IRB Resources

Resources

• IRB Membership Roster
• ICH Statement of Compliance Sept 2011
• IRB fee schedule
• 2011 IRB submission schedule
• 2012 IRB submission schedule
• IRB Reviewer Checklist

Ethical Guidance

• Belmont Report
• Nuremberg Code
• Declaration of Helsinki

Regulations

• DHHS Regulations 45 CFR 46 -The Common Rule
• FDA 21 CFR 50 – Protection of Human Subjects
• FDA 21 CFR 56 – Institutional Review Boards
• FDA 21 CFR 11 – Electronic Records; Electronic Signatures
• FDA 21 CFR 54 – Financial Disclosure by Clinical Investigators
• FDA 21 CFR 312 – Investigational New Drug Application
• FDA 21 CFR 812
• FDA 21 CFR 814

Guidance

• Office for Human Research Protections (OHRP) Policy & Guidance Index
• FDA Device Advice
• FDA Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
• FDA GCP Guidance for Industry