HRPP Newsletter – November 2024
Introducing New IRB Analysts
We are excited to announce that the IRB’s Minimal Risk Research team has two new analysts joining the team in November.
Mariel White has a bachelor’s in sociology and global health from the UW-Madison, as well as a master’s in public health in epidemiology from Texas A&M University. She worked at the National Institute of Public Health in Mexico City in the Center for Nutrition and Health Research.
Dean Yu is coming to the IRB Office from the Cancer Center. He has a BS in microbiology from the UW-Madison.
We look forward to them bringing their skills and experience to the IRB Office. Welcome, Mariel and Dean!
Presentation on Enrolling Research Participants with Limited English Proficiency
12/10 from 12-1pm, online, register here
Individuals with Limited English Proficiency (LEP) are those whose limited ability to read, speak, write, or understand English interferes with effective communication in the English language. Including individuals with LEP can make your research more equitable and generalizable. Learn what’s needed to make your research accessible to LEP research participants and the resources available to help you support these participants.
Coming Soon: Guidance on Research Involving Artificial Intelligence (AI) and Machine Learning (ML) Technology
The IRB Office is in the process of finalizing new guidance and worksheets for studies involving AI and ML technologies. These new documents will assist study teams in identifying the correct application type to submit for IRB review and will include guidance on how to describe these projects so that the IRB has the information necessary to conduct their review. Please check our website periodically for updates.
Selecting the Correct Application Type
When submitting an IRB application, choosing the right application type helps to ensure a more efficient review process.
The protocol-based application (PBA) is appropriate in the following scenarios: studies involving clinical interventions; more than minimal risk studies; creation of registries and repositories; and clinical trials. See Protocol-Based Application (PBA) guidance for more detailed information.
The non-protocol-based application (nPBA) is appropriate for: exempt studies; most education and social/behavioral science studies; studies that qualify for expedited review as outlined in HRP-313; and health care record review studies. See Non-Protocol Based Application guidance for more information. When submitting an nPBA, it is not necessary to also include a standalone protocol document.
For studies in which machine learning and/or artificial intelligence (AI) is involved, one in which the machine learning algorithm and/or AI is still in the development/validation stage is likely to be appropriate for an nPBA application. Once you have progressed to later stages of development, such as deploying the algorithm/AI in a live clinical environment, a standalone protocol document submitted with a PBA may be required.
As always, if you are unsure about which application type is most appropriate for your study, please contact the IRB office.