Search results for: regulatory focus

Authors: Gülçin Akbas Uslu

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Honor cultures put importance on the sexual purity of women. Women are expected to avoid acts that may spoil their honor. The emphasis on honor leads to the subordination of women and the dominance of men. In order to protect and clean honor, women are exposed to physical and psychological violence. Therefore, understanding the motivations driving people to endorse honor bears importance. For this purpose, this study aims to explore honor endorsement from the joint perspective of System Justification Theory (SJT) and Regulatory Focus Theory (RFT). SJT asserts that people have a tendency to support and rationalize the system. The motivation to maintain the system may be a factor in the endorsement of honor. RFT proposes two distinct regulatory processes, namely promotion and prevention focus. Having a dominant prevention focus, such as a deep concern for responsibilities, risk avoidance, and minimizing negative outcomes, may have a role in honor. Data were collected conveniently from 366 participants (216 women; 150 men). Participants filled out Honor Endorsement Index, Honor Based System Justification Scale and Regulatory Focus Orientation Scale Results revealed that both regulatory focus and system justification play a role in understanding honor. One-way ANOVA findings showed that individuals with a dominant prevention focus endorse honor beliefs more than individuals with a dominant promotion focus. Besides, regression analysis revealed that prevention focus and system justification significantly and positively predict honor. Results provide clarifications for why honor has an important meaning in individuals’ life and why honor-based violence is approved. These findings bear great importance in Turkey, where emphasis on honor is high and can be used in reducing people’s adherence to honor, which is based on women’s sexuality and men’s power over women.

Keywords: honor, system justification theory, regulatory focus theory, prevention focus

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Authors: Katharina Ninaus, Ralf Terlutter, Sandra Diehl

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Information and communication technologies (ICT) have become pervasive in all areas of modern life, both in work and leisure. Technological developments and particularly the ubiquity of smartphones have made it possible for ICT consumers to be constantly connected to work, fostering an always-on mentality and increasing the pressure to be accessible at all times. However, performing work tasks outside of working hours using ICT results in a lack of mental detachment and recovery from work. It is, therefore, necessary to develop effective behavioral interventions to increase risk awareness of a constant connection to the workplace in the employed population. Drawing on regulatory focus theory, this study aims to investigate the persuasiveness of tailoring messages to individuals’ chronic regulatory focus in order to encourage ICT consumers to set boundaries by defining fixed times for professional accessibility outside of working hours in order to contribute to the well-being of ICT consumers with high ICT involvement in their work life. The experimental study examines the interaction effect between consumers’ chronic regulatory focus (i.e. promotion focus versus prevention focus) and positive or negative message framing (i.e. gain frame versus loss frame) on consumers’ intention to perform the advocated behavior. Based on the assumption that congruent messages create regulatory fit and increase message effectiveness, it is hypothesized that behavioral intention will be higher in the condition of regulatory fit compared to regulatory non-fit. It is further hypothesized that ad believability and attitude toward the ad will mediate the effect of regulatory fit on behavioral intention given that ad believability and ad attitude both determine consumer behavioral responses. Results confirm that the interaction between regulatory focus and message frame emerged as a predictor of behavioral intention such as that consumers’ intentions to set boundaries by defining fixed times for professional accessibility outside of working hours increased as congruency with their regulatory focus increased. The loss-framed ad was more effective for consumers with a predominant prevention focus, while the gain-framed ad was more effective for consumers with a predominant promotion focus. Ad believability and attitude toward the ad both emerged as predictors of behavioral intention. Mediation analysis revealed that the direct effect of the interaction between regulatory focus and message frame on behavioral intention was no longer significant when including ad believability and ad attitude as mediators in the model, indicating full mediation. However, while the indirect effect through ad believability was significant, the indirect effect through attitude toward the ad was not significant. Hence, regulatory fit increased ad believability, which then increased behavioral intention. Ad believability appears to have a superior effect indicating that behavioral intention does not depend on attitude toward the ad, but it depends on whether or not the ad is perceived as believable. The study shows that the principle of regulatory fit holds true in the context of ICT consumption and responds to calls for more research on mediators of health message framing effects.

Keywords: always-on mentality, Information and communication technologies (ICT) consumption, message framing, regulatory focus

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Authors: Shuchi Bharti

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This article intends to analyse the transforming nature of state and corporate sector relationship in the light of evolving regulatory and institutional aspects pertaining to Corporate Social Responsibility (CSR) in India. The focus is on evaluating the accounts of law and decentred discourses, relevant within the changing regulatory and institutional paradigm that substantially goes ahead of formal legal control of state towards corporate actors. At this vantage point, it is important to understand the state’s posture towards a changing scenario particularly as the tone is set by regulatory parameters pertaining to CSR to drive process of engagement with the stakeholders. The tripartite framework of the article intends to focus on finding on the vital interconnected aspects of the CSR provisions (Section 135) of The Companies Act 2013 (The Act), rise of new institutions and the emergence of the decentred regulatory space. Thus is earmarked in a neo-liberal paradigm; state is witnessed to perform a responsive function in engendering enhanced public role for the corporate sector. In this overarching framework the aim is to undertake a causal, exploratory and relational analysis of aspects pertaining law, regulation and institutional transformations. Firstly, focus is drawn on to investigate the relational facets of the advent of law and regulatory framework of CSR. Secondly, in the light of the historical evolution, a causal connection is attempted between globalization, emergence of international soft law framework and the Indian case of CSR. Finally, I look into how the new Companies Act mandates CSR expenditure vis- a -vis multiple parameters and guidelines.

