title: New Guidance on Electronic Informed Consent.
abstract: The federal government has issued new guidance on the use of electronic tools to inform and obtain consent from potential participants in FDA-regulated research. The document answers common questions about how to present information to subjects and submit materials to regulators as part of new drug or device applications.
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent; D014481:United States; D014486:United States Food and Drug Administration