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This study investigates the shift in private banking from conventional creditworthiness assessment to advanced machine learning (ML) models. Employing a synthesis technique, this study conducts a review of literature and case studies and highlights how ML models, through the integration of alternative big data and advanced algorithms, can enhance accuracy in forecasting customer defaults and contribute to financial inclusion. The research underscores legal and ethical concerns regarding alternative data processing, necessitating thorough compliance checks by banks and regulatory authorities. Furthermore, it underlines the necessity for banks and regulators to develop technical skills to ensure ML models remain transparent and understandable, avoiding the pitfalls of becoming “black boxes”. Future research is suggested to explore risk mitigation strategies based on its ML deployment approach, technical aspects of ML algorithms, and the impact of ML-based credit scoring on broader macro-financial linkages.

Financial disasters can have catastrophic consequences for economies that extend beyond the organisational walls. This case study will examine the downfall of Silicon Valley Bank by exploring ineffective risk management practices and the absence of the Chief Risk Officer (CRO). It will begin by establishing a basic understanding of the bank's history and client base before diving into the events that led up to the third-largest bank run in US history. In our upcoming discussion, we will delve into the risk management standards that financial organisations typically employ to avoid insolvency. Additionally, we will emphasise the pivotal importance of the CRO role within such institutions. Finally, the study will conclude by emphasising the critical role of robust risk management practices, effective regulatory oversight and organisational reforms in mitigating the risks associated with financial disasters and safeguarding the resilience of the banking ecosystem. Understanding the impacts and lessons of past financial disasters is essential to build a more stable and resilient economic landscape as the financial system evolves. [ABSTRACT FROM AUTHOR]

Genome editing (GnEd) has the potential to provide many benefits to animal agriculture, offering a means for achieving rapid growth, disease resistance, and novel phenotypes. The technology has the potential to be useful for rapidly incorporating traits into existing selectively bred animals without the need for crossbreeding and backcrossing. Yet only four products from animals created via biotechnology, all growth-enhanced fishes, have reached commercialization and only on a limited scale. The past failure of genetically engineered (or GM) products to reach conventional producers can largely be attributed to the high cost of meeting GMO regulatory requirements. We review the history of GMO regulations internationally, noting the influence of Codex Alimentarius on the development of many existing regulatory frameworks. We highlight new regulatory approaches for GnEd organisms, first developed by Argentina, and the adoption of similar approaches by other countries. Such new regulatory approaches allow GnEd organisms that could have been developed by conventional means to be regulated under the same rules as conventional organisms and in the future is likely to enhance the opportunity for biotech animals to enter production. Treating certain GnEd products as conventional has had a large impact on the variety of biotechnological innovations successfully navigating regulatory processes. We suggest that for the full potential of GnEd technologies to be realized, enabling public policies are needed to facilitate use of GnEd as a breeding tool to incorporate new traits within existing animal breeding programs, rather than only a tool to create distinct new products.

Abstract The EU is about to relax its oversight of genetically modified organisms, focusing on plants and products that are obtained through certain new genomic techniques. The aim is to promote new genomic techniques as an innovative technology and employing it as a means to transform agriculture to sustainability. The present contribution describes and evaluates the planned reform. It discusses whether standards of legal certainty and legitimacy are met, how environmental side-effects are taken into account, how sustainability goals are integrated, what socio-economic effects are to be expected, and whether higher rank law is respected. As several shortcomings are found an alternative approach is submitted that combines a certain easing of administrative oversight with better integration of sustainability goals. Auspices for organic and conventional GMO-free agriculture are also sketched out.

