Novermber/December 2021 IRB presentations will be virtual, by Zoom. Please register to receive the Zoom link.
Using the eMRPC Form for Human Subjects Trials Involving Radiation
In 2020, the Medical Radiation Protection Committee rolled out an electronic application system, called eMRPC, that is linked to the HawkIRB system. Representatives from MRPC will give this presentation in a computer lab to provide hands-on experience with eMRPC for research that includes radiation exposure to subjects. We will review the form, section by section, explaining the proper way to answer each question, obtain subject dose estimates, and avoid common pitfalls.
|Wednesday, September 22, 2021
11:30 AM - 12:30 PM
Information Commons East, 216 HLHS/Zoom
Research Billing Compliance: Ensuring a Smooth Road to Success for Your Study
Researchers submitting a New Project application in HawkIRB must obtain a number of Other Committee reviews along with IRB review, depending on the type of research they’re proposing. One of those Other Committees is Research Billing Compliance (RBC), whose purpose is to help ensure charges for clinical trial services at UI Health Care are billed in compliance with applicable regulations and policies, and to provide a centralized research billing process. Non-compliant billing can lead to serious consequences, including large fines, damage to the institution’s reputation, and even criminal penalties.
In this presentation, Denise Krutzfeldt, Compliance Associate Director, will provide guidance on how to obtain RBC approval as quickly as possible AND avoid inappropriate billing of research services to subjects or their insurance providers.
|Wednesday, September 29, 2021
10:00 AM - 11:00 AM
Conference Room C44A GH/Zoom
Human Subjects Research Hot Topics & Updates - October 2021
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.
- 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 Hot Topics for this month include:
- Data Governance Committee – requests to share data outside UIHC
- PI leaving the UI and taking data with them – PI Departure Checklists
- IRB Educational Tools
- Exempt Application Form – programming updates and upcoming presentations and trainings
|Monday, October 11, 2021
12:00 PM - 1:00 PM
ClinicalTrials.gov PRS: A Roadmap to the Regulations for Clinicaltrials.Gov Registration and Results Reporting
Researchers conducting clinical trials must comply with many rules and regulations. One of them is the requirement to register and report the results of an applicable clinical trials (ACT) in the ClinicalTrials.gov Protocol Registration and Results System (PRS). Researchers can also register clinical trials even if the clinical trial does not meet the definition of an applicable clinical trial.
This presentation will provide a roadmap for registration and results reporting to ClinicalTrials.gov:
- Purpose of registration and results reporting
- Record Basics - Steps to Posting a new Study Record on ClinicalTrials.gov
- Requirements for reporting results
- Consequences for non-compliance
- HawkIRB – Push to PRS feature
- PRS support, training, and assistance
NOTE: This is the same presentation as the September 2, 2021, ICTS Clinical Lecture Series.
|Tuesday, October 12, 2021
1:00 PM - 2:00 PM
Rembolt Conference Room, 115 CDD/Zoom
Announcing Improvements to Exempt HawkIRB Applications
Human Subjects Office (HSO) and Institutional Review Board (IRB) leadership have been working on a major update to the HawkIRB system for projects that qualify for Exempt Status. The revised Common Rule that took effect in 2019 included significant revisions to the categories of exempt research. These revisions to the HawkIRB application will allow UI researchers and the IRB to take full advantage of these exemptions to the federal regulations for human subjects research.
This presentation will:
- Review the exempt categories of research
- Provide a high-level overview of the changes in HawkIRB
- Highlight resources available for UI researchers
|Wednesday, November 3, 2021
1:00 PM - 2:00 PM
|Wednesday, November 10, 2021
9:30 AM - 10:30 AM