Regulatory impact assessment (RIA) is seen as a tool for increasing evidence-based policy making and as such it is being integrated into decision-making procedures on a wide range of issues. Based on systematic consultation, clear criteria for policy choice, and economic analysis of how costs and benefits impact on a wide range of affected parties, this tool operates by using scientific knowledge and technical analysis rather than political considerations. Scientific knowledge can be used to achieve instrumental (...) learning (Radaelli, 2009, OECD), policy change (Sabatier, 1999), to impact on decision making (Caplan, 1979; C.H.Weiss, 1999) but also to seek legitimacy from the policy environment (Edelman, 1985; Schrefler, 2010). This article suggests an analytical framework for analysing RIA documents with insight from knowledge utilization theories. We argue that in order to better understand the RIA itself, we need to look at institutional factors as well. The combination of institutional context variables and variables for RIA document content analysis which make up worldviews in this framework provide the basis for the document analysis and exploration of RIA in its context. (shrink)

The growing reliance on non-governmental independent regulators in many social and economic domains, including corporate financial reporting, has brought to the fore concerns over their regulatory accountability. This study looks at one aspect of the regulatory due process-regulatory impact assessment (IA). Drawing on the analytical framework developed by Bovens (Public accountability: a framework for the analysis and assessment of accountability arrangements in the public domain. CONNEX papers, Research Group 2, Democracy and Accountability in the (...) EU, 2006, Eur Law J 13(4): 447–468, 2007), we evaluate the contribution of IA as an instrument for enhancing regulatory accountability in the context of the Financial Reporting Council, an independent regulator for the accountancy profession in the UK. The study’s findings suggest that, despite an increasing level of sophistication in the manner in which IA is used within FRC, the contribution of IA to regulatory accountability remains limited. Specifically, there are concerns as to whether IA is used to achieve a transparent and fair regulatory process or simply to maintain an image of good governance and justify policy decisions that would have been made even in the absence of IA. (shrink)

Behind the pendulum-like regulatory swings between interventionism and laissezpasser that are nothing but the results of changing contexts are the legal principles as their denominators and connectors. Legal principles guide explanations and give paths that a decision maker must not circumvent. In the enhanced dynamic environment that is based more on risk and prediction than solely ex post adaptation they cannot cope with the more numerous information and communication channels. Principles can be more fully embraced with the help of (...) more systematically-elaborated reality. Without clear steps needed for the formation of principles talks about the regulatory impact assessment, risk management, evidence-based approach and other regulatory notions are only a stuff for filling the paper lines than the real tools for the management of reality. (shrink)

Spatial developments contribute to climate change through greenhouse gas emissions and disordered land use. At the same time, climate change impacts have spatial implications, influencing the land uses and settlements development, and damaging habitats, ecosystems, infrastructure and other assets. Considering its regulatory character and multi-sectorial approach, spatial planning is gaining an increasingly important role in climate change management. As such, it could be better utilized in increasing climate resiliency and achieving decarbonization targets in Kosovo as well. While Kosovo is (...) prone to natural hazards such as floods, landslides, droughts, and wildfires, the future climate change could further impact the economy, infrastructure, buildings, energy, health and wellbeing of its communities. Assuming that climate change considerations are not sufficiently integrated in spatial planning policies at the national level in Kosovo, this research assesses the extent that the Law on Spatial Planning and the Spatial Plan of Kosovo (also referred as the Spatial Planning Strategy) address those considerations. Upon the identified gaps, this research provides recommendations for better climate change management, risk reduction and resiliency building. Considering that the Spatial Plan of Kosovo has expired, and the Kosovo’s institutions are currently reviewing and considering the updating of the Law on Spatial Planning, the findings of this research could better inform and orient climate change mainstreaming in spatial planning at the central level. (shrink)

For the purposes of conservation or suppression of species, gene drive technology has significant potential. Theoretically speaking, with the release of even relatively few animals with gene drive systems in an ecosystem, beneficial or harmful genes could be introduced into the entire wild-type population of that species. Given the profound impact that gene drives could have on species and ecosystems, their use is a highly contentious issue. Communities and groups have differing beliefs about nature and its conservation or preservation, (...) as well as concerns about the ecological safety of the eradication, replacement or enhancement of particular species of animals by means of genetic engineering. For all those reasons, the rigorous regulation of insects and other animals with gene drive systems is crucial. In this paper, we consider the question of whether the United States Food and Drug Administration is prepared to effectively regulate insects and other animals with gene drives. (shrink)

There is a “revolving door” between federal agencies and the industries regulated by them. Often, at the end of their industry tenure, key industry personnel seek employment in government regulatory entities and vice versa. The flow of workers between the two sectors could bring about good. Industry veterans might have specialized knowledge that could be useful to regulatory bodies and former government employees could help businesses become and remain compliant with regulations. But the “revolving door” also poses at (...) least three ethical and policy challenges that have to do with public trust and fair representation. First, the presence of former key industry personnel on review boards could adversely impact the public’s confidence in regulatory decisions about new technology products, including agrifood biotechnologies. Second, the ‘‘revolving door’’ may result in policy decisions about technologies that are biased in favor of industry interests. And third, the ‘‘revolving door’’ virtually guarantees industry a voice in the policy-making process, even though other stakeholders have no assurance that their concerns will be addressed by regulatory agencies. We believe these three problems indicate a failure of regulatory review for new technologies. The review process lacks credibility because, at the very least, it is procedurally biased in favor of industry interests. We argue that prohibiting the flow of personnel between regulatory agencies and industry would not be a satisfactory solution to the three problems of public trust and just representation. To address them, regulatory entities must reject the traditional notion of objectivity. Instead they should adopt the conception of objectivity developed by Sandra Harding and re-configure their regulatory review on the basis of it. That will ensure that a heterogeneous group of stakeholders is at the decision-making table. The fair representation of interests of different constituencies in the review process could do much to inspire warranted public confidence in regulatory protocols and decisions. (shrink)

