Everything you need to get started with the IRB process
Registering with the IRB
IRB Initial Submission Process
IRB Continuing Review Process
- Continuing review is a way of reporting your studies’ status and progress to the IRB. It should be completed annually unless the IRB states otherwise. If a continuing review is not completed by the study expiration date approval will be lapsed, and all research activities must stop.
- Submission Deadlines for 2013 and 2014
- Helpful Tutorials:
IRB Adverse Event Reporting Process
- Adverse event: An undesirable and unintended, although not necessarily unexpected, result arising during the course of a research protocol.
- Reporting criteria: This criterion applies to all adverse events that occur at THR or at another study site.
- Adverse events that are serious, unexpected, and are related, probably related, or possibly related to the study intervention must be reported within 5 working days of the investigator becoming aware of the event.
- Adverse events that are serious or unexpected, and are related, probably related, or possibly related to the study intervention must be reported within 10 working days of the investigator becoming aware of the event.
- Helpful Tutorial:
IRB Protocol Amendment Process
- Amendments are proposed changes to an already approved protocol.
- Amendment examples include, but are not limited to:
- Changes to the protocol
- Changes to the consent form
- Changes to surveys/ questionnaires
- Changes to recruiting materials
- Addition or removal of a stipend
- Changes in study personnel
- Updated investigator's brochure
- Changes in conflict of interest
- Changes to the sample size
- Addition or deletion of sites
- Changes to inclusion/ exclusion criteria
- Revision to data and safety monitoring plan
- Requesting additional funding
- Other changes as determined by the IRB
- Helpful Tutorial:
Texas Health Resources IRB Office
612 E. Lamar Blvd., Suite 1212
Arlington, TX 76011
(Click here for directions.)
Director of Research Compliance
Tanya Poe, CIP
Monitoring & Audits
Education & Training
Adrienne Charlot, MSPH, CCRP
Erik Soliz (Tarrant County)
Daniel Gonzalez (Dallas County)
IRB Administrative Assistant