Ethical Conduct of Clinical Research Involving Children
Ethical Conduct of Clinical Research Involving Children

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2004-07-09

Total Pages: 445

ISBN-13: 0309133386

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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.

Risk Management
Risk Management

Author: Carl L. Pritchard, PMP, PMI-RMP, EVP

Publisher: CRC Press

Published: 2014-12-17

Total Pages: 478

ISBN-13: 1482258455

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This new edition of Risk Management: Concepts and Guidance supplies a look at risk in light of current information, yet remains grounded in the history of risk practice. Taking a holistic approach, it examines risk as a blend of environmental, programmatic, and situational concerns. Supplying comprehensive coverage of risk management tools, practices, and protocols, the book presents powerful techniques that can enhance organizational risk identification, assessment, and management—all within the project and program environments. Updated to reflect the Project Management Institute’s A Guide to the Project Management Body of Knowledge (PMBOK® Guide), Fifth Edition, this edition is an ideal resource for those seeking Project Management Professional and Risk Management Professional certification. Emphasizing greater clarity on risk practice, this edition maintains a focus on the ability to apply "planned clairvoyance" to peer into the future. The book begins by analyzing the various systems that can be used to apply risk management. It provides a fundamental introduction to the basics associated with particular techniques, clarifying the essential concepts of risk and how they apply in projects. The second part of the book presents the specific techniques necessary to successfully implement the systems described in Part I. The text addresses project risk management from the project manager’s perspective. It adopts PMI’s perspective that risk is both a threat and an opportunity, and it acknowledges that any effective risk management practice must look at the potential positive events that may befall a project, as well as the negatives. Providing coverage of the concepts that many project management texts ignore, such as the risk response matrix and risk models, the book includes appendices filled with additional reference materials and supporting details that simplifying some of the most complex aspects of risk management.

The Governance, Compliance and Risk KPI Dictionary
The Governance, Compliance and Risk KPI Dictionary

Author: The Kpi The KPI Institute

Publisher:

Published: 2015-07-30

Total Pages: 30

ISBN-13: 9781515295723

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By assembling the first comprehensive dictionary of Key Performance Indicators (KPIs) for Governance, Compliance and Risk, The KPI Institute provides professionals a useful resource for novices and experts alike.It can be used in the early stages of implementing a performance management framework, in the process of selecting and documenting KPIs, but also to improve an existing performance measurement system. The KPI taxonomy presented in the dictionary covers all major functions related to Governance, Compliance and Risk, such as:- Compliance and Audit Management- Governance- Risk Management

Foundations of Quality Risk Management
Foundations of Quality Risk Management

Author: Jayet Moon

Publisher: Quality Press

Published: 2022-10-22

Total Pages: 340

ISBN-13: 195105833X

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In today's uncertain times, risk has become the biggest part of management. Risk management is central to the science of prediction and decision-making; holistic and scientific risk management creates resilient organizations, which survive and thrive by being adaptable. This book is the perfect guide for anyone interested in understanding and excelling at risk management. It begins with a focus on the foundational elements of risk management, with a thorough explanation of the basic concepts, many illustrated by real-life examples. Next, the book focuses on equipping the reader with a working knowledge of the subject from an organizational process and systems perspective. Every concept in almost every chapter is calibrated to not only ISO 9001 and ISO 31000, but several other international standards. In addition, this book presents several tools and methods for discussion. Ranging from industry standard to cutting edge, each receives a thorough analysis and description of its role in the risk management process. Finally, you'll find a detailed and practical discussion of contemporary topics in risk management, such as supply chain risk management, risk-based auditing, risk in 4.0 (digital transformation), benefit-risk analyses, risk-based design thinking, and pandemic/epidemic risk management. Jayet Moon is a Senior ASQ member and holds ASQ CQE, CSQP, and CQIA certifications. He is also a chartered quality professional in the U.K. (CQP-MCQI). He earned a master's degree in biomedical engineering from Drexel University in Philadelphia and is a Project Management Institute (PMI) Certified Risk Management Professional (PMI-RMP). He is a doctoral candidate in Systems and Engineering Management at Texas Tech University