Cet article illustre les différences entre les processus d’expertise en France et aux États-Unis par une comparaison des procédés d’évaluation des risques du perchlorate, un contaminant environnemental détecté dans les eaux de consommation et dans l’alimentation. Ce cas atteste d’une opposition entre deux modèles, l’un fondé sur la confrontation et l’ouverture aux parties prenantes, l’autre fondé sur le consensus et la centralisation de l’expertise. Les différences principales concernent la formalisation de l’interaction entre différentes instances évaluatives et les autres parties prenantes, (...) les processus permettant des évaluations externes de la qualité des évaluations des risques et le rôle du chercheur dans leur élaboration. Après avoir décrit les différences, l’article développe les avantages et les désavantages des deux systèmes d’expertise, et conclut sur la possibilité de développement d’une voie intermédiaire pour l’expertise institutionnelle européenne, alliant centralisme, collégialité et pluralité.This article illustrates the differences between expert assessment procedures in France and the United States by comparing their respective procedures for the risks raised by perchlorate, an environmental contaminant detected in drinking water and food. This example highlights the contrast between the two models, one based on confrontation and stakeholder involvement, the other on consensus and the centralisation of experience. The main differences lie in the way interactions between the various bodies responsible for the assessments and the other stakeholders are formalised, in the procedures governing audits of the risk assessments, and in the role of researchers in the production of these assessments. After describing the differences, the article describes the advantages and drawbacks of the two systems and concludes with a proposal for the development of an intermediate method for EU institutional expert appraisals, combining a centralising approach with pluralist and collegial principles. (shrink)

BackgroundThe boundaries between health-related research and practice have become blurred as initiatives traditionally considered to be practice increasingly use the same methodology as research. Further, the application of different ethical requirements based on this distinction raises concerns because many initiatives commonly labelled as “non-research” are associated with risks to patients, participants, and other stakeholders, yet may not be subject to any ethical oversight. Accordingly, we sought to develop a tool to facilitate the systematic identification of risks to human participants and (...) determination of risk level across a broad range of projects and health-related contexts. This paper describes the development of the Public Health Ontario Risk Screening Tool.MethodDevelopment of the PHO Risk Screening Tool included: preparation of a draft risk tool ; expert appraisal; internal stakeholder validation; external validation; pilot testing and evalution of the draft tool; and revision after 1 year of testing.ResultsA risk screening tool was generated consisting of 20 items organized into five risk domains: Sensitivity; Participant Selection, Recruitment and Consent; Data/Sample Collection; Identifiability and Privacy Risk; and Commercial Interests. The PHO Risk Screening Tool is an electronic tool, designed to identify potential project-associated risks to participants and communities and to determine what level of ethics review is required, if any. The tool features an easy to use checklist format that generates a risk score associated with a suggested level of ethics review once all items have been completed. The final score is based on a threshold approach to ensure that the final score represents the highest level of risk identified in any of the domains of the tool.ConclusionsThe PHO Risk Screening Tool offers a practical solution to the problem of how to maintain accountability and appropriate risk oversight that transcends the boundaries of research and practice. We hope that the PHO Risk Screening Tool will prove useful in minimizing the problems of over and under protection across a wide range of disciplines and jurisdictions. (shrink)

BackgroundIncreasingly, hospitals and research institutes are developing technical solutions for sharing patient data in a privacy preserving manner. Two of these technical solutions are homomorphic encryption and distributed ledger technology. Homomorphic encryption allows computations to be performed on data without this data ever being decrypted. Therefore, homomorphic encryption represents a potential solution for conducting feasibility studies on cohorts of sensitive patient data stored in distributed locations. Distributed ledger technology provides a permanent record on all transfers and processing of patient data, (...) allowing data custodians to audit access. A significant portion of the current literature has examined how these technologies might comply with data protection and research ethics frameworks. In the Swiss context, these instruments include the Federal Act on Data Protection and the Human Research Act. There are also institutional frameworks that govern the processing of health related and genetic data at different universities and hospitals. Given Switzerland’s geographical proximity to European Union (EU) member states, the General Data Protection Regulation (GDPR) may impose additional obligations.MethodsTo conduct this assessment, we carried out a series of qualitative interviews with key stakeholders at Swiss hospitals and research institutions. These included legal and clinical data management staff, as well as clinical and research ethics experts. These interviews were carried out with two series of vignettes that focused on data discovery using homomorphic encryption and data erasure from a distributed ledger platform.ResultsFor our first set of vignettes, interviewees were prepared to allow data discovery requests if patients had provided general consent or ethics committee approval, depending on the types of data made available. Our interviewees highlighted the importance of protecting against the risk of reidentification given different types of data. For our second set, there was disagreement amongst interviewees on whether they would delete patient data locally, or delete data linked to a ledger with cryptographic hashes. Our interviewees were also willing to delete data locally or on the ledger, subject to local legislation.ConclusionOur findings can help guide the deployment of these technologies, as well as determine ethics and legal requirements for such technologies. (shrink)

There is a dearth of business ethics research on family firms, despite the importance of such firms to the US economy. We answer Vazquez’s call to examine the intersection of family-firm research and business ethics, by investigating whether external auditors assess higher risk of fraud in family firms. We test the contradictory predictions of two dominant theoretical perspectives in family-firm research—entrenchment theory and alignment theory. We conduct an experiment with highly experienced external audit professionals, who assess the (...) risk of fraud and make client acceptance decisions for family firms versus non-family firms with different strength of corporate governance: strong versus weak audit committees. We find that auditors assess the risk of fraud as higher for family firms than for non-family firms, consistent with the predictions of entrenchment theory. Auditors are also less likely to make client acceptance recommendations for family firms. The strength of the AC moderates the family-firm effect, whereby auditors assess family firms with weak ACs to have the highest fraud risk and to be the least desirable audit clients. Our findings suggest that auditors perceive more severe agency conflicts to be present in family firms than in non-family firms, consistent with entrenchment theory, according to which family members may behave opportunistically to extract rents and potentially expropriate the firm’s resources at the expense of minority shareholders. (shrink)

