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Author: Aurali Dade Publisher: IAP ISBN: 1681231336 Category : Education Languages : en Pages : 568
Book Description
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.
Author: Aurali Dade Publisher: IAP ISBN: 1681231336 Category : Education Languages : en Pages : 568
Book Description
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.
Author: Ernestoh Khomu Publisher: GRIN Verlag ISBN: 3668455252 Category : Medical Languages : en Pages : 16
Book Description
Seminar paper from the year 2017 in the subject Health - Public Health, grade: 2, , course: Bachelor of Public Health, language: English, abstract: All successful clinical or healthcare research endeavors in the current era depend on a carefully designed oversight process. One integral part of the same is the Research Compliance Program. This paper skims trough some of the most basic parts of the Research Compliance Department as part of studies related to understanding the relationship between the Department itself and the program. I hope it accurately reveals new insight into the subject matter.
Author: Martin T. Biegelman Publisher: John Wiley & Sons ISBN: 0470278404 Category : Business & Economics Languages : en Pages : 320
Book Description
Written by a long-standing practitioner in the field, this timely and critical work is your best source for understanding all the complex issues and requirements associated with corporate compliance. It provides clear guidance for those charged with protecting their companies from financial and reputational risk, litigation, and government intervention, who want a robust guide to establish an effective compliance program.
Author: Robert H. Weichbrod Publisher: CRC Press ISBN: 1498748457 Category : Medical Languages : en Pages : 917
Book Description
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).
Author: Thomas Fox Publisher: ISBN: 9781783583300 Category : Languages : en Pages : 554
Book Description
Thomas Fox, the Compliance Evangelist, is one of the leading writers, thinkers and commentators on the nuts and bolts of compliance. His always practical advice is now available in one volume, The Complete Compliance Handbook. This book incorporates the most recent pronouncements and guidance from the Department of Justice, including 2017's Evaluation of Corporate Compliance Programs and FCPA Corporate Enforcement Policy, to provide the most up-to-date advice on what constitutes a best practices compliance program. In this single volume compendium, Fox brings together the tops ideas, topics and techniques you can incorporate your compliance program, literally in 31-days to more fully operationalize your compliance regime. If you want one volume to guide you in operationalizing compliance, this is it. The book is designed to provide you with a step-by-step guide to the design, creation, implementation of or enhancement to a compliance program. It begins with 31-days to a more effective compliance program. Each entry presents one thing you can accomplish, at little to no cost, to improve any level of compliance program. There are three key-takeaways for each entry. The final chapter goes through the same process for you to operationalize your compliance program. In between these bookends, The Complete Compliance Handbook features chapters on: -Operationalizing Compliance Through Human Resources -The Role of the Board of Directors and Compliance -360-Degrees of Communication in Compliance -Better Third-Party Risk Management -Reporting and Investigations -Internal Controls -Innovation in Compliance -Written Standards -More Effective Compliance for Business Ventures -Continuous Improvement The author, Thomas Fox, has written 15 books on compliance, leadership and business ethics. He founded the Compliance Podcast Network and has one of the largest social media presences in compliance. He has worked in the compliance arena for over 10 years and draws upon his many years of experience in the profession to create this single volume which will become the standard 'nuts and bolts' text on compliance. Fox's writing style is suited for any skill level of compliance practitioner or maturity of corporate compliance program.
Author: John I. Gallin Publisher: Elsevier ISBN: 0080489567 Category : Science Languages : en Pages : 447
Book Description
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government
Author: Benjamin van Rooij Publisher: Cambridge University Press ISBN: 1108754139 Category : Law Languages : en Pages : 1559
Book Description
Compliance has become key to our contemporary markets, societies, and modes of governance across a variety of public and private domains. While this has stimulated a rich body of empirical and practical expertise on compliance, thus far, there has been no comprehensive understanding of what compliance is or how it influences various fields and sectors. The academic knowledge of compliance has remained siloed along different disciplinary domains, regulatory and legal spheres, and mechanisms and interventions. This handbook bridges these divides to provide the first one-stop overview of what compliance is, how we can best study it, and the core mechanisms that shape it. Written by leading experts, chapters offer perspectives from across law, regulatory studies, management science, criminology, economics, sociology, and psychology. This volume is the definitive and comprehensive account of compliance.
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: Adil E. Shamoo Publisher: Oxford University Press ISBN: 0199709602 Category : Medical Languages : en Pages : 441
Book Description
Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.
Author: Aurali Dade
Author: Aurali Dade
Author: Ernestoh Khomu
Author: Martin T. Biegelman
Author: 
Author: Robert H. Weichbrod
Author: Thomas Fox
Author: John I. Gallin
Author: Benjamin van Rooij
Author: Institute of Medicine
Author: Adil E. Shamoo