Full 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. Clinical Trials and Human Research is a practical tool to help anyone involved in clinical research.
Contents
Ch. 1. The evolution of human experimentation regulation Ch. 2. Current federal regulations and agencies involved in human research
Ch. 3. State regulation of human research
Ch. 4. Selection and recruitment of research subjects
Ch. 5. Informed consent in clinical trials
Ch. 6. Confidentiality of clinical trials information
Ch. 7. The investigator
Ch. 8. Research protocols
Ch. 9. The institutional review board
Ch. 10. Patient safety in clinical trials research
Ch. 11. Human research under the Food, Drug & Cosmetic Act
Ch. 12. Behavior research
Ch. 13. Multisite and collaborative studies
Ch. 14. Medical malpractice liability in human research
Ch. 15. Quality improvement, accrediation, and risk management in clinical trials
Ch. 16. Corporate compliance and human research
Ch. 17. Ethics in human research
Ch. 18. International research
