IRB Forms & Standard Operating Procedures
Forms and SOPs
If you are having trouble downloading any of the forms or if a link does not work on a specific form and/or other document, please call 215.707.3390 or e-mail the IRB office at irb@temple.edu.
Please note, you will not be able to view HRP-300 through HRP-480 unless you have Adobe Acrobat Reader or above. Adobe Acrobat Reader DC can be downloaded for free at the following website which can be found here
- Statement of Compliance
- Practice Runs Training
- HRP-000-099 POLICY
- HRP-100-199 SOP
- HRP-200-299 FORM
- HRP-300-399 CHECKLIST
- HRP-400-499 WORKSHEET
- HRP-500-599 TEMPLATE
- HRP-800-899 INVESTIGATOR GUIDANCE
- HRP-900-999 OTHER DOCUMENTS
- HRP-000-099 POLICY
- HRP-001 POLICY - Definitions.tu.docx
- HRP-002 POLICY - Abbreviations.docx
- HRP-003 POLICY - Designations.tu.docx
- HRP-010 POLICY - Human Research Protection Program.tu.docx
- HRP-020 POLICY - IRB Member Review Expectations.docx
- HRP-021 POLICY - Legally Authorized Representatives Children and Guardians.tu.docx
- HRP-022 POLICY - End Approval Dates.docx
- HRP-023 POLICY - IRB Records.docx
- HRP-024 POLICY - IRB Roster.docx
- HRP-050 POLICY - States and Transitions.docx
- HRP-070 POLICY- Investigator Obligations
- HRP-071 POLICY- Prompt Reporting Requirements
- HRP-100-199 SOP
- HRP-101 SOP - Regulatory Review.docx
- HRP-102 SOP - Designated Reviewers.docx
- HRP-103 SOP - Non-Committee Review Preparation.docx
- HRP-104 SOP - Non-Committee Review Conduct.tu.docx
- HRP-105 SOP - Committee Review Preparation.docx
- HRP-106 SOP - Committee Review Conduct.tu.docx
- HRP-107 SOP - Committee Review Monitoring.docx
- HRP-108 SOP - Minutes.docx
- HRP-109 SOP - Not Otherwise Approvable Research.docx
- HRP-110 SOP - Consultation.docx
- HRP-111 SOP - Post Review.tu.docx
- HRP-112 SOP - New Information.docx
- HRP-113 SOP - Unexpected Incarceration.docx
- HRP-114 SOP - Suspension and Termination by the Organization.docx
- HRP-116 SOP- Subject Complaints
- HRP-120 SOP - Management of Financial Interests.tu.docx
- HRP-121 SOP - Organizational Financial Interests.tu
- HRP-122 SOP - Undue Influence of the HRPP.docx
- HRP-130 SOP - IRB Formation.docx
- HRP-131 SOP - IRB Deactivation.docx
- HRP-132 SOP - IRB Member Addition.docx
- HRP-133 SOP - IRB Member Removal.docx
- HRP-134 SOP - Designated Exempt Reviewers.docx
- HRP-135 SOP - Designated Exempt Review Conduct.docx
- HRP-140 SOP - IRB Records Retention.docx
- HRP-141 SOP - Annual Tasks.docx
- HRP-142 SOP - Monthly/Quarterly Tasks.docx
- HRP-143 SOP - Daily Tasks.docx
- HRP-144 SOP - Meeting Scheduling
- HRP-170 SOP - External IRB Screening.docx
- HRP-180 SOP - Emergency and Compassionate Uses.docx
- HRP-200-299 FORM
- HRP-300-399 CHECKLIST
- HRP-300 CHECKLIST- Waiver of Consent.pdf
- HRP-303 CHECKLIST - Waiver of Documentation of Consent.pdf
- HRP-305 CHECKLIST - Pregnant Women.pdf
- HRP-306 CHECKLIST - Neonates of Uncertain Viability.pdf
- HRP-307 CHECKLIST - Nonviable Neonates.pdf
- HRP-308 CHECKLIST - Prisoners.pdf
- HRP-309 CHECKLIST - Unexpected Incarceration.pdf
- HRP-310 CHECKLIST - Children.pdf
- HRP-326 CHECKLIST - Devices.pdf
- HRP-400-499 WORKSHEET
- HRP-400 WORKSHEET - Criteria for Approval.pdf
- HRP-405 WORKSHEET - Additional Criteria DOD.pdf
- HRP-406 WORKSHEET - Additional Criteria DOJ.pdf
- HRP-407 WORKSHEET - Additional Criteria ED.pdf
- HRP-408 WORKSHEET - Additional Criteria EPA.pdf
- HRP-409 WORKSHEET - Additional Criteria DOE.pdf
- HRP-410 WORKSHEET - Additional Criteria International.pdf
- HRP-411 WORKSHEET - New Information.pdf
- HRP-412 WORKSHEET - Financial Interest Management.pdf
- HRP-413 WORKSHEET - Closure Criteria.pdf
- HRP-414 WORKSHEET - Adults Lacking Capacity.pdf
- HRP-420 WORKSHEET - Regulatory Review.pdf
- HRP-421 WORKSHEET - Human Research.pdf
- HRP-422 WORKSHEET - Engagement.pdf
- HRP-423 WORKSHEET - Exemptions.pdf
- HRP-424 WORKSHEET - Expedited Review.pdf
- HRP-425 WORKSHEET - Drugs.pdf
- HRP-428 WORKSHEET - HIPAA Waiver of Authorization.pdf
- HRP-430 WORKSHEET - IRB Composition.pdf
- HRP-431 WORKSHEET - Quorum.pdf
- HRP-432 WORKSHEET - Contracts.pdf
- HRP-450 WORKSHEET - Criteria for Approval HUD.pdf
- HRP-451 WORKSHEET - Emergency Use Drugs and Biologics.pdf
- HRP-452 WORKSHEET - Emergency Use Devices.pdf
- HRP-453 WORKSHEET - Compassionate Use Devices.pdf
- HRP-454 WORKSHEET- Expanded Access Drugs and Bioligics
- HRP-470 WORKSHEET - External IRB Screening.pdf
- HRP-480 WORKSHEET - FERPA.pdf
- HRP-481 WORKSHEET - PPRA.pdf
- HRP-500-599 TEMPLATE
- HRP-800-899 INVESTIGATOR GUIDANCE
- HRP-802 INVESTIGATOR GUIDANCE - Informed Consent.docx
- HRP-803 INVESTIGATOR GUIDANCE - Documentation of Informed Consent.docx
- HRP-804 INVESTIGATOR GUIDANCE- Incidental Findings.docx
- HRP-810 INVESTIGATOR GUIDANCE - Additional DOD Obligations.docx
- HRP-811 INVESTIGATOR GUIDANCE - Additional DOE Obligations.docx
- HRP-812 INVESTIGATOR GUIDANCE - Additional DOJ Obligations.docx
- HRP-813 INVESTIGATOR GUIDANCE - Additional ED Obligations.docx
- HRP-814 INVESTIGATOR GUIDANCE - Additional EPA Obligations.docx
- HRP-815 INVESTIGATOR GUIDANCE - Additional FDA Obligations.docx
- HRP-816 INVESTIGATOR GUIDANCE - Additional ICH-GCP Obligations.docx
- HRP-817 INVESTIGATOR GUIDANCE- Additional ISO 14155 Obligations.docx
- HRP-900-999 OTHER DOCUMENTS