In this paper, we distinguish between different sorts of assessments of algorithmic systems, describe our process of assessing such systems for ethical risk, and share some key challenges and lessons for future algorithm assessments and audits. Given the distinctive nature and function of a third-party audit, and the uncertain and shifting regulatory landscape, we suggest that second-party assessments are currently the primary mechanisms for analyzing the social impacts of systems that incorporate artificial intelligence. We then discuss two kinds of (...) as-sessments: an ethical risk assessment and a narrower, technical algo-rithmic bias assessment. We explain how the two assessments depend on each other, highlight the importance of situating the algorithm within its particular socio-technical context, and discuss a number of lessons and challenges for algorithm assessments and, potentially, for algorithm audits. The discussion builds on our team’s experience of advising and conducting ethical risk assessments for clients across dif-ferent industries in the last four years. Our main goal is to reflect on the key factors that are potentially ethically relevant in the use of algo-rithms, and draw lessons for the nascent algorithm assessment and audit industry, in the hope of helping all parties minimize the risk of harm from their use. (shrink)

The paper examines twelve legal regimes related to the governance and regulation of both the environmental risks and opportunities brought forth by the use of AI systems and AI models in the Artificial Intelligence Act (‘AIA’) of EU law. The assessment of risks and opportunities of AI related to the environment includes the high-risk management procedures under Art. 9 of the AIA, the “fundamental rights impact assessment” of Art. 27, and the codes of conduct of Art. 95. (...) These provisions are supplemented by further regulatory regimes, such as the proposal of EU directive on sustainable consumption and green claims, and Reg. (EU) 2023/588 on environmental and space sustainability, among others. The aim of the analysis is to specify which are the less or the more environmentally friendly regulatory regimes set up with the AIA. The claim is that Art. 9, 27 and 95 are among the less green pieces of the whole legislation. (shrink)

Risk analysis and regulatory systems are usually evaluated according to utilitarian frameworks, as they are viewed to operate “objectively” by considering the health, environmental, and economic impacts of technological applications. Yet, the estimation of impacts during risk analysis and the decisions in regulatory review are affected by value choices of actors and stakeholders; attention to principles such as autonomy, justice, and integrity; and power relationships. In this article, case studies of biotechnology are used to illustrate how non-utilitarian principles (...) are prominent in risk analysis and regulatory review and to argue that these relationships should be carefully considered as we consider nanotechnology oversight systems for its products. We argue that there are not distinct separations between “science-based” review systems, in which evaluations of the consequences of technological products are primarily considered, and principles of integrity, justice, non-maleficence, and autonomy. It should further be expected that, given research into fair treatment during decision-making processes, attention to ethics will affect how citizens assess emerging technologies. Finally, a more holistic approach for evaluating oversight systems for the products of nanotechnology is suggested, one which does not draw a sharp distinction between risk analysis, regulation, and respect for non-utilitarian values. (shrink)

This article presents and evaluates arguments supporting that an approval procedure for genome-edited organisms for food or feed should include a broad assessment of societal, ethical and environmental concerns; so-called non-safety assessment. The core of analysis is the requirement of the Norwegian Gene Technology Act that the sustainability, ethical and societal impacts of a genetically modified organism should be assessed prior to regulatory approval of the novel products. The article gives an overview how this requirement has been (...) implemented in the regulatory practice, demonstrating that such assessment is feasible and justified. Even in situations where genome-edited organisms are considered comparable to non-modified organisms in terms of risk, the technology may have—in addition to social benefits—negative impacts that warrant assessments of the kind required in the Act. The main reason is the disruptive character of the genome editing technologies due to their potential for novel, ground-breaking solutions in agriculture and aquaculture combined with the economic framework shaped by the patent system. Food is fundamental for a good life, biologically and culturally, which warrants stricter assessment procedures than what is required for other industries, at least in countries like Norway with a strong tradition for national control over agricultural markets and breeding programs. (shrink)

The quality of working conditions have a direct impact on the individuals’ quality of life and level of well-being. Attention to well-being in work environments has become a matter of great interest for legislators. However, the well-being concept has not yet found a legal definition. The first commitment to achieve a global well-being strategy was made by the World Health Organisation. The European Union claims that a positive relationship between work and well-being is a necessary factor to reach greater (...) economic and social progress, since full and quality employment is one of the main elements of economic stability and social cohesion in a country. The Italian regulatory framework consists of various legislative provisions: the importance of the workers’ good health and quality of life has generated a complex regulatory system. In the digital society the potential health risks associated with the use of IT tools and the risk of an increased overlapping between work and personal life should not be overlooked. (shrink)