Keywords: corporate social responsibility, stakeholders, soft law, decentred regulation

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Authors: Daud Abdia, Aqsa Shamim, Farhan Tabassum

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In order to achieve specific goals, basketball players have to use different skills to enhance their motivation, one such skill is deliberate practice. The aim of this study was to explore the relationship between deliberate practice of dribbling and self-regulatory behavior of male basketball players. For this purpose, a sample of 108 basketball players using stratified sampling was taken from public and private sector universities. Sample was divided into two groups that are experimental (n=54) and control group (n=54) using comparative experimental design. Experimental group was involved in the training of deliberate practice of dribbling for 5 weeks. Amounts of weekly practice activity and Self-Regulation of Learning Self-Report Scale (SRL-SRS) were used for self-regulatory behavior to collect data after the deliberate practice. The reliability of amounts of weekly practice activity was found to be 0.852, whereas SRL-SRS was found to be 0.890. The results of the study indicated a strong positive correlation between deliberate practice of dribbling and self-regulatory behavior (r=0.755, n=54, p=.000). Whereas, paired sample t-test; t(53)=1.37, p < 0.005 shows statistically significant improvement in the self-regulatory behavior after the training program of deliberate practice from 3.02 ± 0.64m to 3.21 ± 0.75m (p < 0.005). It was concluded that in order to enhance the self-regulatory behavior of basketball players we should work on the deliberate practice of the players.

Keywords: self-regulatory behavior, deliberate practice, dribbling, basketball

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Authors: Geuna Kim, Sanghyun Kim

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This study investigates various factors that may influence the ISM process, including the organization’s internal needs and external pressure, and examines the role of regulatory pressure in ISM development and performance. The 105 sets of data collected in a survey were tested against the research model using SEM. The results indicate that NP and TP had positive effects on the ISM process, except for perceived benefits. Regulatory pressure had a positive effect on the relationship between ISM awareness and ISM development and performance.

Keywords: information security management, need pull, technology push, regulatory pressure

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Authors: Mhaned Oubounyt, Jan Baumbach

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Differences in co-expression networks between two or multiple cells (sub)types across conditions is a pressing problem in single-cell RNA sequencing (scRNA-seq). A key challenge is to define those co-variations that differ between or among cell types and/or conditions and phenotypes to examine small regulatory networks that can explain mechanistic differences. To this end, we developed SCANet, an all-in-one Python package that uses state-of-the-art algorithms to facilitate the workflow of a combined single-cell GCN (Gene Correlation Network) and GRN (Gene Regulatory Networks) pipeline, including inference of gene co-expression modules from scRNA-seq, followed by trait and cell type associations, hub gene detection, co-regulatory networks, and drug-gene interactions. In an example case, we illustrate how SCANet can be applied to identify regulatory drivers behind a cytokine storm associated with mortality in patients with acute respiratory illness. SCANet is available as a free, open-source, and user-friendly Python package that can be easily integrated into systems biology pipelines.

Keywords: single-cell, co-expression networks, drug-gene interactions, co-regulatory networks

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Authors: Muhammad Umar Kibiya

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The study aims to examine whether regulatory changes have an impact on the financial reporting quality of Microfinance Banks in Nigeria. The research employed a panel data analysis technique, using data from 2018 to 2022. The sample includes 72 microfinance banks, using regression analyses to examine the relationship between variables. The findings indicate that Board Chairmanship has a positive and significant effect on financial reporting quality. It also reveals that share ownership has a negative and significant impact on financial reporting quality. The results suggest that regulatory changes have a positive and significant influence on financial reporting quality. Thus, findings have important implications for microfinance banks in Nigeria. It suggests that having a strong and competent board chairperson can enhance financial reporting quality, leading to more transparent and reliable information for stakeholders. Furthermore, the study highlights the importance of regulatory changes in improving financial reporting practices in the microfinance banking sector. The study contributes to the extant literature by providing empirical evidence on the relationship between board chairmanship, share ownership, financial reporting quality, and regulatory changes in microfinance banks. It further supports the concept that governance mechanisms and regulatory reforms play a crucial role in ensuring transparency and accountability within the microfinance banking sector. It recommends that microfinance banks should appoint experienced and qualified individuals as board chairpersons to enhance financial reporting quality. Furthermore, policymakers and regulatory authorities should continue to implement and enforce regulations that promote transparent financial reporting practices in microfinance banks.

Keywords: board chairman, share ownership, financial reporting quality, microfinance, regulatory changes

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Authors: Fadhl Alakwaa

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One of the sustainable goals of the system biology is understanding gene-gene interactions. Hence, gene regulatory networks (GRN) need to be constructed for understanding the disease ontology and to reduce the cost of drug development. To construct gene regulatory from gene expression we need to overcome many challenges such as data denoising and dimensionality. In this paper, we develop an integrated system to reduce data dimension and remove the noise. The generated network from our system was validated via available interaction databases and was compared to previous methods. The result revealed the performance of our proposed method.

