Human Monitoring and Oversight

Mission

The purpose of the Human Monitoring and Oversight Program is to improve the quality of the human subjects’ protection program through education, training, and post approval monitoring of research studies. This program is intended to be proactive, not punitive, and focuses on educating investigators and research staff about their ethical and regulatory responsibilities in the conduct of research.

External Links

Ethics Documents

• Belmont Report
• Declaration of Helsinki
• Nuremburg Code

Department of Health and Human Services (DHHS) Regulations

• Title 45 CFR 46: Protection of Human Subjects (The Common Rule)  
• Title 45 CFR 164 Health Insurance Portability and Accountability Act (HIPAA) of 1996

Food and Drug Administration (FDA) Regulations

• Title 21 CFR 11: (Electronic records; electronic signature)
• Title 21 CFR 50: (Protection of human subjects)
• Title 21 CFR 54 : (Financial disclosure by clinical investigators) 
• Title 21 CFR 56: (Institutional review boards)
• Title 21 CFR 312: (Investigational new drug application)
• Title 21 CFR 314: (FDA Approval to market a new drug)
• Title 21 CFR 600: (Biological products)
• Title 21 CFR 601: (Licensing)
• Title 21 CFR 812: (Investigational device exemptions)
• Title 21 CFR 814: (Pre-market approvals of medical devices)
• ICH Good Clinical Practice (GCP) Guidelines