This study investigates the shift in private banking from conventional creditworthiness assessment to advanced machine learning (ML) models. Employing a synthesis technique, this study conducts a review of literature and case studies and highlights how ML models, through the integration of alternative big data and advanced algorithms, can enhance accuracy in forecasting customer defaults and contribute to financial inclusion. The research underscores legal and ethical concerns regarding alternative data processing, necessitating thorough compliance checks by banks and regulatory authorities. Furthermore, it underlines the necessity for banks and regulators to develop technical skills to ensure ML models remain transparent and understandable, avoiding the pitfalls of becoming "black boxes". Future research is suggested to explore risk mitigation strategies based on its ML deployment approach, technical aspects of ML algorithms, and the impact of ML-based credit scoring on broader macro-financial linkages. [ABSTRACT FROM AUTHOR]

The EU is about to relax its oversight of genetically modified organisms, focusing on plants and products that are obtained through certain new genomic techniques. The aim is to promote new genomic techniques as an innovative technology and employing it as a means to transform agriculture to sustainability. The present contribution describes and evaluates the planned reform. It discusses whether standards of legal certainty and legitimacy are met, how environmental side-effects are taken into account, how sustainability goals are integrated, what socio-economic effects are to be expected, and whether higher rank law is respected. As several shortcomings are found an alternative approach is submitted that combines a certain easing of administrative oversight with better integration of sustainability goals. Auspices for organic and conventional GMO-free agriculture are also sketched out. [ABSTRACT FROM AUTHOR]

Ventral incisional hernias are common indications for elective repair and frequently complicated by recurrence. Surgical meshes, which may be synthetic, bio-synthetic, or biological, decrease recurrence and, resultingly, their use has become standard. While most patients are greatly benefited, mesh represents a permanently implanted foreign body. Mesh may be implanted within the intra-peritoneal, preperitoneal, retrorectus, inlay, or onlay anatomic positions. Meshes may be associated with complications that may be early or late and range from minor to severe. Long-term complications with intra-peritoneal synthetic mesh (IPSM) in apposition to the viscera are particularly at risk for adhesions and potential enteric fistula formation. The overall rate of such complications is difficult to appreciate due to poor long-term follow-up data, although it behooves surgeons to understand these risks as they are the ones who implant these devices. All surgeons need to be aware that meshes are commercial devices that are delivered into their operating room without scientific evidence of efficacy or even safety due to the unique regulatory practices that distinguish medical devices from medications. Thus, surgeons must continue to advocate for more stringent oversight and improved scientific evaluation to serve our patients properly and protect the patient–surgeon relationship as the only rationale long-term strategy to avoid ongoing complications. [ABSTRACT FROM AUTHOR]

Abstract Background In Ireland, there are currently three educational institutions (recognised institutions- RIs) providing paramedic programmes, accredited by the regulator, the Pre-Hospital Emergency Care Council (PHECC). Each RI assesses their students in-house, and in order to acquire a licence to practice, students must also pass summative assessments provided by PHECC. These assessments comprise multiple choice questions, short answer questions and skills assessments. The objective of this study was to explore the perceptions and experiences of paramedic educators of assessments used within their institution and by the regulator to provide insights that could inform the future design of paramedic assessments. Methods A qualitative study with an interpretivist approach and purposive sampling strategy was performed. Semi-structured interviews were conducted with educators from one RI, across their three sites. Data were analysed using an inductive approach to thematic analysis. Results Four major themes were identified in the data: improving assessments by enhancing authenticity, modifying the current process of assessment, aligning the PHECC and RI examinations and opportunities to use assessment as learning. Conclusions This study identifies perceived deficits and opportunities in the assessments currently used for paramedic students and ways in which these assessments could be improved. While participants were relatively content with their own RI assessments, they identified ways to improve both the RI and PHECC assessments. Modifying some of the current methods could be a useful first step. In particular, assessments used by PHECC could be improved by reflecting ‘real-world’ practice. The inclusion of additional assessment methods by PHECC, a continuous assessment process or devolvement of the entire assessment suite, to the RI/University has the potential to enhance assessments, particularly summative assessments, for paramedic students.

