Guidance Information
Activities Not Under the Jurisdiction of the IRB
Audits
Blood Withdrawal from Pediatric Subjects of Research Studies
Coded Private Information or Biological Specimens
Child Clearances
Coordinating Center
Model Consent Documents
Building Your Consent Document
"Cost Language" in Research Consent Forms When a Research Study Includes Any Use of UPMC Clinical Services
Development of Informed Consent Documents
Electronic Signatures and Other Strategies for Documenting Consent and HIPAA Authorizations
Family Members' Informed Consent when Research Involves the Collection of Their Private Information
FDA Mandated Changes in Consent Form Language
Non-English Speaking Subjects
Arabic Short Form Consent
English Short Form Consent
French Short Form Consent
Mandarin Short Form Consent
Portuguese Short Form Consent
Russian Short Form Consent
Serbo-Croation Short Form Consent
Spanish Short Form Consent
Vietnamese Short Form Consent
Pregnant Women and Neonates
Reproductive Risk Language for Consents
Re-consent of Research Participants
Data and Safety Monitoring Plans
Emergency Use of an Unapproved Investigational Drug, Biologic, or Device: Requirements and Procedures
Federal Certificate of Confidentiality
Fee information
Human Use Subcommittee, Radiation Safety and Radioactive Drug Research Committee
Humanitarian Device Exemptions
Investigational Devices
Leaving the University of Pittsburgh, a Checklist for Investigators
Modifications to the Research Protocol and Informed Consent Document
"Off-Label" and Investigational Use of Approved Drugs and Biologics
Parallel Review Process for Projects under the Jurisdiction of the University of Pittsburgh IRB and Requiring the Review/Approval of the UPMC Research Fiscal Review Department
Privacy versus Confidentiality
Protection of Pupil Rights Amendment (PPRA)
Tissue Samples for Genetic Studies and Other Research Purposes, Special Considerations for the Collection and Use