Download or read book Protecting Study Volunteers in Research written by Cynthia McGuire Dunn and published by . This book was released on 2004 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: Protecting Study Volunteers in Research is a suggested educational resource by NIH and FDA (source: NIH Notice OD-00-039, 2000, page 37841, Federal Registry 2002) and has become required reading in many academic institutions, IRBs, investigative sites, and for many Biopharmaceutical and CRO companies. This well-organized and concise manual teaches organizations how to successfully implement the highest standards of safe and ethical treatment of study volunteers while addressing current and emerging issues that are critical to our system of human subject protection oversight. Topics covered include: Conflicts of interest in research, Participant recruitment and retention in clinical trials, Research with secondary subjects, tissue studies, and records review, Historical perspectives on human subject research, Updated ethics and federal regulations, Roles and responsibilities of institutions and independent sites, Roles and responsibilities of investigators and the study process. --Amazon.com
Download or read book Protecting Study Volunteers in Research written by Gary Chadwick and published by . This book was released on 2021 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Responsible Research written by Philip A. Cola and published by Remedica. This book was released on 2006 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: The editors (of U. Hospitals of Cleveland and Rx Trials, Inc.) offer a guide to the practical and ethical issues in the conduct of clinical research coordinators that places the topic in broad international perspective by including approaches from the European Union, Japan, Canada, and the United States. Thirteen chapters discuss ethics and human subjects protection, responsible conduct, the informed consent process, pediatric informed consent and assent, study implementation and start-up, recruitment and retention of research subjects, documentation, quality assurance in clinical trials, communication, education and training, and future trends in professionalization. Distributed in the US by BookMasters. Annotation :2006 Book News, Inc., Portland, OR (booknews.com).
Download or read book Ethics Dumping written by Doris Schroeder and published by Springer. This book was released on 2017-12-04 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book provides original, up-to-date case studies of “ethics dumping” that were largely facilitated by loopholes in the ethics governance of low and middle-income countries. It is instructive even to experienced researchers since it provides a voice to vulnerable populations from the fore mentioned countries. Ensuring the ethical conduct of North-South collaborations in research is a process fraught with difficulties. The background conditions under which such collaborations take place include extreme differentials in available income and power, as well as a past history of colonialism, while differences in culture can add a new layer of complications. In this context, up-to-date case studies of unethical conduct are essential for research ethics training.
Download or read book Responsible Research written by Institute of Medicine and published by National Academies Press. This book was released on 2003-02-06 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The CRC s Guide to Coordinating Clinical Research written by Karen E. Woodin and published by CenterWatch. This book was released on 2004 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidebook is filled with valuable information on the role and responsibilities of a clinical research coordinator (CRC) and explains the research process from the site and CRC perspective. Topics covered include: identifying the regulations governing clinical research; describing the drug development process; discussing good clinical practices and how to apply them in clinical trials and organizing a clinical practice.
Download or read book Institutional Review Board written by Elizabeth A. Bankert and published by Jones & Bartlett Learning. This book was released on 2006 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Designing User Studies in Informatics written by Gondy Leroy and published by Springer Science & Business Media. This book was released on 2011-08-05 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a practical, hands-on guide to conducting user studies in informatics. Its purpose is to explain the foundations of different experimental designs together with the appropriate statistical analyses for studies most often conducted in computing. Common mistakes are highlighted together with guidelines on how they should be avoided. The book is intended for advanced undergraduate students, beginning graduate students and as a refresher for any researcher evaluating the usefulness of informatics for people by doing user studies. With clear, non-technical language, fundamental concepts are explained and illustrated using diverse examples. In addition to the foundations, practical tips to starting, acquiring permission, recruiting participants, conducting and publishing studies are included. A how-to guide, in the form of a cookbook, is also included. The cookbook recipes can be followed step-by-step or adjusted as necessary for different studies. Each recipe contains step-by-step instructions and concrete advice.