Keywords: gene regulatory network, biclustering, denoising, system biology

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Authors: V. Petkova, V. Valchanova, D. Grekova, K. Andreevska, S. T. Geurguiev, V. Madgarov, D. Grekov

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Introduction: Production, distribution and sale of cosmetics is a global industry, which played a key role in the European Union (EU), the US and Japan. A major participant EU whose market cosmetics is greater than in the US and 2 times greater than that in Japan. The output value of the cosmetics industry in the EU is estimated at about € 35 billion in 2001. Nearly 5 billion cosmetic products (number of packages) are sold annually in the EU, and the main markets are France, Germany, Italy, Spain and the UK. The aim of the study is legal and marketing analysis of cosmetic products dispensed in a pharmacy. Materials and methodology: Historical legislative analysis - the method is applied in the analysis of changes in the legislative regulation of the activities of cosmetic products in Japan and Bulgaria Comparative legislative analysis - the method is applied when comparing the legislative requirements for cosmetic products in the already mentioned countries. Both methods are applied to the following regulations: 1) Japanese Pharmaceuticals Affairs Law, Tokyo, Japan, Ministry of Health, Labour and Welfare; 2) Law on Medicinal Products for Human Use; effective from 3.01.2014. Results: The legislative framework for cosmetic products in Bulgaria and Japan is close and generally includes general guidelines: Definition of a medicinal product; Categorization of drugs (with differences in sub-categories); Pre-registration and marketing approval of the competent authorities; Compulsory compliance with gmp (unlike cosmetics); Regulatory focus on product quality, efficacy and safety; Obligations for labeling of such products; Created systems Pharmacovigilance and commitment of all parties - industry and health professionals; The main similarities in the regulation of products classified as cosmetics are in the following segments: Full producer responsibility for product safety; Surveillance of market regulatory authorities; No need for pre-registration or pre-marketing approval (a basic requirement for notification); Without restrictions on sales channels; GMP manuals for cosmetics; Regulatory focus on product safety (than over efficiency); General requirements in labeling: The main differences in the regulation of products classified as cosmetics are in the following segments: Details in the regulation of cosmetic products; Future convergence of regulatory frameworks can contribute to the removal of barriers to trade, to encourage innovation, while simultaneously ensuring a high level of protection of consumer safety.

Keywords: cosmetics, legislation, comparative analysis, Bulgaria, Japan

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Authors: SeungKu Ahn, Sewon Lee

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This study examines the effects of regulatory policies on corporate R&D activities and innovation and suggests regulatory directions for the enhancement of corporate performance. This study employs a regression model with R&D activities as dependent variables and the regulatory index as an independent variable. The results of this study are as follows: The regulation is negatively associated with the input and output of R&D activities. The regulation encourages small and medium-sized firms to invest in R&D. The regulation has a positive effect on patent applications for small and medium-sized firms.

Keywords: governmental regulation, research and development performance, small and medium-sized firms, technological innovation

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Authors: Guldana Zhigerbayeva, Ming Yang

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Transportation of hazardous materials (HAZMAT) is inevitable in the process industries. The statistics show a significant number of accidents has occurred during the transportation of HAZMAT. This makes risk management of HAZMAT transportation an important topic. The tree-based methods including fault-trees, event-trees and cause-consequence analysis, and Bayesian network, have been applied to risk management of HAZMAT transportation. However, there is limited work on the development of a systematic approach. The existing approaches fail to build up the linkages between the regulatory requirements and the safety measures development. The analysis of historical data from the past accidents’ report databases would limit our focus on the specific incidents and their specific causes. Thus, we may overlook some essential elements in risk management, including regulatory compliance, field expert opinions, and suggestions. A systematic approach is needed to translate the regulatory requirements of HAZMAT transportation into specified safety measures (both technical and administrative) to support the risk management process. This study aims to first adapt the House of Quality (HoQ) to House of Safety (HoS) and proposes a new approach- Safety Function Deployment (SFD). The results of SFD will be used in a multi-criteria decision-support system to develop find an optimal route for HazMats transportation. The proposed approach will be demonstrated through a hypothetical transportation case in Kazakhstan.

Keywords: hazardous materials, risk assessment, risk management, quality function deployment

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Authors: Zidane Abderrezzaq

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In contrast to recent successful developments in macro monetary policies, the modelling, measurement and management of systemic financial stability has remained problematical. Indeed, the focus of most effort has been on improving individual, rather than systemic, bank risk management; the Basel II objective has been to bring regulatory bank capital into line with the (sophisticated) banks’ assessment of their own economic capital. Even at the individual bank level there are concerns over appropriate diversification allowances, differing objectives of banks and regulators, the need for a buffer over regulatory minima, and the distinction between expected and unexpected losses (EL and UL). At the systemic level the quite complex and prescriptive content of Basel II raises dangers of ‘endogenous risk’ and procyclicality. Simulations suggest that this latter could be a serious problem. In an extension to the main analysis we study how liquidity effects interact with banking structure to produce a greater chance of systemic breakdown. We finally consider how the risk of contagion might depend on the degree of asymmetry (tiering) inherent in the structure of the banking system. A number of our results have important implications for public policy, which this paper also draws out.

Keywords: systemic stability, financial regulation, credit risk, systemic risk

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Authors: Jahanshah Ashkani, Kevin J. Naidoo

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Glycosylation is the major posttranslational modification (PTM) process in cellular development. In tumour development, it is marked by structural alteration of carbohydrates (glycans) that is the result of aberrant glycosylation. Altered glycan structures affect cell surface ligand-receptor interactions that interfere with the regulation of cell adhesion, migration, and proliferation. The resulting changes in glycan biosynthesis pathways originate from altered expression of glycosyltransferases and glycosidases. While the alteration in glycosylation patterns is a recognized “hallmark of cancer”, the influential overview of the biology of cancer proposes eight hallmarks with no explicit suggestion to connectivity with glycosylation. Recently, we have discovered a connection between the glycosyltransferase gene expression and cancer type and subtype. Here we present an association between aberrant glycosylation and the biological hallmarks of breast cancer by exploring the common regulatory mechanisms at the genomic scale. The result of this study bridges the glycobiological and biological pathways that are accepted hallmarks of cancer by connecting their common regulatory pathways. This is an impetus for further investigation as target therapies of breast cancer are very likely to be uncovered from this.