Genetically engineered animals that are meant for release in the wild could significantly impact ecosystems given the interwoven or entangled existence of species. Therefore, among other things, it is all too important that regulatory agencies conduct entity appropriate, rigorous risk assessments that can be used for informed decision-making at the local, national and global levels about the release of those animals in the wild. In the United States, certain GE animals that are intended for release in the wild (...) may be regulated as new animal drugs by the Food and Drug Administration. This paper argues that the decision to treat them as new animal drugs is attributable to the influence of neoliberalism on the US biotechnology regulatory policy framework. The case is made that there should be public democratic deliberations and decision-making about the values and concerns that should guide the nation’s biotechnology regulatory policy paradigm, including the risk assessment process for GE animals meant for release in the wild. -/- . (shrink)

Research shows that trained mentors achieve better results than untrained ones. Their training should particularly address their expectations for their future mentoring. Our study involved 190 preservice teachers, potential mentors of ongoing school mentoring for primary and secondary school students of all grades. They were randomly assigned to one of four conditions in a 2-x-2 between-subjects design of mentoring type (traditional mentoring versus e-mentoring) and mentoring context (non-pandemic versus COVID-19 pandemic). Participants assessed mentoring conducted under these four conditions in terms (...) of its appropriateness for achieving four mentoring program targets: learning, key skills, social targets, and problem coping. Participants were also asked to assess the resources available to achieve each program target. Overall, the potential mentors considered the various conditions to be suitable for achieving the four program targets. They were particularly favorable in their assessment of the possibility for the realization of learning targets. Likewise, they assumed that sufficient resources were available to achieve the targets. However, a repeated-measures MANOVA showed that the potential mentors considered more ambitious targets to be possible in traditional mentoring than in e-mentoring and normal (i.e., pre-pandemic) contextual conditions than during the COVID-19 pandemic. In contrast, they estimated the resources available to achieve the targets to be about the same in the four conditions. This indicates a decoupling of mentoring targets from the consideration of the resources needed to achieve them. This assumption was confirmed in correlation analyses and has implications for mentor training. (shrink)

BackgroundThe SARS-COVID-19 pandemic and its associated disease control restrictions have in multiple ways affected families with young children, who may be especially vulnerable to mental health problems. Studies report an increase in perinatal parental distress as well as symptoms of anxiety or depression in children during the pandemic. Currently, little is known about the impact of the pandemic on infants and their development. Infant regulatory problems have been identified as early indicators of child socio-emotional development, strongly associated with (...) maternal mental health and the early parent–infant interaction. Our study investigates whether early parenthood under COVID-19 is associated with more maternal depressive symptoms and with a perception of their infants as having more RPs regarding crying/fussing, sleeping, or eating, compared to mothers assessed before the pandemic.MethodsAs part of a longitudinal study, 65 women who had given birth during the first nationwide disease control restrictions in Northern Germany, were surveyed at 7 months postpartum and compared to 97 women assessed before the pandemic. RPs and on maternal depressive symptoms were assessed by maternal report. Number of previous children, infant negative emotionality, and perceived social support were assessed as control variables.ResultsCompared to the control cohort, infants born during the COVID-19 pandemic and those of mothers with higher depressive symptoms were perceived as having more sleeping and crying, but not more eating problems. Regression-based analyses showed no additional moderating effect of parenthood under COVID-19 on the association of depressive symptoms with RPs. Infant negative emotionality was positively, and number of previous children was negatively associated with RPs.LimitationsDue to the small sample size and cross-sectional assessment, the possibility for more complex multivariate analysis was limited. The use of parent-report questionnaires to assess infant RPs can support but not replace clinical diagnosis.ConclusionsThe pandemic conditions affecting everyday life may have a long-term influence on impaired infant self- and maternal co-regulation and on maternal mental health. This should be addressed in peripartum and pediatric care. Qualitative and longitudinal studies focusing on long-term parental and infant outcomes under ongoing pandemic conditions are encouraged. (shrink)

The Adverse Outcome Pathway (AOP) concept is a knowledge assembly and communication tool to facilitate the transparent translation of mechanistic information into outcomes meaningful to the regulatory assessment of chemicals. The AOP framework and associated knowledgebases (KBs) have received significant attention and use in the regulatory toxicology community. However, it is increasingly apparent that the potential stakeholder community for the AOP concept and AOP KBs is broader than scientists and regulators directly involved in chemical safety assessment. (...) In this paper we identify and describe those stakeholders who currently—or in the future—could benefit from the application of the AOP framework and knowledge to specific problems. We also summarize the challenges faced in implementing pathway-based approaches such as the AOP framework in biological sciences, and provide a series of recommendations to meet critical needs to ensure further progression of the framework as a useful, sustainable and dependable tool supporting assessments of both human health and the environment. Although the AOP concept has the potential to significantly impact the organization and interpretation of biological information in a variety of disciplines/applications, this promise can only be fully realized through the active engagement of, and input from multiple stakeholders, requiring multi-pronged substantive long-term planning and strategies. (shrink)

BackgroundCountries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants.DiscussionResearch ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation (...) programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices.The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals.ConclusionOutcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective participants' decisions about whether to participate in research? Third, does it change participants' subjective experiences in studies or their attitudes about research? Fourth, does it reduce the riskiness of research? Fifth, does it result in more research responsive to the local community's self-identified needs? Sixth, is research ethics committees' guidance to researchers actually being followed? (shrink)

Increasingly our society relies upon government regulatory agencies to protect its people, its institutions and its environment from the negative impacts of new technologies. These agencies are saddled with the task of deciding among strongly conflicting viewpoints represented by a wide range of interest groups and “value communities” within the society. When regulatory decisions are made some interests and values are protected while others are curtailed.

