Regulatory Oversight (regulatory + oversight)

Distribution by Scientific Domains

Selected Abstracts

ASTS Recommended Practice Guidelines for Controlled Donation after Cardiac Death Organ Procurement and Transplantation

D. J. Reich
The American Society of Transplant Surgeons (ASTS) champions efforts to increase organ donation. Controlled donation after cardiac death (DCD) offers the family and the patient with a hopeless prognosis the option to donate when brain death criteria will not be met. Although DCD is increasing, this endeavor is still in the midst of development. DCD protocols, recovery techniques and organ acceptance criteria vary among organ procurement organizations and transplant centers. Growing enthusiasm for DCD has been tempered by the decreased yield of transplantable organs and less favorable posttransplant outcomes compared with donation after brain death. Logistics and ethics relevant to DCD engender discussion and debate among lay and medical communities. Regulatory oversight of the mandate to increase DCD and a recent lawsuit involving professional behavior during an attempted DCD have fueled scrutiny of this activity. Within this setting, the ASTS Council sought best-practice guidelines for controlled DCD organ donation and transplantation. The proposed guidelines are evidence based when possible. They cover many aspects of DCD kidney, liver and pancreas transplantation, including donor characteristics, consent, withdrawal of ventilatory support, operative technique, ischemia times, machine perfusion, recipient considerations and biliary issues. DCD organ transplantation involves unique challenges that these recommendations seek to address. [source]

Effect of regulatory oversight on the association between internal governance characteristics and audit fees

El'fred Boo
G34; M42; N40 Abstract We examine the relationship between internal governance, external audit monitoring and regulatory oversight for a sample comprising industrial companies and financial/utility companies subject to additional industry-specific regulation. Our results indicate that the association between audit fees and board/audit committee independence and size are weaker for regulated companies. These observations are consistent with the notion that regulatory oversight partially substitutes the external audit as a monitoring mechanism. However, boards/audit committees with more multiple directorships demand a more extensive audit in the presence of regulatory oversight to protect their reputation capital. Our study enhances our understanding of the complex relationships among the major corporate governance elements. [source]

Venous needle dislodgement during hemodialysis: An unresolved risk of catastrophic hemorrhage

S. Sandroni
Venous line disconnection or needle dislodgement during hemodialysis with resultant hemorrhage is a potentially lethal event. The risk is compounded by the frequent failure of standard dialysis machines to detect the event, as blood flow through the venous needle typically creates enough back pressure to prevent venous pressure alarms even if the needle is completely out of the patient's AV access. Manufacturers are well aware of the risk and device literature contains specific warnings about it. The FDA publishes reports on its website about these events; so far this year there have been seven reported events with five deaths. Informal sources indicate that the actual (unreported) occurrence is much more frequent; we are aware of four additional events within our region alone. Efforts to reduce the risk include protocols requiring the access needles to always be visible, and use of enuresis detection devices. Anecdotal experience with these efforts suggests they are not highly effective. Protocols requiring documentation of more frequent needle site checks or alternate methods of securing the needles have not been formally evaluated. However, such efforts do not address the primary problem: there is a need for an engineered solution to this problem. Requirements for such a solution include: reliable detection of needle position and blood flow discrepancies, a useful alarm, and feedback to stop the blood pump. Persistence of this problem raises issues of regulatory oversight. [source]

The Financial Crisis: Causes and Lessons,

Kenneth E. Scott
The author argues that the root cause of the recent crisis was a housing bubble whose origins can be traced to loose monetary policy and a government housing policy that continually pushed for lower lending standards to increase home ownership. The negative consequences of such policies were amplified when transmitted throughout the financial system by financial institutions through the process of securitization. In attempting to assess culpability for the crisis and identify possible reforms, the author focuses on three categories: 1Defects in Financial Products: Without criticizing derivatives and the process of securitization, the author identifies the sheer complexity of the securities as a major source of the problem,for which the solution is a simpler security design combined with greater disclosure about the underlying assets being securitized. 2Defects in Risk Management: Thanks in large part to agency and other incentive problems, there was universal underestimation of risks by mortgage originators and financial institutions throughout the securitization chain. Changing incentive pay structures is part of the solution, and so are better accounting rules for SPEs. But more effective regulatory oversight and ending "too big to fail" may well be the only way to curb excessive private risk-taking. 3Defects in Government Policy and Regulation: While acknowledging the need for more effective oversight, the author argues that there was ample existing authority for U.S. regulators to have addressed these issues. Lack of power and authority to regulate was not at the heart of the problem,the real problem was lack of foresight and judgment about the unexpected. After expressing doubt that regulators can prevent major financial failures, the author recommends greater attention to devising better methods of resolving such failures when they occur. One of the main goals is to ensure that losses are borne not by taxpayers but by private investors in a way that maintains incentives for market discipline while limiting spillover costs to the entire system. [source]