Keywords: aberrant glycosylation, biological hallmarks, breast cancer, regulatory mechanism

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Authors: Jill Round

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In the economic system, the financial sector plays a crucial role as an intermediary between market participants, other financial institutions, and customers. Financial institutions such as banks have to make decisions to satisfy the demands of all the participants by keeping abreast of regulatory change. In recent years, progress has been made regarding frameworks, development of rules, standards, and processes to manage risks in the banking sector. The increasing focus of regulators and policymakers placed on risk management, corporate governance, and the organization’s culture is of special interest as it requires a well-resourced risk controlling function, compliance function, and internal audit function. In the past years, the relevance of these functions that make up the so-called Three Lines of Defense has moved from the backroom to the boardroom. The approach of the model can vary based on the various organizational characteristics. Due to the intense regulatory requirements, organizations operating in the financial sector have more mature models. In less regulated industries there is more cloudiness about what tasks are allocated where. All parties strive to achieve their objectives through the effective management of risks and serve the identical stakeholders. Today, the Three Lines of Defense model is used throughout the world. The research looks at trends and emerging issues in the professions of the Three Lines of Defense within the banking sector. The answers are believed to helping to explain the increasing regulatory requirements for the banking sector. While the number of supervisory practices increases the risk management requirements intensify and demand more regulatory compliance at the same time. The Structural Equation Modeling (SEM) is applied by making use of conducted surveys in the research field. It aims to describe (i) the theoretical model regarding the applicable linearity relationships, (ii) the causal relationship between multiple predictors (exogenous) and multiple dependent variables (endogenous), (iii) taking into consideration the unobservable variables and (iv) the measurement errors. The surveys conducted on the research field suggest that the observable variables are caused by various latent variables. The SEM consists of the 1) measurement model and the 2) structural model. There is a detectable correlation regarding the cause-effect relationship among the performed supervisory practices and the increasing scope of regulation. Supervisory practices reinforce the regulatory density. In the past, controls were placed after supervisory practices were conducted or incidents occurred. In further research, it is of interest to examine, whether risk management is proactive, reactive to incidents and supervisory practices or can be both at the same time.

Keywords: risk management, structural equation model, supervisory practice, three lines of defense

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Authors: Abigail Ekeigwe, Bethany McGowan, Loran C. Parker, Stephen Byrn, Kari L. Clase

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There are growing calls in the literature to develop and implement competency-based regulatory sciences education (CBRSE) in sub-Saharan Africa to expand and create a pipeline of a competent workforce of regulatory scientists. A defined competence framework is an essential component in developing competency-based education. However, such a competence framework is not available for regulatory scientists in sub-Saharan Africa. The purpose of this research is to identify entry-level competencies for inclusion in a competency framework for regulatory scientists in sub-Saharan Africa as a first step in developing CBRSE. The team systematically reviewed the literature following the PRISMA guidelines for systematic reviews and based on a pre-registered protocol on Open Science Framework (OSF). The protocol has the search strategy and the inclusion and exclusion criteria for publications. All included publications were coded to identify entry-level competencies for regulatory scientists. The team deductively coded the publications included in the study using the 'framework synthesis' model for systematic literature review. The World Health Organization’s conceptualization of competence guided the review and thematic synthesis. Topic and thematic codings were done using NVivo 12™ software. Based on the search strategy in the protocol, 2345 publications were retrieved. Twenty-two (n=22) of the retrieved publications met all the inclusion criteria for the research. Topic and thematic coding of the publications yielded three main domains of competence: knowledge, skills, and enabling behaviors. The knowledge domain has three sub-domains: administrative, regulatory governance/framework, and scientific knowledge. The skills domain has two sub-domains: functional and technical skills. Identification of competencies is the primal step that serves as a bedrock for curriculum development and competency-based education. The competencies identified in this research will help policymakers, educators, institutions, and international development partners design and implement competence-based regulatory science education in sub-Saharan Africa, ultimately leading to access to safe, quality, and effective medical products.

Keywords: competence-based regulatory science education, competencies, systematic review, sub-Saharan Africa

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Authors: Piotr J. Balwierz, Mikhail Pachkov, Phil Arnold, Andreas J. Gruber, Mihaela Zavolan, Erik van Nimwegen

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Understanding the key players and interactions in the regulatory networks that control gene expression and chromatin state across different cell types and tissues in metazoans remains one of the central challenges in systems biology. Our laboratory has pioneered a number of methods for automatically inferring core gene regulatory networks directly from high-throughput data by modeling gene expression (RNA-seq) and chromatin state (ChIP-seq) measurements in terms of genome-wide computational predictions of regulatory sites for hundreds of transcription factors and micro-RNAs. These methods have now been completely automated in an integrated webserver called ISMARA that allows researchers to analyze their own data by simply uploading RNA-seq or ChIP-seq data sets and provides results in an integrated web interface as well as in downloadable flat form. For any data set, ISMARA infers the key regulators in the system, their activities across the input samples, the genes and pathways they target, and the core interactions between the regulators. We believe that by empowering experimental researchers to apply cutting-edge computational systems biology tools to their data in a completely automated manner, ISMARA can play an important role in developing our understanding of regulatory networks across metazoans.

