This essay starts by accepting Cécile Fabre's argument in her book Spying through a Glass Darkly that intelligence work, including using incentives and pressures to encourage betrayal and treason, can be morally justified based on the criteria of necessity, effectiveness, and proportionality. However, while assessments of spying tend to be based on Cold War notions, I explore it here in the messier reality of counterinsurgency, counterterrorism, and “new wars.” In addition, I suggest a methodological expansion: adding a sociological perspective to (...) the ethical discussion by exploring the wider effects on society, over longer periods, of the operation of informers. Based on these shifts in perspective and context, I identify additional social harms generated by espionage that should lead to a more restrictive view of ethical espionage than the one emerging from Fabre's work. I argue that many of these social harms are created by the mass recruitment of informers, in asymmetrical conflicts where governments have leverage over suspected communities, and given the (often mistaken) belief that everyone recruited to act as informer is an “asset,” primarily providing advantages. I argue, therefore, that the decisive issue is one of scale: many of the ethical problems created by espionage in these contexts result from the widespread systematic recruitment of informers, while small-scale, targeted, ad-hoc recruitment can more easily avoid such problems. (shrink)

ABSTRACT A key selling point of pharmacogenetics is the genetic stratification of either patients or diseases in order to target the prescribing of medicine. The hope is that genetically ‘tailored’ medicines will replace the current ‘one‐size‐fits‐all’ paradigm of drug development and usage. This paper is concerned with the relationship between difference and justice in the use of pharmacogenetics. This new technology, which facilitates the identification and use of difference, has, we shall argue, the potential to lead to injustice either (...) by the inappropriate use of difference or through the inappropriate failure to use difference. We build on empirical data from a detailed study of the range of options for the development of pharmacogenetics to present a consideration of the ethical issues that surround patient and disease stratification. In it we explore the ways in which the use of pharmacogenetics may lead to the creation of new, genetically stratified, forms of difference and new forms of injustice based on these divisions. We also examine the ways in which existing forms of difference and social stratification may interact with the use of pharmacogenetics. In conclusion, we suggest how an understanding of these ethical issues could usefully inform future policy discussions. (shrink)

Background: In Southeast Asia, the process of obtaining informed consent is influenced by both culture and policy at the hospital and national level. Both physicians and nurses play vital roles in this process, but physicians influence the roles of nurses. Objectives: Since the physicians and nurses often have different perspectives, it is important to investigate their views about the informed consent process and nurses’ roles therein and whether there is a difference between ideal and experienced practice (reality), and whether this (...) differs across hospitals. Methods: A questionnaire was developed and a survey was conducted among physicians and nurses. Using exploratory factor analysis a three factor structure was determined: ‘nurses’ roles’, ‘barriers in informed consent’, and ‘adequacy of information’. Non-parametric tests were applied to compare nurses and physicians, and hospital setting. Participants and research context: Responses were obtained from 129 physicians and 616 nurses from two Indonesian hospitals. Those hospitals differ in ownership, location, and size. Ethical consideration: The study was reviewed by the hospital ethical committee. Participation was voluntary and confidentiality was ensured by keeping the responses anonymous. Findings: Physicians and nurses differ significantly on all three factors. The scores reflecting disparity between ideal and reality regarding nurses’ roles varied across professions, while barriers in informed consent differed between hospitals. Discussion: The differences between ideal and reality indicated that improvement in the informed consent process and nurses’ roles therein is called for. Varying views between physicians and nurses on nurses’ roles may hinder collaboration. The differences between hospital settings showed interventions may have to be customized for different settings. Conclusion: Views on nurses’ roles vary across professions. Views on barriers in informed consent vary across hospitals. Therefore interprofessional education is needed to promote interprofessional collaboration and intervention to improve informed consent practice should be tailored to the hospital context. (shrink)

Background Currently there is increasing recognition of the need for research in developing countries where disease burden is high. Understanding the role of local factors is important for undertaking ethical research in developing countries. We explored factors relating to information and communication during the process of informed consent, and the approach that should be followed for gaining consent. The study was conducted prior to a family-based genetic study among people with podoconiosis (non-filarial elephantiasis) in southern Ethiopia. Methodology/Principal Findings We (...) adapted a method of rapid assessment validated in The Gambia. The methodology was entirely qualitative, involving focus-group discussions and in-depth interviews. Discussions were conducted with podoconiosis patients and non-patients in the community, fieldworkers, researchers, staff of the local non-governmental organisation (NGO) working on prevention and treatment of podoconiosis, and community leaders. We found that the extent of use of everyday language, the degree to which expectations of potential participants were addressed, and the techniques of presentation of information had considerable impact on comprehension of information provided about research. Approaching podoconiosis patients via locally trusted individuals and preceding individual consent with community sensitization were considered the optimal means of communication. Prevailing poverty among podoconiosis patients, the absence of alternative treatment facilities, and participants' trust in the local NGO were identified as potential barriers for obtaining genuine informed consent. Conclusions Researchers should evaluate the effectiveness of consent processes in providing appropriate information in a comprehensible manner and in supporting voluntary decision-making on a study-by-study basis. (shrink)

In this article ethical issues are discussed which play a role in pharmacogenetics. Developments in pharmacogenetics have a large impact on many different practices such as clinical trials, the practice of medicine and society at large. In clinical trials, questions rise regarding the exclusion of genetic subgroups that may be non- or poor-responders to the experimental drug. Also, the question is asked how pharmaceutical companies should deal with their growing knowledge about the relations between genetic variation and adverse effects. Moreover, (...) pharmacogenetics may provide disease-specific predictive information which may have a significant impact on the relations between physicians, patients and their relatives in the practice of medicine. Here, issues also arise regarding responsibility of patients and physicians for health and disease. In the society at large, the high costs of new pharmacogenetic possibilities lead to questions concerning solidarity and fair distribution on a national as well as an international level. It is concluded that in the near future, ethical research should be focused on the themes responsibility, inclusion and exclusion and global justice. (shrink)

We discuss the implementation of Responsible Research and Innovation (RRI) within a project for the development of an AI-supported exergame for assisted movement training, outline outcomes and reflect on methodological opportunities and limitations. We adopted the responsibility-by-design (RbD) standard (CEN CWA 17796:2021) supplemented by methods for collaborative, ethical reflection to foster and support a shift towards a culture of trustworthiness inherent to the entire development process. An embedded ethicist organised the procedure to instantiate a collaborative learning effort and implement RRI (...) in a translational context. Within the interdisciplinary setting of the collaboration and with the support of a technoethicist, we successfully identified relevant, project-specific challenges and developed a roadmap with derived actions, thus meaningfully integrating RRI into the development process. We discuss the methodological procedure in terms of its effectiveness and efficiency, the allocation of responsibilities and roles, particularly regarding potential frictions in the interdisciplinary context with embedded ethics, and the challenges of the translational context. We conclude that the responsibility-by-design standard effectively established a productive workflow for collaborative investigation and work on ethical challenges. We reflect on methodological difficulties and propose possible avenues to our approach. (shrink)

