University at Buffalo - The State University of New York

Useful Resources/Links

General Resources

• Other UB IRBs that Review Human Subjects Research
• Health Sciences IRB
• Social & Behavioral Sciences IRB
• Office of the Vice President for Research
• CITI Human Subjects Protection Tutorial
• Lay Terms for Use in Consent Forms
• NIH (National Institutes of Health)
• Tips for Writing an Understandable Consent Document
• UB HIPAA Web Site
• UB HRPP Standard Operating Procedures (SOP)
• UB Sponsored Projects Services (SPS)

Ethical Principles and Guidelines

• Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
• Nuremburg Code

Regulations

• DHHS Regulations (Department of Health & Human Resources)
• DHHS 45 CFR Part 46 - Protection of Human Subjects/ Institutional Review Boards
• OHRP Site (Office for Human Research Protections)
• FDA Regulations (Federal Drug Administration)
• FDA 21 CFR Part 50 - Protection of Human Subjects
• FDA 21 CFR Part 56 - Institutional Review Boards
• FDA 21 CFR Part 312 – Investigational New Drug Application
• FDA 21 CFR Part 812 – Investigational Device Exemptions
• FDA Site (Food and Drug Administration)