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Research Regulatory Compliance

Research Regulatory Compliance
  • Author : Mark A. Suckow,Bill Yates
  • Publisher :Unknown
  • Release Date :2015-06-14
  • Total pages :344
  • ISBN : 9780124200654
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Summary : 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

Clinical Trials and Human Research
  • Author : Fay A. Rozovsky, JD, MPH,Rodney K. Adams
  • Publisher :Unknown
  • Release Date :2003-06-10
  • Total pages :656
  • ISBN : 0787965707
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Summary : 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 and Integrity for Social Scientists

Research Ethics and Integrity for Social Scientists
  • Author : Mark Israel
  • Publisher :Unknown
  • Release Date :2014-10-20
  • Total pages :264
  • ISBN : 9781473909168
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Summary : 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.

Clinical Research Law and Compliance Handbook

Clinical Research Law and Compliance Handbook
  • Author : John E. Steiner
  • Publisher :Unknown
  • Release Date :2006
  • Total pages :460
  • ISBN : 0763747254
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Summary : Written in clear, practical language, this title will help you navigate the clinical research maze as it addresses critically important legal, operational, ethical and business issues associated with clinical research trials.

Management of Animal Care and Use Programs in Research, Education, and Testing

Management of Animal Care and Use Programs in Research, Education, and Testing
  • Author : Robert H. Weichbrod,Gail A. (Heidbrink) Thompson,John N. Norton
  • Publisher :Unknown
  • Release Date :2017-09-07
  • Total pages :872
  • ISBN : 9781351648226
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Summary : AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all types of programs involving animal care and use. The new edition has more than doubled the number of chapters in the original volume to present a more comprehensive overview of the current breadth and depth of the field with applicability to an international audience. Readers are provided with the latest information and resource and reference material from authors who are noted experts in their field. The book: - Emphasizes the importance of developing a collaborative culture of care within an animal care and use program and provides information about how behavioral management through animal training can play an integral role in a veterinary health program - Provides a new section on Environment and Housing, containing chapters that focus on management considerations of housing and enrichment delineated by species - Expands coverage of regulatory oversight and compliance, assessment, and assurance issues and processes, including a greater discussion of globalization and harmonizing cultural and regulatory issues - Includes more in-depth treatment throughout the book of critical topics in program management, physical plant, animal health, and husbandry. Biomedical research using animals requires administrators and managers who are knowledgeable and highly skilled. They must adapt to the complexity of rapidly-changing technologies, balance research goals with a thorough understanding of regulatory requirements and guidelines, and know how to work with a multi-generational, multi-cultural workforce. This book is the ideal resource for these professionals. It also serves as an indispensable resource text for certification exams and credentialing boards for a multitude of professional societies Co-publishers on the second edition are: ACLAM (American College of Laboratory Animal Medicine); ECLAM (European College of Laboratory Animal Medicine); IACLAM (International Colleges of Laboratory Animal Medicine); JCLAM (Japanese College of Laboratory Animal Medicine); KCLAM (Korean College of Laboratory Animal Medicine); CALAS (Canadian Association of Laboratory Animal Medicine); LAMA (Laboratory Animal Management Association); and IAT (Institute of Animal Technology).

Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children
  • Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
  • Publisher :Unknown
  • Release Date :2004-07-09
  • Total pages :445
  • ISBN : 0309133386
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Summary : 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.

Implementing a Comprehensive Research Compliance Program

Implementing a Comprehensive Research Compliance Program
  • Author : Aurali Dade,Lori Olafson,Suzan M. DiBella
  • Publisher :Unknown
  • Release Date :2015-07-01
  • Total pages :569
  • ISBN : 9781681231334
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Summary : The senior research compliance administrator has emerged as a critically important position as universities and other research organizations face an increasingly intricate regulatory environment. These administrators are tasked with a special challenge: ensuring that their institutions conduct safe, ethical, and compliant research while also helping researchers understand and meet compliance requirements and achieve their research goals. These competing responsibilities can make the role of the research administrator complex; however, those who serve in this role may find that they have limited preparation for the challenges and little or no formal education in the field. Thus, the goal of this handbook is to provide practical guidance to research administrators who are responsible for a wide variety of compliance programs. Previous volumes on these topics have focused primarily on educating research faculty, staff, and students. An assumption in many of these handbooks is that all additional questions related to research ethics and regulations should be directed to the senior research administrator; yet, the books have limited guidance intended for the senior research administrators themselves. This handbook is designed, therefore, to serve as a detailed program implementation manual for these administrators, who are expected to be conversant on a broad range of complex ethical and regulatory topics and to provide guidance to those conducting research, as well as upper administration and others interested in safe, ethical, and compliant research.