BackgroundThis study aimed to determine the elements and the extent of information that child participants and their parents would like to read in an informed assent form /informed consent form of a pediatric drug trial.MethodsA descriptive survey was conducted to determine the perceived importance of each element of the ICF content from child participants and their parents who underwent informed assent/consent of a multi-center pediatric drug trial. The respondents were asked to indicate the level of importance of each item (...) in a questionnaire, by giving a rating scale from 1 to 5.ResultsA total of 22 families, 17 child participants with the diagnosis of hematology or oncology diseases and 27 parents, were enrolled. Among 30 items, risk–benefit aspects were perceived to be of most concerning items from both child participants’ and parents’ viewpoint. None of the items were considered ‘slightly important’ or lower by more than 20% of the respondents.ConclusionsFor pediatric drug trials, risk–benefit information should be made a salient feature of an IAF/icf. This empirical data could help related stakeholders arrange essential information in order of importance and tailor an IAF/icf to better suit child participants’ and parents’ needs, particularly for pediatric drug trials involving children with the diagnosis of hematology or oncology diseases. (shrink)

A great part of human genetics research is carried out collecting data and building large databases of biological samples that are in a non-anonymous format. These constitute a valuable resource for future research. The construction of such databases and tissue banks facilitates important scientific progress. However, biobanks have been recognized as ethically problematic because they contain thousands of data that could expose individuals and populations to discrimination, stigmatization and psychological stress if misused. Informed consent is regarded as a cornerstone in (...) the protection of personal autonomy in research involving human subjects. Yet in recent years this fundamental concept has been overwhelmed by the genomic revolution. From a general overview of international literature, it seems evident that informed consent issues have come into sharp focus, in particular in relation to the twin issues of time extension (blanket versus specific/repeated consent) and personal extension (group consent). After an introduction on obtaining informed consent in the context of genetic research, this paper addresses the apparent lack of a single, universal model of obtaining informed consent among populations involved in genetic research and it argues for the need to develop an ethical framework tailored to the specific features of each project. In order to support this theory of contextualizing, the case of a private biotechnology company, SharDNA is presented. The present paper explores the management of its biobank, developed from a genetic research project carried out on isolated populations living on the Italian island of Sardinia. In particular, the paper highlights how the company is tackling the problem of informed consent and other ethical requirements for genetic research, such as the respect of individual privacy, the population approach and the existing Italian legal regulatory framework. (shrink)

Conversation analytical methodology was used to specify the new opening practices in Finnish mobile call openings, which differ systematically from Finnish landline call openings. Since the responses to a mobile call orient to the summons identifying the caller, answers have changed and diversified. A known caller is greeted. The self-identification opening that was canonical in Finnish landline calls is mainly used for answering unknown callers, while channel-opener openings involve orientation to ongoing mutual business between the speakers. Some of these changes (...) reflect real-time coordination of the social action that the mobility of mobile phones enables. In all, the adoption of new ways of answering a call shows that people orient themselves to affordances that new technologies allow them. Mobile phone communication opens a salient new area both for the analysis of talk-ininteraction itself and also for understanding communicative behaviour in the era of ubiquitous information technology. (shrink)

The price of sequencing all the DNA in a person's genome is falling so fast that, according to one biotech leader, soon it won't cost much more than flushing a toilet. Getting all that genomic data at an ever‐lower cost excites the imaginations not only of biotech investors and researchers but also of the President and many members of Congress. They envision the data ushering in an age of “personalized medicine,” where medical care is tailored to persons’ genomes. The (...) new name “precision medicine” should not distract us from the fact that the genomic information it depends on is more complex, uncertain, and ambiguous than anyone had hoped, nor should it distract us from an important ethical point. Unfortunately, several developments of the last fifteen years suggest that, in our excitement about the technological capacity to gather genomic data at an ever lower cost, we are drifting away from what has long been a basic ethical commitment: to offer persons a process that enables them to provide informed consent before they or anyone else accesses their genetic information. (shrink)

The role of software architecture in large-scale Agile development is important because several teams need to work together to release a single software product while helping to maximise teams’ autonomy. Governing and aligning Agile architecture across autonomous squads, when using the Spotify model, is a challenge because the Spotify model lacks practices for addressing Agile architecture governance. To explore how software architecture can be governed and aligned by scaling the Spotify model, we conducted a longitudinal embedded case study in a (...) multinational FinTech organisation. Then, we developed and evaluated an approach for architectural governance by conducting an embedded case study. The collected data was analysed using Thematic Analysis and informed by selected Grounded Theory techniques such as memoing, open coding, constant comparison, and sorting. Our approach for architectural governance comprises an organisational structure change and an architecture change management process. The benefits reported by the practitioners include devolving architectural decision-making to the operational level, enhancing architectural knowledge sharing among squads, minimising wasted effort in architectural refactoring, and other benefits. The practitioners in our case study realised an improved squad autonomy by the ability to govern and align architectural decisions. We provide two key contributions in this paper. First, we present the characteristics of our proposed architectural governance approach, its evaluation, benefits, and challenges. Second, we present how the novel Heterogeneous Tailoring model was enhanced to accommodate our architectural governance approach. (shrink)

Informed by a search of the literature about the usage of genetic testing information (GTI) by insurance companies, this paper presents a practical ethical analysis of several distinct public policy options that might be used to govern or constrain GTI usage by insurance providers. As medical research advances and the extension to the Human Genome Project (2016, https://en.wikipedia.org/wiki/human_genome_project_-_write) moves to its fullness over the next decade, such research efforts will allow the full synthesis of human DNA to be connected (...) to predictive health dispositions. As testing costs fall, there will be ever more pressure for citizens to disclose GTI. Genetic testing information is integral to future medical care because it can be used to better assess individually tailored medical therapies as well as to allow a more informed risk analysis by the insurance industry, which in some countries such as the USA underwrites a majority of citizen medical expenses. As discussed in this examination, the revelation of people’s uniquely personal GTI to insurers has enormous societal implications. The major contribution of the paper is to offer policy makers and concerned citizens a nuanced articulation of the basic options to regulate GTI, with a special consideration for ethical fairness and equity. As genetic-based medicine blossoms and pressures to reduce healthcare costs increase, there will be an ever greater impetus for countries to revisit their genetic testing policies. Organizations and policy makers striving to create GTI oversights perceived to be both “fair and effective” need to be aware of the ethical perspectives discussed in this paper. (shrink)

