Intelligent Authoring Tool for Informed Consent

We propose to specify, design, and prototype an intelligent authoring tool for informed consent. This limited prototype will demonstrate the feasibility of helping users create complete and accessible informed consent documents. The authoring system willprompt the user for the information required in an informed consent document. This information may contain decision biases, such as framing effects, which will automatically be detected and corrected by the authoring tool. We will use our expertise inintelligent authoring and knowledge acquisition to create this system, while relying on a diverse set of subject matter experts to assist us with domain knowledge. Jon Merz, a bioethicist, and Susan Brown, a regulatory documents specialist, will both beinvolved in this project. The end results of this Phase I effort will be a prototype authoring tool that creates informed consent documents capable of presenting risk information to the patient in a sufficiently thorough, understandable, and unbiasedmanner while still providing legal protection to the care provider, as well as the specification and design of the system to be completed in Phase II. The two main benefits for clinical medicine and medical research are a greater understanding of framingeffects in informed consent and a method of creating complete, accessible, and unbiased informed consent documents.