Findings about the desire for health-risk information are heterogeneous and sometimes contradictory. In particular, they seem to be at variance with established psychological theories of information-seeking behavior.The present paper posits the decision about treating illness with medicine as the causal determinant for the expected net value of information, and attempts to explain idiosyncrasies in information-seeking behavior by using the notion of decision sensitivity to incoming information.Furthermore, active information avoidance is explained by modeling the (...) expected emotional distress potentially brought about by “bad news” as a disutility factor in pay-off maximization.In this context two notions of uncertainty are distinguished: an epistemic uncertainty related to the prognostic probability assigned to the risk, and an emotional uncertainty related to the expected damage. Health-risk information can both reduce epistemic and increase emotional uncertainty, giving rise to idiosyncratic processing strategies. (shrink)

Response to wrongdoing is modeled as a decision process in an organizational context. The model is grounded in theory of risk, ambiguity, and informational influences on decision making. Time pressure, inadequate information and coworker influences are addressed. Along the way, a handful of propositions are provided which emphasize influences on the actual choice between response options.

DePrince relates problems such as dissociation, revictimization and difficulties in social cognition. In particular, she states that individuals with dissociation or have been, by their own testimony, revictimized show obvious difficulties to solve selection tasks designed as social contracts or precautory problems. In my view, these facts mean that, if we accept the theories that there are mechanisms in human mind to regulate social exchanges and situations of risk, individuals with dissociation or revitimized may have altered such mechanisms. However, (...) these theories have been critized and we have no evidence that they are valid. Therefore, in this paper, not admitting the existence of these mechanisms, I try to show that DePrince’s outcomes can be interpreted from other perspectives. DePrince establece relaciones entre problemas como la disociación, la revictimización y ciertas dificultades en la cognición social. En concreto, afirma que las personas que padecen de disociación o que han sufrido, según su propio testimonio, episodios de revictimización manifiestan evidentes dificultades para resolver tareas de selección planteadas como contratos sociales o como problemas de precaución. En nuestra opinión, esto significa que, si aceptamos las teorías que defienden que existen mecanismos en la mente humana que regulan los intercambios sociales y las situaciones de riesgo, las personas que han sido diagnosticadas con disociación o que han sido revictimizadas pueden presentar alteraciones de tales mecanismos. No obstante, esas teorías han sido cuestionadas y no contamos con pruebas concluyentes de que sean válidas. Por ello, en este trabajo, no admitiendo la existencia de los mencionados mecanismos, intentamos mostrar que los resultados de DePrince pueden ser interpretados desde otras perspectivas. (shrink)

BackgroundPositive and negative focus in information processing associated with age has a diverse role in COVID-19 vaccine uptake. The aim of the study was the exploration of the generational diversity among psychological predictors of COVID-19 vaccine uptake.MethodsA cross-sectional research was conducted. The sample included 978 Hungarian women. Based on former literature findings, the COVID-19 vaccine uptake predictors were chosen from the health beliefs model, COVID-19 vaccine hesitancy, and psychological flexibility. Multivariate logistic regression analysis was conducted to investigate the (...) predictors of COVID-19 vaccine uptake in women of Gen X, Gen Y, and Gen Z.ResultsIn Gen X women, the influence of significant predictors are more prone to the positivity in COVID-19 vaccine uptake behavior, perceived benefits being the most relevant, increasing the likelihood of vaccine uptake more than four times. In Gen Y women, perceived barriers, lack of confidence/skepticism and avoidance significantly reduce the probability of vaccine uptake, showing an accentuated negative focus in information processing related to COVID-19 vaccination. The vaccine uptake in Gen Z is predicted only by the perceived benefits, and the likelihood of COVID-19 vaccine uptake is heightened in chance more than 19 times.ConclusionWomen belonging to Gen X or Gen Y, the perceived benefits hold the key to vaccine uptake, while in women of Gen Z, low risks, lack of threats, and accessibility could motivate the decision of vaccine uptake. The findings are useful in generation-adapted vaccination campaigns and can also serve as inspiration for evolutionary psychology studies on health behavior and the broad area of study in cognitive biases in health information processing. (shrink)

Ever since the outbreak of the coronavirus disease, people have been flooded with vast amounts of information related to the virus and its social consequences. This paper draws on social amplification theory and the extended parallel process model and assesses the following: how two amplification stations—news media and peoples’ personal networks—influence the risk-related perceptions of people and how these risk-related perceptions impact people’s health-protective behaviors. This study surveyed 1,946 participants. The results indicate that peoples’ exposure to news (...) media significantly and positively predicted both perceived efficacy and perceived threat. It also shows that peoples’ exposure to risk-related information through their personal networks negatively predicted their perceived efficacy, but it positively predicted their perceived threat. The mediating effect of fear was examined, and the result was contradictory to the EPPM. In short, this study reveals the underlying mechanism of individuals’ exposure to risk information, processing, and precautionary measures. (shrink)

Implantable brain–computer interface technology is an expanding area of engineering research now moving into clinical application. Ensuring meaningful informed consent in implantable BCI research is an ethical imperative. The emerging and rapidly evolving nature of implantable BCI research makes identification of risks, a critical component of informed consent, a challenge. In this paper, 6 core risk domains relevant to implantable BCI research are identified—short and long term safety, cognitive and communicative impairment, inappropriate expectations, involuntariness, affective impairment, and privacy and (...) security. Work in deep brain stimulation provides a useful starting point for understanding this core set of risks in implantable BCI. Three further risk domains—risks pertaining to identity, agency, and stigma—are identified. These risks are not typically part of formalized consent processes. It is important as informed consent practices are further developed for implantable BCI research that attention be paid not just to disclosing core research risks but exploring the meaning of BCI research with potential participants. (shrink)