Diverse legal and regulatory measures are used internationally to control the information provided during pharmaceutical sales visits. Little is known about the comparative effectiveness of these measures however. We analyzed the perceptions of regulators, pharmaceutical industry officials, health professionals, and consumer respondents concerning these approaches in Canada, France, and the United States using an empirical realist interests-based approach. Interviews focused on the aims and effectiveness of regulation, barriers and enablers to regulation and suggestions for improvement. An alignment was found (...) in North America regulator and industry respondents' satisfaction with the status quo and their view that further intervention is unfeasible and unnecessary. Health professionals generally expressed a lack of confidence in the impact of regulations on sales visit information while consumer advocates voiced their disappointment in both regulators and health professionals for their failure to counteract the influence of pharmaceutical marketing. Regulator and industry respondents in France differed from their North American counterparts in their willingness to increase and diversify the scope of regulatory interventions. As the first international comparison of regulatory experiences in this sector, the findings highlight the universal need for more focused and inclusive discussions among groups about how to tailor regulations to achieve public health goals. (shrink)

The exponential growth of genetic knowledge and precision medicine research raises hopes for improved prevention, diagnosis, and treatment options for children with behavioral and psychiatric conditions. Although well-intended, this prospect also raise the possibility — and concern — that behavioral, including psychiatric genetic data would be increasingly used — or misused — outside the clinical context, such as educational settings. Indeed, there are ongoing calls to endorse a “personalized education” model that would tailor educational interventions to children's behavioral and psychiatric (...) genetic makeup. This article explores the justifications for, and prospects and pitfalls of such endeavors. It considers the scientific challenges and highlights the ethical, legal, and social issues that will likely arise should behavioral genetic data become available and are routinely incorporated in student education records. These include: when to disclose students' behavioral and psychiatric genetic profile; whose genomic privacy is protected and by whom; and how students' genetic data may affect education-related decisions. I argue that the introduction of behavioral genetics in schools may overshadow the need to address underlying structural and environmental factors that increase the risk for psychiatric conditions of all students, and that the unregulated use of student behavioral genetic profiles may lead to unintended consequences that are detrimental for individuals, families and communities. Relevant stakeholders — from parents and students to health professionals, educators, and policy-makers — ought to consider these issues before we forge ahead with a genomically informed education system. (shrink)

Informal caregivers provide care to their family or friends in case of an illness, disability, or frailty. The caregiving situation of informal caregivers may vary based on the relationship they have with the care recipient, e.g., being a spouse or being an adult child. It might be that these different ICGs also have different needs. This study aims to explore and compare the needs of different groups of ICGs based on the relationship they have with their CR. We conducted a (...) systematic review, performing a search in the databases PubMed, CINAHL, and PsycINFO. We included studies with qualitative, quantitative, or mixed-method study designs. We analyzed the data using the thematic analysis method. We included 22 articles. The included articles reported the needs of ICGs taking care of a spouse, parent, or sibling aged 18 years or above. We did not include other relationships due to the limited number of articles on these relationships. The most prominent needs reported by the spousal, adult child, and adult sibling ICGs were the need for information and need for support. The three groups differed in their needs as well. Adult child and adult sibling ICGs indicated a need to be acknowledged by the people around them for their role of carer, while they also needed to be seen as an individual having their own personal needs. Moreover, spousal ICGs indicated a unique need of redefining their role and relationship with their CR. Overall, the findings indicate that along with experiencing common needs, the investigated groups have unique needs as well. Knowing the needs of different groups of ICGs can help develop tailored solutions to improve the quality of life of the ICGs and their CR.Systematic Review Registration: [www.crd.york.ac.uk/prospero/], identifier [CRD42020188560]. (shrink)

Stage models are becoming increasingly popular in explaining change from current behavior to more environmentally friendly alternatives. We review empirical applications of a recently introduced model, the stage model of self-regulated behavioral change (SSBC). In the SSBC, change toward pro-environmental behavior takes place in four, qualitatively different stages (predecisional, preactional, actional, and postactional) which are each influenced by constructs taken from theories previously established to describe and predict pro-environmental behavior. We performed a systematic literature search to retrieve peer-reviewed SSBC-based studies. (...) The review includes 10 studies published between 2013 and 2018, six of which employed a cross-sectional, three an interventional and one a correlational longitudinal design. The cross-sectional and longitudinal studies generally support the model, although there are some irregularities that warrant further investigation. The interventional studies found stage-tailored informational measures to be more effective than non-stage-tailored measures in promoting stage progression and behavioral change. Furthermore, we identified several challenges that researchers may face when applying the SSBC. These include whether and how to analyze multiple behavioral alternatives; how to address the challenge of measuring a comprehensive model while keeping questionnaire length manageable; selecting and defining the role of model constructs in a behavioral context while keeping results comparable; and establishing a validated and reliable tool to diagnose a person’s stage of change. Based on these insights, we develop recommendations for researchers designing SSBC studies, in order to support a founded and efficient advancement of the theory which will then serve both researchers and practitioners aiming to promote pro-environmental behavior. (shrink)

This paper uses chronic beryllium disease as a case study to explore some of the challenges for decision-making and some of the problems for obtaining meaningful informed consent when the interpretation of screening results is complicated by their probabilistic nature and is clouded by empirical uncertainty. Although avoidance of further beryllium exposure might seem prudent for any individual whose test results suggest heightened disease risk, we will argue that such a clinical precautionary approach is likely to be a mistake. Instead, (...) advice on the interpretation of screening results must focus not on risk per se, but on avoidable risk, and must be carefully tailored to the individual. These points are of importance for individual decision-making, for informed consent, and for occupational health. (shrink)

In the "big data age", providing informed consent online has never been more challenging. Countless companies collect and share our personal data through devices, apps, and websites, fuelling a growing data economy and the emergence of surveillance capitalism. Few of us have the time to read the associated privacy policies and terms and conditions, and thus are often unaware of how our personal data are being used. This is a problem, as in the last few years, large tech companies have (...) abused our personal data. As privacy self-management, through the mechanism of providing online consent, has become increasingly difficult, some have argued that surveillance capitalism, and the data economy more broadly, need to be overthrown. This book presents a different perspective. It departs from the concept of revolutionary change to focus on pragmatic, incremental solutions tailored to everyday contexts. It scrutinizes how consent is currently sought and provided online and offers suggestions about how online consent practices can be improved upon. These include: the possibility of subjecting consent-gathering practices to ethics committees for review; the creation of visual-based consent agreements and privacy policies, to help with transparency and engagement; the development of software to protect privacy; and the idea of automated consent functionalities that allow users to bypass the task of reading vast amounts of online consent agreements. The author suggests that these "small-scale" changes to online consent-obtaining procedures, could, if successfully implemented, provide us with a way of self-managing our privacy in a way that avoids a revolutionary dismantling of the data economy. In the process, readers are encouraged to rethink the very purpose of providing inform consent online. Rethinking Informed Consent in the Big Data Age will appeal to researchers in normative ethics, applied ethics, philosophy of law, and the philosophy of AI. It will also be of interest to business scholars, communication researchers, students, and those in industry. (shrink)

