Responsible Research
Responsible Research

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2003-02-06

Total Pages: 313

ISBN-13: 0309084881

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When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants' safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: Improved research review processes, Recognition and integration of research participants' contributions to the system, and Vigilant maintenance of HRPPP performance. Issues addressed in the book include the need for in-depth, complimentary reviews of science, ethics, and conflict of interest reviews; desired qualifications for investigators and reviewers; the process of informed consent; federal and institutional oversight; and the role of accreditation. Recommendations for areas of key interest include suggestions for legislative approaches, compensation for research-related injury, and the refocusing of the mission of institutional review boards. Responsible Research will be important to anyone interested in the issues that are relevant to the practice of using human subjects as research participants, but especially so to policy makers, research administrators, investigators, and research sponsorsâ€"but also including volunteers who may agree to serve as research participants.

Occupational Health and Workplace Monitoring at Chemical Agent Disposal Facilities
Occupational Health and Workplace Monitoring at Chemical Agent Disposal Facilities

Author: National Research Council

Publisher: National Academies Press

Published: 2001-02-01

Total Pages: 56

ISBN-13: 0309075750

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In keeping with a congressional mandate (Public Law 104-484) and the Chemical Weapons Convention, the United States is currently destroying its chemical weapons stockpile. The Army must ensure that the chemical demilitarization workforce is protected from the risks of exposure to hazardous chemicals during disposal operations and during and after facility closure. Good industrial practices developed in the chemical and nuclear energy industries and other operations that involve the processing of hazardous materials include workplace monitoring of hazardous species and a systematic occupational health program for monitoring workers' activities and health. In this report, the National Research Council Committee on Review and Evaluation of the Army Chemical Stockpile Disposal Program examines the methods and systems used at JACADS and TOCDF, the two operational facilities, to monitor the concentrations of airborne and condensed-phase chemical agents, agent breakdown products, and other substances of concern. The committee also reviews the occupational health programs at these sites, including their industrial hygiene and occupational medicine components. Finally, it evaluates the nature, quality, and utility of records of workplace chemical monitoring and occupational health programs.

Advances in Patient Safety
Advances in Patient Safety

Author: Kerm Henriksen

Publisher:

Published: 2005

Total Pages: 526

ISBN-13:

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v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.

Cal/OSHA Pocket Guide for the Construction Industry
Cal/OSHA Pocket Guide for the Construction Industry

Author:

Publisher:

Published: 2015-01-05

Total Pages:

ISBN-13: 9781622701070

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The Cal/OSHA Pocket Guide for the Construction Industry is a handy guide for workers, employers, supervisors, and safety personnel. This latest 2011 edition is a quick field reference that summarizes selected safety standards from the California Code of Regulations. The major subject headings are alphabetized and cross-referenced within the text, and it has a detailed index. Spiral bound, 8.5 x 5.5"

Ensuring Safe Food
Ensuring Safe Food

Author: Institute of Medicine and National Research Council

Publisher: National Academies Press

Published: 1998-08-19

Total Pages: 208

ISBN-13: 0309173973

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How safe is our food supply? Each year the media report what appears to be growing concern related to illness caused by the food consumed by Americans. These food borne illnesses are caused by pathogenic microorganisms, pesticide residues, and food additives. Recent actions taken at the federal, state, and local levels in response to the increase in reported incidences of food borne illnesses point to the need to evaluate the food safety system in the United States. This book assesses the effectiveness of the current food safety system and provides recommendations on changes needed to ensure an effective science-based food safety system. Ensuring Safe Food discusses such important issues as: What are the primary hazards associated with the food supply? What gaps exist in the current system for ensuring a safe food supply? What effects do trends in food consumption have on food safety? What is the impact of food preparation and handling practices in the home, in food services, or in production operations on the risk of food borne illnesses? What organizational changes in responsibility or oversight could be made to increase the effectiveness of the food safety system in the United States? Current concerns associated with microbiological, chemical, and physical hazards in the food supply are discussed. The book also considers how changes in technology and food processing might introduce new risks. Recommendations are made on steps for developing a coordinated, unified system for food safety. The book also highlights areas that need additional study. Ensuring Safe Food will be important for policymakers, food trade professionals, food producers, food processors, food researchers, public health professionals, and consumers.

