Improving Understanding of Clinical Research Studies: An Experimental Study to Compare Two Simple Informed Consent Strategies to Traditional Informed Consent in the Context of Ongoing, Real Clinical Studies

Informed Consent remains too long and complex. Proposed changes to federal regulations-and bioethics literature suggest consent forms should be shorter and simpler, yet simple, adaptable, evidence-based approaches are unavailable. Bioethics and research oversight leaders will collaborate to test two simplified, easily reproducible consent approaches: a bulleted fact sheet and a video interview between a Principal Investigator and patient. Both emphasize key information, in discrete chunks, using lay language. Patients considering enrollment in any of five ongoing Johns Hopkins University clinical studies will be randomized to one of these simplified approaches or standard consent to see which achieves better understanding and/or satisfaction.