New in Research
Mary Washington Hospital Research Department has recently implemented electronic
and verbal consenting and remote monitoring.
Electronic Informed Consent (eIC) and Electronic Signature
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 that may or may not include multimedia components,
such as videos, audio or weblinks embedded in the consent.
An 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.
Remote monitoring has been implemented and is used as guidance for other
clinical research projects where monitoring is required at the discretion
of either the MWH research department, Sponsor and/or Investigator.