Keywords: gene expression analysis, high-throughput sequencing analysis, transcription factor activity, transcription regulation

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Authors: Lucas Bublitz, Michael Herdrich

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By achieving the first commercialization approval in San Francisco the Autonomous Driving (AD) industry proves the technology maturity of the SAE L4 AD systems and the corresponding software and hardware stack. This milestone reflects the upcoming phase in the industry, where the focus is now about scaling and supervising larger autonomous vehicle (AV) fleets in different operation areas. This requires an operation framework, which organizes and assigns responsibilities to the relevant AV technology and operation stakeholders from the AV system provider, the Remote Intervention Operator, the MaaS provider and regulatory & approval authority. This holistic operation framework consists of technological, processual, and organizational activities to ensure safe operation for fully automated vehicles. Regarding the supervision of large autonomous vehicle fleets, a major focus is on the continuous field monitoring. The field monitoring approach must reflect the safety and security criticality of incidents in the field during driving operation. This includes an automatic containment approach, with the overall goal to avoid safety critical incidents and reduce downtime by a malfunction of the AD software stack. An End-to-end (E2E) field monitoring approach detects critical faults in the field, uses a knowledge-based approach for evaluating the safety criticality and supports the automatic containment of these E/E faults. Applying such an approach will ensure the scalability of AV fleets, which is determined by the handling of incidents in the field and the continuous regulatory compliance of the technology after enhancing the Operational Design Domain (ODD) or the function scope by Functions on Demand (FoD) over the entire digital product lifecycle.

Keywords: field monitoring, incident management, multicompliance management for AI in AD, root cause analysis, database approach

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Authors: Princess Ncube

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In the context of South Africa's banking sector, the prevention of bank failures is of paramount importance to ensure financial stability and economic growth. This paper focuses on the role of regulatory frameworks in safeguarding the resilience of South African banks and mitigating the risks of failures. It aims to assess the effectiveness of existing regulatory measures and proposes strategies to enhance the resilience of financial institutions in the country. The paper begins by examining the specific regulatory frameworks in place in South Africa, including capital adequacy requirements, stress testing methodologies, risk management guidelines, and supervisory practices. It delves into the evolution of these measures in response to lessons learned from past financial crises and their relevance in the unique South African banking landscape. Drawing on empirical evidence and case studies specific to South Africa, this paper evaluates the effectiveness of regulatory frameworks in preventing bank failures within the country. It analyses the impact of these frameworks on crucial aspects such as early detection of distress signals, improvements in risk management practices, and advancements in corporate governance within South African financial institutions. Additionally, it explores the interplay between regulatory frameworks and the specific economic environment of South Africa, including the role of macroprudential policies in preventing systemic risks. Based on the assessment, this paper proposes recommendations to strengthen regulatory frameworks and enhance their effectiveness in bank failure prevention in South Africa. It explores avenues for refining existing regulations to align capital requirements with the risk profiles of South African banks, enhancing stress testing methodologies to capture specific vulnerabilities, and fostering better coordination among regulatory authorities within the country. Furthermore, it examines the potential benefits of adopting innovative approaches, such as leveraging technology and data analytics, to improve risk assessment and supervision in the South African banking sector.

Keywords: banks, resolution, liquidity, regulation

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Authors: Zohar Manber, Ran Elkon

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Accumulation of somatic mutations (SMs) in the genome is a major driving force of cancer development. Most SMs in the tumor's genome are functionally neutral; however, some cause damage to critical processes and provide the tumor with a selective growth advantage (termed cancer driver mutations). Current research on functional significance of SMs is mainly focused on finding alterations in protein coding sequences. However, the exome comprises only 3% of the human genome, and thus, SMs in the noncoding genome significantly outnumber those that map to protein-coding regions. Although our understanding of noncoding driver SMs is very rudimentary, it is likely that disruption of regulatory elements in the genome is an important, yet largely underexplored mechanism by which somatic mutations contribute to cancer development. The expression of most human genes is controlled by multiple enhancers, and therefore, it is conceivable that regulatory SMs are distributed across different enhancers of the same target gene. Yet, to date, most statistical searches for regulatory SMs have considered each regulatory element individually, which may reduce statistical power. The first challenge in considering the cumulative activity of all the enhancers of a gene as a single unit is to map enhancers to their target promoters. Such mapping defines for each gene its set of regulating enhancers (termed "set of regulatory elements" (SRE)). Considering multiple enhancers of each gene as one unit holds great promise for enhancing the identification of driver regulatory SMs. However, the success of this approach is greatly dependent on the availability of comprehensive and accurate enhancer-promoter (E-P) maps. To date, the discovery of driver regulatory SMs has been hindered by insufficient sample sizes and statistical analyses that often considered each regulatory element separately. In this study, we analyzed more than 2,500 whole-genome sequence (WGS) samples provided by The Cancer Genome Atlas (TCGA) and The International Cancer Genome Consortium (ICGC) in order to identify such driver regulatory SMs. Our analyses took into account the combinatorial aspect of gene regulation by considering all the enhancers that control the same target gene as one unit, based on E-P maps from three genomics resources. The identification of candidate driver noncoding SMs is based on their recurrence. We searched for SREs of genes that are "hotspots" for SMs (that is, they accumulate SMs at a significantly elevated rate). To test the statistical significance of recurrence of SMs within a gene's SRE, we used both global and local background mutation rates. Using this approach, we detected - in seven different cancer types - numerous "hotspots" for SMs. To support the functional significance of these recurrent noncoding SMs, we further examined their association with the expression level of their target gene (using gene expression data provided by the ICGC and TCGA for samples that were also analyzed by WGS).

