Spring 2022 IRB Presentations


Spring 2022 IRB presentations will be virtual, by Zoom. Please register to receive the Zoom link.

ClinicalTrials.gov: Guidelines for Reporting Results

It is not enough to just register a research study with ClinicalTrials.gov. The responsible party (PI) must also submit scientific and administrative information about the results of the trial. The person submitting results information to ClinicalTrials.gov must be very familiar with the study design and data analysis to accurately summarize the results information in compliance with federal regulations (section 801 of the Food and Drug Administration Amendments Act, FDAA 801) and the ClinicalTrials.gov review criteria.

This presentation will provide an overview of the purpose and guidelines for reporting results in ClinicalTrials.gov:

  • Overview of ClinicalTrials.gov results database
  • Purpose of results reporting
  • Steps for submitting results of a clinical trial
  • Editing and updating the record results
  • PRS support, training material, and assistance
  • ClinicalTrials.gov results information review process
Wednesday, February 9, 2022
10:00 AM - 11:00 AM
Zoom

Pre-registration is recommended.

 

Human Subjects Research Hot Topics & Updates – March 2022

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.

Wednesday, March 9, 2022
12:00 PM - 1:00 PM
Zoom

Pre-registration is recommended.

 

Single IRB Review Model for Federally Funded, Multi-Site Research

In the single IRB (sIRB) review model, one IRB oversees research at multiple study sites. The UI IRB could serve as the Lead IRB or rely on another IRB to oversee UI research activities. This presentation will provide a high-level overview of the single IRB review model, including various scenarios for when the single IRB review model could or must be used and how the roles and responsibilities of the IRB and researcher change when serving as the Lead IRB or when relying on another IRB. This session will also cover how to prepare for a grant submission that requires the use of the single IRB review model.

Tuesday, March 29, 2022
1:00 PM - 2:00 PM
Zoom

Pre-registration is recommended.

 

You Never Walk Alone: Using the Carousel Index in HawkIRB

The Carousel Index (also referred to as the application index) provides a wealth of information about the HawkIRB application including a brief description of each section, the information or materials you may need to complete each section and references to federal regulations, accreditation standards, UI policies and IRB policies that explain why the IRB asks for the kind of information we do. The Carousel Index was designed to assist with navigation in the HawkIRB application. During this presentation, we will briefly review the layout and features of the Carousel Index and provide case examples that will allow you to roll up your sleeves and learn how to get the most out of this helpful tool in HawkIRB.

Wednesday, April 27, 2022
11:00 AM - 12:00 PM
Zoom

Pre-registration is recommended.