Georgetown Research Services
Georgetown Research Services

IRB Policies, Guidance, and Manuals

Georgetown University IRB Policies and Procedures

IRB Policies and Procedures Manual

Submitting to the Georgetown-MedStar IRB System Guidance

Where to Upload Documents in Your IRB Application
IRB Internal Submission User Guide
How to Create and Submit a Social Behavioral IRB Application Video
How to Create and Submit a Biomedical IRB Application Video.

Investigator Manual

Investigator Manual

Review of Research & Related Guidance and Considerations

Facilitated Review (IRB of Record)Policy
Case Reports Policy
Radiation Safety/Biosafety Committee Review
NIH Genomic Data Sharing Policy

Special Considerations

Research with Minors Policy
Student Participation in Research Policy
Guidelines for Obtaining Informed Consent from a Surrogate Decision Maker

Reportable Events

Reporting Adverse Events and Unanticipated Problems Policy
Reporting Protocol Deviations Policy

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS):

Subpart A: Basic Policy for Protection of Human Research Subjects [Definitions; Categories for Expedited Review and Exemption; Consent Form, etc.]