The Informed Consent Process in Biomedical Research Made Easier with AI Chatbot
The informed consent process in biomedical research can be challenging for those who cannot meet with clinical study staff during working hours. However, a recent study presented by Professor Eric Vilain at the European Society of Human Genetics conference introduces a solution that promotes inclusivity and efficiency. Through the use of a chatbot called GIA (Genetics Information Assistant), developed by Invitae Corporation, the consent process becomes more accessible and yields faster completion rates with high levels of understanding.
To streamline the consent process, Prof Vilain’s team collaborated with their institutional review board (IRB) to design a script for the GIA chatbot. This chatbot transformed the trial consent form and protocol into a logical flow and script. Unlike traditional methods, the chatbot was able to assess participants’ knowledge by asking them questions. It also provided flexibility by allowing individuals to access it at any time, even outside normal business hours. Prof Vilain highlights the significance of this feature: “We saw that more than half of our participants interacted with the bot during non-business hours, indicating that it reduces barriers to research entry. Many potential participants may have limited free time and lack knowledge about ongoing studies.”
The study involved 72 families participating in the consent process as part of the GREGoR consortium, a National Institutes of Health initiative for rare disease research. Out of the total families, 37 completed consent using the traditional process, while 35 utilized the chatbot. The results indicated several advantages of using the chatbot. The median length of the consent process was significantly shorter for chatbot users (44 minutes compared to 76 minutes). Moreover, the time from referral to consent completion was faster for chatbot users (five days versus 16 days). The chatbot users also displayed a high level of understanding, with 96% passing a 10-question quiz. Feedback from participants revealed that 86% had a positive experience.
“I was pleasantly surprised to see that a significant number of people felt comfortable communicating with a chatbot,” said Prof Vilain. “We took extensive measures to ensure accurate knowledge transmission and minimize errors. When the chatbot couldn’t answer a question, it prompted the participant to speak with a member of our study team.”
Apart from the time savings achieved through the chatbot’s flexible nature, cost savings were also anticipated. Chatbot users could pause the consent process at any time, enabling quicker completion rates. For instance, four participants completed the process within 24 hours. Additionally, results showed that 83% of quick consent conversations (under an hour) were handled by the chatbot, while longer conversations (between one and two hours) involved a study staff member (66%).
However, speed is not the only advantage of the chatbot. Unlike traditional methods, it objectively tests comprehension. Traditional methods rely on the study staff member’s belief that the consent has been properly understood. In contrast, the chat-based method ensures users demonstrate understanding before providing consent. If there is a lack of comprehension, participants are connected with a genetic counselor to address the issue.
Prof Vilain concludes, “Our work contributes significantly to obtaining properly-informed consent, and we hope to see it utilized in different languages to reach global populations.”
Professor Alexandre Reymond, the conference chair, emphasizes the importance of ensuring informed consent is truly informed and advocates exploring all possibilities to achieve this in the future.