{"product_id":"clinical-trials-and-human-research-isbn-9780787965709","title":"Clinical Trials and Human Research","description":"This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. \u003ci\u003eClinical Trials and Human Research\u003c\/i\u003e is a practical tool to help anyone involved in clinical research. Ch. 1. The evolution of human experimentation regulation \u003cp\u003eCh. 2. Current federal regulations and agencies involved in human research\u003c\/p\u003e \u003cp\u003eCh. 3. State regulation of human research\u003c\/p\u003e \u003cp\u003eCh. 4. Selection and recruitment of research subjects\u003c\/p\u003e \u003cp\u003eCh. 5. Informed consent in clinical trials\u003c\/p\u003e \u003cp\u003eCh. 6. Confidentiality of clinical trials information\u003c\/p\u003e \u003cp\u003eCh. 7. The investigator\u003c\/p\u003e \u003cp\u003eCh. 8. Research protocols\u003c\/p\u003e \u003cp\u003eCh. 9. The institutional review board\u003c\/p\u003e \u003cp\u003eCh. 10. Patient safety in clinical trials research\u003c\/p\u003e \u003cp\u003eCh. 11. Human research under the Food, Drug \u0026amp; Cosmetic Act\u003c\/p\u003e \u003cp\u003eCh. 12. Behavior research\u003c\/p\u003e \u003cp\u003eCh. 13. Multisite and collaborative studies\u003c\/p\u003e \u003cp\u003eCh. 14. Medical malpractice liability in human research\u003c\/p\u003e \u003cp\u003eCh. 15. Quality improvement, accrediation, and risk management in clinical trials\u003c\/p\u003e \u003cp\u003eCh. 16. Corporate compliance and human research\u003c\/p\u003e \u003cp\u003eCh. 17. Ethics in human research\u003c\/p\u003e \u003cp\u003eCh. 18. International research\u003c\/p\u003e \"Ideal for anyone who wants a comprehensive understanding of clinical research…\" (\u003ci\u003eJournal of Clinical Research Best Practices\u003c\/i\u003e)  \u003cb\u003eFay A. Rozovsky\u003c\/b\u003e,Fay A. Rozovsky, J.D., M.P.H. is an affiliate associate professor in the Department of Legal Medicine at Virginia Commonwealth University's School of Medicine. Ms. Rozovsky has served as the administrator of an Institutional Review Board and is a member of human research committees in the United States and Canada. \u003cbr\u003e  \u003cb\u003eRodney K. Adams\u003c\/b\u003e, J.D., L.L.M., is an attorney in Richmond, Virginia, where he specializes in defending healthcare providers and patient care issues. Mr. Adams is cochairman of the American Bar Association subcommittee on medical ethics. He also is adjunct assistant professor at University of Richmond, T. C. Williams College of Law, Richmond, Virginia.   This easy-to-read reference book provides a practical approach for dealing with the legal and regulatory compliance issues involved in human research. Covering a broad range of topics, such as consent, confidentiality, subject recruitment and selection, the role of the investigator and Institutional Review Board, it offers timely and useful strategies for achieving regulatory compliance while reducing liability. In addition, insurance, quality management, accreditation, and risk management are topics examined in the book. The practical insights found in this volume are not found in other books on the subject. \u003ci\u003eClinical Trials and Human Researc\u003c\/i\u003eh is a practical tool to help anyone involved in clinical research.  \u003cp\u003e\u003cb\u003ePraise for \u003ci\u003eClinical Trials and Human Research\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\"I would recommend the book for anyone new to the Institutional Review Board process, regardless of their clinical or administrative background or responsibilities. It is a valuable resource to orient risk managers, clinicians, and administrators to the clinical trial process and pitfalls.\"\u003cbr\u003e  — Deborah Boyd, M.S., R.H.I.A., C.P.H.R.M., senior risk management consultant, Zurich North America, Atlanta, Georgia\u003c\/p\u003e \u003cp\u003e\"As more and more research programs get into trouble, there's been a mad scramble to get on top of the problems. The logical starting point is regulatory compliance. Researchers and research administrators must understand the regulations if they hope to achieve high ethical standards in the performance of human subjects research. This thoughtful and well-organized book should be read by anyone who is interested in human subjects research, such as bioethicists, researchers, IRB and DSMB members, and study sponsors.\"\u003cbr\u003e  — Evan DeRenzo, Ph.D., Center for Ethics at Washington Hospital Center,\u003cbr\u003e  Washington, D.C., The Johns Hopkins University, Baltimore, Maryland\u003c\/p\u003e","brand":"Jossey-Bass","offers":[{"title":"Default Title","offer_id":47988935426277,"sku":"NP9780787965709","price":139.5,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9780787965709.jpg?v=1761782117","url":"https:\/\/k12savings.com\/es\/products\/clinical-trials-and-human-research-isbn-9780787965709","provider":"K12savings","version":"1.0","type":"link"}