Research Regulatory Compliance

Author: Mark A. Suckow
Publisher: Academic Press
ISBN: 0124200656
Format: PDF
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Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users for the deluge of regulatory and compliance issues they will face while conducting their scientific programs. The book is edited and authored by known leaders in the field of compliance and regulations, and contains extensive research on the topics. It represents the new standard for information in every laboratory. Provides a “one-stop" , go-to resource for the many regulatory and compliance issues that affect laboratory study and research models Extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and also a great asset for faculty or new researchers coming in to the laboratory environment Focuses on United States regulations, covering both animal models and human subjects Written and edited by known leaders in the field of regulatory compliance who bring many years of collective experience to the book

Clinical Trials and Human Research

Author: Fay A. Rozovsky, JD, MPH
Publisher: Jossey-Bass
ISBN: 9780787965709
Format: PDF, Docs
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This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research.

Research Ethics for Social Scientists

Author: Mark Israel
Publisher: SAGE
ISBN: 9781412903905
Format: PDF
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`This is an excellent book which can be recommended both to the professional ethicist seeking to situate research ethics for a social scientific audience and to social scientists seeking an overview of the current ethical landscape of their discipline' - Research Ethics Review Ethics is becoming an increasingly prominent issue for all researchers across the western world. This comprehensive and accessible guide introduces students to the field and encourages knowledge of research ethics in practice. Research Ethics for Social Scientists sets out to do four things: The first is to demonstrate the practical value of thinking seriously and systematically about what constitutes ethical conduct in social science research. Secondly, the text identifies how and why current regulatory regimes have emerged. Thirdly, it seeks to reveal those practices that have contributed to the adversarial relationships between researchers and regulators. Finally, the book hopes to encourage both parties to develop shared solutions to ethical and regulatory problems. Research Ethics for Social Scientists is an excellent introductory text for students as it: - introduces students to ethical theory and philosophy; - provides practical guidance on what ethical theory means for research practice; - provides case studies to give real examples of ethics in research action. The result is an informative, accessible and practical guide to research ethics for any student or researcher in the social sciences.

Research Ethics and Integrity for Social Scientists

Author: Mark Israel
Publisher: SAGE
ISBN: 1473909163
Format: PDF, ePub, Docs
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Ethics and integrity in research are increasingly important for social scientists around the world. We are tackling more complex problems in the face of expanding and not always sympathetic regulation. This book surveys the recent developments and debates around researching ethically and with integrity and complying with ethical requirements. The new edition pushes beyond the work of the first edition through updated and extended coverage of issues relating to international, indigenous, interdisciplinary and internet research. Through case studies and examples drawn from all continents and from across the social science disciplines, the book: demonstrates the practical value of thinking seriously and systematically about ethical conduct in social science research identifies how and why current regulatory regimes have emerged reveals those practices that have contributed to the adversarial relationships between researchers and regulators encourages all parties to develop shared solutions to ethical and regulatory problems.

Ethical Conduct of Clinical Research Involving Children

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 9780309133388
Format: PDF, ePub, Docs
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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.

The Sourcebook for Clinical Research

Author: Natasha Martien
Publisher: Academic Press
ISBN: 0128162430
Format: PDF, ePub, Mobi
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A single trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines and specific protocol instructions to follow. And yet, there has existed no single-volume, comprehensive clinical research reference manual for investigators, medical institutions, and national and international research personnel to keep on the shelf as a ready reference to navigate through trial complexities and ensure compliance with U.S. Federal Regulations and ICH GCP until The Sourcebook for Clinical Research. An actionable, step-by-step guide through beginning to advanced topics in clinical research with forms, templates and checklists to download from a companion website (https://www.elsevier.com/books-and-journals/book-companion/9780128162422), so that study teams will be compliant and will find all the necessary tools within this book. Moreover, The Sourcebook for Clinical Research contains clear information and guidance on the newest changes in the industry to keep seasoned investigators and staff current and compliant, in addition to providing detailed information regarding the most complex topics. This book serves as a quick, actionable, off-the-shelf resource to keep by your side at the medical clinic. Makes vital trial conduct information easy to understand and instructs on how to practically apply current Federal regulations and Good Clinical Practice (ICH GCP) Offers extensive guidance that is crucial for guaranteeing compliance to clinical research regulations during each step of the clinical research process Provides up-to-date and extensive coverage of beginning to advanced topics, and, step-by-step actions to take during exceptional circumstances, including compassionate use, emergency use, human subjects protections for vulnerable populations, and federal audits Furnishes a detailed clinical research Glossary, and a comprehensive Appendix containing ready-to-use forms, templates, and checklists for clinical trial personnel to download and begin using immediately. Written for the fast-paced clinic environment with action steps and forms in the book to respond to a research subject’s needs urgently and compliantly

