HRPP Toolkit
The HRPP Toolkit is a comprehensive set of documents that include standard operating procedures, worksheets, checklists, templates, and manuals.
Standard Operating Procedures
SOPs are now organized by business process (e.g. pre-review, review, post-review) rather than by topic. They cross reference worksheets and checklists, so information is not duplicated. While the majority of SOPs are for HRPP/IRB staff and IRB members, there are two SOPs for researchers: HRP-090 - SOP - Informed Consent Process for Research and HRP-091 - SOP - Written Documentation of Consent.
- HRP-001 - SOP - Definitions
- HRP-012 - SOP - Observation of Consent Process
- HRP-013 - SOP - LARs, Children, and Guardians
- HRP-020 - SOP - Incoming Items
- HRP-021 - SOP - Pre-Review
- HRP-024 - SOP - New Information
- HRP-025 - SOP - Investigations
- HRP-026 - SOP - Susp or Term Issued Outside of Conv IRB
- HRP-030 - SOP - Designated Reviewers
- HRP-031 - SOP - Non-Committee Review Preparation
- HRP-032 - SOP - Non-Committee Review Conduct
- HRP-040 - SOP - IRB Meeting Preparation
- HRP-041 - SOP - IRB Meeting Conduct
- HRP-042 - SOP - IRB Meeting Attendance Monitoring
- HRP-043 - SOP - IRB Meeting Minutes
- HRP-044 - SOP - Not Otherwise Approvable Research
- HRP-050 - SOP - Conflicting Interests of IRB Members
- HRP-051 - SOP - Consultation
- HRP-052 - SOP - Post-Review
- HRP-063 - SOP - Expiration of IRB Approval
- HRP-070 - SOP - IRB Records
- HRP-071 - SOP - Toolkit Management
- HRP-072 - SOP - IRB Records Retention
- HRP-080 - SOP - IRB Formation and Registration
- HRP-081 - SOP - IRB Removal
- HRP-082 - SOP - IRB Membership Addition
- HRP-083 - SOP - IRB Membership Removal
- HRP-084 - SOP - IRB Meeting Scheduling and Notification
- HRP-090 - SOP - Informed Consent Process for Research
- HRP-091 - SOP - Written Documentation of Consent
- HRP-096 - SOP - Post Approval Monitoring
Worksheets
Worksheets are used by HRPP/IRB staff for regulatory decision making during the review process that does not need to be formally documented.
- HRP-301 - WORKSHEET - Review Materials
- HRP-302 - WORKSHEET - Approval Intervals
- HRP-303 - WORKSHEET - Communication of Review Results
- HRP-304 - WORKSHEET - IRB Composition
- HRP-305 - WORKSHEET - Quorum and Expertise
- HRP-306 - WORKSHEET - Drugs and Biologics
- HRP-307 - WORKSHEET - Devices
- HRP-308 - WORKSHEET - Pre-Review
- HRP-309 - WORKSHEET - Ancillary Review Matrix – Coming soon!
- HRP-310 - WORKSHEET - Human Research Determination
- HRP-311 - WORKSHEET - Engagement Determination
- HRP-312 - WORKSHEET - Exemption Determination
- HRP-313 - WORKSHEET - Expedited Review
- HRP-314 - WORKSHEET - Criteria for Approval
- HRP-314a - WORKSHEET - Criteria for Consent
- HRP-315 - WORKSHEET - Advertisements
- HRP-316 - WORKSHEET - Payments
- HRP-318 - WORKSHEET - Additional Federal Agency Criteria
- HRP-319 - WORKSHEET - Limited IRB Review and Broad Consent
- HRP-320 - WORKSHEET - Scientific or Scholarly Review
- HRP-321 - WORKSHEET - Review of Information Items
- HRP-324 - WORKSHEET - Contracts
- HRP-326 - WORKSHEET - Performance Evaluation for IRB Chairs
- HRP-327 - WORKSHEET - Performance Evaluation for IRB Members
- HRP-328 - WORKSHEET - Performance Evaluation for IRB Staff
- HRP-330 - WORKSHEET - HIPAA Authorization
- HRP-331 - WORKSHEET - FERPA Compliance
- HRP-332 - WORKSHEET - NIH GDS Institutional Certification
- HRP-333 - WORKSHEET - Certificate of Confidentiality
- HRP-351 - WORKSHEET - Protocol-Specific Emergency-Disaster Risk Mitigation Planning
- HRP-352 - WORKSHEET - Additional Emergency-Disaster Review Considerations
Checklists
Checklists are used by HRPP/IRB staff for regulatory decision making that must be documented and retained in the study record within PERA.
- HRP-410 - CHECKLIST - Waiver or Alteration of Consent Process
- HRP-411 - CHECKLIST - Waiver of Written Documentation of Consent
- HRP-412 - CHECKLIST - Pregnant Women
- HRP-413 - CHECKLIST - Non-Viable Neonates
- HRP-414 - CHECKLIST - Neonates of Uncertain Viability
- HRP-415 - CHECKLIST - Prisoners
- HRP-416 - CHECKLIST - Children
- HRP-417 - CHECKLIST - Adults with Impaired Decision-Making Capacity
- HRP-418 - CHECKLIST - Non-Significant Risk Device