Monitoring for Health Hazards at Work
Monitoring for Health Hazards at Work

Author: John Cherrie

Publisher: John Wiley & Sons

Published: 2011-06-09

Total Pages: 280

ISBN-13: 1444325124

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Monitoring for Health Hazards at Work has become an essential companion for students and professionals in occupational hygiene, offering a concise account of the dangers faced in a wide variety of work environments and giving practical, step-by-step guidance to gauge exposure. It includes: Coverage of most major health hazards: airborne dust, fibres, gases, vapours, noise, radiation, and biological agents Accounts of the latest equipment and techniques required to monitor such hazards Full guidance on how to undertake risk assessments Now thoroughly revised and restructured by an eminent new team of authors, the fourth edition brings this valuable handbook right up to date.

Data and Safety Monitoring Committees in Clinical Trials
Data and Safety Monitoring Committees in Clinical Trials

Author: Jay Herson

Publisher: CRC Press

Published: 2016-12-19

Total Pages: 266

ISBN-13: 1498784127

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Praise for the first edition: "Given the author’s years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this book—not only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC." -S. T. Ounpraseuth, The American Statistician In the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, Data and Safety Monitoring Committees in Clinical Trials, Second Edition is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and regulatory agency staff. The second edition guides the reader through newly emerging DMC responsibilities brought about by regulations emphasizing risk vs benefit and the emergence of risk-based monitoring. It also provides the reader with many new statistical methods, clinical trial designs and clinical terminology that have emerged since the first edition. The references have been updated and the very popular end-of-chapter Q&A section has been supplemented with many new experiences since the first edition. New to the Second Edition: Presents statistical methods, tables, listings and graphs appropriate for safety review, efficacy analysis and risk vs benefit analysis, SPERT and PRISMA initiatives. Newly added interim analysis for efficacy and futility section. DMC responsibilities in SUSARs (Serious Unexpected Serious Adverse Reactions), basket trials, umbrella trials, dynamic treatment strategies /SMART trials, pragmatic trials, biosimilar trials, companion diagnostics, etc. DMC responsibilities for data quality and fraud detection (Fraud Recovery Plan) Use of patient reported outcomes of safety Use of meta analysis and data outside the trial New ideas for training and compensation of DMC members Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.

Guidelines for Risk Based Process Safety
Guidelines for Risk Based Process Safety

Author: CCPS (Center for Chemical Process Safety)

Publisher: John Wiley & Sons

Published: 2011-11-30

Total Pages: 761

ISBN-13: 111820963X

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Guidelines for Risk Based Process Safety provides guidelines for industries that manufacture, consume, or handle chemicals, by focusing on new ways to design, correct, or improve process safety management practices. This new framework for thinking about process safety builds upon the original process safety management ideas published in the early 1990s, integrates industry lessons learned over the intervening years, utilizes applicable "total quality" principles (i.e., plan, do, check, act), and organizes it in a way that will be useful to all organizations - even those with relatively lower hazard activities - throughout the life-cycle of a company.

Space Safety Regulations and Standards
Space Safety Regulations and Standards

Author: Joseph N. Pelton

Publisher: Elsevier

Published: 2010-09-16

Total Pages: 546

ISBN-13: 0080961924

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When international rules and regulations governing space travel were first being developed, only a few countries had any space presence and commercial space activity was non-existent. Today, over 50 countries have on-orbit satellites and commercial space presence is essential to commercial telecommunications and broadcasting, yet international space law remains in its infancy.Space Safety Regulations and Standards is the definitive book on regulatory initiatives involving space safety, new space safety standards, and safety related to new space technologies under development. More than 30 world experts come together in this book to share their detailed knowledge of regulatory and standard making processes in the area, combining otherwise disparate information into one essential reference and providing case studies to illustrate applications throughout space programs internationally. They address the international regulatory framework that relates to traditional space safety programs as well as the emerging regulatory framework that relates to commercial space programs, space tourism, and efforts to create commercial space station facilities. Fully endorsed by the International Association for the Advancement of Space Safety (IAASS) and provides the only definitive reference on regulations and standards for the field of space safety Combines the technical, legal and regulatory information in a clear and integrated reference work suitable for technical professionals, regulators, legal experts, and students in the field Presents a truly global insight from experienced space safety experts worldwide, with representatives from the leading associations, institutions and companies operating in the arena today