Download or read book Intentional Human Dosing Studies for EPA Regulatory Purposes written by National Research Council and published by National Academies Press. This book was released on 2004-06-04 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.
Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
Download or read book Animal Biotechnology written by National Research Council and published by National Academies Press. This book was released on 2002-11-29 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genetic-based animal biotechnology has produced new food and pharmaceutical products and promises many more advances to benefit humankind. These exciting prospects are accompanied by considerable unease, however, about matters such as safety and ethics. This book identifies science-based and policy-related concerns about animal biotechnologyâ€"key issues that must be resolved before the new breakthroughs can reach their potential. The book includes a short history of the field and provides understandable definitions of terms like cloning. Looking at technologies on the near horizon, the authors discuss what we know and what we fear about their effectsâ€"the inadvertent release of dangerous microorganisms, the safety of products derived from biotechnology, the impact of genetically engineered animals on their environment. In addition to these concerns, the book explores animal welfare concerns, and our societal and institutional capacity to manage and regulate the technology and its products. This accessible volume will be important to everyone interested in the implications of the use of animal biotechnology.
Download or read book Regulation written by Jerry Brito and published by Mercatus Center at George Mason University. This book was released on 2012-08-13 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: Federal regulations affect nearly every area of our lives and interest in them is increasing. However, many people have no idea how regulations are developed or how they have an impact on our lives. Regulation: A Primer by Susan Dudley and Jerry Brito provides an accessible overview of regulatory theory, analysis, and practice. The Primer examines the constitutional underpinnings of federal regulation and discusses who writes and enforces regulation and how they do it. Published by the Mercatus Center at George Mason University, it also provides insights into the different varieties of regulation and how to analyze whether a regulatory proposal makes citizens better or worse off. Each chapter discusses key aspects of regulation and provides further readings for those interested in exploring these topics in more detail.
Download or read book Regulatory Aspects of Artificial Intelligence on Blockchain written by Tehrani, Pardis Moslemzadeh and published by IGI Global. This book was released on 2021-09-24 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: The convergence of Artificial Intelligence (AI) in blockchain creates one of the world’s most reliable technology-enabled decision-making systems that is virtually tamper-proof and provides solid insights and decisions. The integration of AI and Blockchain affects many aspects from food supply chain logistics and healthcare record sharing to media royalties and financial security. It is imperative that regulatory standards are emphasized in order to support positive outcomes from the integration of AI in blockchain technology. Regulatory Aspects of Artificial Intelligence on Blockchain provides relevant legal and security frameworks and the latest empirical research findings in blockchain and AI. Through the latest research and standards, the book identifies and offers solutions for overcoming legal consequences that pertain to the application of AI into the blockchain system, especially concerning the usage of smart contracts. The chapters, while investigating the legal and security issues associated with these applications, also include topics such as smart contacts, network vulnerability, cryptocurrency, machine learning, and more. This book is essential for technologists, security analysts, legal specialists, privacy and data security practitioners, IT consultants, standardization professionals, researchers, academicians, and students interested in blockchain and AI from a legal and security viewpoint.
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Download or read book Standards for Internal Control in the Federal Government written by United States Government Accountability Office and published by Lulu.com. This book was released on 2019-03-24 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: Policymakers and program managers are continually seeking ways to improve accountability in achieving an entity's mission. A key factor in improving accountability in achieving an entity's mission is to implement an effective internal control system. An effective internal control system helps an entity adapt to shifting environments, evolving demands, changing risks, and new priorities. As programs change and entities strive to improve operational processes and implement new technology, management continually evaluates its internal control system so that it is effective and updated when necessary. Section 3512 (c) and (d) of Title 31 of the United States Code (commonly known as the Federal Managers' Financial Integrity Act (FMFIA)) requires the Comptroller General to issue standards for internal control in the federal government.
Download or read book Business Regulatory Framework Latest Edition 2020 written by Dr. O.P. Gupta and published by SBPD Publishing House. This book was released on 2020-10-01 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: Who can buy? Students of BBA, B.Com, and law must buy this book as it is in their syllabus. General students interested in running a business should know the acts given in this book, so it is helpful for them as well. Business Regulatory Framework is specially designed to serve as an undergraduate textbook for B.Com. (Honors & General) students of the different universities across India. This book is designed especially to cater to the needs of commerce students, equipping them with a strong foundation for an understanding of the current business law situation. The book seeks to provide comprehensive coverage of the various topics relating to business law. It offers content that is simple to understand but does not compromise on necessary technical detail.
Download or read book International Convergence of Capital Measurement and Capital Standards written by and published by Lulu.com. This book was released on 2004 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book OECD Framework for Regulatory Policy Evaluation written by OECD and published by OECD Publishing. This book was released on 2014-06-18 with total page 159 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication provides countries with a Framework for Regulatory Policy Evaluation, an overview of evaluation practices in OECD countries and concrete examples.
Download or read book Public Health Effectiveness of the FDA 510 k Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Download or read book Regulatory Frameworks for Water Resources Management written by Salman M. A. Salman and published by World Bank Publications. This book was released on 2006-01-01 with total page 218 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title examines how regulatory frameworks have addressed the various basic issues related to water resources management, and provides a comparative analysis of those issues. It elicits and discusses what it considers are the essential elements for a regulatory framework for water resources management, and identifies some emerging trends.
Download or read book Functions and Processes of the Regulatory Body for Safety written by International Atomic Energy Agency and published by . This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Safety Guide provides recommendations on meeting the requirements of IAEA Safety Standards Series No. GSR Part 1 (Rev. 1), Governmental, Legal and Regulatory Framework for Safety, on the regulatory body's core functions and associated regulatory processes. This guidance is particularly important for regulatory bodies having responsibilities covering a range of facilities and activities that give rise to radiation risks and the important organizational interfaces between various regulatory authorities, which require effective coordination and cooperation. It promotes a consistent approach to regulation and specifically addresses the release of facilities and activities from regulatory control including sites, buildings, equipment and material. The publication is intended to be used mainly by regulatory bodies but will also be useful for governments that are developing a regulatory framework for safety. It will also assist authorized parties and others dealing with radiation sources in understanding regulatory procedures, processes and expectations.
Download or read book Governmental Legal and Regulatory Framework for Safety written by and published by . This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book International Health Regulations 2005 written by World Health Organization and published by World Health Organization. This book was released on 2008-12-15 with total page 82 pages. Available in PDF, EPUB and Kindle. Book excerpt: In response to the call of the 48th World Health Assembly for a substantial revision of the International Health Regulations, this new edition of the Regulations will enter into force on June 15, 2007. The purpose and scope of the Regulations are "to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade." The Regulations also cover certificates applicable to international travel and transport, and requirements for international ports, airports and ground crossings.
Download or read book Better Regulation Practices across the European Union written by OECD and published by OECD Publishing. This book was released on 2019-03-19 with total page 199 pages. Available in PDF, EPUB and Kindle. Book excerpt: Laws and regulations affect the daily lives of businesses and citizens. High-quality laws promote national welfare and growth, while badly designed laws hinder growth, harm the environment and put the health of citizens at risk. This report analyses practices to improve the quality of laws ...
Download or read book Reclaiming Development in the World Trading System written by Yong-Shik Lee and published by Cambridge University Press. This book was released on 2016-10-20 with total page 519 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this second edition, Lee provides extensive coverage of international trade law from an economic development perspective.
