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.
The Toolkit contains a large catalog of SOPs (HRP-001 through HRP-096), Worksheets (HRP-301 series), Checklists (HRP-410 series), Templates (HRP-502, HRP-503, HRP-593 series), and the Investigator Manual. A complete document index migration is pending.
SOPs are 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.
The full SOP catalog (HRP-001 through HRP-096) is hosted on SharePoint.
Worksheets are used by HRPP/IRB staff for regulatory decision making during the review process that does not need to be formally documented. The full Worksheet catalog (HRP-301 through HRP-352) is hosted on SharePoint.
Checklists are used by HRPP/IRB staff for regulatory decision making that must be documented and retained in the study record within PERA. The full Checklist catalog (HRP-410 through HRP-418) is hosted on SharePoint.
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.
- 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)
Consent / Assent / Permission Templates
Additional appendices (HRP-593 Appendix A–O) cover specific populations and situations and are available in the SharePoint Protocol & Consent Templates library:
- 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 G – Multi-site Research
- 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