IRB Procedure Manual

• Laminates
• Guidances

Checklists

• Consent Observation Checklist
• Continuing Review
• Exemption Eligibility
• Expedited Modification (to determine review procedure)
• Informed Consent (medical: clinical studies)
• Informed Consent (medical: expedited/minimal risk)
• Informed Consent (nonmedical: surveys, social, behavioral, education research)
• Informed Consent (CIRB)
• Neonates
• Other Federal Agency Requirements:
  • Dept. of Defense (DoD), Dept. of Navy (DON)
  • Dept. of Education (ED)
  • Dept. of Energy (DOE)
  • Dept. of Justice (DOJ)
  • Environmental Protection Agency (EPA)
• Protocol - Medical
• Protocol - Expedited (initial review)
• Protocol - Nonmedical
• VA Research; see Reviewing VA Research for additional requirements

Forms Concerning IRB Membership and Meetings

• Consultant Conflict of Interest Declaration
• Confidentiality Agreement
• Determining if IRB Public Members are Unaffiliated
• Determining if IRB Members are Non-Scientists
• Email Template to Members Re: Agenda List and Minutes
• Email Template to Members Re: Meeting
• Evaluation of IRB Chairs
• Evaluation of IRB Members
• IRB Chair Script (pdf)
• IRB Member Conflict of Interest Declaration 

Other

• Certificate of Confidentiality Process
• Communications Notes
• Email Template Reportable Decision to Dean of Research
• Email Template Report Memo to Protocol Director
• Email Template Not Serious, Not Continuing Noncompliance
• Email Template Parental Permission to Protocol Director
• Exemption from IRB Review: Emergency Use of a Test Article
• HSR: Human Subject Research (HSR) Determination
• HSR: Determining when Organization is Engaged
• Meeting Preparation - Protocol Notes
• Procedure for Observation of Consenting Process 
• Report Handling Timeframes
• Review of Scientific and Scholarly Validity, and Oversight - Academic Sponsor
• Review of Scientific and Scholarly Validity
• Scientific Review Protocol (for projects not otherwise undergoing scientific review)
• SIR Requirements for New, Continuing Review, Final Report
• Reviewing VA Research