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

• HRP-090 – SOP: Informed Consent Process for Research
• HRP-091 – SOP: Written Documentation of Consent

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-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-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
• HRP-2000 - WORKSHEET: Continuing or Serious NonCompliance

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-431 - CHECKLIST: Minutes Quality Improvement Assessment
• HRP-441 – CHECKLIST: HIPAA Waiver of Authorization