Regulatory Matters Research Articles

Complexity and conservation of regulatory landscapes underlie evolutionary resilience of mammalian gene expression.

To gain insight into how mammalian gene expression is controlled by rapidly evolving regulatory elements, we jointly analysed promoter and enhancer activity with downstream transcription levels in liver samples from fifteen species. Genes associated with complex regulatory landscapes generally exhibit high expression levels that remain evolutionarily stable. While the number of regulatory elements is the key driver of transcriptional output and resilience, regulatory conservation matters: elements active across mammals most effectively stabilise gene expression. In contrast, recently-evolved enhancers typically contribute weakly, consistent with their high evolutionary plasticity. These effects are observed across the entire mammalian clade and robust to potential confounders, such as gene expression level. Using liver as a representative somatic tissue, our results illuminate how the evolutionary stability of gene expression is profoundly entwined with both the number and conservation of surrounding promoters and enhancers.

Statistical Sampling in Litigation and Regulatory Proceedings: Methods, Insights, and an Economic Model of Optimal Sample Size

A sample of elements can effectively act as a surrogate for a large population that cannot be studied due to resource constraints. Thus, in a variety of legal and regulatory matters, relying on a statistical sample may be the only feasible approach to effectively adjudicate questions of causation, liability, or damages. The current paper works through in detail some of the more salient aspects of statistical sampling and sample size determination. An economic model is presented to provide insight into the mental calculus that is theoretically involved in making decisions about sample sizes in the context of litigation.

Does regulatory regime matter for bank risk taking? A comparative analysis of US and Canada

In the wake of the worst financial crisis in 2008, most US banks were bailed out while Canadian banks sailed through the crisis relatively unscathed. This has compelled some analysts to question why banking crises happen in America but not in Canada. We examine the risk-taking behavior of banks in the US and Canada prior to the recent financial crisis and find that Canadian banks had lower risk than their US counterparts over the study period. Further analysis shows that entry restrictions, which create concentrated banking structure, strong supervisory power, and discipline constrain excessive risk taking by Canadian banks. Entry restrictions enable Canadian banks to generate higher profits and lower variability of asset returns, while restrictions on activities reduce profitability and increase variability in asset return. However, the former seems to overwhelm the effect of asset restrictions, given the lower risk that we observe for the Canadian banks. The less concentrated but competitive banking structure in the US is associated with higher bank risk taking.

Missing links between regulatory resources and risk concerns: Evidence from the case of food safety in China

AbstractDo resources available to regulatory agencies matter for public perceptions of social risks? In this paper we use the case of food safety in China to empirically examine the relationship between regulatory resources and risk concerns. The multilevel model estimates suggest that neither regulatory revenue nor personnel is significantly related to public concerns over food safety. There is also no significant interaction effect between regulatory resources and food scandals. Despite the fact that sufficient fiscal revenue and manpower are the prerequisites of effective food safety regulation, they do not elicit more favorable public perceptions. These are the two missing links leading to the insignificant effect of regulatory resource inputs. First, ineffective distribution and deployment of resources and the lack of external participation retard the growth of regulatory capacity. Second, underinvestment in risk communication and the amplification effect of risks undermine regulatory legitimacy. We discuss the theoretical and policy implications of the results, and conclude with research limitations and suggestions for future research.

The evolution of the U.S. nuclear regulatory process

This paper provides historical perspectives and insights on the early development of the U.S. nuclear regulatory process and its subsequent evolution towards risk-informed processes. After the landmark Reactor Safety Study (WASH-1400) and the TMI-2 accident, the U.S. Nuclear Regulatory Commission (NRC) began to use probabilistic risk assessment (PRA) methods and insights in regulatory applications as deemed necessary or useful. In 1995, the NRC adopted a policy that promotes increasing the use of probabilistic risk analysis in all regulatory matters to the extent supported by the state of the art to complement the deterministic approach. The NRC then started moving toward a much expanded use of PRAs in what is termed risk-informed regulatory approach. This paper discusses the challenges and the success stories of the use of probabilistic assessment of the risk to support and inform regulatory decisions.

