains in the details and several topics are largely or completely unaddressed in guidance documents.

Ownership of individual-level health data, data sharing, and data governance.

BACKGROUND: The ownership status of individual-level health data affects the manner in which it is used. In this paper we analyze two competing models of the ownership status of the data discussed in the literature recently: private ownership and public ownership. MAIN BODY: In this paper we describe the limitations of these two models of data ownership with respect to individual-level health data, in particular in terms of ethical principles of justice and autonomy, risk mitigation, as well as technological, economic, and conceptual issues. We argue that undifferentiated application of neither private ownership nor public ownership will allow us to resolve all the problems associated with effective, equitable, and ethical use of data. We suggest that, instead of focusing on data ownership, we should focus on the institutional and procedural aspects of data governance, such as using Data Access Committees (DACs) or equivalent managed access processes, which can balance the elements of these two ownership frameworks. CONCLUSION: Undifferentiated application of the ownership concept (private or public) is not helpful in resolving problems associated with sharing individual-level health data. DACs or equivalent managed access processes should be an integral part of data governance. They can approve or disapprove data access requests after considering the potential benefits and harms to data subjects, their communities, primary researchers, and the wider society.

Cognitive Processes and Personality Traits Underlying Four Phenotypes of Susceptibility to (Mis)Information.

Misinformation on social media poses a serious threat to democracy, sociopolitical stability, and mental health. Thus, it is crucial to investigate the nature of cognitive mechanisms and personality traits that contribute to the assessment of news items' veracity, failures in the discernment of their truthfulness, and behavioral engagement with the news, especially if one wants to devise any intervention to stop the spread of misinformation in social media. The current research aimed to develop and test a 4-fold taxonomy classifying people into four distinct phenotypes of susceptibility to (mis)information. In doing so, it aimed to establish differences in cognitive and psychological profiles between these phenotypes. The investigated cognitive processes included sensitivity to feedback, belief updating, and cognitive judgment bias. Psychological traits of interest included the Big Five model, grandiose narcissism, anxiety, and dispositional optimism. The participants completed online surveys that consisted of a new scale designed to classify people into one of four phenotypes of susceptibility to (mis)information, advanced cognitive tests, and reliable psychological instruments. The four identified phenotypes, Doubters, Knowers, Duffers, and Consumers, showed that believing in misinformation does not imply denying the truth. In contrast, the numerically largest phenotypes encompassed individuals who were either susceptible (Consumers) or resistant (Doubters), in terms of veracity judgment and behavioral engagement, to any news, regardless of its truthfulness. Significantly less frequent were the phenotypes characterized by excellent and poor discernment of the news' truthfulness (the Knowers and the Duffers, respectively). The phenotypes significantly differed in sensitivity to positive and negative feedback, cognitive judgment bias, extraversion, conscientiousness, agreeableness, emotional stability, grandiose narcissism, anxiety, and dispositional optimism. The obtained results constitute a basis for a new and holistic approach in understanding susceptibility to (mis)information as a psycho-cognitive phenotype.

Psychological interventions countering misinformation in social media: A scoping review.

Introduction: The rise of social media users and the explosive growth in misinformation shared across social media platforms have become a serious threat to democratic discourse and public health. The mentioned implications have increased the demand for misinformation detection and intervention. To contribute to this challenge, we are presenting a systematic scoping review of psychological interventions countering misinformation in social media. The review was conducted to (i) identify and map evidence on psychological interventions countering misinformation, (ii) compare the viability of the interventions on social media, and (iii) provide guidelines for the development of effective interventions. Methods: A systematic search in three bibliographic databases (PubMed, Embase, and Scopus) and additional searches in Google Scholar and reference lists were conducted. Results: 3,561 records were identified, 75 of which met the eligibility criteria for the inclusion in the final review. The psychological interventions identified during the review can be classified into three categories distinguished by Kozyreva et al.: Boosting, Technocognition, and Nudging, and then into 15 types within these. Most of the studied interventions were not implemented and tested in a real social media environment but under strictly controlled settings or online crowdsourcing platforms. The presented feasibility assessment of implementation insights expressed qualitatively and with numerical scoring could guide the development of future interventions that can be successfully implemented on social media platforms. Discussion: The review provides the basis for further research on psychological interventions counteracting misinformation. Future research on interventions should aim to combine effective Technocognition and Nudging in the user experience of online services. Systematic review registration: [https://figshare.com/], identifier [https://doi.org/10.6084/m9.figshare.14649432.v2].

Ethical issues in biomedical research using electronic health records: a systematic review.

