Although much attention has been given to the challenge of providing research volunteers with adequate information to make informed choices, major problems in most consent documents remain. They are frequently written at levels beyond volunteers' ability to comprehend, they are missing key information, or they present information in ways that invite what some researchers have called the therapeutic misconception. HIV research, especially vaccine and treatment Phase I and II clinical trials, where the likelihood of effective treatment is low, are subject to these problems. This proposal describes our plans to extend the iMIC consent authoring system to cover consent issues specific to HIV-related research. The work plan includes preparing a conceptual model describing the breadth of HIV research. This model will be used to identify research studies that can be integrated into a Content Library of example consent issues. In the consent authoring process, a """"""""wizard"""""""" program draws example content from the Library to create a tailored, template document that closely matches the needs of the study. After template content is edited, the software produces three documents: a paper consent form to document the volunteer's consent and provide a reference for the study, an annotated paper consent form that includes information to facilitate IRB review of the form, and an interactive computer tutorial to educate volunteers about the trial. We will conduct a validation study that compares iMIC-HIV consent documents to currently used consent documents, with outcome measures that include subjects' preference and research study knowledge acquisition.
