Table 3.

Key operational and regulatory questions to ask when developing an electronic informed consent (eIC) approach

Operational
• What materials related to the eIC does an institutional reviewer boards (IRB) need to review? • How should any applicable interactive elements be presented to the IRB? • How should changes to the informed consent (IC) be tracked? • How should the versions of the eIC be tracked? • What constitutes the copy of the IC that should be provided to participants? • What alternatives should be offered for participants who do not have access to the internet or are not comfortable with eIC? • If a single IRB will review the research study, how should site-specific information be incorporated into the eIC?
Regulatory
• Which regulations apply to the study? • Is documentation of informed consent required? • Are there state or local laws or organizational policies that could affect an IC process? • If the study is a clinical trial, how will the research team represent their eIC on a publicly available Federal website?