Despite regulatory reforms aimed at inhibiting aggressive financial reporting, earnings management persists and continues to concern practitioners, regulators, and standard setters. To provide insight into this practice and how to mitigate it, we conduct an experiment to examine the impact of two independent variables on CFOs’ discretionary expense accruals. One independent variable, incentive conflict, is manipulated at two levels —i.e., the presence or absence of a personal financial incentive that conflicts with a corporate financial incentive. The other independent (...) variable is CFOs’ earnings management ethics, measured as their assessment of the ethicalness of key earnings management motivations. We find that incentive conflict and EM-Ethics interact to determine CFOs’ discretionary accruals such that in the presence of incentive conflict, CFOs with low EM-Ethics tend to give into the personal incentive by booking higher expense accruals; and in the absence of an incentive conflict, CFOs with low EM-Ethics tend to give into the corporate incentive by booking lower expense accruals. We also find support for a mediated-moderation model in which CFOs’ level of EM-Ethics influences their moral disengagement tendencies which, in turn, differentially affect their discretionary accruals, depending on the presence or absence of incentive conflict. Theoretical and practical implications of these findings are discussed. (shrink)

A tension between the professions' pursuit of autonomy and the public's demand for accountability has led to the development of codes of ethics as both a foundation and guide for professional conduct in the face of morally ambiguous situations. The profession as an institution serves as a normative reference group for individual practitioners and through a code of ethics clarifies, for both its members and outsiders, the norms that ought to govern professional behavior. Three types of codes can be identified (...) — aspirational, educational and regulatory. All codes serve multiple interests and, as a consequence, perform many functions, eight of which are discussed. The process of developing a code of ethics is assessed because of the role it plays in gaining consensus on professional values and ethical norms. After discussing some of the weaknesses in current approaches to professional self-regulation, several new private and public initiatives are proposed. (shrink)

In recent years, we have been observing an increasing significance of industrial heritage in international heritage studies. Developed in response to urban development needs, industrial heritage is now considered a valuable part of the city. Such an approach has resulted in the adaptive reuse of industrial heritage in the developing countries. This is, indeed, a practical solution for sustainable development of cities and the subject matter of many academic discussions. In this respect Heritage Impact Assessment (HIA) seems to (...) be a useful tool. This paper aims to study the role of HIA in adaptive reuse practice in industrial heritage sites in Iran. For that purpose, the authors have used a combined research method including historic study, analytical-description techniques and questionnaire-based interviews (with heritage managers and planners). The results indicate that HIA guidelines play a useful role in preserving the significance of historic cultural heritage and should be observed in the adaptive reuse practice in respect of the industrial heritage sites in Iran. Based on the analysed examples of successfully converted sites, this paper advocates using HIA as a useful tool in determining the potential of a given industrial heritage site for a successful reuse. (shrink)

Economic growth and development remain embedded in the very core of our current international economic system and the so called “material economy”. However, depleting natural resources and environmental degradation, which now threaten the well-being of future generations, has challenged this premise, and placed sustainable development as a necessary objective of business activity and expansion. Environmental impact assessments (EIAs) have emerged as a key tool for governments, businesses, and NGOs to manage the negative impact of their activities on the (...) environment. Businesses in particular play a key role in averting or mitigating current environmental trends given that the economic growth they have stimulated has serious consequences for both the environment and social well-being. However, research on the use of EIAs has been conducted mostly from a governmental perspective producing a clear gap between research development and business (corporate) practice. To bridge this gap in knowledge, we develop a new EIA process tailored to real world business constraints and provide a range of propositions which we hope will stimulate future research efforts toward understanding and guiding how businesses integrate environmental issues into their decision-making processes. (shrink)

In recent years, genetically engineered (GE) mosquitoes have been proposed as a public health measure against the high incidence of mosquito-borne diseases among the poor in regions of the global South. While uncertainties as well as risks for humans and ecosystems are entailed by the open-release of GE mosquitoes, a powerful global health governance non-state organization is funding the development of and advocating the use of those bio-technologies as public health tools. In August 2016, the US Food and Drug Agency (...) (FDA) approved the uncaged field trial of a GE Aedes aegypti mosquito in Key Haven, Florida. The FDA’s decision was based on its assessment of the risks of the proposed experimental public health research project. The FDA is considered a global regulatory standard setter. So, its approval of the uncaged field trial could be used by proponents of GE mosquitoes to urge countries in the global South to permit the use of those bio-technologies. -/- From a public health ethics perspective, this paper evaluates the FDA’s 2016 risk assessment of the proposed uncaged field trial of the GE mosquito to determine whether it qualified as a realistic risk evaluation. -/- The FDA’s risk assessment of the proposed uncaged field trial did not proximate the conditions under which the GE mosquitoes would be used in regions of the global South where there is a high prevalence of mosquito-borne diseases. -/- Given that health and disease have political-economic determinants, whether a risk assessment of a product is realistic or not particularly matters with respect to interventions meant for public health problems that disproportionately impact socio-economically marginalized populations. If ineffective public health interventions are adopted based on risk evaluations that do not closely mirror the conditions under which those products would actually be used, there could be public health and ethical costs for those populations. (shrink)

