The CCOS Communications Team interviewed researchers at the 2023 CTSA Fall Program Annual Meeting poster session last month as part of a series to feature ongoing projects across the CTSA hubs. In this article, we’re featuring Shahana Chumki, Ph.D., an Administrative Fellow from the University of Michigan who presented her work on enhancing Informed Consent Documents (ICDs) with GPT4.
Research Question
Informed consent is an essential component of human research and is necessary to uphold participant autonomy. The Key Information (KI) section of ICDs offers critical information needed to help individuals make knowledgeable and well thought out decisions about study participation. Lack of standardization of KI sections can result in inefficiencies during Institutional Review Board (IRB) reviews and readability issues for participants. Dr. Chumki and her team aimed to lessen challenges in interpretation and application of the KI section within ICDs.
Research Plan
To address these challenges, the team conducted a pilot project that utilizes GPT4 to generate KI sections from IRB-approved, study-specific ICDs and pre-approved IRB template language. The GPT4 output underwent a four-phase evaluation plan that assessed factual correctness, clarity, readability, and compliance to the IRB template language.
Next Steps
The team will integrate the optimal GPT4 instructions and inputs into a user-friendly, web-based interface to be piloted with selected researchers. Next, researchers will review the GPT4-generated KI section for factual correctness. Finally, the KI sections will undergo a “blinded” review by an IRB board to assess factual correctness, clarity, and adherence to the required reading levels.
Reflection with the Researcher: What real-world benefits do you envision might come from work like this, and how would patients or community members benefit?
Dr. Chumki sees Chat GPT4 as a promising tool that may help uphold autonomy and increase accessibility so that individuals can make informed decisions about their participation in clinical trials.
