Download or read book Recruiting Human Subjects written by June Gibbs Brown and published by DIANE Publishing. This book was released on 2008-08 with total page 25 pages. Available in PDF, EPUB and Kindle. Book excerpt: Identifies Institutional Review Board (IRB) and professional med. assoc. (MA) human-subject recruitment guidelines that exceed guidelines set forth by the Dept. of Health and Human Services (HHS). HHS guidelines do not address the recruitment practices that IRBs and others involved in clinical research find troubling. Here, HHS presents other sources of guidance for IRBs and investigators, from MA and IRBs. Includes Canadian guidelines on recruitment practices to illustrate how these practices have been addressed by another nation¿s research community. This report focuses on guidance on how 3 main issues -- recruitment incentives, the dual investigator-physician role, and the confidentiality of medical records -- should be handled. Tables.
Download or read book Recruiting Human Subjects written by June Gibbs Brown and published by . This book was released on 2000 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Recruiting Human Subjects written by June Gibbs Brown and published by DIANE Publishing. This book was released on 2008-08 with total page 25 pages. Available in PDF, EPUB and Kindle. Book excerpt: Evaluates the Dept. of Health and Human Services¿ oversight of sponsor and investigator efforts to recruit human subjects for industry-sponsored clinical trials (CT). It focuses on industry-sponsored CT because in recent years industry sponsors have assumed a more prominent role in the search for new drugs. Sponsors and investigators are facing increasing difficulty finding enough subjects in a timely manner to bring drugs to market within their desired time-frame. This report explains the recruitment practices used in industry-sponsored CT for investigational drugs; identifies major concerns about them; and addresses the extent and type of oversight undertaken by institutional review boards and, the FDA, and the NIH.
Download or read book Recruitment and Retention of Women in Clinical Studies written by National Institutes of Health (U.S.). Office of Research on Women's Health and published by . This book was released on 1994 with total page 126 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 Recruiting Human Subjects written by United States. Department of Health and Human Services. Office of Inspector General and published by . This book was released on 2000 with total page 79 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Recruiting Human Subjects written by United States. Department of Health and Human Services. Office of Inspector General and published by . This book was released on 2000 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Patient Recruitment in Clinical Trials written by Bert Spilker and published by . This book was released on 1996 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Recruiting Human Subjects written by United States. Department of Health and Human Services. Office of Inspector General and published by . This book was released on 2000 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Problems with Recruitment and Retention of Human Subjects in Field Research written by Terie Naviaux and published by . This book was released on 1994 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Guidelines for Human Embryonic Stem Cell Research written by National Research Council and published by National Academies Press. This book was released on 2005-09-15 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since 1998, the volume of research being conducted using human embryonic stem (hES) cells has expanded primarily using private funds because of restrictions on the use of federal funds for such research. Given limited federal involvement, privately funded hES cell research has thus far been carried out under a patchwork of existing regulations, many of which were not designed with this research specifically in mind. In addition, hES cell research touches on many ethical, legal, scientific, and policy issues that are of concern to the public. This report provides guidelines for the conduct of hES cell research to address both ethical and scientific concerns. The guidelines are intended to enhance the integrity of privately funded hES cell research by encouraging responsible practices in the conduct of that research.
Download or read book Global Health Research in an Unequal World written by P Wenzel Geissler and published by Saint Philip Street Press. This book was released on 2020-10-09 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a collection of fictionalised case studies of everyday ethical dilemmas and challenges, encountered in the process of conducting global health research in places where the effects of global, political and economic inequality are particularly evident. It is a training tool to fill the gap between research ethics guidelines, and their implementation 'on the ground'. The case studies, therefore, focus on 'relational' ethics: ethical actions and ideas that emerge through relations with others, rather than in regulations. This work was published by Saint Philip Street Press pursuant to a Creative Commons license permitting commercial use. All rights not granted by the work's license are retained by the author or authors.
Download or read book The Ethics and Regulation of Research with Human Subjects written by Carl H. Coleman and published by . This book was released on 2015 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Ethical and Regulatory Aspects of Clinical Research written by Ezekiel J. Emanuel and published by . This book was released on 2003 with total page 532 pages. Available in PDF, EPUB and Kindle. Book excerpt: Professionals in need of such training and bioethicists will be interested.
Download or read book Writing Clinical Research Protocols written by Evan DeRenzo and published by Elsevier. This book was released on 2005-09-08 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. Writing Clinical Research Protocols includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This is an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol Includes a chapter containing Case Histories Contains information on conducting clinical research within the pharmaceutical industry An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations
Download or read book When Experiments Travel written by Adriana Petryna and published by Princeton University Press. This book was released on 2009-04-27 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: The phenomenal growth of global pharmaceutical sales and the quest for innovation are driving an unprecedented search for human test subjects, particularly in middle- and low-income countries. Our hope for medical progress increasingly depends on the willingness of the world's poor to participate in clinical drug trials. While these experiments often provide those in need with vital and previously unattainable medical resources, the outsourcing and offshoring of trials also create new problems. In this groundbreaking book, anthropologist Adriana Petryna takes us deep into the clinical trials industry as it brings together players separated by vast economic and cultural differences. Moving between corporate and scientific offices in the United States and research and public health sites in Poland and Brazil, When Experiments Travel documents the complex ways that commercial medical science, with all its benefits and risks, is being integrated into local health systems and emerging drug markets. Providing a unique perspective on globalized clinical trials, When Experiments Travel raises central questions: Are such trials exploitative or are they social goods? How are experiments controlled and how is drug safety ensured? And do these experiments help or harm public health in the countries where they are conducted? Empirically rich and theoretically innovative, the book shows that neither the language of coercion nor that of rational choice fully captures the range of situations and value systems at work in medical experiments today. When Experiments Travel challenges conventional understandings of the ethics and politics of transnational science and changes the way we think about global medicine and the new infrastructures of our lives.
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.
