Clinical Trials and Human Research

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

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