September IRB Insights 

The September IRB Insights presentation provides researchers with important updates on University of Iowa policies on the use of artificial intelligence (AI) in research, institutional data security expectations, research team management, clinical trial reporting requirements, and changes to the IRB application process. 

Responsible Use of AI in Research

The University of Iowa has policies governing the use of AI in research. These institutional policies apply regardless of the type of research, or the IRB of record. Researchers are encouraged to consult University of Iowa Information Technology resources to review institutional guidance regarding approved and prohibited technologies. AI tools not previously licensed or approved for use at the UI, will require institutional review and\or approval before use. 

Participants should be appropriately informed through the informed consent process, if AI is used in any part of the research. This is particularly true when the technology could affect how data are collected, analyzed, stored, shared, or used.

While AI can improve efficiency and save time, researchers remain responsible for verifying outputs, ensuring accuracy, and overseeing decision-making. AI-generated content should not be accepted without appropriate human review and validation. 

Data Security and Privacy Considerations

The presentation highlights the University's data classification framework and how it applies to AI technologies. AI platforms may not be appropriate for use with data defined as University Internal or restricted, critical data. When working with research information, particularly identifiable or protected health information, investigators must ensure that the selected AI tool is authorized by the institution for use with the relevant data classification level. 

Special caution is advised when handling patient information. Entering protected health information or other sensitive research data into unapproved AI platforms could result in security incidents or privacy breaches. When in doubt, consult with Information Technology Services or Research Computing whenever questions arise regarding the suitability of an AI product. 

Sponsor requirements, funding agreements, and contractual obligations may restrict or regulate the use of AI within a research project. Investigators are strongly encouraged to review these requirements carefully before implementing AI-assisted procedures. 

UI ITS resources cited from this presentation include:

• AI Guidelines and Use Cases
• Using Artificial Intelligence (AI) Tools in Research
• AI Tools
• Data Classification Guidelines (requires UI Hawk ID and password to access)

Deactivating Research Team Members

New automated prompts in HawkIRB help investigators identify team members whose institutional appointments may have changed or ended. These updates assist study teams in accurately identifying University of Iowa faculty, staff, or students involved in research activities in the HawkIRB application. 

This process also supports researchers in appropriately documenting external collaborators, consultants, or individuals affiliated with organizations outside the institution. Investigators may need to update study records and modify team listings to ensure compliance with IRB requirements. The HSO website has additional information on what to do if you have a deactivated team member. Additional information can also be found on conducting research with non-UI team members. 

ClinicalTrials.gov and Results Reporting Changes

Investigators will see additional questions and acknowledgments within the HawkIRB system when modifications involve changes that could affect clinicaltrials.gov registration information. Examples include updates to study procedures, study leadership, or other protocol changes that may require corresponding updates in public reporting systems. These changes are intended to improve consistency between IRB records and clinicaltrials.gov reporting requirements. 

Upcoming HawkIRB Application Enhancements

The presentation also highlights upcoming updates to HawkIRB. The changes are to the bulk of the remaining HawkIRB sections and are designed to streamline submissions, improve data collection, and help researchers provide more complete information. 

Anticipated updates include:

• Enhanced questions related to study populations and vulnerable populations.
• Improved options for describing subject characteristics and recruitment considerations.
• Additional guidance for studies involving greater-than-minimal-risk procedures.
• New prompts to help investigators identify changes that may impact participant-facing materials or require updated consent information.
• Increased use of structured fields and checkboxes in place of free-text responses to improve consistency and reporting. 

Some updates will include new explanatory text and reminders to help researchers understand expectations and submit more complete applications the first time. 

These changes reflect the institution's continuing effort to support innovative research while maintaining high standards for human subjects protection, data security, and regulatory compliance.

Click here to view the recording.