Fall 2023 IRB presentations will be virtual, by Zoom. Please register to receive the Zoom link.
Unlocking the Mystery of IRB Compliance Monitoring
The UI IRB Compliance Monitoring Program conducts a variety of types of visits. Any open project could be selected for monitoring. This presentation will take the mystery out of the compliance monitoring process and provide guidance for how to make the most of the visit. We want you to feel prepared and confident when you receive notification that your study was selected for IRB compliance monitoring.
This presentation will review:
- Types of compliance monitoring visits
- How and why studies are selected for monitoring
- Common compliance monitoring findings and how to avoid them
| Wednesday, September 13, 2023 12:00 PM - 1:00 PM Zoom |
Pre-registration is recommended.
Expanded Access to Investigational Medical Products
There are several names for research activities where an individual or small number of patients with serious or life-threatening disease can receive an investigational product when they cannot participate in a clinical trial. This research is typically initiated by the clinician and is referred to as:
- Expanded Access
- Emergency Use
- Compassionate Use
- Single Patient IND (Investigational New Drug)
This presentation will cover the variations in these approaches, the Food and Drug Administration (FDA) regulations, and the institutional policies and procedures for preparing a HawkIRB application and obtaining IRB approval.
| Wednesday, September 20, 2023 12:00 PM - 1:00 PM Zoom |
Pre-registration is recommended.
Human Subjects Research Hot Topics & Updates – October 2023
Learn about new initiatives, HawkIRB enhancements (rolled out or in-production) and important information/reminders from the Institutional Review Board (IRB) and the UI Human Research Protection Program (HRPP). To supplement the information provided in the monthly IRB Connection Newsletter, the Human Subjects Office (HSO) offers these presentations at least three times a year to disseminate information in a timely manner and to be transparent about current projects and initiatives. Attendees will gain knowledge and resources necessary to design research projects, prepare thorough HawkIRB applications and effectively oversee the conduct of human subjects research.
Target audience:
- Principal Investigators (PIs)
- Faculty Advisors for student PIs
- Study Coordinators
- IRB Liaisons
- Departmental Research Administrators
- Others involved in human subjects research administration or oversight
The topics will be announced closer to the date of the presentation.
| Monday, October 9, 2023 12:00 PM - 1:00 PM Zoom |
Pre-registration is recommended.
Sticky Issues: Web-Based Data Collection for Human Subjects Research
All research must comply with the same federal regulations and institutional policies. But there are some unique considerations when conducting research using web-based data collection platforms. This lecture will explore:
- IRB and UI ITS approval requirements for web-based data collection
- Best practices for study activities – compared to in-person research
- Privacy and confidentiality protections
- Unique considerations for some platform options.
| Wednesday, November 29, 2023 12:00 PM - 1:00 PM Zoom |