Clinical Research Compliance Manual

Clinical Research Compliance Manual
  • Author : Brent,Aspen Publishers,Lawrence W. Vernaglia,Aspen
  • Publisher :Unknown
  • Release Date :2007
  • Total pages :588
  • ISBN : 0735569665
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Summary : For anyone receiving or applying for clinical research funding, Clinical Research Compliance Manual: An Administrative Guide covers today's most crucial topics, including: Human subject protections Institutional Review Board regulations and requirements Conflicts of interest Scientific misconduct Reimbursement issues And much more! Clinical Research Compliance Manual helps you establish best practices and carry out all administrative tasks in a compliant manner while keeping you completely up-to-date on the most recent developments: Covers the major clinical research issues - with chapters written by experts in the field Provides legal explanations of the major regulatory issues in an easy-to-understand format Includes summaries of federal regulatory agencies, analysis of major cases, flow-charts, checklists, and footnotes to in compliance program development, auditing and monitoring Clinical Research Compliance Manual has been updated to include: A new chapter on "Protecting Research Materials, Research Results, and Inventions: A University's Perspective" A new section on "Recent Proposed Changes to the Common Rule" Updated discussion of federal-wide assurance (FWA) OHRP's revision of its FAQs to be consistent with its Final Guidance on Engagement of Institutions in Human Subject Research Recent OHRP guidance on when institutions are not engaged in human subject research And much more!

Research Ethics for Social Scientists

Research Ethics for Social Scientists
  • Author : Mark Israel,Iain Hay
  • Publisher :Unknown
  • Release Date :2006-06-29
  • Total pages :193
  • ISBN : 1412903904
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Summary : 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. Second, the text identifies how and why current regulatory regimes have emerged. Third, 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.

Enterprise, Business-Process and Information Systems Modeling

Enterprise, Business-Process and Information Systems Modeling
  • Author : Terry Halpin,John Krogstie,Selmin Nurcan,Erik Proper,Rainer Schmidt,Pnina Soffer,Roland Ukor
  • Publisher :Unknown
  • Release Date :2009-04-30
  • Total pages :420
  • ISBN : 9783642018626
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Summary : This book contains the proceedings of two long-standing workshops: The 10th International Workshop on Business Process Modeling, Development and Support, BPMDS 2009, and the 14th International Conference on Exploring Modeling Methods for Systems Analysis and Design, EMMSAD 2009, held in connection with CAiSE 2009 in Amsterdam, The Netherlands, in June 2009. The 17 papers accepted for BPMDS 2009 were carefully reviewed and selected from 32 submissions. The topics addressed by the BPMDS workshop are business and goal-related drivers; model-driven process change; technological drivers and IT services; technological drivers and process mining; and compliance and awareness. Following an extensive review process, 16 papers out of 36 submissions were accepted for EMMSAD 2009. These papers cover the following topics: use of ontologies; UML and MDA; ORM and rule-oriented modeling; goal-oriented modeling; alignment and understandability; enterprise modeling; and patterns and anti-patterns in enterprise modeling.

Explaining Compliance

Explaining Compliance
  • Author : Christine Parker,Vibeke Lehmann Nielsen
  • Publisher :Unknown
  • Release Date :2011
  • Total pages :400
  • ISBN : 9780857938732
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Summary : '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.

