IRB Forms and Resources

Review Checklists

• HRP-210 Criteria for Approval Original FDA Regulated
• HRP-218 Criteria for Approval Original 2018 Common Rule, WITH IC
• HRP-219 Criteria for Approval Original 2018 Common Rule, No IC
• HRP-220 Criteria for Approval Amd and CR FDA Regulated with IC
• HRP-221 Criteria for Approval Amd and CR FDA Regulated without IC
• HRP-224 Criteria for Approval Amd and CR_Pre-2018 Common Rule WITHOUT IC
• HRP-225 Criteria for Approval Amd and CR Pre-2018 Common Rule with IC
• HRP-226 Criteria for Approval CR only Pre-2018 Common Rule closed Now Moving under 2018 Rule
• HRP-228 Criteria for Approval Amd and CR 2018 Common Rule with IC
• HRP-229 Criteria for Approval Amd and CR 2018 Common Rule WITHOUT IC
• HRP-306 Checklist - Drugs and Biologics
• HRP-307 Checklist - Devices
• HRP-310 Human Research Determination Checklist
• HRP-312 Exempt and Limited IRB Review Checklist
• HRP-313 Expedited Review Checklist
• HRP-315 Advertisements Checklist
• HRP-316 Pregnant Women and Unborn Baby Checklist
• HRP-321 Review of Information Items Worksheet
• HRP-322 Emergency Use Worksheet
• HRP-323 Criteria for Approval for HUD Checklist
• HRP-410 Waiver or Alteration of Consent Process Checklist
• HRP-410 and 441 Combined Waiver (or Alteration) of Informed Consent Process And Waiver of HIPAA
• HRP-411 Waiver of Written Documentation of Consent Checklist
• HRP-415 Research with Prisoners Checklist
• HRP-416 Children Checklist
• HRP-417 Cognitively Impaired or Unable to Consent Checklist
• HRP-418 Non-Significant Risk Device
• HRP-441 HIPAA Waiver of Authorization Checklist

Rosters

• Health Science Institutional Review Board Roster
• Oncology Institutional Review Board Roster

Policies

Learn more about Avera Institutional Review Board (IRB) policies in our index of IRB Standard Operating Procedures. We are currently working on updating our SOPs. Updated procedures can be found here.