In 2004, prenatal risk assessment (PRA) was implemented as a routine offer in Denmark, in order to give all pregnant women an informed choice about whether to undergo prenatal testing. PRA is a non-invasive intervention performed in the first trimester of pregnancy and measures the risk of a fetus having Down's syndrome or other chromosomal disorders. The risk figure provides the basis for action, i.e. the decision about whether or not to undergo invasive fetal testing via the (...) maternal route (amniocentesis or chorionic villus sampling), which, however, involves the risk of inducing a miscarriage. On the basis of ethnographic fieldwork in an ultrasound clinic in Denmark and interviews with pregnant women and their partners, this paper investigates how ideals such as autonomy and non-directiveness are practised in processes of decision-making. We view such ideals as forming social practice rather than neutral instruments to reach a certain goal. Focusing on one couple's trajectory through the clinical practices of PRA and the process through which a decision is reached, we call into question the assumption that more choice and more objective information is a source of empowerment and control. We make evident how decisions are made through a complicated process of meaning-making, which emerges through the relationship between professionals, the clinical setting and the social life of the couples. In the face of complex risk knowledge, PRA users are reluctant to make choices and seek to re-install authority in the health professionals. However, when assumptions about autonomy and self-determination are inscribed into the social practice of PRA, authority is transferred to the couple undergoing PRA and a new configuration of responsibility evolves between the couple and their relationship to the fetus. It is argued that PRA performs a form of government that works not through compulsion or persuasion but through choice. An ethic of a shared responsibility for PRA and its outcome between pregnant women and health professionals would be more in agreement with how decisions are actually made. (shrink)

In 2004 prenatal risk assessment was implemented as a routine offer to all pregnant women in Denmark. It was argued that primarily the new programme would give all pregnant women an informed choice about whether to undergo prenatal testing. On the basis of ethnographic fieldwork in an ultrasound clinic in Denmark and interviews with pregnant women and their partners, we call into question the assumption underlying the new guidelines that more choice and more objective information is a source (...) of empowerment and control. We focus on one couple's experience of PRA. This case makes it evident how supposed choices in the context of PRA may not be experienced as such. Rather, they are experienced as complicated processes of meaning-making in the relational space between the clinical setting, professional authority and the social life of the couples. PRA users are reluctant to make choices and abandon health professionals as authoritative experts in the face of complex risk knowledge. When assumptions about autonomy and self-determination are inscribed into the social practice of PRA, authority is transferred to the couple undergoing PRA and a new configuration of responsibility evolves between the couple and their relationship to the foetus. It is argued that al-though the new programme of prenatal testing in Denmark presents itself in opposition to quasi-eugenic and paternalistic forms of governing couples' decisions it represents another form of government that works through the notion of choice. An ethics of a shared responsibility of PRA and its outcome would be more in agreement with how decisions are actually made. (shrink)

Research on emotion and emotion regulation is expected to improve our understanding of psychopathology. However, achieving this understanding requires overcoming several obstacles, including the paucity of objective markers of specific emotions or psychiatric diagnoses, and the fact that emotion regulation is a concept that can be difficult to operationalize. We review affective neuroscience research that has addressed these issues by focusing on psychological and neural mechanisms implicated in approach and avoidance behaviors, as revealed by studies of fear, anxiety, and reward (...) processing. Dysfunction in these mechanisms may serve as risk markers for psychopathology, while emotion regulation research demonstrates that some of them are susceptible to volitional control. The conclusion acknowledges limitations of affective neuroscience and highlights goals for future work. (shrink)

Background: Medical tourism, thought of as patients seeking non-emergency medical care outside of their home countries, is a growing industry worldwide. Canadians are amongst those engaging in medical tourism, and many are helped in the process of accessing care abroad by medical tourism brokers - agents who specialize in making international medical care arrangements for patients. As a key source of information for these patients, brokers are likely to play an important role in communicating the risks and benefits of (...) undergoing surgery or other procedures abroad to their clientele. This raises important ethical concerns regarding processes such as informed consent and the liability of brokers in the event that complications arise from procedures. The purpose of this article is to examine the language, information, and online marketing of Canadian medical tourism brokers' websites in light of such ethical concerns. Methods: An exhaustive online search using multiple search engines and keywords was performed to compile a comprehensive directory of English-language Canadian medical tourism brokerage websites. These websites were examined using thematic content analysis, which included identifying informational themes, generating frequency counts of these themes, and comparing trends in these counts to the established literature. Results: Seventeen websites were identified for inclusion in this study. It was found that Canadian medical tourism broker websites varied widely in scope, content, professionalism and depth of information. Three themes emerged from the thematic content analysis: training and accreditation, risk communication, and business dimensions. Third party accreditation bodies of debatable regulatory value were regularly mentioned on the reviewed websites, and discussion of surgical risk was absent on 47% of the websites reviewed, with limited discussion of risk on the remaining ones. Terminology describing brokers' roles was somewhat inconsistent across the websites. Finally, brokers' roles in follow up care, their prices, and the speed of surgery were the most commonly included business dimensions on the reviewed websites. Conclusion: Canadian medical tourism brokers currently lack a common standard of care and accreditation, and are widely lacking in providing adequate risk communication for potential medical tourists. This has implications for the informed consent and consequent safety of Canadian medical tourists. (shrink)

This paper examines the case for an expanded interpretation of the concept of “material risk” such that it necessitates voluntary disclosure of physician inexperience with a specific medical procedure. Informed consent law in the United States, Canada, and most commonwealth jurisdictions has become a driver of standards of risk disclosure by physicians during the informed consent process. The legal standard of risk disclosure expected of a physician hinges on the interpretation of the entity called “material risk.” (...) Any impairment of the physician related to drug usage, disease, or alcohol which compounds the risk of a procedure is very likely to be considered material by a patient. This paper argues that physician inexperience is a factor that a reasonable patient would attach significance to and that it should therefore be viewed as a “material risk” requiring disclosure. (shrink)

