Human Subjects Protection Resources

Office for the Protection of Human Subjects (OHRP)

The Human Subjects Protection Program offers resources to give patient families the necessary tools to make a decision on their child's involvement in research.

• OHRP
• Code of Federal Regulations, Title 45 Part 46

Food and Drug Administration (FDA)

• FDA
• FDA Information Sheets
• Code of Federal Regulations, Title 21 Part 50
• Code of Federal Regulations, Title 21 Part 56
• Investigator-Initiated Investigational New Drug (IND) Applications

National Institutes of Health (NIH)

• NIH Home Page
• Certificates of Confidentiality
• Office of Human Subjects Research

Background Materials and Regulations

• Code of Federal Regulations
• The Belmont Report
• Declaration of Helsinki

Organizations

• Council for International Organizations of Medical Science
• Public Responsibility in Medicine and Research
• IRB Discussion Forum