CHLA HSPP Policies and Procedures
The HSPP Standard Operating Procedures describe CHLA’s IRB policies and procedures for interpretation of the federal regulations, best practice standards, and state and local law. The SOPs posted here serve as a reference for the IRB membership, HSPP staff and the CHLA research community.
General SOPs
- Human Research Protection Program Plan
- HRP-001 – SOP: HSPP Program Definitions
- HRP-012 – SOP: Observation of Consent Process
- HRP-013 – SOP: Legally Authorized Representatives, Children and Guardians
Informed Consent SOPs
IRB Worksheets
- HRP-306 – WORKSHEET: Drugs and Biologics
- HRP-307 – WORKSHEET: Devices
- HRP-310 – WORKSHEET: Human Research Determinations
- HRP-311 – WORKSHEET: Engagement Determinations
- HRP-312 – WORKSHEET: Exemption Determinations
- HRP-313 – WORKSHEET: Expedited Reviews
- HRP-314 – WORKSHEET: Criteria for Approval of Research
- HRP-315 – WORKSHEET: Advertisements
- HRP-316 – WORKSHEET: Payments
- HRP-317 – WORKSHEET: Short-Form Consent Documentation
- HRP-320 – WORKSHEET: Scientific or Scholarly Review
- HRP-321 – WORKSHEET: Review of New Information
- HRP-322 – WORKSHEET: Emergency Use
- HRP-323 – WORKSHEET: Criteria for Approval HUD
- HRP-324 – WORKSHEET: Contracts
- HRP-325 – WORKSHEET: Device Compassionate Use
- HRP-330 – WORKSHEET: HIPAA Authorization
- HRP-331 – WORKSHEET: FERPA Compliance
- HRP-333 – WORKSHEET: Certificate of Confidentiality
IRB Checklists
- 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: Cognitively Impaired Adults
- HRP-418 – CHECKLIST: Non-Significant Risk Device
- HRP-419 – CHECKLIST: Waiver of Consent for Emergency Research
- HRP-441 – CHECKLIST: HIPAA Waiver of Authorization