BackgroundThe present study examined the efficacy of the Michigan Model of Infant Mental Health-Home Visiting infant mental health treatment to promote the socioemotional wellbeing of infants and young children. Science illuminates the role of parental “co-regulation” of infant emotion as a pathway to young children’s capacity for self-regulation. The synchrony of parent–infant interaction begins to shape the infant’s own nascent regulatory capacities. Parents with a history of childhood adversity, such as maltreatment or witnessing family violence, and who struggle with (...) symptoms of post-traumatic stress may have greater challenges in co-regulating their infant, thus increasing the risk of their children exhibiting social and emotional problems such as anxiety, aggression, and depression. Early intervention that targets the infant–parent relationship may help buffer the effect of parental risk on child outcomes.MethodsParticipants were 58 mother–infant/toddler dyads enrolled in a longitudinal randomized control trial testing the efficacy of the relationship-based IMH-HV treatment model. Families were eligible based on child age and endorsement of at least two of four socio-demographic factors commonly endorsed in community mental health settings: elevated depression symptoms, three or more Adverse Childhood Experiences parenting stress, and/or child behavior or development concerns. This study included dyads whose children were born at the time of study enrollment and completed 12-month post-baseline follow-up visits. Parents reported on their own history of ACEs and current posttraumatic stress disorder symptoms, as well as their toddler’s socioemotional development.ResultsMaternal ACEs predicted more toddler emotional problems through their effect on maternal PTSD symptoms. Parents who received IMH-HV treatment reported more positive toddler socioemotional wellbeing at follow-up relative to the control condition. The most positive socioemotional outcomes were for toddlers of mothers with low to moderate PTSD symptoms who received IMH-HV treatment.ConclusionResults indicate the efficacy of IMH-HV services in promoting more optimal child socioemotional wellbeing even when mothers reported mild to moderate PTSD symptoms. Results also highlight the need to assess parental trauma when infants and young children present with socioemotional difficulties. (shrink)

Nearly all current attempts at environmental impact analysis and technology assessment fall victim to an ethical and methodological assumption that Keniston termed “the fallacy of unfinished business.” Related to one version of the naturalistic fallacy, this assumption is that technological and environmental problems have only technical, but not social, ethical, or political solutions. After using several impact analyses to illustrate the policy consequences of the fallacy of unfinished business, I suggest how it might be overcome. Next I (...) present three standard arguments, repeatedly used in technology and environmental impact assessments, by those who subscribe to this “fallacy.” I briefty examine the logical, consequentialist, and historical reasons for rejecting all three arguments in favor of this assumption. If my suggestions are correct, then environmental impact analysis is not only a matter of discovering how to finish our technological business, but also a question of learning how to recognize the ethical and epistemological dimensions of our assessment tasks. (shrink)

This study addresses the growing interest in the social impact assessment of corporate social responsibility (CSR) initiatives. Using the benefit (value) transfer approach, this study seeks to demonstrate how the social return on investment (SROI) of a CSR inclusion initiative promoting disability sport participation can be assessed. Literature on CSR inclusion initiatives, social impact measurement, disability sport participation and disability interventions/organizations was reviewed and compared. This helped identify the stakeholders and social outcomes to include, and the assumptions (...) for the financial proxies and beneficiary percentages. Based on data provided by the Rugby Football League in England, an application to Inclusion Rugby League— a CSR inclusion initiative promoting disability sport participation—was then conducted. The SROI of Inclusion Rugby League is 3.39:1—a social return of £3.39 for £1 invested. Our research quantifies the positive social impact of a CSR inclusion initiative in monetary terms, providing insights for assessing SROI. This study informs future research on the social impact assessment of CSR initiatives, offering valuable guidance for organizations and their managers in making a case for further investments in CSR. Moreover, it encourages potential funders to engage in CSR initiatives. (shrink)

This study addresses the growing interest in the social impact assessment of corporate social responsibility (CSR) initiatives. Using the benefit (value) transfer approach, this study seeks to demonstrate how the social return on investment (SROI) of a CSR inclusion initiative promoting disability sport participation can be assessed. Literature on CSR inclusion initiatives, social impact measurement, disability sport participation and disability interventions/organizations was reviewed and compared. This helped identify the stakeholders and social outcomes to include, and the assumptions (...) for the financial proxies and beneficiary percentages. Based on data provided by the Rugby Football League in England, an application to Inclusion Rugby League— a CSR inclusion initiative promoting disability sport participation—was then conducted. The SROI of Inclusion Rugby League is 3.39:1—a social return of £3.39 for £1 invested. Our research quantifies the positive social impact of a CSR inclusion initiative in monetary terms, providing insights for assessing SROI. This study informs future research on the social impact assessment of CSR initiatives, offering valuable guidance for organizations and their managers in making a case for further investments in CSR. Moreover, it encourages potential funders to engage in CSR initiatives. (shrink)

This paper proposes a framework for an ethical impact assessment which can be performed in regard to any policy, service, project or programme involving information technology. The framework is structured on the four principles posited by Beauchamp and Childress together with a separate section on privacy and data protection. The framework identifies key social values and ethical issues, provides some brief explanatory contextual information which is then followed by a set of questions aimed at the technology developer or (...) policy-maker to facilitate consideration of ethical issues, in consultation with stakeholders, which may arise in their undertaking. In addition, the framework includes a set of ethical tools and procedural practices which can be employed as part of the ethical impact assessment. Although the framework has been developed within a European context, it could be applied equally well beyond European borders. (shrink)

