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Frequently Asked Questions
What is the OUHSC Federalwide Assurance (FWA) number?
Where can I find IRB Member Rosters?
What are the IRB education and training requirements?
Who can be listed as the Principal Investigator (PI) on an application?
How can I find out the status of my submission in iRIS?
Who is considered a human subject?
My study was approved to enroll 45 participants. Can I enroll more than that?
Am I allowed to review PHI while preparing for a research study?
Does "Exempt" mean IRB review is not needed?
What changes can I make to my study, if any, without IRB review and approval?
How long do I have to keep my study records such as consent and HIPAA forms on file?
Am I required to keep signed consent forms and HIPAA forms in paper format or can they be maintained electronically?
How do I destroy paper documents?
What if the PI leaves the University before the record retention period lapses?
What is the OUHSC Federal Wide Assurance (FWA) number?
What is a protocol number?
For Non-English consent forms, are we required to use a certified translator for the translation of the consent form, or, can we use a translator that submits an attestation that the documents are the same?
What is the status of my submission, (New Study, Continuing Review, Protocol Modification, or Board Requested Revisions)?
Can I be granted an extension to the deadline due date for my Continuing Review (CR)?
What are the education requirements for IRB?
Where do I find IRB forms?
Is a faxed copy of the signed consent form acceptable to document informed consent?
Where can I locate Board Member Rosters?