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IRB Forms
Friends Research Institute, Inc. Institutional Review Board (IRB) and Human Research Protections Program
Definition of Terms
IRB Review Procedures
Meeting and Submission Dates for IRB
Submission Forms
New Study/Initial Review Applications
- Application for Behavioral Study Review
- Application for Bio-Medical Study Review
- Application for Exemption from IRB Review
- Application for Expedited Review
Supplementary Applications
- Supplementary Application for Research Involving Children
- Supplementary Application for Research Involving Prisoners
- Supplementary Application for Research Involving Pregnant Women, Human Fetuses, and Neonates
- Supplementary Application for Research Involving DNA/Tissue/Sample Banks
- Supplementary Application: Indications for Investigational New Drug (IND) and Investigational Device Exemption (IDE)
- Supplementary Application: Investigational Drug Information Record
Financial Disclosure Form
Approved Research
- Application for an Amendment (Change)/Addendum (New)
- Application for Continuing Review
- Serious Adverse Event (SAE)/Unanticipated Risk Report Form
- Deviation Form
- Application for Final Review
Templates
FRI Policies
- State of California Requirements Pertaining to the Review of Human Subjects Research
- State of Maryland Requirements Pertaining to the Review of Human Subjects Research
- Scientific Misconduct Policy
- Conflict of Interest Policy
Federal Regulations
- 45 CFR 46 (DHHS)
- 21 CFR 50 (FDA – Protection of Human Subjects)
- 21 CFR 56 (FDA – Institutional Review Boards)
- 21 CFR 312 (FDA – Investigational New Drug Application)
- 21 CFR 812 (FDA – Investigational Device Exemptions)
Useful Information
- Office of Human Research Protections (OHRP)
- OHRP’s IRB Guidebook
- Food and Drug Administration (FDA)
- FDA Guidance for IRBs and Clinical Investigators
- NIH Certificates of Confidentiality
On-Line Tutorials
- CITI Course in the Protection of Human Subjects
- NIH Protection of Human Subjects Computer-Based Training for Researchers
Foundations/History of Human Research Subject Protections