The Office of the VP for Research and the Human Subjects Office launched the IRB Efficiency Initiative to streamline the IRB review process. Attend monthly information sessions on the fourth Wednesdays of the month, 12-1 pm, via Zoom, for:

• Demonstrations of upcoming HawkIRB enhancements
• Updates about expected roll out dates
• Other IRB-related announcements and discussion

Pre-registration is recommended. Select the date to register.

The Roadmap to Regulatory Compliance: Guidelines for ClinicalTrials.gov Registration & Results Reporting 

Wednesday, September 18, 2024

12:00-1:00 PM

Zoom

This presentation will clarify the key aspects of ClinicalTrials.gov registration and results reporting, with an overview of guidelines and practical tips to avoid common errors that researchers encounter during this process. By the end of this presentation, participants will have a clear understanding of how to meet the Food and Drug Administration Amendments Act (FDAAA 801) standards and ClinicalTrials.gov requirements, ensuring successful trial registration and reporting.

• Overview of the ClinicalTrials.gov database
• Which trials need registration & results reporting?
• How to Register a study, Report Results, and Update Records
• Common errors during registration, and results reporting, and how to avoid them
• Navigating the PRS Support System and Help content
• Overview of ClinicalTrials.gov PRS Beta website

Conducting Research Involving Student Records: How to Ensure Compliance 

Wednesday, October 9, 2024

12:00-1:00 PM

Zoom

Accessing student records for research purposes requires compliance with multiple laws, regulations, and policies.  Ensuring compliance is a collaborative effort between several University of Iowa departments.

In this presentation, members of the Human Subjects Office, Office of the General Counsel, and the Office of the Registrar will discuss policies and guidance that researchers must follow to conduct this type of research.  We will also describe procedures for obtaining study approval, recruiting students, and obtaining and documenting informed consent.

Reportable Events Decision Tree

Wednesday, October 16, 2024

12:00-1:00 PM

Zoom

This new tool, created in collaboration with staff from the Institute for Clinical and Translational Science (ICTS), will help investigators and research teams identify events that require reporting to the IRB and select the correct category in the Reportable Event Form (REF) in HawkIRB. This lecture will cover:

• Categories of reportable events
• Orientation to the Reportable Event Decision Tree
• Guidance about UI IRB reporting requirements
• Answers to your questions about reportable events