Introduction
As technology advances, it brings the capacity to enhance and streamline study start-up, through multiple avenues. It is critical to balance technology enhancements with human verification to ensure quality and accuracy.
Use of AI within WCG’s IRB
One of the recent artificial intelligence (AI) add-ons available at WCG’s IRB is Microsoft Copilot. This is a feature that can be used within some Microsoft products, including Microsoft Word. Within Word, Copilot has several features that can be used to obtain information about a document including the use of prompts to search within and to answer questions about the document’s content.
Recently, WCG’s IRB explored leveraging Copilot to create concise summaries in consent documents that originally lacked them—specifically for clients who are aligned with the use of AI.
Concise Summary
Under 45 CFR 46.116, informed consent must begin with a concise and focused presentation of key information that is likely to inform a subject’s decision of whether they want to participate in the research. The FDA does not have matching regulations. However, WCG’s policy is to require a Key Information Summary in all new consent forms regardless of funding. To add one when not originally submitted required substantial effort. Now, WCG’s IRB can utilize Copilot to accelerate the process and ultimately reduce timelines. Importantly, WCG is committed to working with clients to understand unique needs and will adjust processes as agreed upon.
Framework and Prompt Creation
Additionally, WCG’s IRB developed a framework to teach Copilot what elements we consider essential in a concise summary. This framework consists of section titles, template language, and ends with a curved bracket. Next, we created a prompt outlining directions, formatting, and the instruction to insert applicable language from the body of the consent form into the curved bracket. With a consent form open, the prompt and the template language are pasted into Copilot. Below is an example:
Fill in the placeholders {} with content from the document provided. Ensure that no {} remain in your response. Do not include bullets or {} in your response. Add titles above each paragraph. Keep the source formatting consistent. Add clear, bolded titles above each paragraph to enhance readability. Maintain the original font and spacing from the source document. When describing risks and benefits, be specific but keep explanations concise and understandable. Proofread the prompt to correct any typos or grammatical issues.
How long will I be in this research?
We expect that your taking part in this research will last {}.
Why is this research being done?
The purpose of this research is to {}.
What happens to me if I agree to take part in this research?
If you decide to take part in this research study, the general procedures include {}.
Could being in this research hurt me?
The most important risks or discomforts that you may expect from taking part in this research include {}.
Will being in this research benefit me?
The most important benefits that you may expect from taking part in this research include {}.
What other choices do I have besides taking part in this research?
Instead of being in this research, your choices may include {}.
The suggested text is then displayed by Copilot in a separate window. The reviewer can request modifications to the text prior to inserting the finished product into the consent form.
AI Hallucinations
To determine if the AI summary is correct and does not contain hallucinations, Copilot’s summary contains citations for easy verification. By clicking on the citation, the reviewer is taken directly to the source language in the consent form and can evaluate the accuracy of the summary to confirm it is complete and accurate. While Copilot provides citations to the area of the consent form the information was pulled from, it may not pull all the necessary information or may combine the information together in a confusing way. The reviewer must determine when the summary is complete, after checking for accuracy and quality.
Conclusion
Compared to the time it took to manually create concise summaries, this AI enhancement accelerates review timelines substantially without sacrificing an expert review of the final consent form. It is also just one way this technology can be used to develop information for research purposes. WCG’s IRB continues to leverage AI in new, innovative capacities to ultimately advance research. Importantly, we do so in close collaboration with our partners, ensuring alignment with the use of AI-enabled tools. Together, we remain committed to improving patients’ lives.
If you have ethical or regulatory questions or need support with your IRB reviews, WCG’s IRB team is here to help. As the first AAHRPP-accredited central IRB, WCG has a proven track record of reviewing studies for 55+ years. Contact us today for streamlined processes that never comprise ethical standards.
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