In Brazil, every study involving human beings is required to produce an informed consent form that must be signed by study participants: this is stated in Resolution 196/96. 1 Consent must be obtained through a specific structured process. Objective: To present the opinions of women regarding how the process of obtaining informed consent should be conducted when women are invited to participate in studies on contraceptive methods. Subjects and Methods: Eight focus groups were conducted, involving a total of 51 women (...) living in the metropolitan region of Campinas. The women involved in the study were either participating in a clinical trial in the area of women's health or had participated in such a trial in the previous 12 months. A thematic guide was used to conduct the focus group discussions; the discussions were recorded, transcribed and a thematic analysis performed. Results: In general, the person who invites a woman to participate in a study should be a member of the research team but not the principal investigator. Information relating to the study should be given orally and in writing, both individually and in the group setting. Study volunteers should be informed about, among other things, the risks, possible side effects and discomforts, including long-term effects. The use of audiovisual aids to provide information was suggested. Conclusion: The process for obtaining informed consent was seen as a means of establishing a relationship between the volunteers and the investigator/research team. The information that the study participants expected to be given coincides with the requirements established under Resolution 196/96. The use of audiovisual aids would improve understanding of the information provided. (shrink)

Factory floors throughout the global economy are rapidly transforming themselves into potentially fertile laboratories for research in the cognitive sciences. The information revolution has challenged our understanding of perception and cognition. Innovations in information technologies have also provided us with new methods and environments for the study of cognition. On the business and economic front, information technology is supporting the development of new corporate information systems-Enterprise Systems-that will revolutionize the decision-making, reporting and reward environments in corporations. (...) These systems are pervasive and transforming. At all levels, employees will be presented with potentially unlimited amounts of accurate, real-time information and will be expected to use that information effectively. The possibilities for research, especially for modeling the learning and decision-making processes, are unparalleled. Research conducted in these environments offers extraordinary opportunities to address research questions formerly requiring limited synthetic environmental situations. Data collected in firms as they deploy enterprise information systems can be more extensive and accurate and more easily quantified than data from traditional synthetic experiments. Research programs in these settings can also address more complex problems of human interaction and collaborativity. This article describes the aspects of enterprise systems that will be of greates interest to cognitive scientists. It also outlines the nature of potential collaboration between economists and cognitive scientists and offers a list of outstanding questions for systems design and development. (shrink)

Despite the great expansion and many benefits of information and communication technologies in healthcare, the attitudes of Polish general practitioners to e-health have not been explored. The aim of this study was to determine the GPs’ perception of ICT use in healthcare and to identify barriers to the adoption of EMR in the Podlaskie Voivodeship. Online and telephone surveys were conducted between April and May 2013. Responses from 103 GP practices, 43% of all practices in the region, were analysed. (...) The results showed that 67% of the respondents agreed that IT systems improve quality of healthcare services. In the GP group who declared at least partial EMR implementation, 71.4% see the positive impact of IT on practice staff processes and 66.1% on personal working processes. In this group, more than three-quarters of GPs did not see any positive impact of ICT on the average number of patients treated per day, number of patients within the practice or scope of services. The four most common barriers to EMR implementation were: lack of funds, risk of a malfunction in the system, resistance to change, and lack of training and proper information. Although the use of ICT by Polish GPs is limited, their attitude to e-health is generally positive or neutral and resembles the overall pattern in Europe. Barriers identified by GPs need to be taken into account to ensure the effective implementation of e-health across the country. (shrink)

The informed consent process provides protection by ensuring that potential research subjects understand the goals of the research project they are being asked to voluntarily partake in as well as the risks associated with the study. We examined subjects' comprehension and ability to identify issues explicitly raised during the consent process that was conducted as part of their participation in a genetic family study (GFS). We employed cross-sectional design by providing a short, self-administrative questionnaire to 246 participants recruited from families (...) enrolled in the Extended Family Investigation of Nephropathy and Diabetes (EFIND) study conducted at the University of Texas Health Science Center. Participants responded to the questionnaire directly after their enrollment in the EFIND study. The questionnaire consisted of multiple-choice questions and focused on the understanding of the purposes, procedures, and risks associated with their participation in the EFIND study. These questions were formulated to reflect basic information presented to subjects through the consent process. Responses to questions were expressed as percentages, placing equal weight on each response. Participants were Mexican-American, 62.3% female and averaged 35.2 ± 12.7 years old (range: 18-76). Our findings showed that the average comprehension score was 58. About 30% of the participants did not know the name of the study, and 70% did not identify all elements related to the study procedures. The most striking finding was the lack of understanding concerning the social risks associated with participation in EFIND. While 35.1% of participants identified all potential physical risks, only 1.3% could identify all of the social risks. Our findings showed that participants comprehension score was significantly associated with their level of education and income. We conclude that using the informed consent process to communicate research social risks to subjects participating in GFS has some limitations. Future research directed at improving risk communications to subjects of low socioeconomic levels participating in genetic research is justified. (shrink)

Background HIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania. Methods A total of 1146 women at increased risk of HIV acquisition working (...) as alcohol and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate women's perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews conducted immediately after their 4, 24 and 52 week follow-up visits. Results 99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks. In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy. Conclusions Providing information to trial participants in a focussed, locally-appropriate manner, using methods developed in consultation with the community, and within a continuous informed-consent framework resulted in high levels of comprehension and message retention in this setting. This approach may represent a model for researchers conducting HIV prevention trials among other vulnerable populations in resource-poor settings. Trial registration Current Controlled Trials ISRCTN64716212. (shrink)

Given the increasing need for solid organ and tissue transplants and the decreasing supply of suitable allographic organs and tissue to meet this need, it is understandable that the hope for successful xenotransplantation has resurfaced in recent years. The biomedical obstacles to xenotransplantation encountered in previous attempts could be mitigated or overcome by developments in immunosuppression and especially by genetic manipulation of organ source animals. In this essay we consider the history of xenotransplantation, discuss the biomedical obstacles to success, explore (...) recent developments in transgenic sourcing of organs and tissues, and analyze the problem of infectious disease resulting from xenotransplantation (xenosis). We then apply a model of risk analysis to these risks. The conclusions of this risk analysis are used in an ethical evaluation of informed consent in xenotransplantation, with an ethical foundation in Kantian autonomy and Levinasian heteronomic alterity. Our conclusion is that individual and collective informed consent to the infectious disease risks of xenotransplantation requires an open, participatory and dialogical public policy process not yet seen in the United States and Europe. Until that process is created, we propose caution in xenotransplantation in general and a postponement of solid organ xenotransplants in particular. (shrink)

