Huron HRPP Toolkit

Standard Operating Procedures

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-023 - SOP - Emerg and Device Comp Use Review
HRP-024 - SOP - New Information
HRP-025 - SOP - Investigations
HRP-026 - SOP- Susp or Term Issued Outside of Conv IRB
HRP-027 - SOP - Emerg Use Comp Use Indiv Pt Access Post Rev
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-054 - SOP - Institutional Conflicts of Interests
HRP-055 - SOP - Financial Conflicts of Interests
HRP-060 - SOP - Annual Evaluations of the HRPP
HRP-061 - SOP - Quarterly Evaluations of the HRPP
HRP-062 - SOP - Daily Tasks
HRP-063 - SOP - Expiration of IRB Approval
HRP-064 - SOP - NIH GDS Institutional Certification
HRP-065 - SOP - Response Plan for Emergencies-Disasters Impacting the HRPP
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 Activities Subject to IRB Jurisdiction

General Documents

HRP-100 - Huron HRPP Toolkit Table of Contents
HRP-101 - Human Research Protection Program Plan
HRP-102 - Flowcharts
HRP-103 - Investigator Manual
HRP-103p - Investigator Manual - pSite
HRP-104 - Brochure - Should I Take Part in Research?
HRP-105 - OHRP FDA Written Procedure Crosswalk
HRP-108 - FLOWCHART - Study-Specific Emergency-Disaster Risk Mitigation Planning
HRP-109 - IRB Member Manual

Worksheets

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
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-317 - WORKSHEET - Short Form of Consent Documentation
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-322 - WORKSHEET - Emergency Use
HRP-323 - WORKSHEET - Criteria for Approval HUD
HRP-324 - WORKSHEET - Contracts
HRP-325 - WORKSHEET - Device Compassionate Use
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

HRP-401 - CHECKLIST - Pre-Review
HRP-402 - CHECKLIST - Non-Committee Review
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
HRP-419 - CHECKLIST - Waiver of Consent Process for Emergency Research
HRP-430 - CHECKLIST - Investigator Quality Improvement
HRP-431 - CHECKLIST - Minutes Quality Improvement
HRP-441 - CHECKLIST - HIPAA Waiver of Authorization

General Templates

HRP-501 through HRP-508 are available on the HRP Forms page.
HRP-501 - TEMPLATE MINUTES
HRP-502 - TEMPLATE CONSENT DOCUMENTS
HRP-503 - TEMPLATE PROTOCOL NARRATIVES
HRP-504 - TEMPLATE LETTER - School Permission to Conduct Research
HRP-505 - TEMPLATE SOP
HRP-506 - TEMPLATE CONSENT DOCUMENT – Expanded Access
HRP-507 - TEMPLATE CONSENT DOCUMENT - Short Form
HRP-508 - TEMPLATE - SITE SUPPLEMENT

Template Letters - Post Review

HRP-510 - LETTER - Approval
HRP-510a -- LETTER -- Approval -- CR NOT Req
HRP-511 - LETTER - Closure
HRP-512 - LETTER - Modifications Required to Secure Approval
HRP-513 - LETTER - Not Human Research Determination
HRP-514 - LETTER - Exemption
HRP-515 - LETTER - Suspension or Termination
HRP-515a -- LETTER -- Lifting of Suspension
HRP-516 - LETTER - Deferral
HRP-517 - LETTER - Disapproval
HRP-518 - LETTER - Tabled
HRP-519 - LETTER - Information Item
HRP-520 - LETTER - External Report NOT Including OHRP
HRP-520a -- LETTER -- External Report OHRP and Other Agencies
HRP-521 - LETTER - Significant Risk Device
HRP-522 - LETTER - Certification of Prisoner Research
HRP-523 - LETTER - Not Otherwise Approvable Research
HRP-525 - LETTER - OHRP Notification of Emergency Waiver
HRP-527 - LETTER - Not Engaged

Template Letters - Reminders

HRP-530 - LETTER - Continuing Review Reminder
HRP-531 - LETTER - Training Reminder
HRP-532 - LETTER - Continuation of Subjects in Expired Research
HRP-533 - LETTER - Expiration of IRB Approval
HRP-534 - LETTER - Investigator Quality Improvement Assessment
HRP-535 - LETTER - Annual Reminder

Template Letters - IRB Review

HRP-540 - LETTER - Designated Reviewer Materials
HRP-541 - LETTER - IRB Member Review Materials
HRP-542 - LETTER - Implementation of HRPP Emergency-Disaster Response Plan

Template Letters - Failure Notifications

HRP-550 - LETTER - Failure to Submit Continuing Review
HRP-551 - LETTER - Failure to Submit Emergency Use Report
HRP-553 - LETTER - Failure to Submit Emergency Use Protocol
HRP-554 - LETTER - Failure to Undergo Training

Template Letters - Committee Management

HRP-560 - LETTER - IRB Member Appointment
HRP-561 - LETTER - IRB Member Thank You
HRP-562 - LETTER - IRB Member Appreciation

Template Letters - Emergency Use

HRP-570 - LETTER - Pre-Review of Emergency Use - Criteria Met
HRP-571 - LETTER - Pre-Review of Emergency Use - Criteria Not Met
HRP-572 - LETTER - Review of Emergency Use - Criteria Met– Emergency Use
HRP-573 - LETTER - Review of Emergency Use - Criteria Not Met
HRP-574 - LETTER - Device Compassionate Use
HRP-575 - LETTER - Rev of IRB Waiver for Indiv Pt Drug Exp Access

Database

HRP-601 – DATABASE – IRB ROSTER

SIRB Documents

HRP-801 - SOP - Establishing Authorization Agreements
HRP-802 - SOP - Institutional Profile Management
HRP-804 - SOP - External IRB Post-Review
HRP-805 - SOP - External IRB Updates
HRP-806 - SOP - Review Request to Cede Review
HRP-811 - FORM - Basic Site Information
HRP-812 - FORM - Site Continuing Review
HRP-813 - FORM - Site Modification
HRP-814 - FORM - Site Reportable New Information
HRP-815 - FORM - Institutional Profile
HRP-816 - FORM - External IRB Study Update
HRP-830 - WORKSHEET - Communication and Responsibilities
HRP-832 - WORKSHEET - Considerations for Relying on an External IRB
HRP-833 - WORKSHEET - Considerations for Serving as the sIRB
HRP-850- LETTER - Decline to Serve
HRP-851 - LETTER - Invitation Decision
HRP-856 - LETTER - Decline Reliance on an External IRB
HRP-857 - LETTER - Acknowledge External IRB
HRP-859 - LETTER - Acknowledge External IRB Update
HRP-861 - WORKBOOK - Institutional Profiles
HRP-870 - LETTER - Site Approval
HRP-872 - LETTER - Site Modifications to Secure Approval
HRP-876 - LETTER - Site Deferral
HRP-877 - LETTER - Site Disapproval
HRP-879 - LETTER - Review of Site Information Item