Keywords: cancer genomics, enhancers, noncoding genome, regulatory elements

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Authors: M. McHugh, D. Lillis

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Mobile applications are being used to perform a wide variety of tasks in day-to-day life, ranging from checking email to controlling your home heating. Application developers have recognized the potential to transform a smart device into a medical device, by using a mobile medical application i.e. a mobile phone or a tablet. When initially conceived these mobile medical applications performed basic functions e.g. BMI calculator, accessing reference material etc.; however, increasing complexity offers clinicians and patients a range of functionality. As this complexity and functionality increases, so too does the potential risk associated with using such an application. Examples include any applications that provide the ability to inflate and deflate blood pressure cuffs, as well as applications that use patient-specific parameters and calculate dosage or create a dosage plan for radiation therapy. If an unapproved mobile medical application is marketed by a medical device organization, then they face significant penalties such as receiving an FDA warning letter to cease the prohibited activity, fines and possibility of facing a criminal conviction. Regulatory bodies have finalized guidance intended for mobile application developers to establish if their applications are subject to regulatory scrutiny. However, regulatory controls appear contradictory with the approaches taken by mobile application developers who generally work with short development cycles and very little documentation and as such, there is the potential to stifle further improvements due to these regulations. The research presented as part of this paper details how by adopting development techniques, such as agile software development, mobile medical application developers can meet regulatory requirements whilst still fostering innovation.

Keywords: agile, applications, FDA, medical, mobile, regulations, software engineering, standards

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Authors: Dalia Kubiliūtė

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Lithuania is known as a trusted location for global business institutions, and it attracts investors with it’s competitive environment for financial service providers. Along with the aspiration to offer a strong results-oriented and innovations-driven environment for financial service providers, Lithuanian regulatory authorities consistently implement the European Union's high regulatory standards for financial activities, including sustainability-related disclosures. Since European Union directed its policy towards transition to a climate-neutral, green, competitive, and inclusive economy, additional regulatory requirements for financial market participants are adopted: disclosure of sustainable activities, transparency, prevention of greenwashing, etc. The financial sector is one of the key factors influencing the implementation of sustainability objectives in European Union policies and mitigating the negative effects of climate change –public funds are not enough to make a significant impact on sustainable investments, therefore directing public and private capital to green projects may help to finance the necessary changes. The topic of the study is original and has not yet been widely analyzed in Lithuanian legal discourse. There are used quantitative and qualitative methodologies, logical, systematic, and critical analysis principles; hence the aim of this study is to reveal the problem of the implementation of the regulation on sustainability in the Lithuanian financial sector. Additional regulatory requirements could cause serious changes in financial business operations: additional funds, employees, and time have to be dedicated in order for the companies could implement these regulations. Lack of knowledge and data on how to implement new regulatory requirements towards sustainable reporting causes a lot of uncertainty for financial market participants. And for some companies, it might even be an essential point in terms of business continuity. It is considered that the supervisory authorities should find a balance between financial market needs and legal regulation.

Keywords: financial, legal, regulatory, sustainability

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Authors: Julius Y Asamoah

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Mobile money has seen faster adoption in the decade. Its emergence serves as an essential driver of financial inclusion and an innovative financial service delivery channel, especially to the unbanked population. The rising importance of mobile money services has caught policymakers and regulators' attention, seeking to understand the many issues emerging from this context. At the same time, it is unlocking the potential of knowledge of this new technology. Regulatory responses and support are essential, requiring significant changes to current regulatory practices in Ghana. The article aims to answer the following research questions: "What risk does an unregulated mobile money service pose to consumers and the financial system? "What factors stimulate and hinder the introduction of mobile payments in developing countries? The sample size used was 250 respondents selected from the study area. The study has adopted an analytical approach comprising a combination of qualitative and quantitative data collection methods. Actor-network theory (ANT) is used as an interpretive lens to analyse this process. ANT helps analyse how actors form alliances and enrol other actors, including non-human actors (i.e. technology), to secure their interests. The study revealed that government regulatory policies impact mobile money as critical to mobile money services in developing countries. Regulatory environment should balance the needs of advancing access to finance with the financial system's stability and draw extensively from Kenya's work as the best strategies for the system's players. Thus, regulators need to address issues related to the enhancement of supportive regulatory frameworks. It recommended that the government involve various stakeholders, such as mobile phone operators. Moreover, the national regulatory authority creates a regulatory environment that promotes fair practices and competition to raise revenues to support a business-enabling environment's key pillars as infrastructure.