Research on the cognitive abilities involved in decision making has shown that, under objective risk conditions (i.e., when explicit information about possible outcomes and risks is available), superior decisions are especially predicted by executive functions and exact number processing skills, also referred to as objective numeracy. So far, decision-making research has mainly focused on exact number processing skills, such as performing calculations or transformations of symbolic numbers. There is evidence that such exact numeric skills are based (...) on approximate number processing (ANP) skills, which enable quick and accurate processing of non-symbolic numbers (e.g. Chen and Li, 2014). Very few studies, however, have investigated ANP skills in the context of risky decision making and have analyzed direct associations among the aforementioned sub functions. Possible interactions between the closely related skills have not been considered. The current study (N = 128) examines interactions of ANP skills with executive functions and objective numeracy, in predicting risky choice behavior. ANP skills are represented by the accuracy in a dot-comparison task. Decision making is measured by two versions of the Game of Dice Task (GDT), which place different emphases on the reflection of potential risks. The results show two-way as well as three-way interactions between the measures of ANP skills, executive functions, and objective numeracy in predicting risky decisions in both GDT versions. The riskiest decisions were most frequently made in case of low scores in all of the three competencies, while good performance in any one of them resulted in significant reductions of disadvantageous decisions. The findings indicate that high ANP skills can positively affect choice behavior in individuals who have weaknesses in reflectively attributed skills, namely executive functions and objective numeracy. Potential compensatory effects and mechanisms of ANP in decision making are discussed. (shrink)

Management of modern economic systems in the context of increasing influence of different types of risks requires significant improvement. Among such systems are logistics systems, which play an important role in the optimization of economic processes and require the use of information technology, which will facilitate faster and more accurate management decisions making. The purpose of scientific work is to develop a new approach to risk management of logistics systems, which will allow to plan more effectively, evaluate and (...) control logistics processes by using information technology. To ensure more flexible risk management, it is possible to change the parameters and configuration of the recommended model in accordance with the conditions of its formation. (shrink)

Objectives: To determine the effects of risk and payment on subjects’ willingness to participate, and to examine how payment influences subjects’ potential behaviours and risk evaluations.Methods: A 3 × 3 , between subjects, completely randomised factorial design was used. Students enrolled at one of five US pharmacy schools read a recruitment notice and informed consent form for a hypothetical study, and completed a questionnaire. Risk level was manipulated using recruitment notices and informed consent documents from hypothetical biomedical (...) research projects. Payment levels were determined using the payment models evaluated by Dickert and Grady as a guide. Five dependent variables were assessed in the questionnaire: willingness to participate, willingness to participate with no payment, propensity to neglect to tell about restricted activities, propensity to neglect to tell about negative effects, and risk rating.Results: Monetary payment had positive effects on respondents’ willingness to participate in research, regardless of the level of risk. However, higher monetary payments did not appear to blind respondents to the risks of a study. Payment had some influence on respondents’ potential behaviours regarding concealing information about restricted activities. However, payment did not appear to have a significant effect on respondents’ propensity to neglect to tell researchers about negative effects.Conclusions: Monetary payments appear to do what they are intended to do: make subjects more willing to participate in research. Concerns about payments blinding subjects to risks could not be substantiated in the present study. However, the findings do raise other concerns—notably the potential for payments to diminish the integrity of a study’s findings. Future research is critical to make sound decisions about the payment of research subjects. (shrink)

In this paper, the stylized features of incomplete and asymmetric information in the interbank market leading to banks’ precautionary behaviors are introduced. Based on banks’ stylized behavioral rules, the influencing mechanism of information diffusion on interbank risk contagion is analyzed, and how the existence of information diffusion and banks’ information-obtaining ability influence the interbank risk contagion is verified through computational simulations. The results show that information diffusion can significantly accelerate the process of and (...) magnify the extent and probability of interbank risk contagion, and improving banks’ information-obtaining ability could lower the speed and extent of the interbank risk contagion. This paper also finds and explains some special phenomena of rollover risk contagion when information diffusion exists: the saltatory risk contagion, the circular liquidity trap, and the risk discovery of information diffusion. (shrink)

Looks into evaluation of information provision probability from different sources, based on use of linguistic variables. Formation of functions appurtenant for its unclear variables provides for adoption of decisions by the decision maker, in conditions of nonprobabilistic equivocation. The development of market relations in Ukraine increases the independence and responsibility of enterprises in justifying and making management decisions that ensure their effective, competitive activities. As a result of the analysis, it is determined that the condition of economic facilities can (...) be described and determined by the decision-maker, in the presence of the necessary information. The confidence of the decision-maker in the information received is different and the decisions made have a correspondingly different level of information risk. It is important to substantiate the procedure for assessing the numerical extent of information risk in decision-making based on the information obtained in conditions of uncertainty. The use of a linguistic variable in the processing of expert data presented in the form of a matrix of binary relations of values of the membership function, which allowed to move to further processing of knowledge to support decision-making in the management of industrial, commercial, financial and other activities. As a mathematical model for estimating the numerical measure of information risk when making decisions based on the information obtained in conditions of non-stochastic uncertainty, a model has been developed to model natural language uncertainties, which differs from existing ones by formalizing knowledge taking into account uncertainty of input information. Making such a clear decision in a fuzzy environment has appropriate values of effectiveness and risk. The paper proposes all the functions and accessories of indicators of both quantitative nature and qualitative nature to bring their values in the field of definition to one scale. Then the indicator of the effectiveness of decision-making will be a measure of the clarity of the cross-section of fuzzy subsets, which correspond to the introduced indicators of information risk. The condition of economic facilities can be described and determined by the decision-maker, if the necessary information is available. Decision-making on thenumerical measure of information risk must be determined by a set of basic indicators, which can be both quantitative and qualitative in nature. Predictive values of indicators should be determined in conditions of nonstochastic uncertainty. In this case, the indicators of a quantitative nature can be determined by fuzzy triangular numbers, which implement a high level of confidence in the subjective judgments of experts. Indicators of qualitative nature should be presented in linguistic variables. The values of the indicators of qualitative nature that are predicted must be considered for all fuzzy variable terms-sets of linguistic variables introduced into consideration. For any fuzzy variable, the introduction to the consideration of a clear set of values as carriers of the α-level of its membership function allows to reduce to a single interpretation of the predicted values of indicators of quantitative and qualitative nature in terms of non-stochastic uncertainty. (shrink)

