Developing informed content requires a lot of back and forth communication between multiple stakeholders. The newly released joint FDA and OHRP electronic Informed Consent (eConsent) guidance addresses many of the challenges facing researchers by proposing the use of eConsent as a solution. This guidance clarifies the role of the IRB, sponsor and investigator to ensure a successful electronic informed consent process. The guidance explains the IRB’s responsibilities in the eConsent process particularly in regards to intangible aspects of eConsent, such as when systems use hyperlinks to convey study-related information. IRBs should review the contents to which subjects are referred in order to determine if the study-related information that has been supplied is accurate and appropriate.
eConsent offers a streamlined, collaborative process that promotes faster content development, approval and deployment on one platform, while guaranteeing that only the most current and approved consent version is used each time. eConsent supports quicker informed consent approval by utilizing templates with pre-approved language and powerful collaborative tools to achieve accurate consent the first time, while also improving patient retention.
SAM reviews the ways that eConsent streamlines the informed consent development process in this short CRF Health’s video:
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-The Clinical Pathways Team