Regulatory Affairs at the University of Pennsylvania

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IRB Forms

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Title	Form
IRB Submissions
Biomedical Science Application: Section I: Face Sheet Section II: Protocol Summary Section III: IRB Required Documents
Social and Behavioral Sciences Application: Section I: Face Sheet Section II: Protocol Summary Section III: IRB Required Documents
Humanitarian Use Device (HUD) Application: Section I: Face Sheet Section II: Protocol Summary Section III: IRB Required Documents
Prime or Umbrella Grant Application: Request for Review of a Prime or Umbrella Grant
Research Privacy Application for Limited Data Sets: Application for Research Involving the Use of Limited Data Sets
Coordinating Center Application: Application for Coordinating Center
Penn/CHOP Cooperative Agreement: Penn/CHOP Cooperative Agreement Determination Form Instructions for Penn/CHOP Cooperative Agreement Determination Form
Supplemental Forms: Research Involving Pregnant Women, Fetuses, and Neonates Research Involving Children Research Involving Prisoners
Consent Form Templates: Biomedical Research Social and Behavioral Sciences Research Venipuncture Consent Template Cancer Study Consent Template Tissue Research Consent Template Assent Form Template Humanitarian Use Device Template
Consent Form - Short Forms ICF Short Form - Arabic ICF Short Form - Chinese ICF Short Form - HaitianCreole ICF Short Form - Italian ICF Short Form - Korean ICF Short Form - Portuguese ICF Short Form - Russian, ICF Short Form - Spanish ICF Short Form - English Template
HIPAA Research Subject Authorization Forms: School of Medicine School of Dental Medicine Request for Waiver of HIPAA Authorization (to use or disclose documents, records, or data sources containing Protected Health Information for research purposes)

Continuing Review Form
Modification Submission Form
Prime/Umbrella Grant Continuing Review Form
Claim of Exemption Form
Claim of Exemption Instructions
Human Research Determination Worksheet
Electronic Request for Exemption (RFE)
Electronic Request for Exemption (RFE) Instructions
Unanticipated Problems Increasing Risks to Subjects or Others Including Reportable Adverse Events

General
Confidential Financial Disclosure Form	or
Data Use Agreement This contract is required to be completed whenever Protected Health Information is being disclosed to a source outside of UPHS or the SOM.
IRB Authorization Agreement
Individual Investigator Agreement

Penn HIPAA Privacy Statement

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