Behavioral Finance is an evolving field that studies how psychological factors affect decision making under uncertainty. This study seeks to find the influence of certain identified behavioral financial biases on the decision-making process of investors in developing countries. This research examines the moderating effect of Information asymmetry on the two most important and commonly used cognitive biases, namely Anchoring bias and Optimism bias and decision making and investigates whether Risk perception mediates the relationship between them or not. Quantitative (...) research has been conducted using a structured questionnaire for data collection. After completing the pilot study, a questionnaire was designed and sent to investors via online channels. Data has been collected from 317 real estate investors. Mediation analysis has been performed using model 4 and moderation analysis by applying model 15 of Process Macros for the interaction effect. The study investigated that both cognitive biases have a significant positive effect on investors’ decisions and Risk perception also significantly mediates the relationship between them. Consistency with other studies suggests that Information asymmetry has a significant moderating effect. The proposed conceptual model provides insight into how investors’ decisions are influenced by behavioral biases in the real estate sector and enhances the understanding of cognitive biases in the real estate sector. This study is recommended for real estate investors and policymakers of emerging and developed countries. The current study is the first of its kind, focusing on cognitive biases on investment decisions with mediating role of Risk perception and the moderating effect of Information asymmetry. (shrink)

Obtaining informed consent has typically become a stylized ritual of presenting and signing a form, in which physicians are acting defensively and patients lack control over the content and flow of information. This leaves patients at risk both for being under-informed relative to their decisional needs and of receiving more information than they need or desire. By personalizing the process of seeking and receiving information and allowing patients to specify their desire for information in a (...) prospective manner, we aim to shift genuine control over the informational process to patients. A new paradigm of Information on Demand, such as we suggest, would also enhance legal certainty, achieve greater congruence between the information patients want and the information they receive, and promote more meaningful patient-physician interactions, a desirable outcome that has been difficult to achieve by other means. (shrink)

Current nanotechnology regulation is focussed on risks. On the other hand, technical guidelines and other soft law tools are increasingly replacing hard law. This risk reduction approach does not seem to be fully aligned with open principles like sustainable nanotechnology. Indeed, risk optimization tends to be rather a continuous process than a way to settle ultimate lists of risks. There is therefore a need for a more dynamic view: Life cycle assessment contributes to add momentum and context to (...) the models. However, a complementary perspective is here suggested, based on information technologies: nanotechnology platforms. Platforms for nanotechnology governance are supposed to complement and enhance the nano-regulation, adding risk assessment and management. These platforms are mainly offering information, coordination, and context or situational awareness. More recently, some informal platforms appear to play a, certainly limited but still clear, co-regulatory role. Can these informal platforms play a relevant role in nanotechnology governance? In the context of the EU Better Regulation strategy, why not envision some of these informal platforms as future co-regulation tools? The main goal of this paper is to start a discussion on the requirements these informal co-regulatory platforms should fulfill before their hypothetical inclusion in a future better regulation toolbox. (shrink)

It has been presumed within bioethics that the benefits and risks of treatments can be assessed independently of information disclosure to patients as part of the informed consent process. Research on placebo and nocebo effects indicates that this is not true for symptomatic treatments. The benefits and risks that patients experience from symptomatic treatments can be shaped powerfully by information about these treatments provided by clinicians. In this paper we discuss the implications of placebo and nocebo research for (...) risk–benefit assessment and informed consent. (shrink)

This study aims to explore the influence mechanism of COVID-19 risk perception on anxiety in emerging adulthood in the context of public health events of the second round of COVID-19 outbreaks and provide support for exploring the path of mental health after the normalization of the epidemic situation. An online questionnaire, combined with community social work, was used in this study, and data of 522 emerging adults were collected in February 2021. The Perceived Risk of COVID-19 pandemic scale, (...) the generalized anxiety disorder 7-item scale, the scale of affect balance, and the connor-davidson resilience scale were used to investigate. The results showed that: first, the risk perception of COVID-19 in early adulthood was positively predictive of anxiety symptoms [B = 0.110, p < 0.05, 95%CI = ]. Second, the affective quality of life plays a mediating role between the risk perception of COVID-19 and anxiety [B = 0.108, 95%CI = ]. Thirdly, resilience plays a moderating role between the risk perception of COVID-19 and anxiety, the higher the resilience of emerging adulthood, the weaker effects of the risk perception of COVID-19 negative prediction of anxiety [B = −0.110, p < 0.001, 95%CI = ]. Therefore, to control the anxiety of emerging adulthood in public health events, we should pay attention to the propaganda and management of epidemic information, improve the quality of life, and attention should be paid to the emerging adulthood with low resilience. (shrink)

The protection of human subjects in biomedical research relies on two principal mechanisms: assessing and comparing the risks and potential benefits of proposed research, and obtaining potential subjects' informed consent. While these have been discussed extensively in the literature, no attention has been paid to whether the processes should be different when the objective of an experimental biomedical intervention is to improve individual appearance, performance, or capability rather than to prevent, cure, or mitigate disease . This essay examines this question (...) in order to ensure that subjects in biomedical enhancement research receive adequate protection. (shrink)

