IRB Frequently Asked Questions

What Activities Need IRB Approval?

Does my study need IRB review?
What exactly qualifies as human subjects research?
Does secondary analysis of a data set gathered for another purpose require a new research project for review?
When do oral histories qualify as human subjects research?
I am conducting human subjects research Off-Site (at a non-UCI location). What are the requirements?
I have submitted a self-determination (for Non-Human Subjects Research or Self-Exemption). Will I get a confirmation email / letter from the IRB of NHSR or Self-Exempt?
I have an existing self-determination that I completed on paper (pre-KRP and pre-ZOT IRB). Do I need to resubmit this form in ZOT IRB?

IRB Application and Submission

How long is the IRB Turnaround time? How can I check the status of my submission?
What is ZOT IRB?
What is my IRB Number for a new study?
How do I respond to questions in the Protocol Narrative / PI Worksheet?
How do I know which PI Worksheet(s) I need?
Why is Department or Organized Lead Unit (OLU) Review Needed?
What is a Master Protocol or Detailed Project Proposal?
Who needs to be listed on the Study Team in the IRB Protocol? (RP Heat Map)
What is the Recruitment Material Master Template?
Do changes to the Recruitment Material Master Template require IRB approval?
Why am I not receiving email notifications for my study from ZOT IRB?
When do I need letters of permission for my research?
What software can be used to collect identifiable information?
What are Protection Levels (P1, P2, P3, and P4)?

CITI Training Questions

Why is my CITI completion not showing up in the UCI IRB application?
I've forgotten my UCINetID password. How can I find out what it is?
I don't have a CITI Account, but do have a UCInetID. How do I access CITI?
I have a CITI Account, but it's from another institution. What do I do?
I don't have a CITI Account and I don't have a UCInetID. How do I access CITI?
What CITI courses are required at UCI?
How can I find out which tutorials I've taken? How can I verify my study team has completed the required tutorials?
What if I fail to complete a Refresher Course by my expiration date?

Informed Consent Questions

Who needs to be listed on the informed consent document?
Who can consent on behalf of a subject for participation in a research study?
Is an English consent document okay to use when enrolling non-English-speaking subjects?
Who must sign the consent form?
Is informed consent required even if the data/specimens will be collected from my friends and colleagues?
Can I have my research coordinator or clinic manager respond to requests from the IRB on my behalf?

Prisoners in Research (Guidance from OHRP)

Does Subpart C apply only where the research targets prisoners as subjects?
What should an investigator do if a subject becomes a prisoner after enrollment in research?
What should be done when a subject becomes a prisoner after enrollment in a study which was not reviewed and approved by the IRB in accordance with the requirements of subpart C?
Is an adolescent (e.g., age 14) detained in a juvenile detention facility a prisoner?
Can research involving prisoners be Expedited?
Do the exemptions apply to research involving prisoners?

Post IRB Approval Questions

Can I share my IRB protocol approval with colleagues working on similar projects?
How do I submit changes to a currently approved protocol?
When should I submit a closing report to the IRB?
The Word version of the consent form in ZOT IRB has Tracked Changes. Where is the clean Word version?