Download or read book Clinical Trials in Osteoporosis written by Derek Pearson and published by Springer Science & Business Media. This book was released on 2013-03-14 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials in Osteoporosis is a practical handbook on clinical trials in the growing field of osteoporosis. Topics covered include study design, technical issues, data collection, quality assurance, data analysis and presentation. It aims to take the user through the process step-by-step from start to finish, also providing a background on regulatory guidelines, ethical implications, endpoints, current therapies and the ideal drug to use. There are no other books at present that specifically address the issue of clinical trials in osteoporosis. A number of issues dealt with in this book have been brought together in one publication for the first time. Clinical Trials in Osteoporosis is intended to serve as a practical manual for clinicians and scientists coming to the subject new and to provide a standard for existing centers to measure themselves against.
Download or read book Partners in Research written by and published by . This book was released on 1995 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Reviewing Clinical Trials written by Chinese University of Hong Kong and published by . This book was released on 2010 with total page 153 pages. Available in PDF, EPUB and Kindle. Book excerpt: The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.
Download or read book Ethics in Research Practice and Innovation written by Sandu, Antonio and published by IGI Global. This book was released on 2018-11-16 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: A particularly important component of any research project is its ethical dimensions which can refer to varied categories of practice – from the protection of human subjects involved in medical and social research to the publication of results research. More recently, with the estimation of the possible consequences of the implementation of technology, it is important for today’s researchers to address the standards of scientific practice and avoid unethical behavior. Ethics in Research Practice and Innovation is an essential reference source that discusses current and historical aspects of ethical values in scientific research and technologies, as well as emerging perspectives of conducting ethical research in a variety of fields. Featuring research on topics such as clinical trials, human subjects, and informed consent, this book is ideally designed for practitioners, medical professionals, nurses, researchers, scientists, scholars, academicians, policy makers, and students seeking coverage on the ethical risks and limitations of research practice.
Download or read book Essentials of Public Health Research Methods written by Richard A. Crosby and published by Jones & Bartlett Learning. This book was released on 2020-03-16 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part of the Essential Public Health Series, Essentials of Public Health Research Methods is specifically written for undergraduate students studying public health who want to fully understand the range of research methods as applied to public health. Using the circular model of public health research as an overarching framework, Essentials of Public Health Research Methods provides a clear, time-tested methodology that leads students step-by-step through the research process -- from framing the questions, identifying the study design and choosing methodology to collecting and analyzing data, and disseminating research findings. By following this process, students learn about various facets of public health, while also learning how to select and apply various research methodologies.
Download or read book Nursing Research written by Janet Houser and published by Jones & Bartlett Learning. This book was released on 2008 with total page 611 pages. Available in PDF, EPUB and Kindle. Book excerpt: Intended to help students learn to read and use research as a basis for nursing practice, this new nursing research textbook puts research into the context of evidence-based practice, helping students gain knowledge of research concepts while learning to apply them. The controversial style of the text minimizes the intimidating aspects of research to maximize understanding.
Download or read book Gaining Access written by Martha S. Feldman and published by Rowman Altamira. This book was released on 2003 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide for social scientists who have developed a research design and are eager to start their first research project, only to discover that no one will talk to them. Political scientists and psychologists offer many access stories, through which they develop a general theory of access that recognizes it as a process of building relationships. They advise researchers to identify those who can help them gain access, learn the art of self-presentation, and nurture relationships once they are established.
Download or read book Nursing Research Reading Using and Creating Evidence written by Janet Houser and published by Jones & Bartlett Publishers. This book was released on 2009-10-07 with total page 611 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nursing Research fills the need for a research text that addresses both traditional content as well as focusing on nursing research as it is used in evidence-based practice, in systematic reviews, and in the development of clinical practice guidelines. This book will address each issue by using a framework for the chapters that is based on an evidence-based practice approach to reading, using, and conducting nursing research. The perfect resource for BSN courses!