About 6,000 individuals participate in the U.S. transplant system as a living organ donor each year. Organ donation by living individuals is a unique procedure, where healthy patients undergo a major surgical operation without any direct functional benefit to themselves. In this article, the authors explore how the ideal of informed consent guides education and evaluation for living organ donation. The authors posit that informed consent for living organ donation is a process. Though the steps in this process are partially (...) standardized through national health policy, they can be improved through institutional structures at the local, transplant center-level. Effective structures and practices aimed at supporting and promoting comprehensive informed consent provide more opportunities for candidates to ask questions about the risks and benefits of living donation and to opt out voluntarily Additionally, these practices could enable new ways of measuring knowledge and improving the consent process. (shrink)

This article addresses the question of how ‘Country of Origin Information’ reports—that is, research developed and used to support decision-making in the asylum process—can be published in an ethical manner. The article focuses on the risk that published COI reports could be misused and thereby harm the subjects of the reports and/or those involved in their development. It supports a situational approach to assessing data ethics when publishing COI reports, whereby COI service providers must weigh up the benefits (...) and harms of publication based, inter alia, on the foreseeability and probability of harm due to potential misuse of the research, the public good nature of the research, and the need to balance the rights and duties of the various actors in the asylum process, including asylum seekers themselves. Although this article focuses on the specific question of ‘how to publish COI reports in an ethical manner’, it also intends to promote further research on data ethics in the asylum process, particularly in relation to refugees, where more foundational issues should be considered. (shrink)

The aim of this paper is to analyze the process of risk communication in the context of assisted reproduction in Latvia. The paper is based on a qualitative methodology and two types of data: media analysis and 30 semi-structured interviews (11 patients, 4 egg donors, 15 experts). The study explores a broad definition of risk communication and explores three types of risks: health, psychosocial, and moral. We ask (1), who is involved in risk communication, (2), how risks (...) are discussed using different channels of communication, and (3), what ethical problems arise during this process. In the process of analysis, we identified four types of information channels and two strategies of risk communication used by patients, as well as several ethical problems. In our view, the analysis of risk communication practices is significant to improve patient/physician relationship, as well as better meet patients' needs for comprehensive risk information. (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)

When laws or legal principles mention mental states such as intentions to form a contract, knowledge of risk, or purposely causing a death, what parts of the brain are they speaking about? We argue here that these principles are tacitly directed at our prefrontal executive processes. Our current best theories of consciousness portray it as a workspace in which executive processes operate, but what is important to the law is what is done with the workspace content rather than the (...) content itself. This makes executive processes more important to the law than consciousness, since they are responsible for channeling conscious decision-making into intentions and actions, or inhibiting action.We provide a summary of the current state of our knowledge about executive processes, which consists primarily of information about which portions of the prefrontal lobes perform which executive processes. Then we describe several examples in which legal principles can be understood as tacitly singling out executive processes, including principles regarding defendants’ intentions or plans to commit crimes and their awareness that certain facts are the case, as well as excusatory principles which result in lesser responsibility for those who are juveniles, mentally ill, sleepwalking, hypnotized, or who suffer from psychopathy. (shrink)

The development of collective beliefs via informational and reputational cascades represents a way of shortcircuiting the difficulties related to the collective action of ‘latent groups’ to ensure the promotion of their particular interests. This essay focuses on the protection of consumers, whose quality of the life has never been so high, despite the prevalence of hazardous products.Rationally ignorant individuals form their opinions by conforming to those of others; this can take two forms, either by consolidating their personal judgement or their (...) private information, or by pure conformist behaviour. It may even be that such individuals rarely hesitate, if necessary, to admit beliefs that they do not actually hold in order to avoid being ostracised by others. ‘Latent groups’ activists manipulate the process of formation of beliefs in order to bring about a predominant opinion on any given issue. Armed with the asset of the prevailing opinion, pressure can be exerted upon politicians in view of obtaining regulations and subsidies which would protect the ‘latent group’ of which they claim to be the representatives.This is the new face of collective action where the “politically correct” replaces physical violence or the strike. This way of shaping public opinion could have a beneficial outcome if it were not founded on erroneous information or led to a violation of individual rights due to regulation. However, this not the case. The very leitmotif of this method is, in fact, to bring about regulation which, by definition, violates private lives. In any case, it is dangerous because the manipulation of public opinion by these activists implies an intensive use of rhetoric, distorting the perception of risk, which in turn involves the circulation of misleading information in order to create a cascade modifying public opinion in favor of the proposed regulation, rather than informing the public on the potential risks and letting them insure freely against it if they judge to do so. But for the activist the end justifies the means. Thus, this manipulation of public opinion is a danger to the notion of modern democracy, already so sensitive to the pertaining to the majority.La formation des croyances par le biais des cascades d’information et de réputation est un moyen de courtcircuiter les difficultés liées à l’action collective des groupes latents pour assurer la promotion de leurs intérêts particuliers. Dans le cadre de cet essai est analysée la protection des consommateurs, dont la valeur de la vie est élevée, contre les produits à risque.Les individus rationnellement ignorants forment leurs opinions en se conformant aux croyances des autres, soit pour conforter leur jugement personnel ou leurs informations privées, soit par conformisme pur. Il se peut même que les individus n’hésitent pas, s’il le faut, à afficher de fausses croyances, pour ne pas être frappés d’ostracisme par les autres.Les activistes des “groupes latents” manipulent le processus de formation des croyances pour faire émerger une opinion majoritaire sur un problème spécifique. Grâce à cette opinion majoritaire ils vont pouvoir faire pression auprès des hommes politiques pour obtenir une réglementation et des subventions à leur propre profit dans le but de protéger le “groupe latent” dont ils prétendent être les représentants. Ce sont les nouvelles formes d’action collective où le politiquement correct remplace la violence physique ou le piquet de grève.Cette façon de former l’opinion publique pourrait avoir des conséquences bénéfiques si elle n’était pas fondée sur des informations erronées et si elle n’aboutissait pas à une violation des droits individuels par la réglementation. Or ce n’est pas le cas. Elle est faite justement pour faire émerger une réglementation qui par définition viole la vie privée des gens. Par ailleurs, elle est dangereuse parce que la manipulation de l’opinion publique par ces activistes implique un usage intensif de figures de rhétorique, de biais dans la perception des risques, de diffusion de fausses informations dans le but d’enclencher une cascade qui va modifier l’opinion publique en faveur de la réglementation et non pas dans le but d’éclairer le public sur les véritables risques encourus, la fin justifiant les moyens.Cette manipulation des croyances est alors un danger pour la démocratie politique contemporaine déjà si sensible à l’opinion majoritaire. (shrink)