Equipment ABS Update from ABS East 2016

This article recaps the Equipment ABS session at the 2016 ABS East conference held in Miami Beach from September 18, 2016, to September 20, 2016. Among the topics covered are the outlook for the underlying equipment finance business; collateral performance; the securitization market for equipment ABS; and regulatory matters facing the equipment asset class. The session’s panel members suggested that collateral performance for the asset class has been exceptionally strong since the financial crisis and is likely to revert to historical norms while still remaining positive. The panelists also discussed the increased inclination of the Consumer Financial Protection Bureau in potentially regulating small business lending. <b>TOPICS:</b>Asset-backed securities (ABS), legal/regulatory/public policy

Does regulatory forbearance matter for bank stability? Evidence from creditors’ perspective

Regulatory forbearance in times of corporate distress has been a common practice in many countries to achieve bank stability, particularly so in the absence of a unified bankruptcy code, yet very little is known in the context of emerging market economies. Exploiting variation of membership across banks in a corporate debt restructuring programme (CDR) sponsored by the central bank in India, this paper finds that the banks that made use of regulatory forbearance (RF) on the restructured corporate loans could increase their stability significantly due to the extension of low provisioning on restructured loans. However, the positive effect of RF diminishes at higher levels of market power, highlighting that member banks with higher market power tend to originate riskier assets (as reflected in their risk-weighted assets) under the auspices of this programme. Our results remain robust to different estimators (including propensity score matching), ownership structure, and alternative measures of bank stability.

Regulating the European Sharing Economy: State of Play and Challenges

The past years have seen an extraordinary proliferation of sharing economy platforms, and the largest platforms have fast become global enterprises with market capitalisations that exceed competitors with “traditional” business concepts. These developments call into question a number of regulatory matters and pose new questions for national and European-level regulators.

A first attempt to determine the partial factors according to Eurocodes for the verification of ULS of steel elements for conditions of the Republic of Belarus

The aim of the study is to develop science-based methodology for estimation the values of the partial factors for design of steel structures for the conditions of the Republic of Belarus, taking into account the specified values of reliability levels. The object of the study is steel structural elements. Methods: mathematical modeling, numerical and analytical methods, parametric and graphic analysis. In January 2010 European standards (EN standards, Eurocodes) for the design, fabrication and erection of building structures were introduced in the Republic of Belarus. The system of European standards (EN 1990) recognise the responsibility of regulatory authorities in each country and guarantee their right to determine values related to regulatory safety matters at national level. According to the reliability concept of building structures adopted in the standard ISO 2394, EN 1990 the target reliability levels for designed structures are set. It caused a necessity to calibrate the partial factors of steel structures for Belarusian National Annex to Eurocode 3 based on the target reliability level using probabilistic methods.DOI: http://dx.doi.org/10.5755/j01.sace.14.1.15066

After talks, Bayer raises takeover offer for Monsanto

After engaging in private talks with Monsanto, Bayer has raised its takeover offer for the St. Louis-based firm by $3.00 to $125 per share, bringing the offer’s total value to about $65 billion. Bayer says it has addressed Monsanto’s questions about financing and regulatory matters. Bayer is also offering to pay $1.5 billion if the deal is canceled for antitrust reasons. Monsanto says it will review the proposal. The offer was revealed hours after a Bloomberg article reported that Monsanto is in talks with BASF, possibly about acquiring BASF’s agrochemicals business.

Regulatory Coherence and the Trans-Pacific Partnership

The Trans-Pacific Partnership includes a chapter on regulatory coherence and measures to reduce trade costs arising from divergent standards. We review the substantive content of the TPP’s measures in light of existing processes in international organizations addressing good regulatory practices, and the track record of mutual recognition as a tool to reduce trade costs, and comment on the extent to which claims made on behalf of the TPP for significant cost reduction in goods trade can be sustained, and the extent to which fears concerning the impact of the TPP measures on democratic choice on regulatory matters are warranted.