Keywords: actor-network theory (ANT), cashless future, Developing countries, Ghana, Mobile Money

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Authors: Chinelle van der Westhuizen

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The introduction of cryptocurrencies as an alternative payment system have placed governments in a challenging position in relation to the regulatory status of cryptocurrencies and the money laundering activities associated with it. In April 2018, the Australian government amended its Anti-Money Laundering laws to regulate digital currency exchanges in an attempt to regulate money laundering activities and the introduction of ‘know-your-customer’ policies within the digital currency sector. Part one of this paper explores the use of cryptocurrencies for money laundering purposes and its significance to money launderers. Part two studies the efficacy of the current Australian Anti-Money Laundering laws and whether more can be done on a regulatory level. This paper will, therefore, highlight recent court decisions and legislation in terms of money laundering activities within these alternative payment systems in Australia and the United Kingdom. Part three of the paper will further analyze recent case studies by the Australian Transaction Reports and Analysis Centre and the Office for Professional Body Anti-Money Laundering Supervision in the United Kingdom as the regulatory bodies for money laundering activities. The case studies and research will explore the legal disputes and future regulation concerning the use of cryptocurrencies and money laundering on a national as well as international level. This paper intends to highlight that although cryptocurrency is viewed as an innovative global phenomenon and an alternative method of payment, there are a number of legal issues associated with its use that indicate the need for regulatory reform. It is recommended in this paper that the Financial Action Task Force, International Monetary Fund as well as concerned governments have ongoing discussions on these regulatory issues and how to address it appropriately, whether through legislation or universal guidelines. Therefore, the conclusion of this paper will emphasize the benefits of a regulatory regime for money laundering activities within the cryptocurrency space and that the lack of such a regime may be detrimental to countries.

Keywords: cryptocurrency, know-your-customer policy, money laundering, regulation

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Authors: Sulila Anar

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Institutions of any kind are regulated by laws which could be formal or informal, visible or invisible that influences the very structure of the institutions itself. Here in this paper the attempt will be to see how institutions of higher education are regulated by the regulatory institutions by taking the case of India, the third largest education system in the world. The attempt is to try to see how regulation of higher education creates a space for contestation among regulatory institutions based on secondary resources and how this affects the governance of university to achieve the goals and visions.

Keywords: higher education, regulation, autonomy, space

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Authors: Dwitya Elvira, Eryati Darwin

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Background: Graves’ disease (GD) is an autoimmune thyroid disease. Imbalance of Th1/Th2 cells and T-regulatory (Treg)/Th17 cells was thought to play pivotal role in the pathogenesis of GD. Treg FoxP3 produced TGF-β to maintain regulatory function, and Th17 cells produced IL-17 as cytokines that were thought in mediating several autoimmune diseases. The aim of this study is to assess the role of IL-17 and TGF-β in the pathogenesis of GD and to investigate its correlation with Thyroid Stimulating Hormone Receptor Antibody (TRAb) and Treg FoxP3 expression. Method: 30 GD patients and 27 age and sex-matched controls were enrolled in this study. Diagnosis of GD was based on clinical and biochemical of GD. Serum IL-17, TGF-β, TRAb, and FoxP3 were measured by enzyme-linked immunosorbent assay (ELISA). Data were analyzed by using SPSS 21.0 (SPSS Inc.). Spearman rank correlation test was used for assessment of correlation. The statistical significance was accepted as P<0.05. Result: There was no significant correlation between IL-17 and TGF-β serum with expression of FoxP3 level in GD, but there was significant correlation between TGF-β and TRAb serum level (P<0.05). Serum levels of IL-17 and TGF-β were found to be elevated in patient group compared to control, where mean values of IL-17 were 14.43±2.15 pg/mL and TGF-β were 10.44±3.19 pg/mL in patients group; and in control group, level of IL-17 were 7.1±1.45 pg/mL and TGF-β were 4.95±1.35 pg/mL. Conclusion: Serum Il-17 and TGF-β were elevated in GD patients that reflect the role of inflammatory and regulatory cytokines activation in pathogenesis of GD. There was significant correlation between TGF-β and TRAb, revealing that Treg cytokines may play a role in pathogenesis of GD.

Keywords: IL-17, TGF-B, FoxP3, TRAb, Graves’ disease

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Authors: Ananya Das, Arun Kumar, Gazala Habib, Vivekanandan Perumal

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Regulatory bodies has proposed limits on Particulate Matter (PM) concentration in air; however, it does not explicitly indicate the incorporation of effects of toxicities of constituents of PM in developing regulatory limits. This study aimed to provide a structured approach to incorporate toxic effects of components in developing regulatory limits on PM. A four-step human health risk assessment framework consists of - (1) hazard identification (parameters: PM and its constituents and their associated toxic effects on health), (2) exposure assessment (parameters: concentrations of PM and constituents, information on size and shape of PM; fate and transport of PM and constituents in respiratory system), (3) dose-response assessment (parameters: reference dose or target toxicity dose of PM and its constituents), and (4) risk estimation (metric: hazard quotient and/or lifetime incremental risk of cancer as applicable). Then parameters required at every step were obtained from literature. Using this information, an attempt has been made to determine limits on PM using component-specific information. An example calculation was conducted for exposures of PM_2.5 and its metal constituents from Indian ambient environment to determine limit on PM values. Identified data gaps were: (1) concentrations of PM and its constituents and their relationship with sampling regions, (2) relationship of toxicity of PM with its components.