BackgroundInformed consent, whose goal is to assure that participants enter research voluntarily after disclosure of potential risks and benefits, may be impossible or impractical in emergency research. In low resource settings, there is limited information on the experiences of the informed consent process for randomized clinical trials in the emergency care context. The objective of this study was to explore the experiences of the informed consent process and factors that motivated participation in two obstetrics and newborn care randomized clinical (...) trials (RCTs).MethodsThis was a qualitative study conducted among former participants of RCTs in the emergency obstetric care context, conducted at Kawempe National Referral Hospital, Uganda. It employed 30 in-depth interviews conducted from June 1, 2019 to August 30, 2019. Issues explored included attitudes about research, the purpose of the research in which they participated, motivations to take part in the study, factors that influenced enrolment decisions, and experiences of the informed consent process.ResultsRespondents felt that research was necessary to investigate the cause, prevention or complications of illness. The decisions to participate were influenced by hope for material or therapeutic benefit, trust in the healthcare system and influence of friends and family members. Many were satisfied with the informed consent process, though they did not understand some aspects of the research.ConclusionRespondents valued participation in RCTs in emergency obstetric and newborn care. Hope for benefit, altruism, desire to further scientific knowledge and trust in the investigators featured prominently in the motivation to participate. Both intrinsic and extrinsic factors were motivators for RCT participation. (shrink)

BackgroundThe consent process for a genetic study is challenging when the research is conducted in a group stigmatized because of beliefs that the disease is familial. Podoconiosis, also known as 'mossy foot', is an example of such a disease. It is a condition resulting in swelling of the lower legs among people exposed to red clay soil. It is a very stigmatizing problem in endemic areas of Ethiopia because of the widely held opinion that the disease runs in families and (...) is untreatable. The aim of this study was to explore the impact of social stigma on the process of obtaining consent for a study on the genetics of podoconiosis in Southern Ethiopia.MethodsWe adapted a rapid assessment tool validated in The Gambia. The methodology was qualitative involving focus-group discussions (n = 4) and in-depth interviews (n = 25) with community members, fieldworkers, researchers and staff of the Mossy Foot Treatment and Prevention Association (MFTPA) working on prevention and treatment of podoconiosis.ResultsWe found that patients were afraid of participation in a genetic study for fear the study might aggravate stigmatization by publicizing the familial nature of the disease. The MFTPA was also concerned that discussion about the familial nature of podoconiosis would disappoint patients and would threaten the trust they have in the organization. In addition, participants of the rapid assessment stressed that the genetic study should be approved at family level before prospective participants are approached for consent. Based on this feedback, we developed and implemented a consent process involving community consensus and education of fieldworkers, community members and health workers. In addition, we utilized the experience and established trust of the MFTPA to diminish the perceived risk.ConclusionThe study showed that the consent process developed based on issues highlighted in the rapid assessment facilitated recruitment of participants and increased their confidence that the genetic research would not fuel stigma. Therefore, investigators must seek to assess and address risks of research from prospective participants' perspectives. This involves understanding the issues in the society, the culture, community dialogues and developing a consent process that takes all these into consideration. (shrink)

Classifying research proposals by risk of harm is fundamental to the approval process and the most pivotal risk category in most regulations is that of “minimal risk.” If studies have no more than a minimal risk, for example, a nearly worldwide consensus exists that review boards may sometimes: (1) expedite review, (2) waive or modify some or all elements of informed consent, or (3) enroll vulnerable subjects including healthy children, incapacitated persons and prisoners even if studies (...) do not hold out direct benefits to them. The moral and social purposes behind this threshold are discussed along with relevant views from the National Commission, NBAC, NHRPAC, Grimes v. Kennedy Krieger Institute, The Nuremberg Code, and The WMA's Declaration of Helsinki. Representative policies from Australia, Canada, South Africa, the U.S., and CIOMS are reviewed revealing different understandings of this sorting threshold. Six of nine frequently cited interpretations of “minimal risk” are untenable. The “absolute” interpretation of the “routine examination” standard is defended as best. (shrink)

Advances in genetic research have created the need to inform consumers. Yet, the communication of hereditary risk and of the options for how to deal with it is a difficult task. Due to the abstract nature of genetics, people tend to overestimate or underestimate their risk. This paper addresses the issue of how to communicate risk information on hereditary breast and ovarian cancer through an online application. The core of the paper illustrates the design of OPERA, (...) a risk assessment instrument that applies the UK National Institute of Health and Clinical Excellence's guidelines on the basis of (i) the number of relatives on the same side of the family with the same cancer or cancers that are known to run together; (ii) the ages of these relatives at diagnosis and (iii) the closeness of the family relationship with the person who is doing the assessment. By relying on the argumentation theory, we explain how the communication strategy that OPERA implements is essentially based on Perelman and Olbrechts-Tyteca's deductive argumentation by association. By using as premises “facts” (propositions about reality that can be assumed without further justification) and “truths” (propositions that make connections about facts), OPERA delivers its claims with an ex auctoritate causal link aimed at transferring the audience's acceptance of the cause to the effect. Overall, the design of OPERA rests on its capacity to induce users' active processing of risk information through an appeal to their reasoning faculty. In the conclusion, we present some results from a pilot evaluation of users' acceptance of OPERA. (shrink)