Digitization of a health record changes its accessibility. An electronic health record (EHR) can be accessed by multiple authorized users. Health information from EHRs contributes to learning healthcare systems' development. The objective of this systematic review is to answer a question: What are ethical issues concerning research using EHRs in the literature? We searched Medline Ovid, Embase and Scopus for publications concerning ethical issues of research use of EHRs. We employed the constant comparative method to retrieve common ethical themes. We descriptively summarized empirical studies. The study reveals the breadth, depth, and complexity of ethical problems associated with research use of EHRs. The central ethical question that emerges from the review is how to manage access to EHRs. Managing accessibility consists of interconnected and overlapping issues: streamlining research access to EHRs, minimizing risk, engaging and educating patients, as well as ensuring trustworthy governance of EHR data. Most of the ethical problems concerning EHR-based research arise from rapid cultural change. The framing of concepts of privacy, as well as individual and public dimensions of beneficence, are changing. We are currently living in the middle of this transition period. Human emotions and mental habits, as well as laws, are lagging behind technological developments. In the medical tradition, individual patient's health has always been in the center. Transformation of healthcare care, its digitalization, seems to have some impacts on our perspective of health care ethics, research ethics and public health ethics.

Balancing professional obligations and risks to providers in learning healthcare systems.

Clinicians and administrators have a professional obligation to contribute (OTC) to improvement of healthcare quality. At the same time, participation in embedded research poses risks to healthcare institutions. Disclosure of an institution's sensitive information could endanger relationships with patients and undermine its reputation. The existing ethical framework (EF) for learning healthcare systems (LHSs) does not address the conflict between the OTC and institutional interests. Ethical guidance and policy regulation are needed to create a safe environment for embedded research. In this article we analyse the EF for LHSs and the concept of professionalism. We suggest that the EF should be supplemented with an obligation to protect provider's legitimate interests. We define legitimate interests as those that enable providers to discharge their primary duties. We argue that both the OTC and the obligation to protect legitimate interests are grounded in the concept of medical professionalism and can be understood as a matter of contract between a democratic society and medical professionals. The proposed supplemented EF can be implemented into a regulatory system in three different ways: the self-regulating: where providers decide themselves how to balance the ethical claims, the centralised: where a governmental institution decides the right balance between providers' interests and interests of a health system; and the mediating: where medical professionals, the state and patients negotiate their interests. Our article contributes to the discussion on ethical relevance of providers' interests and the regulatory model for weighing opposite interests in LHSs.

Data Access Committees.

BACKGROUND: Sharing de-identified individual-level health research data is widely promoted and has many potential benefits. However there are also some potential harms, such as misuse of data and breach of participant confidentiality. One way to promote the benefits of sharing while ameliorating its potential harms is through the adoption of a managed access approach where data requests are channeled through a Data Access Committee (DAC), rather than making data openly available without restrictions. A DAC, whether a formal or informal group of individuals, has the responsibility of reviewing and assessing data access requests. Many individual groups, consortiums, institutional and independent DACs have been established but there is currently no widely accepted framework for their organization and function. MAIN TEXT: We propose that DACs, should have the role of both promotion of data sharing and protection of data subjects, their communities, data producers, their institutions and the scientific enterprise. We suggest that data access should be granted by DACs as long as the data reuse has potential social value and provided there is low risk of foreseeable harms. To promote data sharing and to motivate data producers, DACs should encourage secondary uses that are consistent with the interests of data producers and their own institutions. Given the suggested roles of DACs, there should be transparent, simple and clear application procedures for data access. The approach to review of applications should be proportionate to the potential risks involved. DACs should be established within institutional and legal frameworks with clear lines of accountability, terms of reference and membership. We suggest that DACs should not be modelled after research ethics committees (RECs) because their functions and goals of review are different from those of RECs. DAC reviews should be guided by the principles of public health ethics instead of research ethics. CONCLUSIONS: In this paper we have suggested a framework under which DACs should operate, how they should be organised, and how to constitute them.

Transparent Defaults and Consent for Participation in a Learning Health Care System: An Empirical Study.

We report a preregistered study that was designed to answer three questions about using transparent defaults to increase participation in a hypothetical learning health care system. Do default options influence consent to participate in learning activities within a learning health care system? Does transparency about default options decrease the effect of the defaults? Do people reconsider their choice of participation once they are informed about the defaults applied? In our study, application of the defaults did not have influence on rates of consent, nor did transparency about defaults have an effect on the rates of consent. Participants were also not likely to change their choice after being informed that defaults were applied to their previous choice. In general, our study raises doubts that defaults (both covert and transparent) can be used as an effective means in significantly increasing participation in learning health care systems.

Learning to Regulate Learning Healthcare Systems.

It is commonplace to observe that science often outstrips the ability of society to monitor, supervise and regulate it. A recent challenge in this regard concerns Learning Healthcare Systems, an initiative to collect data and test hypotheses across clinical settings, and therefore to a larger degree than before. Some argue that the line between research and clinical practice is becoming blurred, and that existing regulation seems to obstruct low risk research. They propose the creation of a new ethical framework for Learning Healthcare Systems, to speed up research. This paper opposes that view, and argues that Learning Healthcare Systems do not blur or remove the line between research and practice, and will not result in a single set of regulations for all kinds of biomedical research. The authors suggest that a large proportion of Learning Healthcare System activities resemble public health surveillance to a significant extent. Therefore, they propose that these activities should be organized in accordance with the same ethical principles as public health surveillance, specifically that Learning Healthcare Systems should rest on the principles of comprehensiveness, transparency, and public accountability.

