Clinical Trials and Human Research

A Practical Guide to Regulatory Compliance

Inbunden, Engelska, 2003

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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. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research.

Produktinformation

Utgivningsdatum2003-06-11
Mått184 x 261 x 37 mm
Vikt1 323 g
FormatInbunden
SpråkEngelska
Antal sidor656
FörlagJohn Wiley & Sons Inc
ISBN9780787965709

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Fay A. Rozovsky,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. Rodney K. Adams, 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.

Ch. 1. The evolution of human experimentation regulation Ch. 2. Current federal regulations and agencies involved in human researchCh. 3. State regulation of human researchCh. 4. Selection and recruitment of research subjectsCh. 5. Informed consent in clinical trialsCh. 6. Confidentiality of clinical trials informationCh. 7. The investigatorCh. 8. Research protocolsCh. 9. The institutional review boardCh. 10. Patient safety in clinical trials researchCh. 11. Human research under the Food, Drug & Cosmetic ActCh. 12. Behavior researchCh. 13. Multisite and collaborative studiesCh. 14. Medical malpractice liability in human researchCh. 15. Quality improvement, accrediation, and risk management in clinical trialsCh. 16. Corporate compliance and human researchCh. 17. Ethics in human researchCh. 18. International research