E-Consent: Using DocuSign
DocuSign is a standard electronic consent platform that is used at UVA. It is important to note that electronic consent platforms are evolving. Most importantly, if a study has written consent that requires a signature, the platform used needs to be able to capture a legal signature. The IRB of record is required to review and approve the consenting process, which includes reviewing the plan for how subjects will be recruited, consented (including platforms used) and how the consent from the subject will be documents such as via a paper consent form or the use of an electronic consenting platform. For more information about electronic consents, please see LEARNING SHORT: Use of Electronic Informed Consent
Use of DocuSign at UVA:
Non FDA-regulated studies-use of general research DocuSign accounts are allowed for e-consenting with proper approval from the IRB of record.
FDA-regulated studies-require the use of Part 11 compliant accounts (the accounts enforce Part 11 requirements in such a way that risks of user error/non-compliance are mitigated)
For details on how to access and use DocuSign please visit the DocuSign for Research page.