Useful Resources/Links
General Resources
- Other UB IRBs that Review Human Subjects Research
- Office of the Vice President for Research
- CITI Human Subjects Protection Tutorial
- Lay Terms for Use in Consent Forms
- Tips for Writing an Understandable Consent Document
- NIH (National Institutes of Health)
- Certificates of Confidentiality Kiosk
- UB HIPAA Web Site
- UB HRPP Standard Operating Procedures (SOP)
- UB Sponsored Projects Services (SPS)
- Office for Human Research Protections (OHRP): IRB Guidebook
Ethical Principles and Guidelines
- Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
- International Ethical Guidelines for Biomedical Research Involving Human Subjects [Council for International Organizations of Medical Sciences (CIOMS)]
- 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): Policy and Guidance
- 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): Guidance for IRBs and Investigators
- Investigational New Drug (IND) Applications
- Device Advice: Investigational Device Exemption (IDE)
