Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Returning Individual Research Results to Participants written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-08-23 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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 SAGE Encyclopedia of Communication Research Methods written by Mike Allen and published by SAGE Publications. This book was released on 2017-04-11 with total page 2013 pages. Available in PDF, EPUB and Kindle. Book excerpt: Communication research is evolving and changing in a world of online journals, open-access, and new ways of obtaining data and conducting experiments via the Internet. Although there are generic encyclopedias describing basic social science research methodologies in general, until now there has been no comprehensive A-to-Z reference work exploring methods specific to communication and media studies. Our entries, authored by key figures in the field, focus on special considerations when applied specifically to communication research, accompanied by engaging examples from the literature of communication, journalism, and media studies. Entries cover every step of the research process, from the creative development of research topics and questions to literature reviews, selection of best methods (whether quantitative, qualitative, or mixed) for analyzing research results and publishing research findings, whether in traditional media or via new media outlets. In addition to expected entries covering the basics of theories and methods traditionally used in communication research, other entries discuss important trends influencing the future of that research, including contemporary practical issues students will face in communication professions, the influences of globalization on research, use of new recording technologies in fieldwork, and the challenges and opportunities related to studying online multi-media environments. Email, texting, cellphone video, and blogging are shown not only as topics of research but also as means of collecting and analyzing data. Still other entries delve into considerations of accountability, copyright, confidentiality, data ownership and security, privacy, and other aspects of conducting an ethical research program. Features: 652 signed entries are contained in an authoritative work spanning four volumes available in choice of electronic or print formats. Although organized A-to-Z, front matter includes a Reader’s Guide grouping entries thematically to help students interested in a specific aspect of communication research to more easily locate directly related entries. Back matter includes a Chronology of the development of the field of communication research; a Resource Guide to classic books, journals, and associations; a Glossary introducing the terminology of the field; and a detailed Index. Entries conclude with References/Further Readings and Cross-References to related entries to guide students further in their research journeys. The Index, Reader’s Guide themes, and Cross-References combine to provide robust search-and-browse in the e-version.

Download or read book This Is Service Design Doing written by Marc Stickdorn and published by "O'Reilly Media, Inc.". This book was released on 2018-01-02 with total page 1156 pages. Available in PDF, EPUB and Kindle. Book excerpt: How can you establish a customer-centric culture in an organization? This is the first comprehensive book on how to actually do service design to improve the quality and the interaction between service providers and customers. You'll learn specific facilitation guidelines on how to run workshops, perform all of the main service design methods, implement concepts in reality, and embed service design successfully in an organization. Great customer experience needs a common language across disciplines to break down silos within an organization. This book provides a consistent model for accomplishing this and offers hands-on descriptions of every single step, tool, and method used. You'll be able to focus on your customers and iteratively improve their experience. Move from theory to practice and build sustainable business success.

Download or read book Participant Observation written by Kathleen Musante DeWalt and published by Rowman Altamira. This book was released on 2011 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt: Participant observation is the foundation of ethnographic research design and supports and complements other types of qualitative and quantitative data collection. Qualitative research in such diverse areas as anthropology, sociology, education, medicine draws on the insights gained through the use of participant observation. The authors have written a guide to the collection of systematic data in naturalistic settings - communities in many different cultures - to achieve an understanding of the most fundamental processes and patterns of social life. This book serves as a basic primer for the beginning researcher and as a useful reference and guide for experienced researchers in many fields who wish to reexamine their own skills and abilities in light of best practices of participant observation. This new edition includes discussions of participant observation in nontypical settings, such as the Internet, participant observation in applied research, and ethics of participant observation. It also explores in greater depth the use of computer-assisted analysis of textual data in issues of sampling and in linking method with theory.

Download or read book Participant Observer written by William Foote Whyte and published by Cornell University Press. This book was released on 2019-05-15 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: While it documents a remarkable career, Participant Observer is also a personal chronicle in which William Foote Whyte reflects on his childhood, his education, his courageous struggles with polio and with the crises of family and academic life. Beginning with the study of gangs in Boston's North End recorded in Street Corner Society, Whyte listened to what working people had to say, becoming a powerful voice for worker participation and workplace democracy. His career is a model for the social sciences, and his story should be read by any serious student of them.

Download or read book Ethics in Qualitative Research written by Tina Miller and published by SAGE. This book was released on 2012-09-13 with total page 211 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fresh, confident second edition expands its focus on the theoretical and practical aspects of doing qualitative research in light of new ethical dilemmas facing researchers today. In a climate of significant social and technological change, researchers must respond to increased ethical regulation and scrutiny of research. New sources, types of data and modes of accessing participants are all challenging and reconfiguring traditional ideas of the research relationship. This engaging textbook explores key ethical dilemmas - including research boundaries, informed consent, participation, rapport and analysis - within the context of a rapidly changing research environment. The book effectively covers the ethical issues related to the data collection process, helping readers to address the ethical considerations relevant to their research. This fully updated new edition: - Maps the changing and increasingly technology-reliant aspects of research relationships and practices - Provides researchers with guidance through practical examples, enabling those engaged in qualitative research to question and navigate in ethical ways This book is essential reading for all those engaged in qualitative research across the social sciences.

Download or read book Federal Register written by and published by . This book was released on 2013-02 with total page 626 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 Code of Federal Regulations written by and published by . This book was released on 2007 with total page 1072 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Collecting Qualitative Data written by Greg Guest and published by SAGE. This book was released on 2013 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides a very practical and step-by-step guide to collecting and managing qualitative data,

Download or read book Code of Federal Regulations written by United States. Department of Agriculture and published by . This book was released on 2011 with total page 1114 pages. Available in PDF, EPUB and Kindle. Book excerpt: Special edition of the Federal register, containing a codification of documents of general applicability and future effect as of ... with ancillaries.

Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Download or read book Participant Observation written by Danny L. Jorgensen and published by SAGE Publications. This book was released on 1989-02-01 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt: While providing an introduction to basic principles and strategies, Participant Observation also explores the philosophy and methodology underlying the actual practice of participant observation. Taking a thoroughly practical approach to the methods of participant observation, Danny L. Jorgensen illustrates these methods with both classic and current research studies. By using the materials in this book, the reader can begin conducting participant observation research on their own.