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CHOP Institutional Review Board
Research Institute at The Children's Hospital of Philadelphia
Institutional Review Board
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Investigator Responsibilities
Who can be a PI?
Study Planning: Feasibility Assessment
Delegation of Responsibilities
Reporting Unanticipated Problems
Submitting Changes
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What must be reviewed by the IRB?
What is research?
Who is a Human Subject?
Engagement in Human Subjects Research (HSR)
Quality Improvement vs Research
FAQ: HIPAA
FAQ: IRB Review Requirements
Preparation for Study Submission
Protocol
Protocol Templates
Study Design
Writing a Protocol
FAQ: Protocols
Informed Consent
Consent Form Requirements
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Assent
FAQ: Assent of Children
Short Form Consent
FAQ: Short Form Consent
Short Form Consent Forms
Electronic Signatures
Scientific Review
Submissions for a Determination
Not human subjects research
HIPAA Attestations
Exempt Research
FAQ: Exempt Research
Submissions for Review/Approval
Division/Department Review
Expedited Review
FAQ: Expedited Review
Full Board Review
FAQ: Full Board Review
Ancillary Review
Waivers
Waiver of Documentation of Consent
FAQ: Waiver of Documentation
Waiver or Alteration of Consent
Waiver or Alteration of HIPAA
Waiver of Assent
Waiver of Parental Permission
FAQ: Waivers
Oversight of Multicenter Research
IRB Timelines
Criteria for IRB Approval
Minimizing Risk
Risk and Benefit
Risk of Common Procedures
Equitable Selection
Informed Consent & Documentation
Data-Safety Monitoring
Privacy and Confidentiality
Vulnerable Populations
Children in Research
Pregnant Women & Fetus
FAQ: Pregnant Women & Fetus
Prisoners
Adults with Diminished Capacity
During and After the Study Approval Period
Continuing Review
Amendments
One-time Amendments
Reportable Events
Unanticipated Problems
FAQ: Unanticipated Problems
Protocol Deviations
FAQ: Protocol Deviations
Change in Subject Status
Other Reportable Events
Document Retention
FAQ: Document Retention
Special Topics
Behavioral Research
Certificates of Confidentiality
Registries & Repositories
Honest Broker
Sharing Data and Biospecimens
Coded vs De-identified
Sharing Genomic Data
FAQ: Sharing Genomic Data
Incidental Findings
Investigational Drugs & Devices
Sponsorship and Funding
Drugs and Biologics
Devices
Device Regulation & Classification
Humanitarian Use Devices
FAQ: Devices
Emergency Use
Recruitment vs Screening
FAQ: Recruitment vs Screening
Payments to Subjects
Validated Instruments
HIPAA and Research
HIPAA Glossary
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FAQs: Study Review
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FAQ: Waivers
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