Financial Regulation and Compliance

Author: H. David Kotz
Publisher: John Wiley & Sons
ISBN: 1118972236
Format: PDF, Docs
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Devise an organized, proactive approach to financial compliance Financial Regulation and Compliance provides detailed, step-by-step guidance for the compliance professional seeking to manage overlapping and new regulatory responsibilities. Written by David Kotz, former Inspector General of the SEC with additional guidance provided by leading experts, this book is a one-stop resource for navigating the numerous regulations that have been enacted in response to the financial crisis. You'll learn how best to defend your organization from SEC, CFTC, FINRA, and NFA Enforcement actions, how to prepare for SEC, FINRA, and NFA regulatory examinations, how to manage the increasing volume of whistleblower complaints, how to efficiently and effectively investigate these complaints, and more. Detailed discussion of the regulatory process explains how aggressive you should be in confronting federal agencies and self-regulatory organizations and describes how commenting on issues that affect your business area can be productive or not. The companion website includes a glossary of terms, regulations and government guidance, relevant case law, research databases, and FAQs about various topics, giving you a complete solution for keeping abreast of evolving compliance issues. These days, compliance professionals are faced with a myriad of often overlapping regulatory challenges. Increased aggressiveness on the part of regulators has led to increased demand on financial firms, but this book provides clear insight into navigating the changes and building a more robust compliance function. Strengthen internal compliance and governance programs Manage whistleblower programs and conduct effective investigations Understand how to minimize exposure and liability from Enforcement actions Learn how to prepare for the different types of regulatory examinations Minimize exposure from FCPA violations Understand the pros and cons of commenting on regulations The volume and pace of regulatory change is causing new and diverse pressures on compliance professionals. Navigate the choppy waters successfully with the insider guidance in Financial Regulation and Compliance.

Explaining Compliance

Author: Christine Parker
Publisher: Edward Elgar Publishing
ISBN: 0857938738
Format: PDF, ePub
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'Taking a broad view of regulation, and covering a wide range of issues and industries, this collection is the most innovative effort to date to understand the responses of business firms to regulation. The book brings together an impressive group of scholars who analyze the concept of compliance and offer theoretically informed studies of its assumed links to regulation. A must read for both academics and practitioners, this ground-breaking collection firmly establishes a scholarly field of compliance studies.' Ronen Shamir, Tel Aviv University, Israel 'Business responses to regulation is a key area of social science research. Parker and Nielsen's collection brings together an excellent group of scholars with innovative, and I believe highly influential contributions that problematize the relations between regulation and compliance. The collection is a highly welcome addition to our field, that will redefine the research agenda on compliance. A significant achievement that will help to improve policy making and frame the scholarly research agenda for the years to come.' David Levi-Faur, The Hebrew University of Jerusalem, Israel and the Free University of Berlin, Germany 'A timely and important set of analyses on how and why businesses respond to regulation in the way that they do from some of the leading authors in the field, covering business responses to both state and non-state regulatory systems.' Julia Black, London School of Economics, UK Explaining Compliance consists of sixteen specially commissioned chapters by the world's leading empirical researchers, examining whether and how businesses comply with regulation that is designed to affect positive behaviour changes. Each chapter consists of reflective summaries on business compliance with different state or voluntary regulation, and the theoretical lessons to be drawn from it. As a whole, the book develops understanding and explanations of how, why and in what circumstances, firms come to comply with regulation, and when they do not. It also uncovers the complexity, ambiguity and transformation of regulation as it is interpreted, implemented and negotiated by firms, their stakeholders and internal constituencies in everyday business life. This unique and detailed resource will appeal to academics, graduate students and senior undergraduates in law, political science, sociology, criminology, economics, and psychology, as well as business and interdisciplinary areas such as law and society, and law and economics. Anyone researching business regulation, corporate social responsibility, regulation and compliance, enforcement and compliance, and public administration, will also find this book beneficial.

Principles and Practice of Clinical Research

Author: John I. Gallin
Publisher: Academic Press
ISBN: 0128499044
Format: PDF, Docs
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Principles and Practice of Clinical Research, Fourth Edition has been thoroughly revised to provide a comprehensive look at both the fundamental principles and expanding practice of clinical research. New to this edition of this highly regarded reference, authors have focused on examples that broadly reflect clinical research on a global scale while including a discussion of international regulations, studies, and implications. In addition to key topics such as bioethics, clinical outcome data, cultural diversity, protocol guidelines, and “omic platforms, this edition contains new chapters devoted to electronic health records and information resources for clinical researchers, as well as the many opportunities associated with big data. Covering a vast number of topics and practical advice for both novice and advanced clinical investigators, this book is a highly relevant and essential resource for all those involved in conducting research. Features input from experts in the field dedicated to translating scientific research from bench to bedside and back Provides expanded coverage of global clinical research Contains hands-on, practical suggestions, illustrations, and examples throughout Includes new chapters on the international regulation of drugs and biologics, the emergence of the important role of comparative effectiveness research and how to identify clinical risks and manage patient safety in a clinical research setting