Integrating Artificial Intelligence (AI) in healthcare represents a transformative shift with substantial potential for enhancing patient care. This paper critically examines this integration, confronting significant ethical, legal, and technological challenges, particularly in patient privacy, decision-making autonomy, and data integrity. A structured exploration of these issues focuses on Differential Privacy as a critical method for preserving patient confidentiality in AI-driven healthcare systems. We analyze the balance between privacy preservation and the practical utility of healthcare data, emphasizing the effectiveness of encryption, Differential Privacy, and mixed-model approaches. The paper navigates the complex ethical and legal frameworks essential for AI integration in healthcare. We comprehensively examine patient rights and the nuances of informed consent, along with the challenges of harmonizing advanced technologies like blockchain with the General Data Protection Regulation (GDPR). The issue of algorithmic bias in healthcare is also explored, underscoring the urgent need for effective bias detection and mitigation strategies to build patient trust. The evolving roles of decentralized data sharing, regulatory frameworks, and patient agency are discussed in depth. Advocating for an interdisciplinary, multi-stakeholder approach and responsive governance, the paper aims to align healthcare AI with ethical principles, prioritize patient-centered outcomes, and steer AI towards responsible and equitable enhancements in patient care. [ABSTRACT FROM AUTHOR]

Background: In Ireland, there are currently three educational institutions (recognised institutions- RIs) providing paramedic programmes, accredited by the regulator, the Pre-Hospital Emergency Care Council (PHECC). Each RI assesses their students in-house, and in order to acquire a licence to practice, students must also pass summative assessments provided by PHECC. These assessments comprise multiple choice questions, short answer questions and skills assessments. The objective of this study was to explore the perceptions and experiences of paramedic educators of assessments used within their institution and by the regulator to provide insights that could inform the future design of paramedic assessments. Methods: A qualitative study with an interpretivist approach and purposive sampling strategy was performed. Semi-structured interviews were conducted with educators from one RI, across their three sites. Data were analysed using an inductive approach to thematic analysis. Results: Four major themes were identified in the data: improving assessments by enhancing authenticity, modifying the current process of assessment, aligning the PHECC and RI examinations and opportunities to use assessment as learning. Conclusions: This study identifies perceived deficits and opportunities in the assessments currently used for paramedic students and ways in which these assessments could be improved. While participants were relatively content with their own RI assessments, they identified ways to improve both the RI and PHECC assessments. Modifying some of the current methods could be a useful first step. In particular, assessments used by PHECC could be improved by reflecting 'real-world' practice. The inclusion of additional assessment methods by PHECC, a continuous assessment process or devolvement of the entire assessment suite, to the RI/University has the potential to enhance assessments, particularly summative assessments, for paramedic students. [ABSTRACT FROM AUTHOR]

We empirically investigate how regulatory oversight on external auditors is jointly influenced by audit committee financial expertise and independence. To measure regulatory oversight on external auditors, we use comment letters issued by the Securities and Exchange Organization of Iran. We show that audit committee financial expertise increases (decreases) regulatory oversight on external auditors when audit committee independence is low (high). We further show that this interactive effect is stronger under higher regulatory reviewers' workload compression. Collectively, our findings suggest that, first, financial expertise and independence of audit committees should be analysed together as independence moderates the benefit of financial expertise. Second, the consideration of regulatory reviewers' workload compression is important in this analysis. [ABSTRACT FROM AUTHOR]

Abstract Purpose We explored the views of Botswana stakeholders involved in developing, implementing and applying ethical standards for return of individual study results from genomic research. This allowed for mapping opportunities and challenges regarding actionability requirements that determine whether individual genomic research results should be fed back. Methods Using in-depth interviews, this study explored the views of sixteen (16) stakeholders about the extent, nature and timing of feedback of individual genomic research findings, including incidental findings that arise in the context of African genomics research. Coded data was analyzed through an iterative process of analytic induction to document and interpret themes. Results Overall, respondents were of the view that feedback of actionable individual genomic results was an important outcome that could benefit participants. However, a number of themes surfaced that pointed to opportunities and challenges that exist in Botswana that could help in planning for feeding back of individual genomic results that were mapped. Some of the opportunities cited by the respondents included the existence of good governance; democracy and humanitarianism; universal healthcare system; national commitment to science; research and innovation to transform Botswana into a knowledge-based economy; and applicable standard of care which could promote actionability. On the other hand, contextual issues like the requirement for validation of genomic research results in accredited laboratories, high cost of validation of genomic results, and linkage to care, as well as lack of experts like genomic scientists and counselors were considered as challenges for return of individual results. Conclusion We propose that decisions whether and which genomic results to return take into consideration contextual opportunities and challenges for actionability for return of results in a research setting. This is likely to avoid or minimize ethical issues of justice, equity and harm regarding actionability decisions.

