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Author: Evan DeRenzo
Publisher: Academic Press
ISBN: 0123869358
Category : Medical
Languages : en
Pages : 368
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Book Description
Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more.
Author: Evan DeRenzo
Publisher: Academic Press
ISBN: 0123869358
Category : Medical
Languages : en
Pages : 368
Get Book Here
Book Description
Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more.
Author: United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher:
ISBN:
Category : Ethics, Medical
Languages : en
Pages : 614
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Book Description
Author: John I. Gallin
Publisher: Elsevier
ISBN: 0080489567
Category : Science
Languages : en
Pages : 447
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Book Description
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government
Author: Evan DeRenzo
Publisher: Academic Press
ISBN: 0123869544
Category : Medical
Languages : en
Pages : 370
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Book Description
Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more. - Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol - Includes case histories that illustrate key points - Contains information on conducting clinical research within the pharmaceutical industry - Includes internet resources and worldwide web addresses for important research ethics documents and regulations - Contains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations
Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: World Health Organization
ISBN: 9789290360889
Category : Bioethics
Languages : en
Pages : 0
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Book Description
"In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309171148
Category : Medical
Languages : en
Pages : 221
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Book Description
Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Author: Adil E. Shamoo
Publisher: Oxford University Press
ISBN: 0199709602
Category : Medical
Languages : en
Pages : 441
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Book Description
Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.
Author: Milica Prostran
Publisher: BoD – Books on Demand
ISBN: 1789232007
Category : Medical
Languages : en
Pages : 226
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Book Description
This book Clinical Trials in Vulnerable Populations has 12 chapters divided into 4 sections: Minority Patients, Women, Medically Compromised Patients and Clinical Trials. Contributing authors came from several countries, from Serbia to Turkey. The book was edited by Professor Milica Prostran MD, Ph.D., specialist in Clinical Pharmacology. The potential reader is shown a modern approach to clinical trials in vulnerable populations, from different points of view. The chapters deal at length and clarity with their topics. Finally, I believe, that this book I edited and reviewed with dedication will capture the attention of many readers, from medical students to practicing doctors and pharmacists. All of whom must consider this very important field of medicine: clinical trials in vulnerable patients.
Author: United States. National Bioethics Advisory Commission
Publisher:
ISBN:
Category : Clinical trials
Languages : en
Pages : 166
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Book Description
Author: J.A. Magnuson
Publisher: Springer Science & Business Media
ISBN: 1447142373
Category : Medical
Languages : en
Pages : 665
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Book Description
This revised edition covers all aspects of public health informatics and discusses the creation and management of an information technology infrastructure that is essential in linking state and local organizations in their efforts to gather data for the surveillance and prevention. Public health officials will have to understand basic principles of information resource management in order to make the appropriate technology choices that will guide the future of their organizations. Public health continues to be at the forefront of modern medicine, given the importance of implementing a population-based health approach and to addressing chronic health conditions. This book provides informatics principles and examples of practice in a public health context. In doing so, it clarifies the ways in which newer information technologies will improve individual and community health status. This book's primary purpose is to consolidate key information and promote a strategic approach to information systems and development, making it a resource for use by faculty and students of public health, as well as the practicing public health professional. Chapter highlights include: The Governmental and Legislative Context of Informatics; Assessing the Value of Information Systems; Ethics, Information Technology, and Public Health; and Privacy, Confidentiality, and Security. Review questions are featured at the end of every chapter. Aside from its use for public health professionals, the book will be used by schools of public health, clinical and public health nurses and students, schools of social work, allied health, and environmental sciences.