Frequency of Man-Made Disasters in the 20th Century

Les Coleman
This paper analyses two disaster databases maintained by the Center for Research on the Epidemiology of Disasters and by Emergency Management Australia. The objective is to quantify the frequency, nature and changes in man-made disasters in industrialised countries during the past century. The analysis shows an exponential growth in disaster frequency, largely due to an increase in traditional hazards such as fires and explosions, rather than from new technologies. Although the number of incidents has grown, this has been offset by a decline in fatalities per incident. An important implication of these results is that regulatory oversight and internal corporate governance processes are inadequate to ensure effective management of modern industrial risks. [source]

US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars

Alan McHughen
Summary This paper reviews the history of the federal regulatory oversight of plant agricultural biotechnology in the USA, focusing on the scientific and political forces moulding the continually evolving regulatory structure in place today. Unlike most other jurisdictions, the USA decided to adapt pre-existing legislation to encompass products of biotechnology. In so doing, it established an overarching committee (Office of Science and Technology Policy) to study and distribute various regulatory responsibilities amongst relevant agencies: the Food and Drug Administration, Environmental Protection Agency and US Department of Agriculture. This paper reviews the history and procedures of each agency in the execution of its regulatory duties and investigates the advantages and disadvantages of the US regulatory strategy. [source]

The effectiveness of NGO self-regulation: theory and evidence from Africa

Mary Kay Gugerty
Abstract Non-governmental organizations (NGOs) play an increasingly important role in public service provision and policy making in sub-Saharan Africa, stimulating demand for new forms of regulatory oversight. In response, a number of initiatives in NGO self-regulation have emerged. Using cross-national data on 20 African countries, the article shows that self-regulation in Africa falls into three types: national-level guilds, NGO-led clubs and voluntary codes of conduct. Each displays significant weaknesses from a regulatory policy perspective. National guilds have a broad scope, but require high administrative oversight capacity on the part of NGOs. Voluntary clubs have stronger standards but typically have much weaker coverage. Voluntary codes are the most common form of self-regulation, but have the weakest regulatory strength. This article argues that the weakness of current attempts to improve the accountability and regulatory environment of NGOs stems in part from a mismatch between the goals of regulation and the institutional incentives embedded in the structure of most self-regulatory regimes. The article uses the logic of collective action to illustrate the nature of this mismatch and the tradeoffs between the potential breadth and strength of various forms of NGO self-regulation using three detailed case studies. Copyright © 2008 John Wiley & Sons, Ltd. [source]

Commentary: Is It Possible to Determine the Extent to Which Informational Asymmetries and Prejudice Bias Responses?

Terrance HurleyArticle first published online: 17 DEC 200
This commentary provides a brief overview of the methods and results presented by Jennifer Kuzma, Pouya Najmaie, and Joel Larson in "Evaluating Oversight Systems for Emerging Technologies: A Case Study of Genetically Engineered Organisms." It offers suggestions regarding how supplemental information might be used to gain additional insights into the authors' results and how future research could further enhance our understanding of the attributes and outcomes of regulatory oversight for genetically engineered organisms. [source]

Organ Donation and Utilization in the United States: 1998,2007

J. E. Tuttle-Newhall
Organ transplantation remains the only life-saving therapy for many patients with organ failure. Despite the work of the Organ Donation and Transplant Collaboratives, and the marked increases in deceased donors early in the effort, deceased donors only rose by 67 from 2006 and the number of living donors declined during the same time period. There continues to be increases in the use of organs from donors after cardiac death (DCD) and expanded criteria donors (ECD). This year has seen a major change in the way organs are offered with increased patient safety measures in those organ offers made by OPOs using DonorNet©. Unfortunately, the goals of 75% conversion rates, 3.75 organs transplanted per donor, 10% of all donors from DCD sources and 20% growth of transplant center volume have yet to be reached across all donation service areas (DSAs) and transplant centers; however, there are DSAs that have not only met, but exceeded, these goals. Changes in organ preservation techniques took place this year, partly due to expanding organ acceptance criteria and increasing numbers of ECDs and DCDs. Finally, the national transplant environment has changed in response to increased regulatory oversight and new requirements for donation and transplant provider organizations. [source]

The Development of Commodity Exchanges in the Former Soviet Union, Eastern Europe, and China

Anne E. Peck
The virtual collapse of the centrally planned economies of the countries of the former Soviet Union (FSU) and the more gradual transition from central planning to a market-oriented economy in China were both accompanied by the opening of hundreds of exchanges trading many agricultural, resource, and other physical commodities. Although many viewed them as harbingers of full-fledged market-based economies, most of the new exchanges in fact have since closed either for lack of activity or by government intervention, a history that this paper documents. New exchanges faced numerous obstacles in sustaining interest, from developing standardised contract terms to establishing effective self-regulation and state regulatory oversight. In several countries, the transparency of transactions on exchanges attracted governments interested in collecting taxes and customs duties which only drove trade away from the exchanges or turned them into little more than state agencies. In China, regulators struggled with duplicative exchanges and products, price volatility, large speculative interest, and several manipulations and have recently reduced the number of exchanges to just three and severely limited the commodities traded. There have been some successes too, including (at least prospectively) the three remaining exchanges in China, the Budapest Commodity Exchange in Hungary, and the Poznan Commodity Exchange in Poland. For all, identifying the terms to create standardised contracts has been (and continues to be) a major challenge. [source]