Development Of An Online Approach To Informed Consent

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DESCRIPTION (provided by applicant): In this Phase II SBIR, HealthMark Multimedia proposes to evaluate the use of the prototype multimedia online informed consent process developed in Phase I with a cancer clinical trial and to further refine the processes needed to aid an investigator in using an online consent process to augment face-to-face interactions with patients. HealthMark Multimedia staff will work with the clinical trial staff to identify key educational elements needed in the consent. HealthMark Multimedia will then develop a multimedia online consent for the trial that features education and decision tools in Spanish and English. After the clinical trial has completed enrollment, key informants at the cancer center will be interviewed to discuss organizational and personal barriers to adoption of this type of consent. Concurrently with the evaluation of use of the online consent process, HealthMark Multimedia will develop the back office system for managing the development of the multimedia consent process, including templates for uploading consent information and data collection, options for multimedia and options for communicating with clinical trial staff (e.g., email). The evaluation and key informant interviews will inform the final business processes for development of an online informed consent process for an individual trial.