Single IRB Review Model and New Regulations for Federally Funded, Multi-site Research
This presentation will provide a high-level overview of the single IRB review model, including:
- How to prepare for a grant requiring a single IRB of record submission
- Various possibilities for using an external or single IRB model
- The UI IRB serving as the IRB of record OR relying on another IRB
- How your roles and responsibilities change when using a single IRB
- New! Effective January 20, 2020, the Federal Regulations for the Protection of Human Subjects (45 CFR 46) require use of a Single IRB for all federally funded research
|Thursday, February 13, 2020
12:00 PM - 1:00 PM
Braley Auditorium, 01136 Pomerantz Family Pavilion, UIHC
To Participate or Not to Participate…What is ‘Key Information’ Anyway?
The revised Common Rule included a new requirement for researchers to provide a concise and focused summary of key information about the study to potential subjects prior to presenting the full Informed Consent Document. This presentation will explore the regulatory requirement, including the justification for this change and how to determine what to include as key information based on the study and the subject population. Attendees will consider the subject perspective as they draft a key information summary for a fictitious study protocol. Attendees will be able to apply the content of the presentation to assist them in writing clear and concise summaries of key information for their own research studies.
|Thursday, March 26, 2020
1:00 PM - 2:30 PM
Seebohm Conference Room, 283 EMRB
Researchers Coming & Going: New Faculty Survey and PI Departure Checklists
This presentation provides guidance for what new faculty & staff researchers should do when they arrive and a checklist they should complete before their time at the UI comes to an end. This presentation will be especially useful for departmental administrators and those who work with faculty, staff and student/trainee researchers when they arrive on campus and when they leave the UI.
Coming to the UI: The New Faculty/Staff Researcher Survey is a collaborative effort among the Research Administration and Compliance Departments and other entities that work with UI researchers. After a researcher completes the survey to describe their planned research activities (human, animal or bench science), representatives from these offices provide guidance for getting started with conducting research at the UI.
Leaving the UI: At the end of their employment/education, there are PI Departure Checklists to make sure researchers complete all of the required actions before they leave the UI. There are separate checklists to complete based on whether there was funding for the research project.
|Monday, April 6, 2020
1:00 PM - 2:00 PM
Herky Room (#343), Iowa Memorial Union
|Friday, April 17, 2020
10:00 AM - 11:00 AM
Ziffren Conference Room (JCP 1502), Colloton Pavilion, UIHC
Top Monitoring Findings
The University of Iowa Compliance and Education department regularly monitors studies to educate investigators and research teams about their responsibilities after IRB approval. This presentation will cover the various types of monitoring visits, expectations of the researcher(s), along with common findings and outcomes found at a monitoring visit. These common findings should be helpful to researchers so they can avoid common errors and hopefully prevent frustration. This presentation should provide insight and education into why we do monitoring visits.
|Monday, April 20, 2020
10:30 AM - 11:30 AM
2520 D, University Capitol Center
|Wednesday, April 29, 2020
2:00 PM - 3:00 PM
Rembolt Conference Room, Center for Disabilities & Development
Behind the Scenes with the IRB
Have you ever wondered what sections in the HawkIRB application generate the most workflow questions? Do you want to know what to fix when initially submitting HawkIRB New Project forms to help your application go through the IRB review process more smoothly? This advanced IRB presentation will focus on the most common workflow issues from the past three years and provide guidance about how to avoid these issues in your HawkIRB forms. This presentation will also include:
- A brief refresher of the ethical principles for the conduct of human subjects research
- The regulatory criteria for IRB approval
- Tools available in the HawkIRB Index that explain what you need to know to complete each section and why the IRB needs this information, and
- A behind the scenes look at the IRB review process and types of IRB review.
This presentation topic was suggested by a member of the UI research community. Have a suggestion for a presentation? Let us know! Send an email to firstname.lastname@example.org.
|Friday, May 15, 2020
9:30 AM - 10:30 AM
Herky Room (#343), Iowa Memorial Union
|Tuesday, May 19, 2020
1:30 PM - 2:30 PM
HP Smith Conference Room, W256, General Hospital, UIHC