Introduction: Interdisciplinary, transdisciplinary and action research of a city in lockdown. As we write this chapter, most cities across the world are subject to a similar set of measures due to the spread of COVID-19 coronavirus, which is now a global pandemic. Independent of city size, location, or history, an observer would note that almost all cities have now ground to a halt, with their citizens being confined to their private dwellings, social and public gatherings being almost entirely forbidden, and (...) commercial areas being nearly devoid of visitors. Striking as these apparent similarities are, closer scrutiny would reveal important differences between cities and within cities – differences that can be highly relevant to consider when scholars are assessing the responses of cities to this pandemic or trying to predict the consequences of those responses. For example, the public health systems in some cities are better prepared than in others for coping with the increasing number of patients in life threatening conditions. Multigenerational households, which are associated with a greater risk for elderly members, are not equally common in all cities. Tourist destinations have taken a more severe economic hit from the lockdown than those cities which are economically less dependent upon this particular source of income. Communal celebrations in one city will result in a higher number of contagions and perhaps even deaths in this situation, whereas that same social fabric generally does contribute to a population’s health. The pandemic has also had unprecedented effects on differences and inequalities within cities. In cities in the United States, neighborhoods primarily inhabited by African Americans have been disproportionately affected by COVID-19 due to living and health conditions, yet also due to the fact they disproportionately perform vital jobs. Parks and green spaces are crowded, while city centers like Amsterdam’s Red Light District have suddenly lost the bustle of tourism, providing opportunities for citizens to reoccupy scarce public spaces and reclaim ownership. Clearly, such differences between cities are in many cases only discernible to the eye of an expert, possessing the necessary background knowledge to interpret the perceptible local changes caused by the global pandemic. Typically, drawing upon his or her disciplinary training, the expert also knows how to further probe the impact of the pandemic in an appropriate way. However, compared to the usual application of expertise, this crisis situation might, in an unusual way, test even experts. For the pandemic has created a unique situation, imposing unfamiliar constraints on the health, economic, social, and other conditions of cities, constraints that interact in sometimes unexpected ways with each other. Such interactions in turn force experts to collaborate across the boundaries commonly associated with disciplines, their concepts, theories, methods, and assumptions (Klein, 1996). These brief observations of how a virus pandemic can have differential impacts upon various cities, and what this exceptional situation might mean for the application of city methods, allow us to draw a few consequences for the current context of this chapter on interdisciplinary and transdisciplinary research. First, whenever we are investigating a complex and dynamic phenomenon it is by no means easy to determine which disciplinary perspectives are required to do justice to it. Indeed, the choice of useful disciplines can only be made after an initial overview of the situation and a preliminary selection of what appear to be the most important features of the situation. Relevance is key in guiding this selection process and scholars must remain open to the possibility that they may need to revise their earlier assessments of what is relevant and what is not. Second, if scholars from different disciplines were to study different features of a city in isolation, their ‘multidisciplinary’ account would miss important dynamic and complex interactions, such as those between a city’s demographics and geographical situation, its governance and economy. In other words, it is the integration of the perspectives of different disciplines that is crucial, as only then are such interactions taken into account. Indeed, this integration between disciplinary perspectives is what distinguishes an interdisciplinary from a multidisciplinary account. Thirdly, in addition to checking the relevance of disciplines and aiming for their integration, the outcome of interdisciplinary and transdisciplinary research has typically limited generalizability. Since a city is sensitive to a multitude of internal and external dynamical factors, in ways that partly rest upon its socio-cultural history, its investigation will often have the nature of a case study rather than be capable of leading to law-like insights (Krohn, 2010; Menken & Keestra, 2016). As can be seen from these three characteristics of ascertaining the relevance of different disciplinary contributions, the challenge of their integration, and the limited generalizability of their results owing to the specificity of interdisciplinary (ID) and transdisciplinary (TD) research, such research into ‘real world problems’ is clearly distinct from most monodisciplinary research. A consequence of this distinction is the absence of a general ID/TD methodology that can guide specific case studies. By contrast, the collaboration implied in such research requires researchers – and stakeholders, if they are involved – to reflect upon their potential contribution and the implicit assumptions associated with that. We will elaborate on this in the next section. Next, we offer several typologies of integration that urban scholars could employ for their research projects, after which we will offer a few brief analyses of initial collaborations of urban research. Finally, we discuss in more detail the process of the interdisciplinary research project. This will include a brief reflection upon the decision-making process that is implied in such projects. In sum, we aim to provide some guidance in conducting an ID/TD project, albeit not in the form of a definite methodology. (shrink)

The functional separation of risk assessment and risk management has long been at the heart of risk analysis structures. Equally long it has been criticized for creating technocratic risk management due to valuations being done in the risk assessment to which the stakeholders do not have access. The criticism has mostly been of an ethical nature. Arguably, in separating risk assessment and risk management, one hopes to fulfil two requirements: Social requirement: we want (...) risk management to meet the goals and needs of society. Scientific requirement: we do not want political views to influence the assessment of facts. We ask in this paper whether it is, in principle, possible to separate risk assessment from risk management. The crucial distinction between risk assessment and risk management we take to be between what kinds of values are involved in them and that separation is meant to shield risk assessment from risk management values and vice versa. Risk assessment is judged to be a scientific activity that should only involve scientific values. We go through a paradigmatic example of good science to see what those scientific values are and whether they are the only ones influencing science. We also present an example of a risk assessment in order to compare it to science. We conclude that the values involved in both science and risk assessment are of the same kind and that they both involve extra-scientific values. The paper ends with a short discussion of whether the above requirements can be met even though risk assessment and risk management are interdependent. (shrink)

Understanding the clinical significance of variants associated with hereditary cancer risk requires access to a pooled data resource or network of resources—a “cancer gene variant commons”—incorporating representative, well-characterized genetic data, metadata, and, for some purposes, pathways to case-level data. Several initiatives have invested significant resources into collecting and sharing cancer gene variant data, but further progress hinges on identifying and addressing unresolved policy issues. This commentary provides insights from a modified policy Delphi process involving experts from a range of (...) stakeholder groups involved in the data-sharing ecosystem. In particular, we describe policy issues and options generated by Delphi participants in five domains critical to the development of an effective cancer gene variant commons: incentives, financial sustainability, privacy and security, equity, and data quality. Our intention is to stimulate wider discussion and lay a foundation for further work evaluating policy options more in-depth and mapping them to those who have the power to bring about change. Addressing issues in these five domains will contribute to a cancer gene variant commons that supports better care for at-risk and affected patients, empowers patient communities, and advances research on hereditary cancers. (shrink)

This study examines the application of a qualitative Ecological Risk Assessment tool to initiate management planning and community engagement in newly legislated Marine Protected Areas. Scientists and the agency expected the participatory element to increase the legitimacy of management by achieving consensus about management priorities as well as to engender trust in science and agency procedures. We point to the complex nature of participatory engagement when expert and lay knowledge are combined while an agency's claim to legitimacy rests (...) on scientific judgements. While community engagement offered agency staff an additional way to claim legitimacy it also challenged the way planners, rangers as well as community representatives previously attained trust. (shrink)