The Public Company Accounting Oversight Board (PCAOB), created in 2002, oversees the audits of public companies and other issuers to protect the interests of investors and further the public interest in the quality of audit reports. In this study, we review PCAOB inspections and enforcement actions for eight firms (Big-4 and four second-tier firms) from 2009-2020 to assess the level of regulatory oversight and whether the scrutiny seen in the early years is maintained. Since the Big-4 firms manage over 78% of all U.S. public audits, the two-tier sample is adequate. Our analysis revealed a gradual decrease in the percentage of audits showing deficiencies, the severity of deficiencies, the number of firms that fail to address quality control criticisms satisfactorily, and the extent of enforcement actions. In addition, we identified common weaknesses related to the same recurring auditing standards and noticed a downward trend in the frequency of occurrence. The downward trend may suggest an improvement in audit quality over time. However, whether the results point to improved quality or a diminished appetite for regulatory oversight on the part of the PCAOB is debatable. [ABSTRACT FROM AUTHOR]

Artificial intelligence (AI) and deep learning (DL) have shown tremendous potential in driving sustainability across various sectors. This paper reviews recent advancements in AI and DL and explores their applications in achieving sustainable development goals (SDGs), renewable energy, environmental health, and smart building energy management. AI has the potential to contribute to 134 of the 169 targets across all SDGs, but the rapid development of these technologies necessitates comprehensive regulatory oversight to ensure transparency, safety, and ethical standards. In the renewable energy sector, AI and DL have been effectively utilized in optimizing energy management, fault detection, and power grid stability. They have also demonstrated promise in enhancing waste management and predictive analysis in photovoltaic power plants. In the field of environmental health, the integration of AI and DL has facilitated the analysis of complex spatial data, improving exposure modeling and disease prediction. However, challenges such as the explainability and transparency of AI and DL models, the scalability and high dimensionality of data, the integration with next-generation wireless networks, and ethics and privacy concerns need to be addressed. Future research should focus on enhancing the explainability and transparency of AI and DL models, developing scalable algorithms for processing large datasets, exploring the integration of AI with next-generation wireless networks, and addressing ethical and privacy considerations. Additionally, improving the energy efficiency of AI and DL models is crucial to ensure the sustainable use of these technologies. By addressing these challenges and fostering responsible and innovative use, AI and DL can significantly contribute to a more sustainable future. [ABSTRACT FROM AUTHOR]

Meta-regulation – the rules that govern how individual policies are developed and reviewed – has not received much attention in the study of health policy. We argue that these rules, far from value-free and objective, have significant potential to shape policy outputs and, as such, health outcomes. Channelling and operationalising wider paradigms like neoliberalism, they determine, for instance, what is considered 'good' policy, how decisions are made, based on which evidence, and whose voices matter. Exploring an archetypal example of meta-regulation, the European Union's Better Regulation agenda, we illustrate why meta-regulatory tools such as impact assessment, stakeholder consultation, and evaluation – and the norms that underlie their application – matter for health. In so doing, we concentrate especially on the ways in which Better Regulation may affect interest groups' ability to exert influence and, conversely, how actors have sought to shape Better Regulation. We argue that attention to meta-regulation contributes to counter-balancing the focus on agency within debates at the intersection of globalisation and health, and notably those on regulatory practices and coordination. Whilst research has noted, for instance, the origins of frameworks like Better Regulation and the increasing inclusion of 'good regulatory practice' provisions within trade and investment agreements, less attention is directed to the role that these frameworks play once institutionalised. Yet, as we illustrate, there is considerable scope for meta-regulation to enhance our understanding of the forces shaping health policy via, for instance, conceptualisations of the (social, economic, political, commercial) determinants of health. As such, we call for increased attention to the role of meta-regulation in research and practice aimed at improving human and planetary health. [ABSTRACT FROM AUTHOR]