Objective To evaluate the questions asked during the informed consent process by adult and adolescent participants as well as their parents in five interventional regulatory studies conducted at our center from 2018 to 2019. Methods The study protocol was approved by Institutional Ethics Committee [EC/OA-116/2019]. Consent narratives in the source documents for the studies were evaluated. Questions asked were classified as per Indian Council of Medical Research’s guidelines. We evaluated total number of questions, nature of questions and whether there was (...) an association between education, gender, phase of trials, physician taking consent and number questions being asked. Results A total of five studies that had N = 297 consent narratives were evaluated. Narratives of n = 284 adult participants/Guardians and of n = 13 children were analysed. A total of 374 questions were asked of which children asked only 10 questions. A total of 131/284 of the participants did not ask any question. Among the participants who asked questions, the majority132/171 participants asked about risks related to investigational products followed by questions related to study procedures 83/171. Participants/guardians with higher education and those who consented for Phase III studies asked significantly more questions. Conclusion A majority of the queries were related to the risks associated with the investigational products. Educational status and the Phase of the trial were found to be significantly associated with the number of questions being asked. (shrink)

We describe the informed consent procedures in a research clinic in Santiago, Chile, and a qualitative study that evaluated these procedures. The recruitment process involves information, counseling and screening of volunteers, and three or four visits to the clinic. The study explored the decision‐making process of women participating in contraceptive trials through 36 interviews. Women understood the research as experimentation or progress. The decision to participate was facilitated by the information provided; time to consider it and to discuss (...) it with partners or relatives; and perceived benefits such as quality of care, non‐cost provision of methods and medical care. For some women, participation was an opportunity to express altruism. The main obstacles for participation were perceived side effects or risks. The final risk‐benefit balance was strongly influenced by women’s needs. Women perceived that the consent form benefited the clinic, proving that participants had made a free decision, and benefited the volunteers by warranting their right to free medical care. The most important problem detected was occasional misunderstanding of the information given on the form. We concluded that a full decision‐making process enhances women’s ability to exercise their right to choose, and assures research institutions that trials are conducted without coercion and that the participants are committed to the study. Researchers have the responsibility of conducting this process. (shrink)

Background: The internationalization of clinical studies requires a shared understanding of the fundamental ethical values guiding clinical studies. It is important that these values are not only embraced at the legal level but also adopted by clinicians themselves during clinical studies. Objective: Our goal is to provide an insight on how clinicians in Germany and Poland perceive and identify the different ethical issues regarding informed consent in clinical studies. Methods: To gain an understanding of how clinicians view clinical studies in (...) the countries they work in, we carried out semi-structured problem-centered interviews per telephone in Poland (n = 6) and Germany (n = 6). Our interviewees concentrated on three main topics: an appraisal of the normative framework, challenges in the information process and the protection of all participants in clinical studies. Results: Clinicians generally supported the normative framework, even though they considered it quite complex. In the two study countries, a widely noted dilemma in the information process was whether to overburden participants with extensive information or risking leaving out important facts. Clinicians were ready to exclude larger population groups from participating in clinical studies when the information process could not be carried out with standard procedures or when their inclusion was ethically sensitive. Conclusion: Clinicians need to gain a better understanding of the consequences of excluding larger population groups form participating in clinical studies. They should seek assistance in improving the information process for the inclusion of underrepresented groups in clinical studies. (shrink)

Obtaining ‘informed consent’ from every individual participant involved in health research is a mandatory ethical practice. Informed consent is a process whereby potential participants are genuinely informed about their role, risk and rights before they are enrolled in the study. Thus, ethics committees in most countries require ‘informed consent form’ as part of an ethics application which is reviewed before granting research ethics approval. Despite a significant increase in health research activity in low-and middle-income countries in recent years, only (...) limited work has been done to address ethical concerns. Most ethics committees in LMICs lack the authority and/or the capacity to monitor research in the field. This is important since not all research, particularly in LMICs region, complies with ethical principles, sometimes this is inadvertently or due to a lack of awareness of their importance in assuring proper research governance. With several examples from Nepal, this paper reflects on the steps required to obtain informed consents and highlights some of the major challenges and barriers to seeking informed consent from research participants. At the end of this paper, we also offer some recommendations around how can we can promote and implement optimal informed consent taking process. We believe that paper is useful for researchers and members of ethical review boards in highlighting key issues around informed consent. (shrink)

Concerns are frequently raised about the extent to which formal consent procedures actually lead to “informed” consent. As part of a study of consent to high-risk medical procedures, we analyzed in-depth interviews with 16 health care professionals working in bone-marrow transplantation in Sydney, Australia. We find that these professionals recognize and act on their responsibility to inform and educate patients and that they expect patients to reciprocate these efforts by demonstrably engaging in the education process. This expectation is largely (...) implicit, however, and when it is not met, this can give rise to trouble that can have adverse consequences for patients, physicians, and relationships within the clinic. We revisit the concept of the sick role to formalize this new role expectation, and we argue that “informed” consent is a process that is usually incomplete, despite trappings and assumptions that help to create the illusion of completeness. (shrink)

In this conceptual paper, the traditional conceptualization of sustainable entrepreneurship is challenged because of a fundamental tension between processes involved in sustainable development and processes involved in entrepreneurship: the concept of sustainable business models contains a paradox, because sustainability involves the reduction of information asymmetries, whereas entrepreneurship involves enhanced and secured levels of information asymmetries. We therefore propose a new and integrated theory of sustainable entrepreneurship that overcomes this paradox. The basic argument is that environmental problems have to (...) be conceptualized as wicked problems or sustainability-related ecosystem failures. Because all actors involved in the entrepreneurial process are characterized by their epistemic insufficiency regarding the solving of these problems, the role of information in the sustainable entrepreneurial process changes. On the one hand, the reduction of information asymmetries primarily aims to enable actors to become critical of sustainable entrepreneurs’ actual business models. On the other hand, the epistemic insufficiency of sustainable entrepreneurs guarantees that information asymmetries remain as a source of new sustainable business opportunities. Three further characteristics of sustainable entrepreneurs are distinguished: sustainability and entrepreneurship-related risk-taking; sustainability and entrepreneurship-related self-efficacy; and the development of satisficing and open-ended solutions, together with multiple stakeholders. (shrink)