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.
|Wednesday, September 16, 2020
10:00 AM - 11:00 AM
Providing Key Information to Potential Subjects
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 interactive 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.
|Monday, September 28, 2020
2:00 PM - 3:30 PM
Behind the Scenes: An Advanced IRB Overview
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.
|Thursday, October 15, 2020
2:00 PM - 3:00 PM
Researchers Coming & Going: New Faculty Survey and PI Departure Checklists
Representatives from the Human Subjects Office (HSO) and the Division of Sponsored Programs (DSP) will provide guidance for new and departing faculty & staff researchers. This presentation will be especially useful for departmental administrators and those who work directly with faculty, staff and student/trainee researchers.
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. When a researcher completes the survey to describe their planned research activities (human, animal or bench science), representatives from these offices provide guidance for conducting research at the UI. The HSO offers an IRB Orientation Session for all new faculty who plan to conduct human subjects research.
Leaving the UI: The PI Departure Checklists help researchers complete all required actions before they leave the UI. There are separate checklists based on whether there was internal, external or no funding for the project.
|Monday, November 16, 2020
2:00 PM - 3:00 PM