Ventral incisional hernias are common indications for elective repair and frequently complicated by recurrence. Surgical meshes, which may be synthetic, bio-synthetic, or biological, decrease recurrence and, resultingly, their use has become standard. While most patients are greatly benefited, mesh represents a permanently implanted foreign body. Mesh may be implanted within the intra-peritoneal, preperitoneal, retrorectus, inlay, or onlay anatomic positions. Meshes may be associated with complications that may be early or late and range from minor to severe. Long-term complications with intra-peritoneal synthetic mesh (IPSM) in apposition to the viscera are particularly at risk for adhesions and potential enteric fistula formation. The overall rate of such complications is difficult to appreciate due to poor long-term follow-up data, although it behooves surgeons to understand these risks as they are the ones who implant these devices. All surgeons need to be aware that meshes are commercial devices that are delivered into their operating room without scientific evidence of efficacy or even safety due to the unique regulatory practices that distinguish medical devices from medications. Thus, surgeons must continue to advocate for more stringent oversight and improved scientific evaluation to serve our patients properly and protect the patient–surgeon relationship as the only rationale long-term strategy to avoid ongoing complications.

Purpose: We explored the views of Botswana stakeholders involved in developing, implementing and applying ethical standards for return of individual study results from genomic research. This allowed for mapping opportunities and challenges regarding actionability requirements that determine whether individual genomic research results should be fed back. Methods: Using in-depth interviews, this study explored the views of sixteen (16) stakeholders about the extent, nature and timing of feedback of individual genomic research findings, including incidental findings that arise in the context of African genomics research. Coded data was analyzed through an iterative process of analytic induction to document and interpret themes. Results: Overall, respondents were of the view that feedback of actionable individual genomic results was an important outcome that could benefit participants. However, a number of themes surfaced that pointed to opportunities and challenges that exist in Botswana that could help in planning for feeding back of individual genomic results that were mapped. Some of the opportunities cited by the respondents included the existence of good governance; democracy and humanitarianism; universal healthcare system; national commitment to science; research and innovation to transform Botswana into a knowledge-based economy; and applicable standard of care which could promote actionability. On the other hand, contextual issues like the requirement for validation of genomic research results in accredited laboratories, high cost of validation of genomic results, and linkage to care, as well as lack of experts like genomic scientists and counselors were considered as challenges for return of individual results. Conclusion: We propose that decisions whether and which genomic results to return take into consideration contextual opportunities and challenges for actionability for return of results in a research setting. This is likely to avoid or minimize ethical issues of justice, equity and harm regarding actionability decisions. [ABSTRACT FROM AUTHOR]

Integrating Artificial Intelligence (AI) in healthcare represents a transformative shift with substantial potential for enhancing patient care. This paper critically examines this integration, confronting significant ethical, legal, and technological challenges, particularly in patient privacy, decision-making autonomy, and data integrity. A structured exploration of these issues focuses on Differential Privacy as a critical method for preserving patient confidentiality in AI-driven healthcare systems. We analyze the balance between privacy preservation and the practical utility of healthcare data, emphasizing the effectiveness of encryption, Differential Privacy, and mixed-model approaches. The paper navigates the complex ethical and legal frameworks essential for AI integration in healthcare. We comprehensively examine patient rights and the nuances of informed consent, along with the challenges of harmonizing advanced technologies like blockchain with the General Data Protection Regulation (GDPR). The issue of algorithmic bias in healthcare is also explored, underscoring the urgent need for effective bias detection and mitigation strategies to build patient trust. The evolving roles of decentralized data sharing, regulatory frameworks, and patient agency are discussed in depth. Advocating for an interdisciplinary, multi-stakeholder approach and responsive governance, the paper aims to align healthcare AI with ethical principles, prioritize patient-centered outcomes, and steer AI towards responsible and equitable enhancements in patient care.