At least since the publication of the monumental Strategic Management: A Stakeholder Approach, the "stakeholder theory" originated by R. E. Freeman has engrossed much of the business ethics literature. Subsequently, some advocates have moved a bit too quickly and without proper definition or argument. They have exceeded Freeman's intentions which are more libertarian and free-market than is often thought. This essay focuses on the versions of stakeholder theory directly authored or coauthored by Freeman in an effort to recover Freeman's intentions (...) and the argumentative justification of stakeholder theory. It then argues that Freeman's appeal to legal, economic, and ethical constraints ultimately produce arguments that are invalid. One can thoroughly support legislation constraining corporations or seeking to prevent age discrimination, market monopolies, and externalities and regret the extent that capitalism is heir to such shortcomings without it following that business beneficiaries should be changed from stockholders to stakeholders and the latter should be given serious decision-making power. Further, stakeholder theory neither defines nor battles any obvious opposition. Hence, it is difficult to see what it changes about business management. In short, stakeholder theory either changes too much about business, or nothing important at all. Efforts to supplant or improve the reigning theory of capitalism will have to do better. (shrink)

The idea of public or stakeholder engagement in governance of science and technology is widely accepted in many policy and academic research settings. However, this enthusiasm for stakeholder engagement has not necessarily resulted in changes of attitudes toward the role of stakeholders in the dialogue nor to the value of public knowledge, practical experience, and other inputs (like salient questions) vis-à-vis expert knowledge. The formal systems of evaluation of the stakeholder engagement activities are often focused on showing that the (...) method is efficient and works. In this article, we argue that every stakeholder engagement process should be evaluated beyond a simple assessment of the methodology and that the wider context of the stakeholder engagement activity should also be addressed. We evaluate two different stakeholder engagement activities against the existing method evaluation criteria and demonstrate their limitations for assessing the quality of a stakeholder engagement. We argue that these criteria need to be extended so that engagement processes will have a chance to improve not only policies but also their democratic legitimacy. (shrink)

Risk assessment is an evidence-based analytical framework used to evaluate research findings related to environmental and public health decision-making. Different routines have been adopted for assessing the potential risks posed by substances and products to human health. In general, the traditional paradigm is a hazard-driven approach, based on a monocausal toxicological perspective. Questions have been raised about the applicability of the general chemical risk assessment approach in the specific case of nanomaterials. Most scientists and stakeholders assume that the (...) current standard methods are in principle suitable, but point out that experimental aspects and practical guidelines need specific adaptations. Beyond this laboratory level, risk assessment of nanomaterials also faces a number of substantive and procedural limitations, which are intrinsically attributed to the general orthodoxy of the risk assessment concept. Moreover, the developed formalism used to organize scientific knowledge is closely interlinked with the underlying governance design and the mode of interaction between the two spheres of ‘science’ and ‘decisions’. This contribution will provide a closer look at the evolution of different institutional settings for risk assessment in the context of decision-making. Improved risk governance frameworks with different narratives, process designs and procedural elements will be compared. The question of a general principle of enhanced organization of risk assessment will be discussed taking account of the barriers of substantive and procedural limitations in the special case of nanomaterials. (shrink)

Corporate social responsibility (CSR) is a comprehensive concept that aims at the promotion of responsible business practices closely linked to the strategy of enterprises. Although there is no single accepted definition of CSR, it remains an inspiring, challenging and strategic development that is becoming an increasingly important priority for companies of all sizes and types, particularly in Europe. Promotion of well-being at work is an essential component of CSR; however, the link between CSR, working conditions and work organisation is still (...) found to be unfamiliar to stakeholders. As CSR is strategic and is regarded by many companies and corporate leaders as an important development, it offers opportunities for psychosocial risk management, an area that is currently among the top priorities in working environment and well-being at work debates. However, the link between CSR and psychosocial risk management has not been addressed clearly before. This paper aims to explore the potential role of CSR in promoting well-being at work through the development of a framework for the management of psychosocial risks. As part of the research, key stakeholders [including the World Health Organization (WHO), the International Labour Organization (ILO), the European Agency for Safety and Health at Work (EU-OSHA), the European Commission (EC), employers’ associations, trade unions and other policy experts] across Europe participated in a survey, interviews and focus groups to assess and clarify the link between CSR and psychosocial risk management. On the basis of the findings, a CSR-inspired approach to the management of psychosocial issues at work is proposed. Such an approach can be a useful tool in contexts where, up until now, expertise and tradition in dealing with psychosocial issues have been lacking. (shrink)

In this systematic review, we summarized and evaluated the evidence for effects of, and associations between, immersive nature-experience on mental, physical and social health promotion outcomes. Immersive nature-experience was operationalized as non-competitive activities, both sedentary and active, occurring in natural environments removed from everyday environments. We defined health according to the World Health Organization’s holistic and positive definition of health and included steady-state, intermediate, and health promotion outcomes. An electronic search was performed for Danish, English, German, Norwegian, and Swedish articles (...) published between January 2004 and May 2017. Manual approaches, e.g., bibliographies from experts, supplemented the literature search. Data were extracted from 461 publications that met the inclusion criteria. To assess the status and quality of the evidence for health promotion effects of immersive nature-experience, we focused on the subset of studies based on controlled designs (n = 133). Outcome level quality of the evidence was assessed narratively. Interventions most often involved adventure-based activities, short-termed walking, and seated relaxation in natural environments. We found positive effects on a range of health promotion outcomes grouped under psychological wellbeing (n = 97; ≈55% positive; ≈13% mixed; ≈29% non-significant; 2% negative); psychosocial function (n = 67; ≈61% positive; ≈9% mixed; ≈30% non-significant); psychophysiological stress response (n = 50; ≈58% positive; ≈18% mixed; ≈24% non-significant), and cognitive performance (n = 36; ≈58% positive; ≈6% mixed; ≈33% non-significant; 3% negative); and social skills and relationships (n = 34; ≈70% positive; ≈7% mixed; ≈22% non-significant). Findings related to outcomes categorized under physical health, e.g., risk of cardiovascular disease, were less consistent (n = 51; ≈37% positive; ≈28% mixed; ≈35% non-significant). Across the types of interventions and outcomes, the quality of the evidence was deemed low and occasionally moderate. In the review, we identify, discuss, and present possible solutions to four core methodological challenges associated with investigating immersive nature-experience and health outcomes: 1) intervention and program complexity; 2) feasibility and desirability of randomization; 3) blinding of participants and researchers; and 4) transferability and generalizability. The results of the review have been published as a popular-scientific report and a scientific research overview, both in Danish language. (shrink)

Post-Normal Science as a theory links epistemology and governance. It not only focuses on problem situations where facts are uncertain, values in dispute, stakes high and decisions urgent, but also tries to develop epistemic approaches that allow for sound scientific answers. The following article addresses major epistemological challenges within a typical ‘‘wicked-problem situation’’, i.e., risk assessment of emerging technologies. Such challenges include epistemological problems intrinsic to the task of proving the absence of risk, problems related to the multi-sited (...) production of evidence and the multitude of epistemic cultures involved, the incompatibility of the various implicit objectives and the complex actor-constellations, that shape not only the way scientific knowledge is translated into action, but also which kind of knowledge is produced and which experts are listened to. To illustrate and discuss these characteristics, the article draws on an empirical study of risk research in the fields of agri-biotechnology and telecommunication technology in Germany. It concludes that although some aspects of PNS are already part of current epistemic practices in these fields, a state of ‘‘functional post-normality’’ depends upon a meaningful co-evolution between post-normal science and post-normal governance that has not yet been achieved. (shrink)

