research regulatory compliance

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Research Regulatory Compliance

Author : Mark A. Suckow
ISBN : 9780124200654
Genre : Medical
File Size : 90. 98 MB
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

Human Subjects Research Regulation

Author : I. Glenn Cohen
ISBN : 9780262526210
Genre : Law
File Size : 57. 79 MB
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Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects.

The Regulatory Environment For Science

Author :
ISBN : 9781428923133
Genre :
File Size : 23. 50 MB
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Critical Care Study Guide

Author : Gerard J. Criner
ISBN : 0387774521
Genre : Medical
File Size : 22. 1 MB
Format : PDF, Mobi
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Critical care medicine is a dynamic and exciting arena where complex pathophysiologic states require extensive knowledge and up-to-date clinical information. An extensive kno- edge of basic pathophysiology, as well as awareness of the appropriate diagnostic tests and treatments that are used to optimize care in the critically ill is essential. Since our frst edition 7 years ago, new information crucial to the care and understanding of the critically ill patient has rapidly accumulated. Because this knowledge base crosses many different disciplines, a comprehensive multidisciplinary approach presenting the information is essential, similar to the multidisciplinary approach that is used to care for the critically ill patient. We have strived to provide this content in an easily digestible format that uses a variety of teaching tools to facilitate understanding of the presented concepts and to enhance information retention. To meet the demand to provide comprehensive and diverse education in order to und- stand the pathogenesis and optimum care of a variety of critical illnesses, we have subst- tially revised the prior topics in the frst edition with updated information. We have also markedly expanded the number of topics covered to include acute lung injury and the acute respiratory distress syndrome, an expanded discussion of the physiology and operation of mechanical ventilation, obstetrical care in the ICU, neurosurgical emergencies, acute co- nary syndromes, cardiac arrhythmias, role of whole body rehabilitation in the ICU, ethical conduct of human research in the ICU, and nursing care of the ICU patient.

Research Ethics And Integrity For Social Scientists

Author : Mark Israel
ISBN : 9781473909168
Genre : Social Science
File Size : 79. 2 MB
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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.

Innovative Research In Life Sciences

Author : E. Andrew Balas
ISBN : 9781119225874
Genre : Medical
File Size : 56. 75 MB
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“I thoroughly enjoyed reading this book as it has taken me on a journey through time, across the globe and through multiple disciplines. Indeed, we need to be thinking about these concepts and applying them every day to do our jobs better.” Farah Magrabi, Macquarie University, Australia “The reader will find intriguing not only the title but also the content of the book. I’m also pleased that public health, and even more specifically epidemiology has an important place in this ambitious discussion.” Elena Andresen, Oregon Health & Science University, USA “This book is very well written and addresses an important topic. It presents many reasons why basic scientists/researchers should establish collaborations and access information outside traditional means and not limit thinking but rather expand such and perhaps develop more innovative and translational research ventures that will advance science and not move it laterally.” Gerald Pepe, Eastern Virginia Medical School, USA “This book gathers logically and presents interestingly (with many examples) the qualities and attitudes a researcher must possess in order to become successful. On the long run, the deep and carefully reexamined research will be the one that lasts.” Zoltán Néda, Babeş-Bolyai University, Romania “I really liked the five pillars delineating the components of humanism in research. This book has made a major contribution to the research ethics literature.” David Fleming, University of Missouri, USA A comprehensive review of the research phase of life sciences from design to discovery with suggestions to improve innovation This vital resource explores the creative processes leading to biomedical innovation, identifies the obstacles and best practices of innovative laboratories, and supports the production of effective science. Innovative Research in Life Sciences draws on lessons from 400 award-winning scientists and research from leading universities. The book explores the innovative process in life sciences and puts the focus on how great ideas are born and become landmark scientific discoveries. The text provides a unique resource for developing professional competencies and applied skills of life sciences researchers. The book examines what happens before the scientific paper is submitted for publication or the innovation becomes legally protected. This phase is the most neglected but most exciting in the process of scientific creativity and innovation. The author identifies twelve competencies of innovative biomedical researchers that described and analyzed. This important resource: Highlights the research phase from design to discovery that precedes innovation disclosure Offers a step by step explanation of how to improve innovation Offers solutions for improving research and innovation productivity in the life sciences Contains a variety of statistical databases and a vast number of stories about individual discoveries Includes a process of published studies and national statistics of biomedical research and reviews the performance of research labs and academic institutions Written for academics and researchers in biomedicine, pharmaceutical science, life sciences, drug discovery, pharmacology, Innovative Research in Life Sciences offers a guide to the creative processes leading to biomedical innovation and identifies the best practices of innovative scientists and laboratories.

Clinical Research Law And Compliance Handbook

Author : John E. Steiner
ISBN : 0763747254
Genre : Business & Economics
File Size : 69. 98 MB
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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.

The Handbook Of Patient Safety Compliance

Author : Fay A. Rozovsky
ISBN : 9780787978686
Genre : Medical
File Size : 78. 83 MB
Format : PDF, Kindle
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Written for virtually every professional and leader in the healthcare field, as well as students who are preparing for careers inhealth services delivery, this book presents a framework fordeveloping a patient safety program, shows how best to examineevents that do occur, and reveals how to ensure that appropriatecorrective and preventative actions are reviewed for effectiveness.The book covers a comprehensive selection of topics including The link between patient safety and legal and regulatorycompliance The role of accreditation and standard-setting organizations inpatient safety Failure modes and effect analysis Voluntary and regulatory oversight of medical error Evidence-based outcomes and standards of care Creation and preservation of reports, data, and device evidencein medical error situations Claims management when dealing with patient safety events Full disclosure Patient safety in human research Managing confidentiality in the face of litigation Managing patient safety compliance through accountability-basedcredentialing for health care professionals Planning for the future

Measuring The Statutory And Regulatory Constraints On Dod Acquisition Research Design For An Empirical Study

Author : Jeffrey A. Drezner
ISBN : 9780833039675
Genre : Political Science
File Size : 46. 70 MB
Format : PDF, ePub
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The Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics asked RAND to evaluate the cost of compliance with acquisition-related statutes and regulations at the program office level. This report identifies the areas considered most burdensome and describes the study's methodology, focus, and data collection process, including the development of a Web-based data collection tool for use by program office personnel.

Ethical Conduct Of Clinical Research Involving Children

Author : Institute of Medicine
ISBN : 9780309091817
Genre : Medical
File Size : 75. 77 MB
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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.

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