BackgroundIndividuals with early phase cognitive impairment are frequently affected by existential distress, social avoidance and associated health issues. The demand for efficient psychological support is crucial from both an individual and a societal perspective. We have developed a novel psychological intervention manual for providing a non-medical path to enhanced psychological health in the cognitively impaired population. The current article provides specific information on the randomized controlled trial -design and methods. The main hypothesis is that participants receiving PIPCI will increase (...) their psychological flexibility compared to participants in the active control group and the waiting list control group. The secondary hypotheses are that participants receiving PIPCI will improve psychological health compared to participants in the active control group and the waiting list control group.Materials and MethodsThis three-arm RCT will recruit participants from the cognitive centers at Karolinska University Hospital in Stockholm and randomize approximately 120 individuals in the early phase of cognitive impairment to either an experimental group, an active control group or a waiting list control group. Intervention outcome will be evaluated with self-report questionnaires on physical and psychological aspects of health, cognitive assessment, biological markers and health care costs. Assessments will be performed at pre- and post-intervention, as well as at a 6-month follow-up.DiscussionThe development of a potentially feasible and effective psychological intervention tailored for early phase cognitive impairment has the potential to advance the non-pharmacological intervention field. This is especially important given the extensive burden for many affected individuals and their families and the current lack of effective treatments. If the psychological intervention discussed here shows feasibility and efficacy, there is potential for far-reaching healthcare implications for patients with early cognitive impairment at risk of developing dementia.Clinical Trial RegistrationClinicalTrials.gov: NCT04356924. Date of registration: April 22, 2020. URL: https://clinicaltrials.gov/ct2/show/NCT04356924. (shrink)

Drawing on interviews with decision makers in multinational corporations (MNCs) in South Korea, we examine the role of informal networks in the social exclusion of women in the workforce. Although legislation in the country is in favor of gender equality, we found that informal barriers in the workplace remain difficult to overcome. Informal networks in Korea, yongo, present an ethical issue in the workplace, as they tend to socially exclude women, limiting possibilities for their participation and career progression. We found (...) that informal networks are pervasive and strong because of the informal institutions in which they are embedded and that there is a complex interplay between informal networks and informal institutions that socially excludes women. Due to difficulties accessing yongo, women appear to build inmaek, a network type that is more open and accessible. We also found that MNCs in Korea can compensate for the lack of local informal networks for their female employees. However, despite providing a more supportive environment for women at work, gender equality policies in MNCs are not yet as effective as they could be due to the dynamics of the workplace and the fact that the policies are not tailored to the local context. We have seen evidence in recent years that MNCs can serve as role models for implementing gender equality policies by creating a more inclusive work environment and demonstrating leadership commitment and support. (shrink)

Elite athletes, coaches and high-performance staff are exposed to a range of stressors that have been shown to increase their susceptibility to experiencing mental ill-health. Despite this, athletes may be less inclined than the general population to seek support for their mental health due to stigma, perceptions of limited psychological safety within sport to disclose mental health difficulties and/or fears of help-seeking signifying weakness in the context of high performance sport. Guidance on the best ways to promote mental health within (...) sporting environments is increasing, though current frameworks and position statements require greater focus on a whole of system approach, in which the needs of athlete, coaches and high-performance staff are considered within the context of the broader ecological system in which they operate and perform. This paper synthesizes existing research, reviewed for translatability by mental health professionals working in elite sport, to provide an evidence-informed framework with real world utility to promote mentally healthy environments for all stakeholders in elite sporting organizations, from athletes through to administrators. Recommendations are provided to positively impact the mental wellbeing of athletes and support staff, which may in turn influence athletic performance. This framework is intended to provide sporting organizations with evidence-informed or best practice principles on which they can develop or progress their policies to support mental health promotion and prevent the onset of mental health difficulties. It is intended that the framework can be adapted or tailored by elite sporting organizations based upon their unique cultural, contextual and resourcing circumstances. (shrink)

To ensure informed consent is tailored to ethnic Asian communities, it is necessary to establish an ethical foundation that is relevant to the specific populations. We hypothesized that certain communitarian factors unique to traditional Kyrgyz culture may influence an individual's decision to participate in research. Guided by Seedhouse's (2005) Rational Field Theory, we conducted qualitative, in‐depth interviews with cultural experts in Kyrgyzstan to identify the ethical foundations of decision‐making for informed consent in Kyrgyz culture. The results indicate that Kyrgyz (...) people have a distinctive decision‐making style influenced by their nomadic culture and history, which values and prioritizes family integrity and reputation. These findings indicate that a multidimensional approach based on socio‐cultural sensitivities is necessary to assess the appropriateness of consent procedures. We believe our results may have implications for revising the guidelines of local and regional research ethics committees in Kyrgyzstan and other Central Asian countries. (shrink)

Stage models are becoming increasingly popular in explaining change from current behavior to more environmentally friendly alternatives. We review empirical applications of a recently introduced model, the stage model of self-regulated behavioral change (SSBC). In the SSBC, change toward pro-environmental behavior takes place in four, qualitatively different stages (predecisional, preactional, actional, and postactional) which are each influenced by constructs taken from theories previously established to describe and predict pro-environmental behavior. We performed a systematic literature search to retrieve peer-reviewed SSBC-based studies. (...) The review includes 10 studies published between 2013 and 2018, six of which employed a cross-sectional, three an interventional and one a correlational longitudinal design. The cross-sectional and longitudinal studies generally support the model, although there are some irregularities that warrant further investigation. The interventional studies found stage-tailored informational measures to be more effective than non-stage-tailored measures in promoting stage progression and behavioral change. Furthermore, we identified several challenges that researchers may face when applying the SSBC. These include whether and how to analyze multiple behavioral alternatives; how to address the challenge of measuring a comprehensive model while keeping questionnaire length manageable; selecting and defining the role of model constructs in a behavioral context while keeping results comparable; and establishing a validated and reliable tool to diagnose a person’s stage of change. Based on these insights, we develop recommendations for researchers designing SSBC studies, in order to support a founded and efficient advancement of the theory which will then serve both researchers and practitioners aiming to promote pro-environmental behavior. (shrink)