This article aims to focus on how signatories versus nonsignatories in the U.S. pharmaceutical sector compare with respect to the internal and external stakeholders and principles of the United Nations Global Compact (UNGC). We seek to answer the question: Do signatories to the UNGC walk the talk better than nonsignatories as determined by a variety of published rankings and data? This research presents an innovative approach to the evaluation of UNGC signatories. It uses several objective and independent data sources (...) to assess a matched group of signatories versus nonsignatories in the U.S. pharmaceutical sector. Signatory organizations in the same sector as determined by SIC codes were matched with nonsignatories on variables such as size and number of employees in U.S. pharmaceutical companies. Then both types of organizations were compared on the following data sources: Coalition for Environmentally Responsible Economies ratings, ratings by external stakeholders, ratings by employees, unionization data, financial measures, and annual reports to shareholders. Using nonparametric testing the research found there are differences between signatories and nonsignatories in the U.S. pharmaceutical sector for some of the external stakeholder measures and no differences were found for the internal stakeholder measures. (shrink)

There is increasing interest in the need to address the ethical dilemmas related to the engagement of adolescents in sexual and reproductive health research. Research projects, including those that address issues related to STIs and HIV, adverse pregnancy outcomes, violence, and mental health, must be designed and implemented to address the needs of adolescents. Decisions on when an individual has adequate capacity to give consent for research most commonly use age as a surrogate rather than directly assessing capacity to understand (...) the issues and make an informed decision on whether to participate in research or not. There is a perception that adolescents participating in research are more likely to be coerced and may therefore not fully comprehend the risk they may be taking when engaging in research. This paper examines the various ethical issues that may impact stakeholders' decision making when considering engaging adolescents in SRH research in Nigeria. It makes a case for lowering the age of consent for adolescents. While some experts believe it is possible to extrapolate relevant information from adult research, studies on ethical aspects of adolescents' participation in research are still needed, especially in the field of sexual and reproductive health where there are often differences in knowledge, attitudes and practices compared to adults. The particular challenges of applying the fundamental principles of research ethics to adolescent research, especially research about sex and sexuality, will only become clear if more studies are conducted. (shrink)

Biobanks act as the custodians for the access to and responsible use of human biological samples and related data that have been generously donated by individuals to serve the public interest and scientific advances in the health research realm. Risk assessment has become a daily practice for biobanks and has been discussed from different perspectives. This paper aims to provide a literature review on risk assessment in order to put together a comprehensive typology of diverse risks biobanks could (...) potentially face. Methodologically set as a typology, the conceptual approach used in this paper is based on the interdisciplinary analysis of scientific literature, the relevant ethical and legal instruments and practices in biobanking to identify how risks are assessed, considered and mitigated. Through an interdisciplinary mapping exercise, we have produced a typology of potential risks in biobanking, taking into consideration the perspectives of different stakeholders, such as institutional actors and publics, including participants and representative organizations. With this approach, we have identified the following risk types: economic, infrastructural, institutional, research community risks and participant’s risks. The paper concludes by highlighting the necessity of an adaptive risk governance as an integral part of good governance in biobanking. In this regard, it contributes to sustainability in biobanking by assisting in the design of relevant risk management practices, where they are not already in place or require an update. The typology is intended to be useful from the early stages of establishing such a complex and multileveled biomedical infrastructure as well as to provide a catalogue of risks for improving the risk management practices already in place. (shrink)

The use of technologies in personnel selection has come under increased scrutiny in recent years, revealing their potential to amplify existing inequalities in recruitment processes. To date, however, there has been a lack of comprehensive assessments of respective discriminatory potentials and no legal or practical standards have been explicitly established for fairness auditing. The current proposal of the Artificial Intelligence Act classifies numerous applications in personnel selection and recruitment as high-risk technologies, and while it requires quality standards to protect (...) the fundamental rights of those involved, particularly during development, it does not provide concrete guidance on how to ensure this, especially once the technologies are commercially available. We argue that comprehensive and reliable auditing of personnel selection technologies must be contextual, that is, embedded in existing processes and based on real data, as well as participative, involving various stakeholders beyond technology vendors and customers, such as advocacy organizations and researchers. We propose an architectural draft that employs a data trustee to provide independent, fiduciary management of personal and corporate data to audit the fairness of technologies used in personnel selection. Drawing on a case study conducted with two state-owned companies in Berlin, Germany, we discuss challenges and approaches related to suitable fairness metrics, operationalization of vague concepts such as migration* and applicable legal foundations that can be utilized to overcome the fairness-privacy-dilemma arising from uncertainties associated with current laws. We highlight issues that require further interdisciplinary research to enable a prototypical implementation of the auditing concept in the mid-term. (shrink)

Artificial intelligence (AI) governance and auditing promise to bridge the gap between AI ethics principles and the responsible use of AI systems, but they require assessment mechanisms and metrics. Effective AI governance is not only about legal compliance; organizations can strive to go beyond legal requirements by proactively considering the risks inherent in their AI systems. In the past decade, investors have become increasingly active in advancing corporate social responsibility and sustainability practices. Including nonfinancial information related to environmental, social, and (...) governance (ESG) issues in investment analyses has become mainstream practice among investors. However, the AI auditing literature is mostly silent on the role of investors. The current study addresses two research questions: (1) how companies’ responsible use of AI is included in ESG investment analyses and (2) what connections can be found between principles of responsible AI and ESG ranking criteria. We conducted a series of expert interviews and analyzed the data using thematic analysis. Awareness of AI issues, measuring AI impacts, and governing AI processes emerged as the three main themes in the analysis. The findings indicate that AI is still a relatively unknown topic for investors, and taking the responsible use of AI into account in ESG analyses is not an established practice. However, AI is recognized as a potentially material issue for various industries and companies, indicating that its incorporation into ESG evaluations may be justified. There is a need for standardized metrics for AI responsibility, while critical bottlenecks and asymmetrical knowledge relations must be tackled. (shrink)

Focusing on the controversial birth control pills Yaz and Yasmin, this article explores how debates about the safety of these drugs have materialized in risk evaluations and the management of technological risk. Drawing on in-depth interviews with stakeholders and content analysis of legal, medical, and regulatory documents, I highlight how professional contraceptive risk assessment is characterized by systemic uncertainty and doubt, resulting in increased responsibility for users themselves to manage the drugs’ potentially increased risks of venous thromboembolism. (...) The analysis centers on three key areas in the assessment process that denote disagreement: risk measurement in postmarket surveillance data, the distinctiveness of the drugs’ benefits when compared to other contraceptive technologies, and the weighing of the risks and benefits against each other. While professionals negotiate uncertainty both in epidemiological research and in clinical practice, users are constructed as agents who should manage risk individually. Such processes are underlined by a diffusion of responsibility in the systemic management of contraceptive risk. This article suggests, more broadly, that medical technologies can be conceptualized as artifacts that are instrumental in the dispersion of risks. (shrink)