Keywords: air, component-specific toxicity, human health risks, particulate matter

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Authors: Razieh Zareia, Hassan ZMB, Darush Moslemic, Amrollah Mostafa-Zaded

Abstract:

Introduction: Shark is a murine organism and its cartilage has antitumor peptides to prevent angiogenesis, at least, in vitro. The purpose of our research was to evaluate the immune-effectiveness on imbalance between IL-23/IL-17 axis, as an inflammatory pathway and TGF/Foxp3 T regulatory as a inhibitory pathway of commercial shark cartilage that is available as a non-common dietary supplement in IRAN. Materials and Methods: First investigated an imbalanced supernatant of cytokines exist in patients with gastric cancer by ELISA. Associated with cytokines measuring such as IL-23, IL-17, TGF-β, IL-4, and γ-IFN, then flow cytometry was employed to determine whether the peripheral blood mononuclear cells such as CD4+CD25+Foxp3highT regulatory cells in patients with gastric cancer were changed correspondingly. Results: The simultaneously presented up-regulation IL-17A indicated, at least cytokine level without changing in TGF-β amount or CD4+CD25+Foxp3 T regulatory cells, that there are not a direct correlation between IL-23/IL-17 axis and Treg/TGF-β pathway in patients with gastric cancer treated by shark cartilage, but IL-23 was not expressed differentially in this group. So, accompany these changes, an imbalance between Th1 immunity (γ-IFN production) and TH2 immunity (IL-4 secretion) evaluated in patients with gastric cancer treated by shark cartilage. Conclusion: On the basis of results, we propose that shark cartilage, by reducing IL-4, decreasing IL-17 a central cytokine in angiogenesis and increasing γ-IFN amplify anti-tumor immune responses in patients with gastric cancer.

Keywords: IL-23/IL17 axis, TGF-β/CD4+CD25+Foxp3high T regulatory pathway, γ-IFN, IL-4, shark cartilage, gastric cancer

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Authors: Salwa M. Almomen, Mona A. Almaghrabi, Saja M. Alhabardi, Adel A. Alrwisan

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Background: Hepatotoxicity is a major reason for medication withdrawal from the markets. Unfortunately, serious adverse hepatic effects can occur after marketing with limited indicators during clinical development. Therefore, finding possible predictors for hepatotoxicity might guide the monitoring program of various stakeholders. Methods: We examined the clinical review documents for drugs approved in the US from 2011 to 2016 to evaluate their hepatic safety profile. Predictors: we assessed whether these medications meet Hy’s Law with hepatotoxicity grade ≥ 3, labeled hepatic adverse effects at approval, or accelerated approval status. Outcome: post-marketing regulatory action related to hepatotoxicity, including product withdrawal or updates to warning, precaution, or adverse effects sections. Statistical analysis: drugs were included in the analysis from the time of approval until the end of 2019 or the first post-marketing regulatory action related to hepatotoxicity, whichever occurred first. The hazard ratio (HR) was estimated using Cox-regression analysis. Results: We included 192 medications in the study. We classified 48 drugs as having grade ≥ 3 hepatotoxicities, 43 had accelerated approval status, and 74 had labeled information about hepatotoxicity prior to marketing. The adjusted HRs for post-marketing regulatory action for products with grade ≥ 3 hepatotoxicity was 0.61 (95% confidence interval [CI], 0.17-2.23), 0.92 (95%CI, 0.29-2.93) for a drug approved via accelerated approval program, and was 0.91 (95%CI, 0.33-2.56) for drugs with labeled hepatotoxicity information at approval time. Conclusion: This study does not provide conclusive evidence on the association between post-marketing regulatory action and grade ≥ 3 hepatotoxicity, accelerated approval status, or availability of labeled information at approval due to sampling size and channeling bias.

Keywords: accelerated approvals, hepatic adverse effects, drug-induced liver injury, hepatotoxicity predictors, post-marketing withdrawal

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Authors: Sami Adwan, Alaa Alhaj Ismail, Claudia Girardone

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This paper examines the changes in the value relevance of book value of equity and net income of financial firms over the crisis period. It also examines how these changes vary with three variables, namely, fair value exposure, ownership concentration, and regulatory capital ratios. Using a sample of financial firms operating in the European Economic Area over 2005-2011, our findings suggest that the value relevance of book value of equity increases while that of net income decreases during the financial crisis. We find that more exposure to fair value accounting mitigates the impact of the crisis on the value relevance of book value of equity and net income. We also find that more concentrated ownership appears to have a mitigating impact on the changes in the value relevance of both book value of equity and net income in times of financial crisis. Finally, we find evidence that the level of regulatory capital ratios tends to have an attenuating effect on the changes in the value relevance of net income (but not book value of equity) in times of financial crisis.

Keywords: value relevance, financial crisis, financial firms, fair value, ownership concentration, regulatory capital

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Authors: Mark Lokanan

Abstract:

The paper analyzes the processing of complaints against investment brokers and dealer members through the Investment Industry Regulatory Organization of Canada (IIROC) from 2008 to 2017. IIROC is the self-regulatory organization (SRO) that is responsible for policing investment dealers and brokerage firms that trade in Canada’s securities market. Data from the study came from IIROC's enforcement annual reports for the years examined. The case processing is evaluated base on the misconduct funnel that was originally designed for street crime and applies to the enforcement of investment fraud. The misconduct funnel is used as a framework to examine IIROC’s claim that it brought in more complaints (funnel in) than government regulators and shows how these complaints are funneled out and funneled away as they are processed through IIROC’s enforcement system. The results indicate that IIROC is ineffective in disciplining its members and is unable to handle the more serious quasi-criminal and improper sales practices offenses. It is hard not to see the results of the paper being used by the legislator in Ottawa to show the importance of a federal securities regulatory agency such as the Securities and Exchange Commission (SEC) in the United States.

Keywords: investment fraud, securities regulation, compliance, enforcement

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