New in Clinical Research at MWH
Mary Washington Hospital Research has recently implemented electronic informed
consent, electronic signature, and verbal consent.
Electronic Informed Consent (eIC)
The Informed Consent Form (ICF) is generally presented on paper. Electronic
Informed Consent (eIC) provides the same information, but in an electronic
format, such as a PDF.
Electronic signature, or e-signature, is a legal way to obtain consent
or approval by electronic document or form. In 2000, the United States
passed the ESIGN ACT, which granted electronic signatures the same legal
status as handwritten signatures throughout the United States, making
them legally recognized as a viable method to indicate agreement to a
contract. Electronic signatures in ADOBE SIGN are secure and HIPPA compliant
and the Research department will follow the 21CRF part 11 guidelines.
Verbal consent means that the individual obtaining consent reads and explains
the consent form and the research volunteers give their verbal consent
in place of written consent to participate.