Institutional Review Board

1. Institutional Review Board “IRB Snapshot”

2. IRB Team • Annabelle Casas—Institutional Coordinator for Research Review (extension 7939) • Irene Holguin—Grants and Contracts Specialist (extension 8683) • Cecy DeSantiago—Administrative Assistant (extension 5401) • IRB Administrator—vacant • irb.orsp@utep.edu

3. Key Personnel • Christian Meissner, PhD, IRB Chairman • Tony Woo, MS, Assistant VP Research & Technology Transfer • Roberto Osegueda, PhD, VP Research • Diana Natalicio, PhD, President

4. 1. What is the IRB? • The Institutional Review Board (IRB) is: • a committee representing various research disciplines • oversees all research involving human subjects conducted by faculty, students, or staff who might use any University property or non-public information to contact human research subjects.

5. 2. Why is the IRB important? • Federal law (45 CFR 46) and the Assurance document signed by Universities and the Office for Human Research Protections (OHRP) require that an IRB be established to review all studies involving human subjects (both funded and unfunded protocols). • Failure to comply with these regulations could lead to a suspension of all university research activities involving human subjects and a loss of federal funding.

6. What does the IRB do? • Reviews • Approves • Disapproves • Suspends • Modifies • Terminates

7. 3. Do I need to submit my study to the IRB? • Is it research? • Does it involve human subjects? • Does it involve intervention or interaction? • Does it involve private information or identifiable information? • Does it meet the definition set forth by DHHS as common rule? If you answered yes, then you will need IRB approval to proceed. If still unsure, contact the IRB office for further assistance.

8. 4. Where do I start? • UTEP IRB Training • Institutional Compliance Office (915) 747-6478 complianceoffice@utep.edu 20001--IRB, Human Subject Research, & Ethics • Register on www.irbnet.org

9. 5. Review Processes • Exemption (IRB Chair) • Zero to Minimal Risk • Expedited (2 Reviewers) • Minimal Risk • Full Review (Full Board) • High Risk

10. 6. What do I need to submit? • Electronic IRB Application Form #IRB-017 • Consent form # IRB-012 (if applicable) • Exempt Request Form #IRB-009 (if applicable) • Tools: Surveys, Questionnaires, Recruitment material, etc

11. 7. Common Mistakes • Submitting a protocol: Expedite vs. Exempt • Revising the protocol on irbnet.org • Unlock and lock feature • Protocols are submitted with the incorrect/old forms (Forms) • Incorrect Contact Information: • UTEP’s Institutional Review Board Tel: (915) 747-8841 Email: irb.orsp@utep.edu • All principal investigators and advisors need to e-sign protocol • Provide proof of IRB training

12. Helpful Tips • Energizers provide helpful information pertaining to irbnet.org. • Average turnaround time on protocols submitted are two weeks. • Submit with plenty of time

13. Questions?