In this toolkit, the Sage Governance Team presents a summary of state/territory-specific requirements we have complied for informed consent processes for research for the 50 US states, 5 inhabited territories, and District of Columbia. We also provide example informed consent templates that can be customized for studies across the United States. These resources are available for use in any context, by any user, for any purpose, as long as attribution is provided back to Sage Bionetworks.
Tools, Templates, and other Resources
Developing a Transparent, Participant-Navigated Electronic Informed Consent for Mobile-Mediated Research
Sage Bionetworks has developed a novel multi-media approach to addressing transparency and comprehension within electronic informed consent (eConsent) for app-mediated research studies. We deployed this eConsent process in minimal-risk research studies. Here we describe the rationale for the framework selected and best practice for application of the framework in other clinical studies.
The goal of the PCC toolkit is to transform the concept of consent from a signature on a legal form to a process that educates, and to allow as many people as possible to engage in consented studies. The PCC toolkit is openly licensed and may be used in any context, by any user, for any purpose, as long as attribution is provided back to Sage Bionetworks.