Scientific knowledge and technological expertise continue to evolve rapidly. Such innovation gives rise to new benefits as well as risks, at an ever-increasing pace. Within this context, regulatory regimes must function in order to address policymakers’ objectives. Innovation, though, can challenge the functioning and effectiveness of regulatory regimes. Questions over fit, effectiveness, and capacity of these regimes to ensure the safe entry of such technologies, and their products, onto the market will be asked in parallel to their development. (...) With this in mind, this article examines the strengths and weaknesses of current regulatory frameworks, including those designed for biotechnology, cosmetics, novel organisms, and foods, in order to inform and help shape Australia’s regulatory landscape around innovation. By focusing on Australia, the article illustrates the need to assess future changes to regulatory frameworks using a careful balancing of key factors. These include, for example, horizon scanning and monitoring, availability of appropriate data, existing health, safety, environmental, ethical, and social risks and impacts, and regulatory capacity. The article argues that rather than using one of these factors in isolation, a careful assessment of where each factor stands can lead regulators to an approach that properly manages the potential risks of emerging technologies. (shrink)

Epistemic trustworthiness depends not only on one’s epistemic but also on moral qualities. Such qualities need to be upheld by scientific communities and institutions as well as by individual scientific experts. While non-experts can often take scientific experts’ epistemic trustworthiness for granted, in some cases they cannot rationally treat it as the default, and they need to be convinced of the experts’ commitment to the well-being of others. This study contributes to philosophical discussions on public trust in science by introducing (...) an impact assessment model. The model helps philosophers understand how scientific experts can build and maintain epistemic trustworthiness in relation to those social groups who have reasons to distrust scientists. (shrink)

Based on its productionguideline, organic agriculture has set foritself the goals of minimizing all forms ofpollution and maintaining sustainability of thefarming system. By striving for these goals,organic farming meets the demands of anincreasing number of consumers who are criticalof conventional production methods. This papergives an overview of the present state of theart in the different issues. Possibilities ofand limitations in performing the self-aimedgoals under the basic standards of organicagriculture are discussed. Concerningenvironmental protection, in general, the riskof adverse environmental effects is (...) lower withorganic than with conventional farming methods,though not necessarily so; with reference tosoil fertility and nutrient management, organicfarming is suited to improve soil fertility andnutrient management markedly on the farm level;regarding biodiversity, comparison studies showthat organic farming has more positive effectson biodiversity conservation; in relation toproduct quality, under the basic standards oforganic farming, there is no sufficientevidence for a system-related effect on productquality due to the production method. (shrink)

Over the years, companies have adopted hiring algorithms because they promise wider job candidate pools, lower recruitment costs and less human bias. Despite these promises, they also bring perils. Using them can inflict unintentional harms on individual human rights. These include the five human rights to work, equality and nondiscrimination, privacy, free expression and free association. Despite the human rights harms of hiring algorithms, the AI ethics literature has predominantly focused on abstract ethical principles. This is problematic for two reasons. (...) First, AI principles have been criticized for being vague and not actionable. Second, the use of vague ethical principles to discuss algorithmic risks does not provide any accountability. This lack of accountability creates an algorithmic accountability gap. Closing this gap is crucial because, without accountability, the use of hiring algorithms can lead to discrimination and unequal access to employment opportunities. This paper makes two contributions to the AI ethics literature. First, it frames the ethical risks of hiring algorithms using international human rights law as a universal standard for determining algorithmic accountability. Second, it evaluates four types of algorithmic impact assessments in terms of how effectively they address the five human rights of job applicants implicated in hiring algorithms. It determines which of the assessments can help companies audit their hiring algorithms and close the algorithmic accountability gap. (shrink)

In this paper, we assess the impact of extended reality technologies as they relate to sexual forms of harassment. We begin with a brief history of the nature of sexual harassment itself. We then offer an account of extended reality technologies focusing specifically on psychological and hardware elements most likely to comprise what has been referred to as “the metaverse”. Although different forms of virtual spaces exist (i.e., private, semi-private, and public), we focus on public social metaverse spaces. We (...) do this to better explain how the concept of sexual harassment must be adjusted to such spaces and how approaches aimed at mitigating harassment must be sensitive to the type of metaverse spaces users utilize. We then offer a typology of sexual harassment for the metaverse focusing on three distinct forms of sexual harassment: (1) invariant (2) mixed variance or modified and (3) unique or metaverse specific. Although existing normative and legal frameworks may function well with respect to the first and, possibly, second forms of harassment, we argue such frameworks will not helpfully address metaverse-specific harassment. Ultimately, the changing nature of privately owned public spaces (POPS) which metaverses are likely to represent pose distinct ethical and regulatory challenges. (shrink)

The first part of the paper is mainly descriptive. Starting from a short historical sketch of the European construction process, from the initial Treaty of Rome to the actual Treaty of the European Union, the changing trade-offs between the environmental and the economic domain will be overviewed. We will focus on a pragmatic examination of the texts, in their dynamic historical evolution.The second part is evaluative. Examining the fifth Environmental Action Programme more in detail, we will try to determine for (...) which environmental ethics the E.U. stands, as confronted with the alternative paradigm defended by environmentalists and the Green Group in the European Parliament. Is the environmental issue a unifying or a dividing factor in the contrasting cultural landscape of the Old Continent? I think probably Cortona is an excellent place to ask such a speculative question, because we are not far away from Assisi, where a successful Interfaith Meeting on the Environment was organised by the W.W.F. in 1986. (shrink)