A growing public awareness of the potential negative impacts of corporate activities on the natural environment and society compels large companies to invest increasing resources in the communication of their responsible conduct. This article employs Appraisal theory in a comparative analysis of BP’s and IKEA’s 2009 social reports, each company’s record of their non-financial performance. The main objective is to explore how, through Appraisal resources, BP and IKEA construct their corporate identity and relationship with their stakeholders. The analysis reveals two (...) markedly different approaches to the construction of a responsible corporate identity. While BP deploys interpersonal resources to portray itself as a trustworthy and authoritative expert, IKEA discloses itself as a sensitive and caring corporation, engaged in a continual effort to improve. These differences are interpreted in light of the legitimization challenges the two companies face. (shrink)

Assessing the impact of CSR initiatives can be a complex task for marketers given the variety of methods of communicating about CSR as well as the broad range of stakeholders that CSR initiatives might interest. Social media helps increase the visibility and credibility of CSR communication and provides new ways of reaching and involving stakeholders in CSR initiatives. Using data collected and coded from Facebook pages of the Top 100 Global Brands, the authors introduce a new measure of effectiveness for (...) CSR communication; CSR communication productivity (CCP). The findings indicate that CCP has a positive impact on firm performance (Tobin’s Q). The authors also investigate the impact of External Stakeholder Involvement in CSR initiatives. The results suggest that when external stakeholders are involved in an organization’s CSR initiatives, both CCP and firm performance (Tobin’s Q) improve. In addition, third-party evaluations of CSR performance positively moderate the impact of External Stakeholder Involvement on CCP. These findings offer contributions to CSR communication and social media marketing theories. They also have implications for marketing managers regarding how to measure and benchmark CCP, and how to maximize returns by involving external stakeholders in CSR efforts. (shrink)

Nearly 90 % of allegations of biomedical research misconduct in the United States are dismissed by responsible institutions without any faculty assessment or auditable record. Recently, members of the U.S. Congress have complained that the penalties for those against whom findings of research misconduct are made are too light and that too few grant funds associated with research misconduct have been recovered for use by other researchers and taxpayers. Here we discuss the laws that empower federal agencies that can (...) oversee investigations of biomedical research misconduct: the Office of Research Integrity and the Office of the Inspector General, both located within the Department of Health and Human Services. Research misconduct investigations pertaining to U.S. physical sciences funded through the National Science Foundation are overseen by the NSF’s OIG. While OIGs may provide some improvement over the ORI in the handling of research misconduct, we have found that a much more serious flaw exists which undermines an ability to conduct performance audits of the effectiveness by which allegations of research misconduct are handled in the United States. Specifically, sufficient data do not need to be retained by U.S. research institutions funded by HHS or NSF to allow effective audit of why allegations of research misconduct are dismissed before being seen by faculty inquiry or investigative committees. U.S. federal Generally Accepted Government Auditing Standards, if applied to the research misconduct oversight process, would allow a determination of whether the handling of allegations of biomedical research misconduct actually functions adequately, and if not, how it might be improved. In particular, we propose that independent, external peer review under GAGAS audit standards should be instituted without delay in assessing the performance of ORI, or any other similarly tasked federal agency, in handling allegations of research misconduct. (shrink)

BackgroundThe complexities of the workplace environment in the downstream oil and gas industry contain several safety-risk factors. In particular, instituting stringent safety standards and management procedures are considered insufficient to address workplace safety risks. Most accident cases attribute to unsafe actions and human behaviors on the job, which raises serious concerns for safety professionals from physical to psychological particularly when the world is facing a life-threatening Pandemic situation, i.e., COVID-19. It is imperative to re-examine the safety management of facilities (...) and employees’ well-being in the downstream oil and gas production sector to establish a sustainable governance system. Understanding the inherent factors better that contribute to safety behavior management could significantly improve workplace safety features.ObjectiveThis study investigates employees’ safety behavior management model for the downstream oil and gas industry to consolidate the safety, health and wellbeing of employees in times of COVID-19.MethodsNominal Group Technique was first employed to screen primary behavioral factors from 10 workplace health and safety experts from Malaysia’s downstream oil and gas industry. Consequently, 18 significant factors were identified for further inquiry. Next, the interpretive structural modeling technique was used to ascertain the complex interrelationships between these factors and proposed a Safety Behavioral Management Model for cleaner production.ResultsThis model shows that management commitment, employee knowledge and training, leadership, and regulations contribute significantly to several latent factors. Our findings support the Social Cognitive Theory, where employees, their environment, and their behaviors are related reciprocally.ConclusionIt is postulated that identifying safety factors and utilizing the proposed model guides various stakeholder groups in this industry, including practitioners and policymakers, for achieving long-term sustainability. (shrink)

Despite a strong plea for integrating sustainability goals into traditional corporate bonus schemes, a comprehensive implementation of these systems has been lacking until recently. This article explores four illustrative cases from the Netherlands, where several multinationals started to pioneer with sustainable bonuses in the past few years. The article examines the setups and the different elements of bonus programmes used, in terms of performance criteria (focusing in particular on external vs. internal benchmarking), their link to specific stakeholders, type and (...) size of bonuses, target levels and transparency. While sustainable bonuses signal corporate awareness of responsibility vis-à-vis society and stakeholders, credibility varies considerably depending on these elements. Our case evidence sheds some light on the extent to which sustainable bonuses may be a credible sign of corporate responsibility or rather just another perverse mechanism meant to keep up bonus levels (window dressing). A definite assessment is hampered by the emergent state and lack of full transparency—while ‘justified’ by companies for competitive reasons, this raises questions. Insights are offered to appraise current and future systems and provide directions for further research. (shrink)

The proposed European Artificial Intelligence Act (AIA) is the first attempt to elaborate a general legal framework for AI carried out by any major global economy. As such, the AIA is likely to become a point of reference in the larger discourse on how AI systems can (and should) be regulated. In this article, we describe and discuss the two primary enforcement mechanisms proposed in the AIA: the _conformity assessments_ that providers of high-risk AI systems are expected to conduct, (...) and the _post-market monitoring plans_ that providers must establish to document the performance of high-risk AI systems throughout their lifetimes. We argue that the AIA can be interpreted as a proposal to establish a Europe-wide ecosystem for conducting AI auditing, albeit in other words. Our analysis offers two main contributions. First, by describing the enforcement mechanisms included in the AIA in terminology borrowed from existing literature on AI auditing, we help providers of AI systems understand how they can prove adherence to the requirements set out in the AIA in practice. Second, by examining the AIA from an auditing perspective, we seek to provide transferable lessons from previous research about how to refine further the regulatory approach outlined in the AIA. We conclude by highlighting seven aspects of the AIA where amendments (or simply clarifications) would be helpful. These include, above all, the need to translate vague concepts into verifiable criteria and to strengthen the institutional safeguards concerning conformity assessments based on internal checks. (shrink)