BackgroundInformed consent forms are intended to facilitate research enrollment decisions. However, the technical language in institutional templates can be unfamiliar and confusing for decision-makers. Standardized language describing financial implications of participation, namely compensation for injury and costs of care associated with participating, can be complex and could be a deterrent for potential participants. This standardized language may also be misleading in the context of comparative effectiveness trials of standard care interventions, in which costs and risk of injury associated with participating (...) may not differ from regular medical care. In addition, the revised U.S. Common Rule contains a new requirement to present key information upfront; the impact of how this requirement is operationalized on comprehension and likelihood of enrollment for a given study is unknown.MethodsTwo online surveys assessed the impact of (1) changes to compensation for injury language (standard vs. tailored language form) and (2) changes to the key information page (using the tailored compensation language form with standard key information vs. modified key information vs. modified key information plus financial information) on both likelihood of enrollment in and understanding of a hypothetical comparative effectiveness trial.ResultsLikelihood of enrolling was not observed to be different between the standard and tailored language forms in Study 1 (73 vs. 75%; p = 0.6); however, the tailored language group had a higher frequency of understanding the compensation for injury process specific to the trial (25 vs. 51%; p < 0.0001). Modifications to the key information sheet in Study 2 did not affect likelihood of enrolling (88 vs. 85 vs. 85%; p = 0.6); however, understanding of randomization differed by form (44 vs. 59 vs. 46%; p = 0.002).ConclusionsThese findings suggest that refining consent forms to clarify key information and tailoring compensation for injury language to the nature of the study, especially in the context of comparative effectiveness trials, may help to improve study comprehension but may not impact enrollment. (shrink)

PurposeThis paper discusses the need for health information specialists who can promote patient empowerment by tailoring the information patients receive as they cope with illness. The objectives of this study are to distinguish the various stages of coping with illness, examine the informational needs of patients during these stages, explore how web information contributes to patient empowerment, and describe the potential role of the health information specialist.Design/methodology/approachIn order to meet the study's objectives, a qualitative research method (...) was used in which 110 in‐depth interviews were conducted with patients who told their story of coping throughout the course of illness. By distinguishing and understanding the different stages of coping with illness, we came to distinguish the distinct informational needs during the coping process, and understand how web information contributes to patient empowerment.FindingsThe process of coping with illness has four stages. In each stage, the patient's informational needs differ, as does his ability to absorb and process information. Health systems do not provide information to match the coping stage of the patient. Patients turn to professional and unprofessional internet sites in their search for medical knowledge. The current study, integrated with other studies that show patients' difficulties using the internet, emphasizes the importance of the information specialist in the patient empowerment process.Originality/valueThe study will aid policy makers in the process of empowering patients by demonstrating patients' dynamic informational needs when coping with illness. This study proposes a role for the information specialists that will enable them to expand into the health domain. This role is the health information specialist, a professional who will, among other things, learn how health systems work, identify types of web information sources, assess medical site quality, recognize patients' coping stages, and adapt information to individual characteristics. (shrink)

Currently, there is no authoritative credentialing process for individuals engaged in ethics practice, no accreditation system that sets minimum education standards for programs aiming to prepare these individuals for their work, and little evidence available that any particular training model is actually achieving its pedagogical goals. At the same time, a number of healthcare organizations and universities now routinely offer post-graduate programs, clinical fellowships and in-house training specifically devised to prepare graduates for ethics practice. However, while their numbers appear to (...) be growing, information about these programs is limited. In this paper, we describe the goals, content and strategies of three educational programs offered in Ontario, Canada. These case studies highlight the diversity of ethics education available to those who engage in ethics practice and underscore the need to take this variety into account in the development of future education standards that would specify minimally acceptable educational requirements. (shrink)

ABSTRACT: One important criticism of algorithmic systems is that they lack transparency. Such systems can be opaque because they are complex, protected by patent or trade secret, or deliberately obscure. In the EU, there is a debate about whether the General Data Protection Regulation (GDPR) contains a “right to explanation,” and if so what such a right entails. Our task in this chapter is to address this informational component of algorithmic systems. We argue that information access is integral for (...) respecting autonomy, and transparency policies should be tailored to advance autonomy. -/- To make this argument we distinguish two facets of agency (i.e., capacity to act). The first is practical agency, or the ability to act effectively according to one’s values. The second is what we call cognitive agency, which is the ability to exercise what Pamela Hieronymi calls “evaluative control” (i.e., the ability to control our affective states, such as beliefs, desires, and attitudes). We argue that respecting autonomy requires providing persons sufficient information to exercise evaluative control and properly interpret the world and one’s place in it. We draw this distinction out by considering algorithmic systems used in background checks, and we apply the view to key cases involving risk assessment in criminal justice decisions and K-12 teacher evaluation. -/- The link below is to an open access version of the chapter. (shrink)

Informed consent represents a specific protocol for obtaining consent from a fully informed human subject to take part in clinical research. Still, informed consent is not only required for clinical trials but it also represents a critical precondition before enrolment in standard everyday medical procedures. Relevant fundamental criteria for obtaining informed consent must be followed, and that is that patient must have the decisional capacity to reach autonomous decision. The patient must be adequately informed and not coerced. Evaluating decisional capacity (...) is crucial to providing the required level of care. The decision of which decisional capacity tool to use can be challenging because of various dissimilarities among the instruments. In this paper, four widely documented instruments have been evaluated, namely, the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), the Hopkins Competency Assessment Test (HCAT), the Structured Interview for Competency/Incompetency Assessment Testing, Ranking Inventory (SICIATRI), and the Capacity Assessment Tool (CAT). Some of them include a fully structured interview; semi-structured forms characterise others. Most of them are adaptable for different scenarios, and yet, some are tailored for specific treatment decisions. Some evaluate all four components of decisional capacity, while others do not. Although a broad range of capacity assessment tools is available, it has been shown that they notably improve the accuracy of capacity evaluations. Given that many pathological conditions could result in impaired decisional capacity, physicians must be able to correctly and consistently assess the capacity for which education and previous experience are pivotal. (shrink)

Contributing to the fast growing new field of neutrosophy, this book provides a significant collection of unedited articles covering the latest ongoing research area. Neutrosopy is above all a new view on modelling, tailored to effectively address the uncertainties inherent of the real world. In short, Neutrosophy supersedes in logics the binary approach of true or false by introducing a third state: neutral, which can be also interpreted as indeterminate, uncertain, inconsistent.

