Intentional Human Dosing Studies for EPA Regulatory Purposes PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Intentional Human Dosing Studies for EPA Regulatory Purposes PDF full book. Access full book title Intentional Human Dosing Studies for EPA Regulatory Purposes by National Research Council. Download full books in PDF and EPUB format.
Author: National Research Council Publisher: National Academies Press ISBN: 0309166411 Category : Science Languages : en Pages : 226
Book Description
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.
Author: National Research Council Publisher: National Academies Press ISBN: 0309166411 Category : Science Languages : en Pages : 226
Book Description
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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309133386 Category : Medical Languages : en Pages : 445
Book Description
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.
Author: Jerry Brito Publisher: Mercatus Center at George Mason University ISBN: 0983607737 Category : Law Languages : en Pages : 128
Book Description
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.
Author: National Research Council Publisher: National Academies Press ISBN: 030916933X Category : Technology & Engineering Languages : en Pages : 200
Book Description
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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309158060 Category : Medical Languages : en Pages : 442
Book Description
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.
Author: United States Government Accountability Office Publisher: Lulu.com ISBN: 0359541828 Category : Reference Languages : en Pages : 88
Book Description
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.
Author: Tehrani, Pardis Moslemzadeh Publisher: IGI Global ISBN: 1799879291 Category : Computers Languages : en Pages : 273
Book Description
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.
Author: Dr. O.P. Gupta Publisher: SBPD Publishing House ISBN: 9350470322 Category : Business & Economics Languages : en Pages : 347
Book Description
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.
Author: OECD Publisher: OECD Publishing ISBN: 9264214453 Category : Languages : en Pages : 159
Book Description
This publication provides countries with a Framework for Regulatory Policy Evaluation, an overview of evaluation practices in OECD countries and concrete examples.
Author: National Research Council
Author: National Research Council
Author: Institute of Medicine
Author: Jerry Brito
Author: National Research Council
Author: Institute of Medicine
Author: United States Government Accountability Office
Author: Tehrani, Pardis Moslemzadeh
Author: 
Author: Dr. O.P. Gupta
Author: OECD