• LMICs need a regulatory pathway for early emergency access to experimental therapies. • This regulatory pathway should come with reporting and oversight measures. • The regulatory pathway must be completemented by public education. Clinicians, especially in low- and middle-income countries (LMICs), contend with limited economic and healthcare resources in deciding appropriate and feasible care for their patients. Some of the LMICs affected by COVID-19 implemented convalescent plasma therapy without sufficient regulatory guidance. Based on this experience, there are several requirements going forward, including: the need for an immediately accessible data gathering and processing system; the necessity of establishing regulatory pathways for early access to experimental treatment during emergency situations; and the accompanying reporting and monitoring requirements must be set. The different stakeholders must also be properly incorporated in the system that such a pathway will create, without neglecting to properly inform the public of the patient rights especially during an emergency situation. [ABSTRACT FROM AUTHOR]

Abstract Background In the US, EU and elsewhere, basic clinical research studies with positron emission tomography (PET) radiotracers that are generally recognized as safe and effective (GRASE) can often be conducted under institutional approval. For example, in the United States, such research is conducted under the oversight of a Radioactive Drug Research Committee (RDRC) as long as certain requirements are met. Firstly, the research must be for basic science and cannot be intended for immediate therapeutic or diagnostic purposes, or to determine the safety and effectiveness of the PET radiotracer. Secondly, the PET radiotracer must be generally recognized as safe and effective. Specifically, the mass dose to be administered must not cause any clinically detectable pharmacological effect in humans, and the radiation dose to be administered must be the smallest dose practical to perform the study and not exceed regulatory dose limits within a 1-year period. In our experience, the main barrier to using a PET radiotracer under RDRC approval is accessing the required information about mass and radioactive dosing. Results The University of Michigan (UM) has a long history of using PET radiotracers in clinical research studies. Herein we provide dosing information for 55 radiotracers that will enable other PET Centers to use them under the approval of their own RDRC committees. Conclusions The data provided herein will streamline future RDRC approval, and facilitate further basic science investigation of 55 PET radiotracers that target functionally relevant biomarkers in high impact disease states.

Ensuring appropriate review, approval, and oversight of research involving animals becomes increasingly complex when researchers collaborate across multiple sites. In these situations, it is important that the division of responsibilities is clear and that all involved parties share a common understanding. The National Institutes of Health Office of Laboratory Animal Welfare and the United States Department of Agriculture Animal Plant Health Inspection Service require an Institutional Animal Care and Use Committee (IACUC) to review the care and use of animals in research, and both agree that it is acceptable for one IACUC to review the work taking place at multiple institutions. With this in mind, several Harvard-affiliated hospitals and academic centers developed the Master Reciprocal Institutional Agreement for Animal Care and Use (Master IACUC Agreement) to support collaboration, decrease administrative burden, increase efficiencies, reduce duplicative efforts, and ensure appropriate protections for animals used in research. Locally, the Master IACUC Agreement has fostered greater collaboration and exchange while ensuring appropriate review and oversight of research involving animals. As multisite animal protocols become more prevalent, this Agreement could provide a model for a distributed, national network of IACUC reliance.

The advent of clustered regularly interspaced short palindromic repeats (CRISPR) technology has quickly ushered in a new era of gene editing and offered exciting potential for the development of biomedical products. While the breadth of applications for CRISPR encompasses nearly the entire field of medical science, its utilization to produce next-generation CAR T cells stands to benefit most substantially in the short-term. These novel therapeutics are now beginning to enter the clinical trial phase of the numerous approval pipelines, but does the existing regulatory framework have the capability to adequately review and approve the initiation of these new age research endeavors in the clinical setting? This analysis will illuminate the similarity and differences between CRISPR developed interventions and existing techniques used to produce biomedical products from a regulatory perspective in the United States. Further, the "gray area" surrounding CRISPR regulatory oversight will be explored and recommendations will be made to facilitate the elimination of inconsistencies that currently exist in the assessment of this work prior to the initiation of associated clinical trials. [ABSTRACT FROM AUTHOR]

This study examines whether auditors' local knowledge of clients can compensate for a weaker regulatory oversight in the audits of foreign companies. Based on a sample of Chinese companies that were listed in the U.S. and after controlling for other factors that may affect audit quality, we find that the audit quality of Hong Kong and Chinese non-Big 4 auditors is comparable to that of U.S. auditors with an affiliate in China and higher than that of U.S. auditors without a Chinese affiliate. Additional analysis indicates that U.S. auditors provide higher audit quality to U.S.-based listed firms than U.S.-listed Chinese firms and the quality difference is reduced for U.S. auditors with a Chinese affiliate. These results indicate that auditors' local knowledge of foreign clients has a positive effect on audit quality and in certain circumstances, it can compensate for a weaker regulatory oversight in an international setting. [ABSTRACT FROM AUTHOR]