ICT for development projects often focus on integrating social factors in information systems design. A well-designed ICT4D solution must be tailored to the needs of the people who will use them and subsequently, requires an extensive understanding of the context and constraints in people’s lives. With an objective to explore how context-specific issues influence the conveyance of appropriate agricultural information to women, this paper uses PROTIC, a 5-year collaborative project between Monash University and Oxfam, as a case. (...) PROTIC was implemented in three climate vulnerable ecological zones of Bangladesh with an aim to overcome the agricultural information gap for rural women. Based on a study in mixed research method and triangulation, this paper brings evidence on the significance of considering context-specific attributes in designing effective and sustainable information services for marginalized women farmers in developing countries. The paper upfolds some significant recommendations which is expected to contribute to the domain of context-specific information system design in resolving socio-economic problems to pave the way of sustainable development. (shrink)

The concept of ‘relevance’ is crucial to legal information retrieval, but because of its intuitive understanding it goes undefined too easily and unexplored too often. We discuss a conceptual framework on relevance within legal information retrieval, based on a typology of relevance dimensions used within general information retrieval science, but tailored to the specific features of legal information. This framework can be used for the development and improvement of legal information retrieval systems.

Social media platforms take on increasingly big roles in political advertising. Microtargeting techniques facilitate the display of tailored advertisements to specific subsegments of society. Scholars worry that such techniques might cause political information to be displayed to only very small subgroups of citizens. Or that targeted communication about policy could make the mandate of elected representatives more challenging to interpret. Policy information in general and pledges, in particular, have received much scientific scrutiny. Scholars have focused largely on (...) party manifestos, but policy information and pledges communicated via online advertisements offer a new arena with new dynamics. This study uses Facebook’s ad library to describe how Dutch political campaigns advertise policy information and pledges in the run-up to the 2019 European Elections. The results show that much policy information is displayed to small subsegments of society. These findings provide evidence for concerns about pledge obfuscation, voter manipulation and mandate interpretation. (shrink)

ObjectiveMost young adults diagnosed with breast or gynecologic cancers experience adverse reproductive or sexual health outcomes due to cancer and its treatment. However, evidence-based interventions that specifically address the RSH concerns of young adult and/or LGBTQ+ survivor couples are lacking. Our goal is to develop a feasible and acceptable couple-based intervention to reduce reproductive and sexual distress experience by young adult breast and gynecologic cancer survivor couples with diverse backgrounds.MethodsWe systematically adapted an empirically supported, theoretically grounded couple-based intervention to address (...) the RSH concerns of young couples coping with breast or gynecologic cancer through integration of stakeholder perspectives. We interviewed 11 couples with a history of breast or gynecologic cancer to review and pretest intervention materials. Three of these couples were invited to review and comment on intervention modifications. Content experts in RSH and dyadic coping, clinicians, and community advisors participated throughout the adaptation process.ResultsFindings confirmed the need for an online, couple-based intervention to support young couples experiencing RSH concerns after breast or gynecologic cancer. Qualitative themes suggested intervention preferences for: A highly flexible intervention that can be tailored to couples’ specific RSH concerns; Active steps to help members of a dyad “get on the same page” in their relationship and family building plans; A specific focus on raising partners’ awareness about how cancer can affect body image and physical intimacy; and Accessible, evidence-based information about RSH for both partners. These results, along with feedback from stakeholders, informed adaptation and finalization of the intervention content and format. The resulting virtual intervention, Opening the Conversation, includes five weekly sessions offering training to couples in communication and dyadic coping skills for addressing RSH concerns.ConclusionThe systematic adaptation process yielded a theory-informed intervention for young adult couples facing breast and gynecological cancers, which will be evaluated in a randomized controlled trial. The long-term goal is to implement and disseminate Opening the Conversation broadly to reach young adult couples with diverse backgrounds who are experiencing RSH concerns in cancer survivorship. (shrink)

BackgroundThe H2020 i-CONSENT project has developed a set of guidelines that offer ethical recommendations and practical tools aimed at making the informed consent process in clinical studies more comprehensive, tailored, and inclusive. An analysis of the appropriateness of some of its novel recommendations was carried out by a group of experts representing different stakeholders.MethodsAn adaptation of the RAND/ucla Appropriateness Method was used to assess the level of agreement on the recommendations among 14 representatives of different stakeholders, including patients, regulators, (...) investigators, ethics experts, and the pharmaceutical industry. The process included two rounds of rating and a virtual meeting.ResultsFifty-three recommendations were evaluated. After the first round, 34 recommendations were judged “appropriate”; 19 were judged “uncertain”; and none was judged “inappropriate”. After the second round, 9 “uncertains” changed to “appropriate”. All recommendations rated medians of 6.5–9 on a 1–9 scale (1 = “extremely inappropriate”, 5 = “uncertain”, 9 = “extremely appropriate”). The sections “General recommendations” and “Gender perspective during the consent process for clinical studies” showed the highest “uncertainty” rating. The four keys to improving the understanding of the ICP in clinical studies are to: (1) consider consent a two-way continuous interaction that begins at the first contact with the potential participant and continues until the end of the study; (2) improve investigators’ communication skills; (3) co-create the information; and (4) use a layered approach, including information to compensate for the potential participant’s possible lack of health literacy and a glossary of terms.ConclusionsThe RAND/ucla method has demonstrated validity for assessing the appropriateness of recommendations in ethical guidelines. The recommendations of the i-CONSENT guidelines were mostly judged “appropriate” by all stakeholders involved in the informed consent process. (shrink)

Background: An ethical, informed consent process requires that potential participants understand the study, their rights, and the risks and benefits. Yet, despite strategies to improve communication, many participants still lack understanding of potential risks and benefits. Investigating attitudes and practices of research nurses can identify ways to improve the informed consent process. Research question: What are the attitudes, practices, and preparedness of nurses involved in the informed consent process regarding communication of risks and benefits? Research design: A survey was developed (...) and administered online to a national purposive sample of 107 research nurses with experience obtaining informed consent for clinical trials. Survey responses stratified by selected work-related characteristics were analyzed. Ethical considerations: Participants were instructed they need not answer each question and could stop at any time. They consented by clicking “accept” on the email which linked to the survey. The study was approved by the Northeastern University Institutional Review Board, Boston, Massachusetts (NU-IRB Protocol #: 13-06-17). Findings: Most research nurses (87%) used a teach-back method to assess participant comprehension, while 72% relied on their intuition. About one-third did not feel prepared to communicate related statistics. About 20% did not feel prepared to tailor information, and half did not feel competent using supplemental materials to enhance risks and benefits comprehension. Only 70% had received training in the informed consent process which included in-person training (84%), case studies (69%), online courses (57%), feedback during practice sessions (54%), and simulation, such as role playing (49%) and viewing videos (45%). Perceived preparedness was significantly associated with greater informed consent experience and training. Conclusion: Research nurses may have inadequate training to encourage, support, and reinforce communication of risks and benefits during the informed consent process. Relevant purposeful education and training should help to improve and standardize the ethical informed consent process. (shrink)