The primary responsibility of the US Food and Drug Administration is to protect public health by ensuring the safety of the food supply. To that end, it sometimes conducts risk assessments of novel food products, such as genetically modified food. The FDA describes its regulatory review of GM food as a purely scientific activity, untainted by any normative considerations. This paper provides evidence that the regulatory agency is not justified in making that claim. It is argued that the (...) FDA’s policy stance on GM food is shaped by neoliberal considerations. The agency’s review of a genetically engineered animal, the AquAdvantage salmon, is used as a case study to track the influence of neoliberalism on its regulatory review protocol. After that, an epistemic argument justifying public engagement in the risk assessment of new GM food is outlined. It is because risk evaluations involve normative judgments, in a democracy, layperson representatives of informal epistemic communities that could be affected by a new GM food should have the opportunity to decide the ethical, political or other normative questions that arise during the regulatory review of that entity. (shrink)

Decisions of regulatory government bodies and courts affect many aspects of citizens’ lives. These organizations and courts are expected to provide timely and coherent decisions, although they struggle to keep up with the increasing demand. The ability of machine learning (ML) models to predict such decisions based on past cases under similar circumstances was assessed in some recent works. The dominant conclusion is that the prediction goal is achievable with high accuracy. Nevertheless, most of those works do not consider (...) important aspects for ML models that can impact performance and affect real-world usefulness, such as consistency, out-of-sample applicability, generality, and explainability preservation. To our knowledge, none considered all those aspects, and no previous study addressed the joint use of metadata and text-extracted variables to predict administrative decisions. We propose a predictive model that addresses the abovementioned concerns based on a two-stage cascade classifier. The model employs a first-stage prediction based on textual features extracted from the original documents and a second-stage classifier that includes proceedings’ metadata. The study was conducted using time-based cross-validation, built on data available before the predicted judgment. It provides predictions as soon as the decision date is scheduled and only considers the first document in each proceeding, along with the metadata recorded when the infringement is first registered. Finally, the proposed model provides local explainability by preserving visibility on the textual features and employing the SHapley Additive exPlanations (SHAP). Our findings suggest that this cascade approach surpasses the standalone stages and achieves relatively high Precision and Recall when both text and metadata are available while preserving real-world usefulness. With a weighted F1 score of 0.900, the results outperform the text-only baseline by 1.24% and the metadata-only baseline by 5.63%, with better discriminative properties evaluated by the receiver operating characteristic and precision-recall curves. (shrink)

This article examines how organizational experience influences social enterprise responses to impact assessment practices. Limited attention has been paid to why organizations resist or challenge impact assessment practices or how prior experience with impact assessment may shape organizational responses. The study draws on interviews with practitioners involved in social enterprise–impact investor dyads in Australia and the United Kingdom. The findings reveal that social enterprises enact either combative or collaborative responses in their relationships with (...) impact investors based on past experiences with impact assessment. The study shows how more experienced social enterprises reach a state of impact lock-in—where they become committed to particular approaches to understanding, measuring, and reporting impact. The article contributes to the literature on impact assessment and impact investment by showing how organizational experience shapes divergent reactions to the demands imposed by impact investors, creating complementary forces of institutionalization and contestation of impact assessment practice. (shrink)

This paper assesses possible reasons why Hermann J. Muller avoided peer-review of data that became the basis of his Nobel Prize award for producing gene mutations in male Drosophila by X-rays. Extensive correspondence between Muller and close associates and other materials were obtained from preserved papers to compliment extensive publications by and about Muller in the open literature. These were evaluated for potential historical insights that clarify why he avoided peer-review of his Nobel Prize findings. This paper clarifies the basis (...) of Muller’s (Muller HJ, Sci 66 84-87, 1927c) belief that he produced X-ray induced “gene” mutations in Drosophila. It then shows his belief was contemporaneously challenged by his longtime friend/confidant and Drosophila geneticist, Edgar Altenburg. Altenburg insisted that Muller may have simply poked large holes in chromosomes with massive doses of X-rays, and needed to provide proof of gene “point” mutations. Given the daunting and uncertain task to experimentally address this criticism, especially within the context of trying to become first to produce gene mutations, it is proposed that Muller purposely avoided peer-review while rushing to publish his paper in Science to claim discovery primacy without showing any data. The present paper also explores ethical issues surrounding these actions, including those of the editor of Science, James McKeen Catell and Altenburg, and their subsequent impact on the scientific and regulatory communities. This historical analysis suggests that Muller deliberately avoided peer-review on his most significant findings because he was extremely troubled by the insightful and serious criticism of Altenburg, which suggested he had not produced gene mutations as he claimed. Nonetheless, Muller manipulated this situation (i.e., publishing a discussion within Science with no data, publishing a poorly written non-peer reviewed conference proceedings with no methods and materials, and no references) due to both the widespread euphoria over his claim of gene mutation and confidence that Altenburg would not publically challenge him. This situation permitted Muller to achieve his goal to be the first to produce gene mutations while buying him time to later try to experimentally address Altenburg’s criticisms, and a possible way to avoid discovery of his questionable actions. (shrink)

A study in the sociology of the social and policy sciences, relying heavily for illustration on the use of social impact assessment in the Canadian North with particular reference to the Berger Inquiry.

