For Reviewer & Staff Use Only
The forms included below are completed by IRB member reviewers and HRPP staff.
These forms are NOT completed by researchers and are not included with the submissions to the IRB.
The revised Common Rule implemented on January 21, 2019 for new studies. Several forms have been updated to incorporate the revised Common Rule requirements (noted below). To view more detailed information about the revised Common Rule changes, please visit the Revised Common Rule webpage.
Not Human Research
- HRP-310 - Worksheet - Human Research Determination (Revised Common Rule) (Word 23KB)
- HRP-310 - Worksheet - Human Research Determination (Pre-2018 Requirements) (Word 23KB)
45 CFR 46.118 Designation
- HRP-315 - Worksheet - 45 CFR 46.118 Designation (Word 21KB)
- HRP-347 - Worksheet - Renewed 45 CFR 46.118 designation (Word 20KB)
Exemption
- HRP-312 - Worksheet - Exemption Determination (Revised Common Rule) (Word 32KB)
- HRP-312 - Worksheet - Exemption Determination (Pre-2018) (Word 25KB)
Expedited/Full Board Studies
Eligibility for Expedited Review
- HRP-313 - Worksheet - Expedited Review (Revised Common Rule) (Word 29KB)
- HRP-313 - Worksheet - Expedited Review (Pre-2018) (Word 27KB)
Criteria for Approval
- HRP-314 - Worksheet - Criteria for Approval (Revised Common Rule) (Word 30KB)
- HRP-314 - Worksheet - Criteria for Approval (Pre-2018) (Word 26KB)
Informed Consent
- HRP-421 - Checklist - Consent Document Checklist for IRB (Revised Common Rule) (Word 23KB)
- HRP-421 - Checklist - Consent Document Checklist for IRB (Pre-2018) (Word 20KB)
- HRP-410 - Checklist - Waiver or Alteration of Consent Process (Revised Common Rule) (Word 27KB)
- HRP-410 - Checklist - Waiver or Alteration of Consent Process (Pre-2018) (Word 23KB)
- HRP-411 - Checklist - Waiver of Written Documentation of Consent (Revised Common Rule) (Word 61KB)
- HRP-411 - Checklist - Waiver of Written Documentation of Consent (Pre-2018) (Word 20KB)
- HRP-447 - Checklist - Waiver or Alteration of Consent Process for Minimal Risk Clinical Investigations - FDA
Subject Populations
- HRP-416 - Checklist - Children (Revised Common Rule) (Word 30KB)
- HRP-416 - Checklist - Children (Pre-2018) (Word 29KB)
- HRP-417 - Checklist - Cognitively Impaired Adults (Word 20KB)
- HRP-414 - Checklist - Neonates of Uncertain Viability (Word 414KB)
- HRP-413 - Checklist - Non-Viable Neonates (Word 21 KB)
- HRP-412 - Checklist - Pregnant Women (Word 24 KB)
- HRP-415 - Checklist Prisoners (Word 31 KB)