Background: Individual, comprehensive, and written informed consent is broadly considered an ethical obligation in research involving the sampling of human material. In developing countries, however, local conditions, such as widespread illiteracy, low levels of education, and hierarchical social structures, complicate compliance with these standards. As a result, researchers may modify the consent process to secure participation. To evaluate the ethical status of such modified consent strategies it is necessary to assess the extent to which local practices accord with the values (...) underlying informed consent. Methods: Over a 2-week period in April 2014 we conducted semistructured interviews with researchers from a genetic research institute in rural Pakistan and families who had given blood samples for their research. Interviews with researchers focused on the institute’s requirements for consent, and the researchers’ strategies for and experiences with obtaining consent in the field. Interviews with donors focused on their motivation for donating samples, their experience of consent and donation, and what factors were central in their decisions to give consent. Results: Researchers often reported modifications to consent procedures suited to the local context, standardly employing oral and elder consent, and tailoring information to the social education level of donor families. Central themes in donors’ accounts of their decision to consent were the hope of getting something out of their participation and their remarkably high levels of trust in the researchers. Several donor accounts indicated a degree of confusion about participation and diagnosis, resulting in misconceived expectations of therapeutic benefits. Conclusions: We argue that while building and maintaining trusting relationships in research is important—not least in developing countries—strategies that serve this endeavor should be supplemented with efforts to ensure proper provision and understanding of relevant information, specifically about the nature of research and measures for individual consent and opt-out. (shrink)

Background: If collectivistic-oriented family carers choose professional care for dependents with dementia, they risk being stigmatised as failing their obligation. This may influence dementia care choices. Research question: How may individualistic and collectivistic values influence choices in dementia care? Method: Qualitative design with in-depth interviews with a total of 29 nurses, 13 family members in Norway and the Balkans and 3 Norwegian dementia care coordinators. A hermeneutic content-focused analysis was used. Ethical considerations: Ethical approval was obtained from the Regional Ethics (...) Committee for Research, South-Eastern Norway, and the nursing homes’ leadership. Findings: Family domain reasons why institutionalisation of dependents with dementia was seen as a last resort: obligation towards family members, particularly parents; worry about other family members’ reactions and inability to cope with the care for the person with dementia. Social domain reasons: feelings of shame and stigma regarding dementia, particularly in connection with institutionalisation of family members. Discussion: Children’s obligation towards their parents is an important aspect of the morality of collectivistic societies. Institutionalising parents with dementia may cause feelings of guilt and shame and worry about being stigmatised and ostracised. To avoid blame and rejection, caregiver(s) try to keep the fact that family members have dementia ‘in the family’. The decision to accept professional healthcare for dependents with severe dementia or have them admitted to a geriatric institution was postponed as long as possible. Conclusion: Family care morality may constitute a significant barrier against seeking professional help for persons with dementia, a barrier based on the expectation that the family will care for their old, even when suffering from severe dementia. Hence, stigma and shame may significantly affect the provision of care. Culturally tailored information may encourage family carers to seek professional help before the disruptive influence of the disease makes institutionalisation the only feasible option. (shrink)

This study explored drug users’ attitudes toward and understanding of randomized controlled trials testing addiction therapies. A video portraying a fictional consent conference for a randomized controlled trial with placebo arm was shown to poor male and female drug users of diverse ethnic status and sexual orientation. The video stimulated focus group discussion in which participants’ comments often reflected “experimental realism”—a realistic view of the trial—and adequate understanding of the uncertain efficacy of the treatment being tested, as well as the (...) concepts of randomization and placebo control. However, participants’ comprehension of the nature of placebos was compromised by the widespread view that placebos are a way of testing a subject’s willpower and personal control over his or her addiction. Comments also showed a mistrust of the video investigator’s integrity and competence and signs of therapeutic misconception and misestimation. The study’s findings underscore the importance of tailoring informed consent encounters to the personal and sociohistorical context of participants’ lived experiences. (shrink)

The COVID-19 pandemic crisis has necessitated widespread adaptation of revised treatment regimens for both urgent and routine medical problems in patients with and without COVID-19. Some of these alternative treatments maybe second-best. Treatments that are known to be superior might not be appropriate to deliver during a pandemic when consideration must be given to distributive justice and protection of patients and their medical teams as well the importance given to individual benefit and autonomy. What is required of the doctor discussing (...) these alternative, potentially inferior treatments and seeking consent to proceed? Should doctors share information about unavailable but standard treatment alternatives when seeking consent? There are arguments in defence of non-disclosure; information about unavailable treatments may not aid a patient to weigh up options that are available to them. There might be justified concern about distress for patients who are informed that they are receiving second-best therapies. However, we argue that doctors should tailor information according to the needs of the individual patient. For most patients that will include a nuanced discussion about treatments that would be considered in other times but currently unavailable. That will sometimes be a difficult conversation, and require clinicians to be frank about limited resources and necessary rationing. However, transparency and honesty will usually be the best policy. (shrink)

Recently the importance of addressing values in discussions of risk perception and adaptation to climate change has become manifest. Values-based approaches to climate change adaptation and the cultural cognition thesis both illustrate this trend. We argue that in the wake of this development it is necessary to take the dynamic relationship between values and beliefs seriously, to acknowledge the possibility of bi-directional relationships between values and beliefs, and to address the variety of values involved. The dynamic relationship between values and (...) beliefs, we claim, highlights the need to bring ethical considerations to bear on climate change communication. In particular, we must ask whether it is acceptable to tailor information about the risks of climate change in an effort to maximize communicative effectiveness given the values of the target group. (shrink)

Tailoring assistive systems for guiding and monitoring an individual in daily living activities is a complex task. This paper presents ALI, an assistive system combining a formal possibilistic argumentation system and an informal model of human activity: the Cultural-Historic Activity Theory, facilitating the delivery of tailored advices to a human actor. We follow an activity-centric approach, taking into consideration the human’s motives, goals and prioritized actions. ALI tracks a person in order to I) determine what activities were performed over (...) a period of time (activity recognition tracking), and II) send personalized notifications suggesting the most suitable activities to perform (decision-making monitoring). The ALI system was evaluated in a formative pilot study related to promote social activities and physical exercise. (shrink)

Tailoring assistive systems for guiding and monitoring an individual in daily living activities is a complex task. This paper presents ALI, an assistive system combining a formal possibilistic argumentation system and an informal model of human activity: the Cultural-Historic Activity Theory, facilitating the delivery of tailored advices to a human actor. We follow an activity-centric approach, taking into consideration the human’s motives, goals and prioritized actions. ALI tracks a person in order to I) determine what activities were performed over (...) a period of time (activity recognition tracking), and II) send personalized notifications suggesting the most suitable activities to perform (decision-making monitoring). The ALI system was evaluated in a formative pilot study related to promote social activities and physical exercise. (shrink)