Control of wild animals may give rise to controversy, as is seen in the case of badger control to manage TB in cattle in the UK. However, it is striking that concerns about the potential suffering of the affected animals themselves are often given little attention or completely ignored in policies aimed at dealing with wild animals. McCulloch and Reiss argue that this could be remedied by means of a “mandatory application of formal and systematic Animal Welfare Impact (...) class='Hi'>Assessment ”. Optimistically, they consider that an AWIA could help to resolve controversies involving wild animals. The aim of this paper is to evaluate the potential of AWIA. We begin by showing how ideas akin to AWIA already play a significant role in other animal ethics controversies, particularly those concerning laboratory animal use and livestock production; and we bring in lessons learnt from these controversies. Then we comment on the suggested development and application of AWIA in the case of badger control. Finally, we discuss the prospects of applying AWIA to other sorts of wild animal controversy. We argue that the AIWA, as developed by McCulloch and Reiss, relies on several dubious premises, including that killing is a welfare issue. Furthermore, we argue that AWIA is unlikely to prevent serious moral disagreements over how to weigh concerns about wild animals against priorities in human health, the health of domestic and farm animals, and biodiversity, but that it may nonetheless serve to limit harms imposed on the wild animals. (shrink)

Research and business investment in emerging nanotechnologies is leading to a diverse range of new substances and products. As workers are faced with handling new materials, often with novel properties, the robustness of current workplace health and safety regulatory frameworks is being brought into question. Here, 12 characteristics of the U.S. occupational safety regulatory framework identified by Choi and Ramachandran are considered in the context of emerging nanotechnologies. The assessment suggests that, as the number of new materials (...) entering the workplace continues to increase, OSHA will need to develop flexible approaches to identifying and reducing potential risks. Relying on conventional approaches in the face of unconventional challenges will increase the probability of otherwise avoidable heath impacts. If the potential for engineered nanomaterials to cause harm is to be understood and managed, the agency will need to look at new approaches to generating, sharing, and using information. (shrink)

This study examines the role of blockchain technology in promoting sustainability in Bangladesh’s banking sector. Using Structural Equation Modeling (SEM), it explores the factors influencing blockchain adoption, including Perceived Ease of Use (PEU), Perceived Usefulness (PU), Perceived Compatibility (PC), Perceived External Variables (PEV), and Intention to Use (IBT). Sustainability (SB) is the ultimate outcome variable to assess the long-term impact of blockchain-driven practices. Data were collected from 380 banking professionals across private and public banks. The results show that PEU, (...) PU, PC, and PEV significantly influence IBT, which strongly impacts SB. PEU and PU emerged as the most important predictors of IBT, emphasizing the role of usability and perceived benefits. Path coefficient analysis confirmed the significance of both direct and indirect effects, with IBT acting as a key mediator. The findings highlight blockchain’s potential to enhance transparency, accountability, and efficiency while supporting sustainable development goals. The study also stresses the importance of aligning blockchain with organizational practices and addressing external factors like infrastructure and social influence. This research provides actionable insights for policymakers and banking institutions, recommending user-friendly blockchain systems, regulatory support, and targeted incentives to foster blockchain adoption for sustainability. (shrink)

The globalization of securities markets has resulted in a rapid increase in securities transactions that cut across the national borders of more than one country. Individual country regulators cannot avoid the question of how regulatory authority should be allocated for such transactions. Rather, they continue with the present territorial regime, which allocates regulatory authority based on the location of a particular transaction and the effects associated with the transaction. This article assesses a range of alternate responses to globalization. (...) Some have argued that a company’s home country should regulate all transactions in the company’s securities regardless of location. Others have argued for increased harmonization across different country securities regulatory regimes. The article instead contends that giving issuers a greater degree of freedom to select among the securities regulatory regimes of different countries will result in both more desirable levels of investor protections as well as increased social welfare. Arguments have been raised against a move toward greater issuer choice in securities regulation. The article responds to such criticism, pointing out that the present territorial regime suffers from even greater flaws. (shrink)

Pharmaceutical promotion is a negative influencing force for prescribing. However, very few regulatory initiatives are taken to overcome this unwarranted influence. The present research was conducted in such context with an attempt to review the regulatory documents related to pharmaceutical promotion in Bangladesh including Code of Pharmaceutical Marketing Practices (CPMP), and to compare CPMP with different global guidelines. The studied guidelines demonstrate effort to regulate promotion, though that varies to a great extent, particularly in enforcement aspects. Clearly defined (...) ethical and legal prohibitions, provisions of punishment for violations and entrusted agency with defined authority are crucial. (shrink)

This paper examines the debate on AI legal personhood, emphasizing the role of path dependencies in shaping current trajectories and prospects. Three primary path dependencies emerge: prevailing legal theories on personhood (singularist vs. clustered), the actual participation of AI in socio-digital institutions (instrumental vs. non-instrumental), and the impact of technological advancements. We argue that these factors dynamically interact, with technological optimism fostering broader attribution of the legal entitlements to AI entities and periods of scepticism narrowing such entitlements. Additional influences (...) include regulatory cross-linkages (e.g., data privacy, liability, cybersecurity) and historical legal precedents. Current regulatory frameworks, particularly in the EU, generally resist extending legal personhood to AI systems. Case law suggests that without explicit legislation, courts are unlikely to grant AI legal personhood on their own, although some authors suggest that the courts can do so. For this to happen, AI systems would first need to prove de facto legitimacy through sustained participation within socio-digital institutions. The chapter concludes by assessing near- and long-term prospects for legal personification, from generative AI and AI agents in the next 5–20 years to transformative possibilities such as AI integration with human cognition via Brain-Machine Interfaces in a more distant future. (shrink)