Focusing on one of the most studied dimensions of Social Psychology, i.e., intergroup relations, this study analyzes its discursive accomplishment in a specific group-based intervention, i.e., the talk and work of an Italian group home, i.e., a small alternative care facility hosting a group of out-of-home children. Particularly, we focused on the fictionally called “Nuns’ Home,” a group home previously investigated for its ethnocentric bias, and its intergroup relations with “inside” and “outside” groups, such as schools, biological families, and social (...) services. By combining a qualitative and quantitative approach in analyzing one audio-recorded ethnographic interview with the whole team of professionals, we aimed at accounting for the multitude of internal and external stakeholders that participants refer to, analyzing the discursive accomplishment of ingroup and outgroup in talk-in-interaction and investigating ingroup bias and group qualification. To do so, we detected social categorization markers and qualifying devices that participants rely on when referring to groups. Results show that, among the numerous groups recognized, participants co-construct intergroup relations and ingroup bias implying negative assessment over external groups. Being different from traditional laboratory studies illustrating substantial contraposition between ingroup and outgroup, our qualitative analysis reveals the multitude of groups by which the ingroup is formed and their internal fragmentation. To conclude, we discussed the implications of qualitatively studying intergroup relations in group homes and indicated future lines of research. (shrink)

The paper explores how the framework of systemic risks can help govern the risks imposed through solar climate engineering research. The central argument is that a systemic perspective of risk is a useful tool for analysing and assessing the risks imposed through Stratospheric Aerosol Injection (SAI) research. SAI is a form of climate engineering that could cool the planet by enhancing its albedo through the injection of aerosols into the stratosphere. Researching such a technology creates systemic risks with a (...) strong sociotechnical component. This component consists of the potential societal harm that a developing or new technology might cause to existing norms, values, institutions, and politics. The systemic risk framework is a valuable heuristic for this case, given the complex interdependencies of societal systems, infrastructures, markets, etc. At the same time, the systemic risk framework can be enhanced through the inclusion of a more robust and reflected ethical considerations on technological risks. Consequently, this article seeks to supplement the systemic risk governance framework with insights from technology ethics. Specifically, the paper offers an ethically reflective conception of societal value dynamism and stakeholder engagement and participation, tying it to existing systemic risk governance approaches. (shrink)

Before participants can be enrolled in a clinical trial, an institutional review board must determine that the risks that the research poses to participants are ‘reasonable.’ This paper examines the two dominant frameworks for assessing research risks and argues that each approach suffers from significant shortcomings. It then considers what issues must be addressed in order to construct a framework for risk assessment that is grounded in a compelling normative foundation and might provide more operationally precise guidance to the (...) deliberations of various stakeholders. The paper concludes by sketching the outlines of what is referred to as the ‘Integrative Approach’ to risk assessment and by highlighting some of the ways in which this approach may be more promising than current alternatives. (shrink)

Dans le champ de l’enseignement supérieur et de la recherche, l’évaluation de l’expertise est effectuée dans quatre domaines : les unités de recherche, les programmes de formation, les organismes de recherche et établissements d’enseignement supérieur et de recherche et les procédures d’évaluation des personnels. L’expertise est au cœur même des méthodes d’évaluation mises en œuvre par l’AERES dans le champ de l’enseignement supérieur et de la recherche.In higher education and research, four areas are subject to assessments of expertise : research (...) units, training programmes, research organisations and higher education and research establishments, and staff assessment procedures. In turn, expert appraisal is central to the assessment methods implemented by AERES in the field of higher education and research. (shrink)

There is an alleged tension between undue inducement and exploitation in research trials. This paper considers claims that increasing the benefits to research subjects enrolled in international, externally-sponsored clinical trials should be avoided on the grounds that it may result in the undue inducement of research subjects. This article contributes to the debate about exploitation versus undue inducement by introducing an analysis of the available empirical research into research participants' motivations and the influence of payments on research subjects' behaviour and (...) risk assessment. Admittedly, the available research in this field is limited, but the research that has been conducted suggests that financial rewards do not distort research subjects' behaviour or blind them to the risks involved with research. Therefore, I conclude that research sponsors should prioritise the prevention of exploitation in international research by providing greater benefits to research participants. (edited). (shrink)

Metaphors for describing the introduction, impacts, and management of non-native species are numerous and often quite outspoken. Policy-makers have adopted increasingly disputed metaphorical terms from scientific discourse. We performed a critical analysis of the use of strong metaphors in reporting scientific findings to policy-makers. Our analysis shows that perceptions of harm, invasiveness or nativeness are dynamic and inevitably display multiple narratives in science, policy or management. Improving our awareness of multiple expert and stakeholder narratives that exist in the context (...) of non-native species management, as well as metaphorical alternatives, is critical. (shrink)

BackgroundResearch ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis.DiscussionBy looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to (...) do all the risk-benefit tasks; instead, RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision.ConclusionAs such, research ethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs’ risk-benefit task. (shrink)

Although the use of the cluster randomized trial (CRT) design to evaluate vaccines, public health interventions or health systems is increasing, the ethical issues posed by the design are not adequately addressed, especially in low- and middle-income country settings (LMICs). To help reveal ethical challenges, qualitative interviews were conducted with key stakeholders experienced in designing and conducting two selected CRTs in Malawi. The 18 interviewed stakeholders included investigators, clinicians, nurses, data management personnel and community workers who were invited to share (...) their experiences related to implementation of CRTs. Data analysis revealed five major themes with ethical implications: (1) The moral obligation for health care providers to participate in health research and its compensation; (2) Suboptimal care services compromising the integrity of CRT; (3) Ensuring scientific validity and withholding care service; (4) Obtaining valid consent and permission for waiver of consent; and (5) Inadequate risk assessment for trial participation. Understanding key ethical issues posed by CRTs in Malawi could improve ethical review and research oversight of this particular study design. (shrink)

Scientific knowledge has not stabilized in the current, early, phase of research and development of nanotechnologies creating a challenge to ‘upstream’ public engagement. Nevertheless, the idea that the public should be involved in deliberative discussions and assessments of emerging technologies at this early stage is widely shared among governmental and nongovernmental stakeholders. Many forums for public debate including focus groups, and citizen juries, have thus been organized to explore public opinions on nanotechnologies in a variety of countries over the past (...) few years. In Switzerland the Centre for Technology Assessment (TA-Swiss) organized such a citizen panel in fall 2006. Drawing from an ethnographic study of this panel called ‘publifocus on nanotechnologies, health, and environment’ this paper looks at the ways members of a stakeholder group deal with the epistemic uncertainty in their deliberation of nanotechnologies. By exploring the statements of the participants in the stakeholder discussion group, this paper reconstructs the narratives that constitute the epistemic foundations of the participants’ evaluations of nanotechnologies. (shrink)