TU‐H‐207B‐02: Funding (NCI) for Radiomics

Research and development in radiomics for precision medicine have been advancing at a rapid pace, and can be extended to eventually be mature enough for integration into clinical practice. To facilitate advances in this field, investigators need updated information on research funding, regulatory matters, and clinical translation efforts. In this special radiomics symposium, the attendee will learn of various novel funding mechanisms – both past and present – that have been used to support a number of quantitative imaging and radiomics research and resource infrastructures. In addition, a regulatory presentation will be given to provide the attendee with an understanding of when a radiomics tool might require FDA clearance or approval, and with what supporting performance data. We will end with insights from a clinical radiologist who is greatly involved in quantitative imaging in order to enable the attendee to appreciate the needs and subtleties involved in moving radiomics into the clinical workflow.J. Boone, This is a memorial and not a funded event.

TU‐H‐207B‐00: Moving Radiomics Forward: Funding, Regulatory Issues, and Clinical Translation

Research and development in radiomics for precision medicine have been advancing at a rapid pace, and can be extended to eventually be mature enough for integration into clinical practice. To facilitate advances in this field, investigators need updated information on research funding, regulatory matters, and clinical translation efforts. In this special radiomics symposium, the attendee will learn of various novel funding mechanisms – both past and present – that have been used to support a number of quantitative imaging and radiomics research and resource infrastructures. In addition, a regulatory presentation will be given to provide the attendee with an understanding of when a radiomics tool might require FDA clearance or approval, and with what supporting performance data. We will end with insights from a clinical radiologist who is greatly involved in quantitative imaging in order to enable the attendee to appreciate the needs and subtleties involved in moving radiomics into the clinical workflow.J. Boone, This is a memorial and not a funded event.

TU‐H‐207B‐03: Radiomics &amp; Regulatory Issues

Research and development in radiomics for precision medicine have been advancing at a rapid pace, and can be extended to eventually be mature enough for integration into clinical practice. To facilitate advances in this field, investigators need updated information on research funding, regulatory matters, and clinical translation efforts. In this special radiomics symposium, the attendee will learn of various novel funding mechanisms – both past and present – that have been used to support a number of quantitative imaging and radiomics research and resource infrastructures. In addition, a regulatory presentation will be given to provide the attendee with an understanding of when a radiomics tool might require FDA clearance or approval, and with what supporting performance data. We will end with insights from a clinical radiologist who is greatly involved in quantitative imaging in order to enable the attendee to appreciate the needs and subtleties involved in moving radiomics into the clinical workflow.J. Boone, This is a memorial and not a funded event.

TU‐H‐207B‐01: Memorial Tribute

Research and development in radiomics for precision medicine have been advancing at a rapid pace, and can be extended to eventually be mature enough for integration into clinical practice. To facilitate advances in this field, investigators need updated information on research funding, regulatory matters, and clinical translation efforts. In this special radiomics symposium, the attendee will learn of various novel funding mechanisms – both past and present – that have been used to support a number of quantitative imaging and radiomics research and resource infrastructures. In addition, a regulatory presentation will be given to provide the attendee with an understanding of when a radiomics tool might require FDA clearance or approval, and with what supporting performance data. We will end with insights from a clinical radiologist who is greatly involved in quantitative imaging in order to enable the attendee to appreciate the needs and subtleties involved in moving radiomics into the clinical workflow.J. Boone, This is a memorial and not a funded event.

TU‐H‐207B‐04: Clinical Translation of Radiomics

Research and development in radiomics for precision medicine have been advancing at a rapid pace, and can be extended to eventually be mature enough for integration into clinical practice. To facilitate advances in this field, investigators need updated information on research funding, regulatory matters, and clinical translation efforts. In this special radiomics symposium, the attendee will learn of various novel funding mechanisms – both past and present – that have been used to support a number of quantitative imaging and radiomics research and resource infrastructures. In addition, a regulatory presentation will be given to provide the attendee with an understanding of when a radiomics tool might require FDA clearance or approval, and with what supporting performance data. We will end with insights from a clinical radiologist who is greatly involved in quantitative imaging in order to enable the attendee to appreciate the needs and subtleties involved in moving radiomics into the clinical workflow.J. Boone, This is a memorial and not a funded event.

