Contents:
1.
The evolution of Human Experimentation Regulation 2.
Current Federal Regulation and Agencies Involved in
Human Research 3.
State Regulation of Human Research 4.
Selection and Recruitment of Research subjects 5.
Informed Consent in Clinical Trials 6.
Confidentiality of Clinical Trials Information 7.
The investigator 8.
Research protocols 9.
The Institutional Review board 10.
Patient Safety in clinical Trials Research 11.
Human Research Under the Food, Drug & Cosmetic Act 12.
Behavior Research 13.
Multisite and Collaborative Studies 14.
Medical Malpractice Liability in Human Research 15.
Quality Improvement, Accreditation, and Risk 16.
Corporate Compliance and Human Research 17.
Ethics in Human Research 18. International Research |
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