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IRB Reviewer Forms and Tools

IRB Member Handbook

INITIAL

• Initial Submission Reviewer Form (04/2012)

FULL BOARD

• Full Board Continuation Reviewer Form  (04/2012 )  
• Full Board Amendment Reviewer Form (02/2012)
• Follow-up, Tabled, or SMR Reviewer Form (02/2012)

EXPEDITED

• Expedited Continuation Reviewer Form (02/2012)

EXEMPT

• Exempt Medical Reviewer Form (12/2011)
• Exempt Social/Behavioral/Education Reviewer Form (7/2012)
   

HIPAA

• HIPAA Documents Reviewer Form (01/2012)

APPENDICES

• IRB Reviewer Form - Children as Research Participants (8/12/2011)
• IRB Reviewer Form - Pregnancy, Fetuses, Neonates (7/14/2011)
• IRB Reviewer Form - Studies Conducted At or By The VA (8/12/2011)
• IRB Reviewer Form - Department of Defense (7/19/2011)
• IRB Reviewer Form - Prisoners as Research Participants (7/27/2011)

 UNEXPECTED PROBLEMS

• Unexpected Problem Checklist

INFORMED CONSENT

• Extra Consent Form Checklist
• Waiver or Alteration to Informed Consent Checklist
• Waiver of Requirement for Written Documentation of Informed Consent Checklist

CIRB

• CIRB Facilitated Review - Initial Submission Reviewer Form
• CIRB Expedited Continuation Reviewer Form

HELPFUL TOOLS

• Tips for reviewing the Informed Consent, Assent, or Information Sheet:  Reviewer Form Attachment
• Guidance for Reviewing Expedited & Exempt Protocols
• Presentation: IRB Responsibilities in Making the Significant Risk and Non-Significant Risk Device Determination (FDA Website)