This paper examines whether regulatory oversight affects managerial ability. To measure regulatory oversight, I use comment letters from two Iranian regulatory agencies. Furthermore, to measure managerial ability, I employ managerial ability-score introduced by Demerjian et al. (Management Science 58(7):1229–1248, 2012). Using a difference-in-differences design with a propensity score matching approach, I reveal that the managerial ability of a firm is enhanced following the receipt of a comment letter by the firm. I further reveal that the managerial ability of a firm is enhanced following the receipt of a comment letter by the firm's industry peers. Collectively, the findings highlight the internalities and externalities of regulatory oversight in the context of managerial ability. [ABSTRACT FROM AUTHOR]

The SARS‐CoV‐2/COVID‐19 pandemic has been devastating to the U.S. health‐care system and sheds light on gaps in preparedness and response to biological threats. From limited personal protective equipment to staffing issues, hospitals are struggling to respond to the novel coronavirus outbreak. Unfortunately, hospital biopreparedness is a product of prioritization for hospital leadership and either exists or is neglected. Federal efforts to enhance health‐care readiness have done little to drive true change across the U.S. health‐care infrastructure. From optional efforts like the tiered hospital approach to special pathogens to the regulatory rule from the Centers for Medicare and Medicaid Services, federal efforts to build a resilient health‐care infrastructure against biological threats are woefully inadequate and dependent upon hospital leadership priorities. The COVID‐19 pandemic has revealed a need to implement regulatory requirements on health‐care facilities to invest in continued preparedness for biological events. [ABSTRACT FROM AUTHOR]

Despite the increasing attention given to tourism regulation in recent years, great ambiguity surrounds this concept and no valid and reliable instrument exists to measure tourism market regulation (TMR). This study uses multi-step mixed methods to develop a measurement scale of TMR from the perspective of tourists. In the first step, interviews and focus groups are undertaken to formulate a clear definition of TMR and its attributes. In the second step, a scale development procedure is adopted to analyze two rounds of data for dimension exploration via exploratory factor analysis and confirmation via confirmatory factor analysis. Through these analyses, five dimensions are generated: regulatory oversight, truth in advertising, tourism contract compliance, fulfilling tourism contracts, and travel feedback processing. The reliable and valid results contribute to refining TMR in the context of China. They also provide a useful tool for tourists and destination marketing organizations to measure and govern TMR in other regions/countries. [ABSTRACT FROM AUTHOR]

During the last years, progress has been made in survival and function of pig‐to‐non‐human primate organ xenotransplantation using organs from genetically modified pigs and immunosuppression regimens that are clinically acceptable. This, together with increased insights into a low risk of pig‐to‐human transmission of porcine endogenous retrovirus, has opened the perspective of starting with first‐in‐human trials with xenogeneic organs. The regulatory path to clinical development is complex. Unlike an organ from human donors, an organ from pigs, either genetically modified or wild‐type pigs, is considered a medicinal product for human use and hence is under regulatory oversight, in the United States by the Food and Drug Administration and in Europe by the national competent authorities of the member states as well as the European Medicines Agency. Related to the status of medicinal product, "(current) good practices" apply in the process of generating a xenogeneic organ through to the transplantation into a patient and life‐long follow‐up. In addition, guidances for xenotransplantation products and genetically modified organisms do apply as well. This commentary focuses on regulatory aspects of transplantation of organs from genetically modified pigs into humans, with the intention to facilitate the interactions between regulatory agencies and institutions (sponsors) in research and clinical development of these organs, to support the perspective of speeding up the process with a proper entry in clinical application, to fill an unmet medical need in patients with end‐stage organ disease. [ABSTRACT FROM AUTHOR]