The perception of two key stakeholders such as policymakers and scientists on genetic modification (GM) technology was examined in Ghana and Nigeria using semi-structured interviews. A total sample of 20 policymakers (16 at ministries and 4 at parliament/cabinet) and 58 scientists (43 at research institutes and 15 at universities) participated at the interviews. This study revealed respondents perspectives on potential benefits and risks of GM technology, status and development of biosafety regulatory frameworks, role of science and technology innovation in agricultural (...) development, intellectual property right and related issues. The study also shed some light on a possible influence of the European Union and United States in the development and potential adoption of GM technology. More importantly, the article suggests that most respondents including policymakers believe that GM technology has great potential to solve part of agricultural problems in both countries. But, lack of appropriate regulatory framework, lack of trained personnel, weak institutions and poor equipped laboratory among others represent a significant challenge in introducing GM technology in this part of Africa. (shrink)

In 2009, Greenpeace launched an aggressive campaign against Nestlé, accusing the organization of driving rainforest deforestation through its palm oil suppliers. The objective was to damage the brand image of Nestlé and, thereby, force the organization to make its supply chain more sustainable. Prominent cases such as these have led to the prevailing view that sustainable supply chain management is primarily reactive and propelled by external pressures. This research, in contrast, assumes that SSCM can contribute positively to the reputation (...) of an organization as a “good citizen” and, thereby, counter the impression that external stakeholder pressure is the only driver of SSCM. The study draws on Resource Dependence Theory in analyzing the three competing models of the potential stakeholder, SSCM and the corporate sustainability performance relationship. A dataset of 1,621 organizations allows the statistical comparison of these three models. Findings suggest that stakeholder pressure and SSCM both contribute to an organization’s sustainability performance. Thus, supply chain managers will perceive benefits from SSCM other than merely the reduction of risk from reputational damage through stakeholder activism. (shrink)

With the growing amount of clinical research, regulations and research ethics are becoming more stringent. This trend introduces a need for quality assurance measures for ensuring adherence to research ethics and human research protection beyond Institutional Review Board approval. Audits, one of the most effective tools for assessing quality assurance, are measures used to evaluate Good Clinical Practice and protocol compliance in clinical research. However, they are laborious, time consuming, and require expertise. Therefore, we developed a simple auditing process and (...) evaluated its feasibility and effectiveness. The screening audit was developed using a routine audit checklist based on the Severance Hospital’s Human Research Protection Program policies and procedures. The measure includes 20 questions, and results are summarized in five categories of audit findings. We analyzed 462 studies that were reviewed by the Severance Hospital Human Research Protection Center between 2013 and 2017. We retrospectively analyzed research characteristics, reply rate, audit findings, associated factors and post-screening audit compliance, etc. Investigator reply rates gradually increased, except for the first year. The studies were graded as “critical,” “major,” “minor,” and “not a finding”, based on findings and number of deficiencies. The auditors’ decisions showed fair agreement with weighted kappa values of 0.316, 0.339, and 0.373. Low-risk level studies, single center studies, and non-phase clinical research showed more prevalent frequencies of being “major” or “critical”. Inappropriateness of documents, failure to obtain informed consent, inappropriateness of informed consent process, and failure to protect participants’ personal information were associated with higher audit grade. We were able to observe critical GCP violations in the routine internal audit results of post-screening audit compliance checks in “non-responding” and “critical” studies upon applying the screening audit. Our screening audit is a simple and effective way to assess overall GCP compliance by institutions and to ensure medical ethics. The tool also provides useful selection criteria for conducting routine audits. (shrink)

Stakeholder theory focuses on how more value is created if stakeholder relationships are governed by ethical principles such as integrity, respect, fairness, generosity and inclusiveness. However, it has not adequately addressed strategies that stakeholders perceive as harmful to their interests and how this perception can even lead some stakeholders to view the firm’s strategies as unethical. To fill the void, this paper directly addresses strategies that stakeholders perceive as harmful to their interests, or what we refer to as harmful stakeholder (...) strategies. Specifically, it identifies factors associated with stakeholder perceptions of harm that are likely to cause them to consider a strategy unethical, examines the negative implications for firms that pursue such strategies in terms of likely stakeholder responses and damage to stakeholder relationships, and provides theory to help explain how firms are likely to respond to stakeholder claims that a strategy is unethical, based on factors such as the strategic importance of the claim to the firm, how long the strategy has been in use, the costs of remediation, the risk of stakeholder mobilization or new regulation, and whether firms can reasonably rationalize their actions. Assessing harm allows a firm to make a more accurate estimate of the costs of a strategy and can assist managers in allocating resources intended to reduce or remediate harm. (shrink)

This study aimed to explore stakeholders’ perspectives on the ethical considerations for returning individual pharmacogenomics research results to people living with HIV. A qualitative approach to investigation involved five focus group discussions with 30 Community representatives, 12 key informant interviews with researchers, and 12 in-depth interviews with research ethics committee members. In total, 54 stakeholders who were involved in pharmacogenomics research and HIV treatment and care contributed to the data collection between September 2021 and February 2022. The study explored (...) five prominent themes: (i) defining the nature of research results to return to participants; (ii) preparing research participants to receive their results; (iii) obtaining informed consent for the return of results; (iv) opinions on health personnel to return the results to participants; and (v) opinions on how research results should be communicated to participants. Respondents identified various strategies for the return of individual results with minimal ethical risks including the setting up of a diverse and independent committee to undertake a risk-benefit assessment based on local context; ongoing discussions about the possible kinds of results and their implications throughout the study; and employing genetic counsellors to communicate results to participants. The strategies identified in this study should be further studied and independently verified. (shrink)

The legitimacy of multi-stakeholder initiatives (MSIs) as institutions for social and environmental governance in the global economy has received much scholarly attention over the past years. To date, however, research has yet to focus on assessing the legitimacy of MSIs in their interactions with other actors within larger systems of deliberation. Drawing on the deliberative systems perspective developed within deliberative democracy theory, we theorise a normative framework to evaluate the roles of MSIs within the broader systems of governance they co-construct (...) through their interactions with other initiatives, governments, non-governmental organisations, and other external actors. As we demonstrate in our evaluation of the illustrative case of the Bangladesh Accord on Fire and Building Safety as a MSI in the context of the Bangladeshi garment industry, this framework can help researchers assess whether a MSI ultimately serves to enhance or undermine the deliberative legitimacy of the overall system of which it forms a part. (shrink)