Interagency Coordination in Drug Research and Regulation

Interagency Coordination in Drug Research and Regulation
  • Author : United States. Congress. Senate. Committee on Government Operations
  • Publisher :Unknown
  • Release Date :1963
  • Total pages :229
  • ISBN : CORNELL:31924000351837
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Summary :

Preparing for Future Products of Biotechnology

Preparing for Future Products of Biotechnology
  • Author : National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology,Board on Agriculture and Natural Resources,Board on Life Sciences,Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System
  • Publisher :Unknown
  • Release Date :2017-07-28
  • Total pages :230
  • ISBN : 9780309452052
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Summary : Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

Optimizing the Nation's Investment in Academic Research

Optimizing the Nation's Investment in Academic Research
  • Author : National Academies of Sciences, Engineering, and Medicine,Policy and Global Affairs,Board on Higher Education and Workforce,Committee on Science, Technology, and Law,Committee on Federal Research Regulations and Reporting Requirements: A New Framework for Research Universities in the 21st Century
  • Publisher :Unknown
  • Release Date :2016-07-29
  • Total pages :282
  • ISBN : 9780309379489
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Summary : Research universities are critical contributors to our national research enterprise. They are the principal source of a world-class labor force and fundamental discoveries that enhance our lives and the lives of others around the world. These institutions help to create an educated citizenry capable of making informed and crucial choices as participants in a democratic society. However many are concerned that the unintended cumulative effect of federal regulations undercuts the productivity of the research enterprise and diminishes the return on the federal investment in research. Optimizing the Nation's Investment in Academic Research reviews the regulatory framework as it currently exists, considers specific regulations that have placed undue and often unanticipated burdens on the research enterprise, and reassesses the process by which these regulations are created, reviewed, and retired. This review is critical to strengthen the partnership between the federal government and research institutions, to maximize the creation of new knowledge and products, to provide for the effective training and education of the next generation of scholars and workers, and to optimize the return on the federal investment in research for the benefit of the American people.

The Changing Face of Compliance

The Changing Face of Compliance
  • Author : Sharon Ward
  • Publisher :Unknown
  • Release Date :2016-04-01
  • Total pages :304
  • ISBN : 9781317039037
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Summary : In the current business climate the impact of the volume and nature of regulatory change and the regulatory risk arising from this is a significant business risk for regulated firms and regulators alike. As a consequence, management of this risk is increasingly high on the board agenda of regulated firms, with those business functions whose activities support this, such as Compliance, facing increasing levels of challenge in their efforts to be effective. The Changing Face of Compliance addresses core aspects of this challenge, considering the relationship between regulation and compliance and key influences on both, offering insight into the effectiveness of current approaches and addressing practical compliance challenges. Sharon Ward explains how the role of Compliance might be strengthened and those who work within it further enabled to support the current focus on improving standards in business, offering recommendations for enhancing this role. The text includes a mix of hands-on advice, examples and research based on the experiences of practitioners, educators and regulators drawn from across a wide range of jurisdictions and sectors. This is a thoughtful and timely book, whether you are concerned about the growing and changing implications of regulatory risk; the benefit of leveraging additional value from your Compliance function or your own Compliance role; or ways of transforming and sustaining the function to ensure its continued relevance to the business.

Contextualizing Compliance in the Public Sector

Contextualizing Compliance in the Public Sector
  • Author : Saba Siddiki,Salvador Espinosa,Tanya Heikkila
  • Publisher :Unknown
  • Release Date :2018-07-06
  • Total pages :160
  • ISBN : 9781351374378
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Summary : Studying compliance to uncover whether compliance is occurring, and what motivates it, is central to the broader study of governance. Contextualizing Compliance in the Public Sector: Individual Motivations, Social Processes and Institutional Design develops an interdisciplinary approach for answering a classic and essential question in any rule-governed context: What factors influence the decision of an individual or organization to comply (or not) with governing rules? Analyzing compliance from an interdisciplinary and multi-level perspective, this book examines the question of what motivates compliance in the context of salient policy issues, such as energy policy, water governance, police profiling, and drug policy, among others. The book brings together an interdisciplinary group of experts who explore the psychological, social, and institutional factors that shape compliance with formal rules embodied in laws and regulations and/or informal rules embodied in social norms. In doing so, they offer a platform for assessing individual compliance, compliance by or in the context of groups, and compliance on a systemic or societal level. Contextualizing Compliance in the Public Sector: Individual Motivations, Social Processes and Institutional Designis an excellent resource for researchers and scholars of public administration and public policy conducting research on compliance, rules, behavior, and policy outcomes.