Ensuring appropriate review, approval, and oversight of research involving animals becomes increasingly complex when researchers collaborate across multiple sites. In these situations, it is important that the division of responsibilities is clear and that all involved parties share a common understanding. The National Institutes of Health Office of Laboratory Animal Welfare and the United States Department of Agriculture Animal Plant Health Inspection Service require an Institutional Animal Care and Use Committee (IACUC) to review the care and use of animals in research, and both agree that it is acceptable for one IACUC to review the work taking place at multiple institutions. With this in mind, several Harvard-affiliated hospitals and academic centers developed the Master Reciprocal Institutional Agreement for Animal Care and Use (Master IACUC Agreement) to support collaboration, decrease administrative burden, increase efficiencies, reduce duplicative efforts, and ensure appropriate protections for animals used in research. Locally, the Master IACUC Agreement has fostered greater collaboration and exchange while ensuring appropriate review and oversight of research involving animals. As multisite animal protocols become more prevalent, this Agreement could provide a model for a distributed, national network of IACUC reliance. [ABSTRACT FROM AUTHOR]

The ability to successfully exploit genome edited organisms for the benefit of food security and the environment will essentially be determined by the extent to which these organisms fall under specific regulatory provisions. In many jurisdictions the answer to this question is considered to depend on the genetic characteristics of the edited organism, and whether the changes introduced in its genome do (or do not) occur naturally. We provide here a number of key considerations to assist with this evaluation as well as a guide of concrete examples of genetic alterations with an assessment of their natural occurrence. These examples support the conclusion that for many of the common types of alterations introduced by means of genome editing, the resulting organisms would not be subject to specific biosafety regulatory provisions whenever novelty of the genetic combination is a crucial determinant.

I develop approaches that quantify the use of discretion for the three main assumptions used for the financial reporting of defined benefit pension obligations: the expected return, the discount rate, and the compensation rate. I then apply these approaches to two regulatory events that affected a different subset of these three assumptions. Across both settings, my analyses indicate that firms reduced discretion in response to regulatory scrutiny—but only in those assumptions targeted by the regulatory event. In contrast, I find that firms increased the use of discretion in the other assumptions, consistent with a substitution effect. I also find that the use of discretion in the discount rate and compensation rate are approximately two to three times more effective at changing reported earnings than the use of discretion in the expected return. Collectively, my analyses highlight the interdependence of the three main pension assumptions and the relative weakness of the expected return as an earnings management tool. [ABSTRACT FROM AUTHOR]

Brownfields remediation and redevelopment continues to be an important issue for policy makers and planners seeking to unlock its many socio-economic and environmental benefits. While technical approaches to assessment and remediation have become rather standardized and governments have largely embraced voluntary programs to oversee their application, the degree of regulatory oversight continues to differ among jurisdictions. This article examines the scale and character of remediation activity in Ontario, Canada over the last decade using records submitted by qualified persons from the private sector. It finds that Ontario’s approach has been quite successful in scale and character in stronger urban real estate markets despite most matters related to cleanup and reuse escaping the direct oversight of provincial regulators. The province’s less-interventionist approach may need some review to address the nature of cleanup techniques being applied and the recent slowdown in cleanup and reuse activity, especially given the growing push toward regional growth management and more effective use of brownfield land resources in both larger urban areas, and smaller ones where greenfields are plentiful and brownfields are less competitive. [ABSTRACT FROM AUTHOR]

Genetically engineered ( GE) crops are subject to regulatory oversight to ensure their safety for humans and the environment. Their approval in the European Union ( EU) starts with an application in a given Member State followed by a scientific risk assessment, and ends with a political decision-making step (risk management). In the United States ( US) approval begins with a scientific (field trial) step and ends with a 'bureaucratic' decision-making step. We investigate trends for the time taken for these steps and the overall time taken for approving GE crops in the US and the EU. Our results show that from 1996-2015 the overall time trend for approval in the EU decreased and then flattened off, with an overall mean completion-time of 1,763 days. In the US in 1998 there was a break in the trend of the overall approval time. Initially, from 1988 until 1997 the trend decreased with a mean approval time of 1,321 days; from 1998-2015, the trend almost stagnated with a mean approval time of 2,467 days. [ABSTRACT FROM AUTHOR]