This comprehensive reference covers three separate areas related to IRBs: administration, daily management; and ethical issues. This instructional manual provides IRB members and administrators with the information they need to run an efficient and effective system of protecting human research subjects, while remaining in compliance with federal research regulations. The text includes case studies, sample forms, and sample policy documents. The updated Second Edition includes seven new chapters: IRB Closure of Study Files, Internet Research, Research in Public Schools, Phase I Clinical Trials in Healthy Volunteers, Vulnerability in Research, Balancing the Risks and Potential Benefits,and HIPAA.
The new edition of the definitive reference work on ethics, featuring hundreds of new and revised entries Unmatched in scholarship and scope, the International Encyclopedia of Ethics is the most comprehensive and authoritative ethics resource of its kind. Available online or as an eleven-volume print set, the Encyclopedia espouses a broad vision of ethics that creates links to many other disciplines, including medicine, technology studies, computer science, business, religion, and law. Entries range in size from shorter definitions and biographies to extended treatments of major topics, and have been blind-reviewed by both the editorial team and an independent review board to ensure exceptional balance and accuracy throughout. Building on its established strengths, the second edition of the Encyclopedia covers topics, movements, arguments, and figures in normative ethics, metaethics, and applied ethics, containing over 850 fully-cross-referenced A-Z entries which emphasize the richness and diversity of the field. New to this edition are more than 300 original and updated entries which add coverage of contemporary topics including voting ethics, artificial intelligence, moral uncertainty, police bias, narcissism, structural injustice, bullying, biopolitics, legal moralism, and intellectual virtue. In its state-of-the-art electronic form, each entry is hyperlinked to other entries and to electronic editions of the renowned Blackwell Companions and Guides ̄ in all, more than 1,500 scholarly articles. The electronic version will continue to receive annual updates, continuing the legacy of the International Encyclopedia of Ethics as the preferred resource for research-active scholars, students, and general readers wanting to engage with ethics in their professional lives. This work is also available as an online resource at www.internationalencyclopediaofethics.com
The Essential Resource for All IRB Members! Designed to give Institutional Review Board (IRB) members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient, the chapters of the Institutional Review Board Member Handbook are short and to the point. Topic-specific chapters list the criteria IRB members should use to determine how to vote on specific kinds of studies and offer practical advice on what IRB members should do before and during full-committee meetings. NEW CHAPTERS in this Edition Include: * Definition of Human Subject Research, Exempt & Expedited Review Categories * IRB Member Conflict of Interest All chapters are completely updated for 2010 practice! This handbook is an excellent accompaniment to Institutional Review Board: Management and Function, Second Edition and the Study Guide that IRB members can access and refer to quickly and easily.
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
With the emergence of effective drugs and observed drug toxicities in babies, two mantras emerged: that children are therapeutic orphans, and that children are not small adults. US and EU laws demand pediatric studies as a condition for the approval of new drugs in adults. This is called “Pediatric Drug Development” (PDD). Although apparently reasonable, there are catches. Children are vulnerable at birth, but they grow and become bodily mature with puberty, well before coming of age. Minors are not another species. The 18th birthday, an administrative/ legal limit, does not correspond to a physiological change. Drugs treat the body, not the legal status. PDD results in pointless studies in bodily mature adolescents, and in exaggerated studies in younger minors. An originally well-intentioned concept results in thousands of questionable studies worldwide. This book draws attention to conflicts of interest and ethical dilemmas of PDD and questions its applicability for adolescents and minors that are no longer babies.
Institutional Review Board (IRB) members and oversight personnel face challenges with research involving new technology, management of big data, globalization of research, and more complex federal regulations. Institutional Review Board: Management and Function, Third Edition provides everything IRBs and administrators need to know about efficiently managing and effectively operating a modern and compliant system of protecting human research subjects. This trusted reference manual has been extensively updated to reflect the 2018 revisions to the Federal Policy for the Protection of Human Subjects (Common Rule). An essential resource for both seasoned and novice IRB administrators and members, Institutional Review Board: Management and Function provides comprehensive and understandable interpretations of the regulations, clear descriptions of the ethical principles on which the regulations are based, and practical step-by-step guidance for effectively implementing regulatory oversight.
The goal of planetary protection is to control, to the degree possible, the biological cross-contamination of planetary bodies. Guidelines developed by the Committee on Space Research (COSPAR) are used by all spacefaring nations to guide their preparations for encounters with solar system bodies. NASA's Science Mission Directorate has convened the Planetary Protection Independent Review Board (PPIRB) to consider updating the COSPAR guidelines given the growing interest from commercial and private groups in exploration and utilization of Mars and other bodies in space. At the request of NASA, this publication reviews the findings of the PPIRB and comments on their consistency with the recommendations of the recent National Academies report Review and Assessment of the Planetary Protection Policy Development Processes.
In the Third Edition of The Psychology Research Handbook editors Frederick T. L. Leong and James T. Austin have assembled experienced expert researchers to provide graduate students and research assistants with a comprehensive framework for conducting many types of psychology research. The book is organized around the idea of a "research script," following the step-by-step process of research planning, design, data collection, analysis, and disseminating research. Many chapters are coauthored by advanced graduate students to give their fellow students a sense of real-world research, adding to the clarity and practicality of many chapters. Students and instructors alike will appreciate chapters on topics typically missing from introductory methods texts, including applying for research grants, dealing with journal editors and reviewers, working within research teams, and conducting cross-cultural research. Structures such as recommended readings and exercises guide students to develop and expand their research skills. New chapters include Power and Evidence, IRB as Critical Collaborators in Research, Alternative Data Collection Strategies, Structural Equation Modeling and Replicability and Reproducibility. A comprehensive, easy-to-understand guide to the entire research process, this book quickly and efficiently equips advanced students and research assistants to conduct a full research project.
