Spotlight

IRB Submission 101

Confused about Human Subjects rules and humanities research? Laverne Estañol, Assistant Director, Human Research Protections, provided explanations, tips and resources at her May 10 presentation in the Humanities Commons. We've compiled the essentials here.

A human subject is defined as a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information about whom includes a subject's opinion on a given topic.

If you are interviewing or otherwise engaging live people in your research, follow these easy steps to determine if your research falls under Human Subjects Protections.

Step 1: Download and complete the Request for Determination of Non Human Subject Research - sign and submit to the UCI IRB office.

**If the IRB office determines that Human Subjects Protections do NOT apply to your research, keep the signed form on file and conduct your research.

Step 2: If the IRB office determines that Human Subjects Protections DO apply to your research, refer to instructions for the category that applies per IRB.

2A: Project qualifies for Exempt Self-Determination
Description and process:  https://www.research.uci.edu/compliance/human-research-protections/researchers/how-to-submit-electronic-irb-applications-for-review.html#Exempt

2B: Project qualifies for Exempt Category research:
Description:  https://www.research.uci.edu/compliance/human-research-protections/researchers/levels-of-review.html#Exempt
Process:  https://www.research.uci.edu/compliance/human-research-protections/researchers/how-to-submit-electronic-irb-applications-for-review.html#Exempt

2C: Project qualifies for Expedited Category research:
Description:  https://www.research.uci.edu/compliance/human-research-protections/researchers/levels-of-review.html#Expedited
Process:  https://www.research.uci.edu/compliance/human-research-protections/researchers/how-to-submit-electronic-irb-applications-for-review.html#Expedited

2D: Project qualifies for Full Committee Review:
Description:  https://www.research.uci.edu/compliance/human-research-protections/researchers/levels-of-review.html#Full
Process:  https://www.research.uci.edu/compliance/human-research-protections/researchers/how-to-submit-electronic-irb-applications-for-review.html#Full

Step 3: Complete and submit the appropriate proposal narrative for exempt or for expedited.

**Once you have received IRB approval, conduct your research.

UCI Human Research Protections website

Still have questions?
  • Download the IRB Submission 101 slides here.
  • Contact Laverne Estañol at lestanol@uci.edu.
  • Check out the Research Protections FAQ.