The Role of Big Data in Governance: A Regulatory and Legal Perspective of Analytics in Global Financial Services

This paper discusses how global financial institutions are using big data analytics within their compliance operations. A lot of previous research has focused on the strategic implications of big data, but not much research has considered how such tools are entwined with regulatory breaches and investigations in financial services. Our work covers two in-depth qualitative case studies, each addressing a distinct type of analytics. The first case focuses on analytics which manage everyday compliance breaches and so are expected by managers. The second case focuses on analytics which facilitate investigation and litigation where serious unexpected breaches may have occurred. In doing so, the study focuses on the micro/data to understand how these tools are influencing operational risks and practices. The paper draws from two bodies of literature, the social studies of information systems and finance to guide our analysis and practitioner recommendations. The cases illustrate how technologies are implicated in multijurisdictional challenges and regulatory conflicts at each end of the operational risk spectrum. We find that compliance analytics are both shaping and reporting regulatory matters yet often firms may have difficulties in recruiting individuals with relevant but diverse skill sets. The cases also underscore the increasing need for financial organizations to adopt robust information governance policies and processes to ease future remediation efforts.

New Guidelines for Forensic Assessment.

The American Academy of Psychiatry and the Law (AAPL) recently published guidelines for forensic assessment intended for psychiatrists and other clinicians working in medicolegal roles, or performing evaluations and offering opinions in relation to legal or regulatory matters. Although these guidelines do not establish a singular standard for forensic evaluation, they are intended to inform practice. Although nuances pertaining to any given case and the pertinent medicolegal issues involved will require professional judgment as to how best to conduct any particular evaluation, the guidelines do offer many helpful tenets and guiding principles that are broadly applicable. Psychiatrists and other clinicians performing forensic evaluations need to be aware of these guidelines and should strive to incorporate them as appropriate. In this column we offer a brief synopsis of the approach to the forensic psychiatric assessment based upon the AAPL Practice Guideline for the Forensic Assessment.

Selecting an Electronic Data Capture System

IntroductionInvestigators encounter numerous challenges when initiating a research project, including selecting an appropriate electronic data capture system. Options range from simple stand-alone spreadsheets to full service, relational databases controlled by certified database administrators. We present an overview of the issues to consider when selecting an electronic data capture system and a survey of available software solutions. We also discuss how to select an electronic data capture system that best meets the data management needs of the study. MethodsWe compared software solutions based on several regulatory and budgetary issues that should be considered by investigators. Regulatory issues include HIPAA (Health Insurance Portability and Accountability Act), case report forms and adverse event reports. Technology costs, ease of use and expertise of personnel are examples of budgetary matters. ResultsStand-alone spreadsheets require extra attention to regulatory matters but are intuitive to investigators. Large-scale relational database management systems can be configured for all regulatory matters but require dedicated effort from a certified database administrator, greatly increasing data management costs. Low cost, server based solutions sacrifice some of the flexibility of a relational database management system in exchange for being extremely easy to design and manage. Software as a service is a scalable third party solution. Cloud based systems are a new solution that are not widely used in institutional review board approved research. ConclusionsDue to the extensive resources required to implement an electronic data capture system it is important to carefully analyze and understand what options are available. In this way the most informed choice can be made.

The Teaching of Financial Services Regulation: A Contextual View

This paper discusses issues and developments that relate to the teaching of bank regulation in tertiary institutions. It considers how course content, teaching texts, and methodology, can become subject to issues like specific, historical, and jurisdictional, cultures and contexts for the discipline. It considers how economic and political approaches impact such teaching. How banking regulations tools are used, and course structures are built, are matters which impinge on the type of trained personnel who later eventually leave academia and end up working on regulatory or compliance matters.