HRPP Toolkit
The HRPP Toolkit is a comprehensive set of documents that include standard operating procedures, worksheets, checklists, templates, and manuals.
Investigators are required to read and follow HRP-103 - INVESTIGATOR MANUAL for conducting research with human participants.
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
Templates
Protocol Templates
Investigators must use one of the templates for writing protocols submitted to the IRB. To know which documents you should submit, first review “Getting Started” and read HRP-103 - Investigator Manual. You should also ensure you’ve completed CITI training in Human Research unless you are asking for a “Is this human research” determination.
- HRP-503a - TEMPLATE - Protocol (Non-Exempt)
- HRP-503c - TEMPLATE - Protocol (Exempt)
- HRP-503b - TEMPLATE - Protocol (Human Research Determination)
- HRP-503e - TEMPLATE - Protocol (External IRB Site Supplement)
The following appendices may need to be included in addition to the written protocol:
- HRP-593 Appendix A - Adults with Impaired Decision-Making Capacity
- HRP-593 Appendix B - Children
- HRP-593 Appendix C - Deception
- HRP-593 Appendix D - Devices
- HRP-593 Appendix E - Drugs, Biologics, and Food
- HRP-593 Appendix F - Genetic Testing
- HRP-593 Appendix H - Non-English-Speaking Individuals
- HRP-593 Appendix L - Repositories
- HRP-593 Appendix M - Waiver of Documentation of Consent/Parental Permission
- HRP-593 Appendix N - Waiver of Parental Permission Process
- HRP-593 Appendix O - Waiver or Alteration of Informed Consent Process
Consent/Assent/Permission Templates
