Using Electronic Signatures to Document Informed Consent
When recruiting participants for a human subjects use research protocol, one important aspect of the research process is discussing the purposes, procedures, risks, benefits, etc. of the study with a participant and then (if appropriate) documenting their consent. Generally in UMBC protocols, this involved obtaining a written signature on a consent form. Research that involves the use of a web-based survey will also use a consent form; in these cases, a "signature" on a consent involves clicking an "I Agree" button at the end of the consent information.
Did you know investigators can use DocuSign to obtain an electronic signature on a consent document? The revised Common Rule states that “informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject (participant)…”.
The IRB recently created guidance for investigators to consider when creating a protocol to obtain "written" from participants. DocuSign consent documents must be created using your UMBC credentials, but can be distributed to persons outside of campus for review and signature.
Found under Consent and Assent Guidelines, using electronic signatures to document consent will involve a bit more information for the IRB to review, but is a useful tool to obtain consent.
Posted: February 6, 2020, 4:36 PM