This study presents the case of a Metropolitan Municipality in the Aegean Region of Turkey, which undertook a series of initiatives to conduct projects on environmental protection and sustainability. This case study was conducted as two separate studies as a part of Horizon 2020-funded ECHOES project under Work Package 6, aiming to gain insight into the collective magnitudes of energy-related choices and behavior. The starting point of the process is marked, in 2015, by the municipality becoming a party to the (...) Covenant of Mayors movement, joining around 8,000 signatories from over 50 countries. In line with European Union’s climate targets and associated energy-related policies, signatories of the Covenant of Mayors aim to decrease carbon emissions by 20% by 2020 and by 40% by 2030. In order to enhance the design and operationalization of policies for achieving these targets, each partner in the Covenant of Mayors is required to develop a Sustainable Energy Action Plan. The SEAP is to be prepared within 2 years of becoming a party to the Covenant of Mayors and involves action plans and projects in order to operationalize the strategies for achieving the associated targets. To this end, this study analyzes the Metropolitan Municipality’s SEAP and its components, which include zero-emission public transportation project, transformation of existing buildings to a more energy-efficient standard and related energy audit studies, a project for decreasing waiting periods in traffic via a Smart Traffic System, a pedestrianization project, and a project for increasing the use of geothermal energy for district heating. This study set out to identify the internal and external factors, as well as bottom-up and top-down mechanisms involved in various phases of the preparation and implementation of the SEAP. The research method was expert interviews, incorporating viewpoints and perceptions of stakeholders from different levels of the municipality. Among the key results are understanding the roles of enthusiasts and frontrunners in such initiative and the importance of top-management and central government support. (shrink)

With more than half of individuals incarcerated having serious mental health concerns, correctional settings offer excellent opportunities for epidemiological, prevention, and intervention research. However, due to unique ethical and structural challenges, these settings create risks and vulnerabilities for participants not typically encountered in research populations. We surveyed 1,224 researchers, Institutional Review Board members, and IRB prisoner representatives to assess their perceptions of risks and vulnerabilities associated with mental health research conducted in correctional settings. Highest ranked risks were related to (...) privacy, stigma, and confidentiality; lowest ranked risks were related to prisoners’ loss of privileges or becoming targets of violence due to having participated in research. Cognitive impairment, mental illness, lack of autonomy, and limited access to services emerged as the greatest sources of vulnerability; being male, being female, being older than age 60, being a minority, and being pregnant were the lowest ranked sources of vulnerability. Researchers with corrections experience perceived lower risks and vulnerabilities than all other groups, raising the question whether these researchers accurately appraise risk and vulnerability based on experience, or if their lower risk and vulnerability perceptions reflect potential bias due to their vested interests. By identifying areas of particular risk and vulnerability, this study provides important information for researchers and research reviewers alike. (shrink)

To effectively pursue ethical action, the business community must recognize that the fundamental form of human association is not the "social contract" into which persons enter as atomic individuals, making partial commitments to each other for the purpose of gaining limited common ends or of satisfying certain laws. The fundamental form of human association is rather the face to face community in which ongoing commitments are the rule and in which aspects of every individual''s experience are conditioned by the continuing (...) membership. The following discussion initiates a preliminary phase in the consideration of what constitutes ethical issues associated with the business applications of expert systems. The focus is on knowledge based expert system applications in public accounting, specifically in the audit domain. Prior research on the development and use of expert systems in auditing has focused on a limited set of ethical issues. Niebuhr''s theory of the "the responsible self" is used here to broaden the scope of what constitutes an ethical issue and provides a framework for identifying responsible action. Within this framework, an action is responsible if it takes into consideration ongoing relationships among the stakeholder groups affected. Actions prior to the development of the system along with the potential consequences for the system must be considered. The discursive requirements that provide the context and conditions necessary for implementing the proposed theoretical framework are presented and an illustration of how the responsibility ethic can be implemented in the audit expert system domain is developed. (shrink)

This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants to be permitted (...) access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)

Background: Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees should evaluate the risks of comparative effectiveness research. Main text: We discuss what has been a prominent focus in the debate about comparative effectiveness research, namely that it is justified when “nothing is known” about the comparative effectiveness of the available alternatives. We argue that this focus may be misleading. (...) Rather, we should focus on the fact that some experts believe that the evidence points in favor of one intervention, whereas other experts believe that the evidence favors the alternative. We will then introduce a case that illustrates this point, and based on that, discuss how ERCs should deal with such cases of expert disagreement. Conclusion: We argue that ERCs have a duty to assess the range of expert opinions and based on that assessment arrive at a risk judgment about the study under consideration. We also argue that assessment of expert disagreement is important for the assignment of risk level to a clinical trial: what is the basis for expert opinions, how strong is the evidence appealed to by various experts, and how can clinical trial monitoring affect the possible increased risk of clinical trial participation. (shrink)

Ethical issues related to comparative effectiveness research, or research that compares existing standards of care, have recently received considerable attention. In this paper we focus on how Ethics Review Committees should evaluate the risks of comparative effectiveness research. We discuss what has been a prominent focus in the debate about comparative effectiveness research, namely that it is justified when “nothing is known” about the comparative effectiveness of the available alternatives. We argue that this focus may be misleading. Rather, we should (...) focus on the fact that some experts believe that the evidence points in favor of one intervention, whereas other experts believe that the evidence favors the alternative. We will then introduce a case that illustrates this point, and based on that, discuss how ERCs should deal with such cases of expert disagreement. We argue that ERCs have a duty to assess the range of expert opinions and based on that assessment arrive at a risk judgment about the study under consideration. We also argue that assessment of expert disagreement is important for the assignment of risk level to a clinical trial: what is the basis for expert opinions, how strong is the evidence appealed to by various experts, and how can clinical trial monitoring affect the possible increased risk of clinical trial participation. (shrink)

Healthy volunteers in biomedical research often face significant risks in studies that offer them no medical benefits. The U.S. federal research regulations and laws adopted by other countries place no limits on the risks that these participants face. In this essay, I argue that there should be some limits on the risks for biomedical research involving healthy volunteers. Limits on risk are necessary to protect human participants, institutions, and the scientific community from harm. With the exception of self-experimentation, limits (...) on research risks faced by healthy volunteers constitute a type of soft, impure paternalism because participants usually do not fully understand the risks they are taking. I consider some approaches to limiting research risks and propose that healthy volunteers in biomedical research should not be exposed to greater than a 1% chance of serious harm, such as death, permanent disability, or severe illness or injury. While this guideline would restrict research risks, the limits would not be so low that they would prevent investigators from conducting valuable research. They would, however, set a clear upper boundary for investigators and signal to the scientific community and the public that there are limits on the risks that healthy participants may face in research. This standard provides guidance for decisions made by oversight bodies, but it is not an absolute rule. Investigators can enroll healthy volunteers in studies involving a greater than 1% chance of serious harm if they show that the research addresses a compelling public health or social problem and that the risk of serious harm is only slightly more than 1%. The committee reviewing the research should use outside experts to assess these risks. (shrink)

ABSTRACT This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants to be (...) permitted access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)