As an experiment in reconnecting academia to the broader democracy, this work is designed to invigorate public policy debate by rededicating academic work to the pursuit of solutions to society's great problems.

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.

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.

Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher's Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher's Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher's Guide was reviewed by members of the National Academies' Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher's Association NSTA Recommends.

This volume introduces readers to regulatory theory. Aimed at practitioners, postgraduate students and those interested in regulation as a cross-cutting theme in the social sciences, Regulatory Theory includes chapters on the social-psychological foundations of regulation as well as theories of regulation such as responsive regulation, smart regulation and nodal governance. It explores the key themes of compliance, legal pluralism, meta-regulation, the rule of law, risk, accountability, globalisation and regulatory capitalism. The environment, crime, health, human rights, investment, migration and tax are among the fields of regulation considered in this ground-breaking book. Each chapter introduces the reader to key concepts and ideas and contains suggestions for further reading. The contributors, who either are or have been connected to the Regulatory Institutions Network (RegNet) at The Australian National University, include John Braithwaite, Valerie Braithwaite, Peter Grabosky, Neil Gunningham, Fiona Haines, Terry Halliday, David Levi-Faur, Christine Parker, Colin Scott and Clifford Shearing.

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.

In this sprawling and ambitious book John Braithwaite successfully manages to link the contemporary dynamics of macro political economy to the dynamics of citizen engagement and organisational activism at the micro intestacies of governance practices. This is no mean feat and the logic works. . . Stephen Bell, The Australian Journal of Public Administration Everyone who is puzzled by modern regulocracy should read this book. Short and incisive, it represents the culmination of over twenty years work on the subject. It offers us a perceptive and wide-ranging perspective on the global development of regulatory capitalism and an important analysis of points of leverage for democrats and reformers. Christopher Hood, All Souls College, Oxford, UK It takes a great mind to produce a book that is indispensable for beginners and experts, theorists and policymakers alike. With characteristic clarity, admirable brevity, and his inimitable mix of description and prescription, John Braithwaite explains how corporations and states regulate each other in the complex global system dubbed regulatory capitalism. For Braithwaite aficionados, Regulatory Capitalism brings into focus the big picture created from years of meticulous research. For Braithwaite novices, it is a reading guide that cannot fail to inspire them to learn more. Carol A. Heimer, Northwestern University, US Reading Regulatory Capitalism is like opening your eyes. John Braithwaite brings together law, politics, and economics to give us a map and a vocabulary for the world we actually see all around us. He weaves together elements of over a decade of scholarship on the nature of the state, regulation, industrial organization, and intellectual property in an elegant, readable, and indispensable volume. Anne-Marie Slaughter, Princeton University, US Encyclopedic in scope, chock full of provocative even jarring claims, Regulatory Capitalism shows John Braithwaite at his transcendental best. Ian Ayres, Yale Law School, Yale University, US Contemporary societies have more vibrant markets than past ones. Yet they are more heavily populated by private and public regulators. This book explores the features of such a regulatory capitalism, its tendencies to be cyclically crisis-ridden, ritualistic and governed through networks. New ways of thinking about resultant policy challenges are developed. At the heart of this latest work by John Braithwaite lies the insight by David Levi-Faur and Jacint Jordana that the welfare state was succeeded in the 1970s by regulatory capitalism. The book argues that this has produced stronger markets, public regulation, private regulation and hybrid private/public regulation as well as new challenges such as a more cyclical quality to crises of market and governance failure, regulatory ritualism and markets in vice. However, regulatory capitalism also creates opportunities for better design of markets in virtue such as markets in continuous improvement, privatized enforcement of regulation, open source business models, regulatory pyramids with networked escalation and meta-governance of justice. Regulatory Capitalism will be warmly welcomed by regulatory scholars in political science, sociology, history, economics, business schools and law schools as well as regulatory bureaucrats, policy thinkers in government and law and society scholars.

New data show that countries that regulate the entry of new firms more heavily have greater corruption and larger unofficial economies, but not better quality goods. The evidence supports the view that regulating entry benefits politicians and bureacrats.

That America's natural environment has been degraded and despoiled over the past 25 years is beyond dispute. Nor has there been any shortage of reasons why-short-sighted politicians, a society built on over-consumption, and the dramatic weakening of environmental regulations. In Retaking Rationality, Richard L. Revesz and Michael A. Livermore argue convincingly that one of the least understood-and most important-causes of our failure to protect the environment has been a misguided rejection of reason. The authors show that environmentalists, labor unions, and other progressive groups have declined to participate in the key governmental proceedings concerning the cost-benefit analysis of federal regulations. As a result of this vacuum, industry groups have captured cost-benefit analysis and used it to further their anti-regulatory ends. Beginning in 1981, the federal Office of Management and Budget and the federal courts have used cost-benefit analysis extensively to determine which environmental, health, and safety regulations are approved and which are sent back to the drawing board. The resulting imbalance in political participation has profoundly affected the nation's regulatory and legal landscape. But Revesz and Livermore contend that economic analysis of regulations is necessary and that it needn't conflict with-and can in fact support-a more compassionate approach to environmental policy. Indeed, they show that we cannot give up on rationality if we truly want to protect our natural environment. Retaking Rationality makes clear that by embracing and reforming cost-benefit analysis, and by joining reason and compassion, progressive groups can help enact strong environmental and public health regulation.