Worksheets, Checklists and SOPs

The following provides PPHS worksheets, check lists, and procedures (criteria IRB uses to make determinations):

PPHS Worksheets

HRP-307—WORKSHEET—Scientific or Scholarly Review
HRP-309—WORKSHEET—Human Research Determination
HRP-310—WORKSHEET—Engagement Determination
HRP-311—WORKSHEET—Criteria for Approval and Additional Considerations
HRP-314—WORKSHEET—Criteria for Approval and Additional Considerations for Humanitarian Use Device (HUD)
HRP-317—WORKSHEET—Emergency Use of a Test Article
HRP-318—WORKSHEET—Short Form of Consent Documentation
HRP-320—WORKSHEET—Exemption Determination
HRP-321—WORKSHEET—Contract Review

PPHS Checklists

HRP-402— CHECKLIST—Non-Committee Review
HRP-413—CHECKLIST—Eligibility for Review Using the Expedited Review Procedure
HRP-415—CHECKLIST—Waiver of Alterations of the Consent Process
HRP-416—CHECKLIST—Waiver of Written Documentation of the Consent Process
HRP-417—CHECKLIST—Research Involving Prisoners
HRP-418—CHECKLIST—Research Involving Pregnant Women
HRP-419—CHECKLIST—Research Involving Non-Viable Neonates
HRP-420—CHECKLIST—Research Involving Neonates of Uncertain viability
HRP-421—CHECKLIST—Research Involving Children
HRP-422—CHECKLIST—Research Involving Cognitively Impaired Adults
HRP-423—CHECKLIST—Non-Significant Risk Device
HRP-424—CHECKLIST—Waiver of Consent Process for Planned Emergency Research

Institutional Standard Operating Procedures

HRP-010—SOP—Annual Evaluations of the Human Research Protection Program
HRP-011—SOP—Quality Improvement Plan Human Research Protection Program
HRP-012—SOP—Observation of the Consent Process
HRP-013—SOP—Legally Authorized Representatives, Children, and Guardians
HRP-014—SOP—Institutional Conflicts of Interests
HRP-020—SOP—Incoming Items Directed to the IRB
HRP-022—SOP—Response to PPHS Required to Secure Approval
HRP-023—SOP—Emergency Use of a Test Article Review
HRP-024—SOP—New Information
HRP-026—SOP—Suspension or Termination of IRB Approval
HRP-027—SOP—Emergency Use of a Test Article Post-Review
HRP-030—SOP—Designated Reviewers
HRP-031—SOP—Non-Committee Review Preparation

HRP-033 - SOP - Exempt Research Determination
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-050—SOP—Conflicting Interests of IRB Members
HRP-055—SOP—Financial Conflicts of Interests

HRP-061—SOP—Expiration of IRB Approval
HRP-070—SOP—IRB Records
HRP-071—SOP—Standard Operating Procedures
HRP-080—SOP—IRB Formation
HRP-081—SOP—IRB Removal
HRP-082—SOP—IRB Membership Addition
HRP-084—SOP—IRB Meeting Scheduling and Notification
HRP-090—SOP—Informed Consent Process for Research
HRP-091—SOP—Written Documentation of Consent

HRP-092 - SOP - Request to Rely (R2R) on an External IRB

HRP-094 - SOP - Request for ISMMS to Serve (R2S) as the Reviewing IRB