The conceptual foundations underpinning the approach to system requirements gathering considered in this paper aredeferred system's design andtailorable information systems. In this approach users of information systems are regarded as active developers. System requirements gathering is considered from an interpretative and situated perspective using the Hyper-Tmodeller CASE tool. The tool enables better interpretative and situated system requirements gathering, through visual modelling by users and professional system developers. It is designed to address the requirements communication gap between system analysts, (...) designers and eventual users. (shrink)

Adults design utterances to match listeners' informational needs by making both “generic” adjustments (e.g., mentioning atypical more often than typical information) and “particular” adjustments tailored to their specific interlocutor (e.g., including things that their addressee cannot see). For children, however, relevant evidence is mixed. Three experiments investigated how generic and particular factors affect children's production. In Experiment 1, 4‐ to 5‐year‐old children and adults described typical and atypical instrument events to a silent listener who could either see or (...) not see the events. In later extensions, participants described the same events to either a silent (Experiment 2) or an interactive (Experiment 3) addressee with a specific goal. Both adults and 4‐ to 5‐year‐olds performed generic adjustments but, unlike adults, children made listener‐particular adjustments inconsistently. These and prior findings can be explained by assuming that particular adjustments can be costlier for children to implement compared to generic adjustments. (shrink)

Tailoring climate change messages to a particular spatial scale (e.g. a specific country or region) is often seen as an effective way to frame communication about climate change. Yet the empirical evidence for the effectiveness of this strategy is scarce, and little is known about how recipients react to spatially-framed climate change messages. To learn more about the effects and usefulness of different spatial frames as a communication and engagement tool, we conducted a study in which we presented members of (...) the general public with either a national or a global framing of climate change. In contrast to previous spatial-framing studies, the present research used semi-structured interviews – rather than survey questions – to obtain rich, in-depth information about participants’ views of climate change. Irrespective of the framing, participants revealed associations that were located at various spatial scales. Moreover, when participants talked about climate change, they repeatedly switched between different spatial scales, revealing patterns that were consistent with seeking to preserve existing beliefs and preferences. These findings improve our understanding of how the public represents climate change, and provide a novel explanation as to why simple spatial framing often fails to achieve the anticipated effects. (shrink)

Humans use their spatial information processing abilities flexibly to facilitate problem solving and decision making in a variety of tasks. This article explores the question of whether a general strategy can be adapted for performing two different spatial orientation tasks by testing the predictions of a computational cognitive model. Human performance was measured on an orientation task requiring participants to identify the location of a target either on a map (find‐on‐map) or within an egocentric view of a space (find‐in‐scene). (...) A general strategy instantiated in a computational cognitive model of the find‐on‐map task, based on the results from, was adapted to perform both tasks and used to generate performance predictions for a new study. The qualitative fit of the model to the human data supports the view that participants were able to tailor a general strategy to the requirements of particular spatial tasks. The quantitative differences between the predictions of the model and the performance of human participants in the new experiment expose individual differences in sample populations. The model provides a means of accounting for those differences and a framework for understanding how human spatial abilities are applied to naturalistic spatial tasks that involve reasoning with maps. (shrink)

ABSTRACT Objective: To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building. Methods: Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the National Ethics Committee (...) of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed. Results: Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision‐making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight. Conclusions: Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research. (shrink)

Trainers often use information from previous learning sessions to design or redesign a course. Although universities conducted numerous research integrity training in the past decades, information on what works and what does not work in research integrity training are still scattered. The latest meta-reviews offer trainers some information about effective teaching and learning activities. Yet they lack information to determine which activities are plausible for specific target groups and learning outcomes and thus do not support course (...) design decisions in the best possible manner. This article wants to change this status quo and outlines an easy-to-use taxonomy for research integrity training based on Kirkpatrick’s four levels of evaluation to foster mutual exchange and improve research integrity course design. By describing the taxonomy for research integrity training (TRIT) in detail and outlining three European projects, their intended training effects before the project started, their learning outcomes, teaching and learning activities, and their assessment instruments, this article introduces a unified approach. This article gives practitioners references to identify didactical interrelations and impacts and (knowledge) gaps in how to (re-)design an RI course. The suggested taxonomy is easy to use and enables an increase in tailored and evidence-based (re-)designs of research integrity training. (shrink)

Despite recent efforts by the Artificial Intelligence (AI) community to move towards standardised procedures for documenting models, methods, systems or datasets, there is currently no methodology focused on use cases aligned with the risk-based approach of the European AI Act (AI Act). In this paper, we propose a new framework for the documentation of use cases that we call use case cards, based on the use case modelling included in the Unified Markup Language (UML) standard. Unlike other documentation methodologies, we (...) focus on the intended purpose and operational use of an AI system. It consists of two main parts: firstly, a UML-based template, tailored to allow implicitly assessing the risk level of the AI system and defining relevant requirements, and secondly, a supporting UML diagram designed to provide information about the system-user interactions and relationships. The proposed framework is the result of a co-design process involving a relevant team of EU policy experts and scientists. We have validated our proposal with 11 experts with different backgrounds and a reasonable knowledge of the AI Act as a prerequisite. We provide the 5 use case cards used in the co-design and validation process. Use case cards allows framing and contextualising use cases in an effective way, and we hope this methodology can be a useful tool for policy makers and providers for documenting use cases, assessing the risk level, adapting the different requirements and building a catalogue of existing usages of AI. (shrink)

Biobank research and genomic information are changing the way we look at health and medicine. Genomics challenges our values and has always been controversial and difficult to regulate. In the future lies the promise of tailored medical treatments and pharmacogenomics but the borders between medical research and clinical practice are becoming blurred. We see sequencing platforms for research that can have diagnostic value for patients. Clinical applications and research have been kept separate, but the blurring lines challenges existing (...) regulations and ethical frameworks.Then how do we regulate it? This book contains an overview of the existing regulatory landscape for biobank research in the Western world and some critical chapters to show how regulations and ethical frameworks are developed and work. How should international sharing work? How design an ethical informed consent? An underlying critique: the regulatory systems are becoming increasingly complex and opaque. The international community is building systems that should respond to that. According to the authors in fact, it is time to turn the ship around. Biobank researchers have a moral responsibility to look at and assess their work in relation to the bigger picture: the shared norms and values of current society. Research ethics shouldn't only be a matter of bioethicists writing guidelines that professionals have to follow. Ethics should be practiced through discourse and regulatory frameworks need to be part of that public discourse. Ethics review should be then not merely application of bureaucracy and a burden for researchers but an arena where researchers discuss their projects, receive advice and practice their ethics skills. (shrink)