Impact of Regulatory Compliance Costs on Small Airports

Impact of Regulatory Compliance Costs on Small Airports
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2013
  • Total pages :84
  • ISBN : UCBK:C101992361
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Summary : "TRB's Airport Cooperative Research Program (ACRP) Report 90: Impact of Regulatory Compliance Costs on Small Airports explores the cumulative costs of complying with regulatory and other federal requirements at small hub and non-hub airports."--Publisher's description.

The Regulatory Craft

The Regulatory Craft
  • Author : Malcolm K. Sparrow
  • Publisher :Unknown
  • Release Date :2011-01-01
  • Total pages :370
  • ISBN : 0815798288
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Summary : The Regulatory Craft tackles one of the most pressing public policy issues of our time—the reform of regulatory and enforcement practice. Malcolm K. Sparrow shows how the vogue prescriptions for reform (centered on concepts of customer service and process improvement) fail to take account of the distinctive character of regulatory responsibilities—which involve the delivery of obligations rather than just services.In order to construct more balanced prescriptions for reform, Sparrow invites us to reconsider the central purpose of social regulation—the abatement or control of risks to society. He recounts the experiences of pioneering agencies that have confronted the risk-control challenge directly, developing operational capacities for specifying risk-concentrations, problem areas, or patterns of noncompliance, and then designing interventions tailored to each problem. At the heart of a new regulatory craftsmanship, according to Sparrow, lies the central notion, "pick important problems and fix them." This beguilingly simple idea turns out to present enormously complex implementation challenges and carries with it profound consequences for the way regulators organize their work, manage their discretion, and report their performance. Although the book is primarily aimed at regulatory and law-enforcement practitioners, it will also be invaluable for legislators, overseers, and others who care about the nature and quality of regulatory practice, and who want to know what kind of performance to demand from regulators and how it might be delivered. It stresses the enormous benefit to society that might accrue from development of the risk-control art as a core professional skill for regulators.

Use of Laboratory Animals in Biomedical and Behavioral Research

Use of Laboratory Animals in Biomedical and Behavioral Research
  • Author : National Research Council,Institute of Medicine,Institute for Laboratory Animal Research,Commission on Life Sciences,Committee on the Use of Laboratory Animals in Biomedical and Behavioral Research
  • Publisher :Unknown
  • Release Date :1988-02-01
  • Total pages :112
  • ISBN : 9780309038393
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Summary : Scientific experiments using animals have contributed significantly to the improvement of human health. Animal experiments were crucial to the conquest of polio, for example, and they will undoubtedly be one of the keystones in AIDS research. However, some persons believe that the cost to the animals is often high. Authored by a committee of experts from various fields, this book discusses the benefits that have resulted from animal research, the scope of animal research today, the concerns of advocates of animal welfare, and the prospects for finding alternatives to animal use. The authors conclude with specific recommendations for more consistent government action.

Ethical and Regulatory Aspects of Clinical Research

Ethical and Regulatory Aspects of Clinical Research
  • Author : Ezekiel J. Emanuel,Chair of the Department of Clinical Bioethics Ezekiel J Emanuel,Christine Grady,The Poynter Center for the Study of Ethics and American Institutions Robert A Crouch,Robert A. Crouch,John D. Arras,David and Lyn Silfen University Professor Jonathan D Moreno, PhD,Jonathan D. Moreno
  • Publisher :Unknown
  • Release Date :2003
  • Total pages :490
  • ISBN : UOM:39015058788673
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Summary : Professionals in need of such training and bioethicists will be interested.

Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making

Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making
  • Author : Institute of Medicine,Roundtable on Research and Development of Drugs, Biologics, and Medical Devices
  • Publisher :Unknown
  • Release Date :1999-07-27
  • Total pages :88
  • ISBN : 0309172802
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Summary : In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.