Research versus practice: The dilemmas of research ethics in the era of learning health-care systems.

In this article we attempt to answer the question of how the ethical and conceptual framework (ECF) for a learning health-care system (LHS) affects some of the main controversies in research ethics by addressing five key problems of research ethics: (a) What is the difference between practice and research? (b) What is the relationship between research ethics and clinical ethics? (c) What is the ethical relevance of the principle of clinical equipoise? (d) Does participation in research require a higher standard of informed consent than the practice of medicine? and (e) What ethical principle should take precedence in medicine? These questions allow us to construct two opposite idealized positions on the distinction between research and practice: the integration model and the segregation model of research and practice. We then compare the ECF for an LHS with these two idealized positions. We argue that the ECF for a LHS does not, in fact, solve these problems, but that it is a third, separate position in the relationship between research ethics and clinical ethics. Moreover, we suggest that the ECF for a LHS raises new ethical problems that require additional ethical analysis and justification. Our article contributes to the discussion on the relationship between research ethics and clinical ethics, revealing that although a learning health-care system may significantly change the landscape of health care, some ethical dilemmas still require resolving on both theoretical and policy-making levels.

Risk and surrogate benefit for pediatric Phase I trials in oncology: A systematic review with meta-analysis.

BACKGROUND: Pediatric Phase I cancer trials are critical for establishing the safety and dosing of anti-cancer treatments in children. Their implementation, however, must contend with the rarity of many pediatric cancers and limits on allowable risk in minors. The aim of this study is to describe the risk and benefit for pediatric cancer Phase I trials. METHODS AND FINDINGS: Our protocol was prospectively registered in PROSPERO (CRD42015015961). We systematically searched Embase and PubMed for solid and hematological malignancy Phase I pediatric trials published between 1 January 2004 and 1 March 2015. We included pediatric cancer Phase I studies, defined as "small sample size, non­randomized, dose escalation studies that defined the recommended dose for subsequent study of a new drug in each schedule tested." We measured risk using grade 3, 4, and 5 (fatal) drug-related adverse events (AEs) and benefit using objective response rates. When possible, data were meta-analyzed. We identified 170 studies meeting our eligibility criteria, accounting for 4,604 patients. The pooled overall objective response rate was 10.29% (95% CI 8.33% to 12.25%), and was lower in solid tumors, 3.17% (95% CI 2.62% to 3.72%), compared with hematological malignancies, 27.90% (95% CI 20.53% to 35.27%); p < 0.001. The overall fatal (grade 5) AE rate was 2.09% (95% CI 1.45% to 2.72%). Across the 4,604 evaluated patients, there were 4,675 grade 3 and 4 drug-related AEs, with an average grade 3/4 AE rate per person equal to 1.32. Our study had the following limitations: trials included in our review were heterogeneous (to minimize heterogeneity, we separated types of therapy and cancer types), and we relied on published data only and encountered challenges with the quality of reporting. CONCLUSIONS: Our meta-analysis suggests that, on the whole, AE and response rates in pediatric Phase I trials are similar to those in adult Phase I trials. Our findings provide an empirical basis for the refinement and review of pediatric Phase I trials, and for communication about their risk and benefit.

Erasmus Mundus Master of Bioethics: a case for an effective model for international bioethics education.

Designing bioethics curriculum for international postgraduate students is a challenging task. There are at least two main questions, which have to be resolved in advance: (1) what is a purpose of a particular teaching program and (2) how to respectfully arrange a classroom for students coming from different cultural and professional backgrounds. In our paper we analyze the case of the Erasmus Mundus Master of Bioethics program and provide recommendations for international bioethics education. In our opinion teaching bioethics to postgraduate international students goes beyond curriculum. It means that such a program requires not only well-defined goals, including equipping students with necessary skills and knowledge, but also it should first and foremost facilitate positive group dynamics among students and enables them to engage in dialogue to learn from one another.

Relevant Information and Informed Consent in Research: In Defense of the Subjective Standard of Disclosure.

In this article, we seek to contribute to the debate on the requirement of disclosure in the context of informed consent for research. We defend the subjective standard of disclosure and describe ways to implement this standard in research practice. We claim that the researcher should make an effort to find out what kinds of information are likely to be relevant for those consenting to research. This invites researchers to take empirical survey information seriously, attempt to understand the cultural context, talk to patients to be better able to understand what can be potentially different concerns and interests prevalent in the target population. The subjective standard of disclosure should be seen as a moral ideal that perhaps can never be perfectly implemented but still can and should be used as a normative ideal guiding research practice. In the light of these discussions, we call for more empirical research on what considerations are likely to be perceived as relevant by potential research participants recruited from different socio-economic and cultural groups.