When consent is required, researchers who decide to obtain consent via a remote method (a method that is not face-to-face) should keep in mind that extra effort should be made to discuss consent before a signature is gathered. Researchers should invite an interactive dialogue to discuss risks, questions, and concerns.

Requirements for Any Method of Electronic Consent

1.  There must be a means to authenticate the signature.

2.  The date of signature must be verifiable.

3.  If an electronic signature company is used, the company website must clearly state that their electronic signature process is compliant with electronic signature laws in the researcher’s home country and participant’s home country. This information is readily available on many e-signature company sites.

4.  The audit trail must be maintained by the researcher. If the e-signature site will also maintain the audit trail, this must be disclosed on the consent form itself.

5.  A printed copy of the consent form must be available to the participant at the time the participant’s electronic signature is executed. This printed copy should have both researcher and participant electronic initials and e-signatures on it.

6.  The researcher must maintain a copy of the consent form showing both the participant’s and the researcher’s electronic initials and e-signatures.

Minimal Risk Research

1. Preferred Method to Obtain Consent Electronically

The researcher should initial and sign each page by hand. The researcher scans or photographs the initialed and signed form, then emails or faxes the form to the participant. The participant should initial and sign each page by hand. The participant scans or photographs the initialed and signed form, then emails or faxes the form to the researcher. The researcher must save all communication to/from a participant. Email dates, times, attachments and/or faxes must be maintained.

2. Other Methods to Obtain Consent Electronically

• The participant can email an unsigned consent form back to the researcher along with a clear statement indicating that the consent form has been read, the participant has had the opportunity to ask questions, and sending back the consent form indicates the participant’s consent. The researcher must acknowledge receipt and email back a similar statement indicating that the reply serves to confirm receipt and to document the researcher’s intended signature. The researcher must save all communication to/from a participant and must save the participant’s emails with email address, date, and all attachments.

• The researcher can use a certified electronic signature program such as DocuSign, AssureSign, PandaDoc, or HelloSign. Any similar company can be used as long as it is compliant with requirements 1-6 above.

Greater Than Minimal Risk Research

The Full IRB Committee will review requests to obtain consent electronically, and the committee will give feedback based on risks to participants. If electronic consent is allowed, it must be obtained via the preferred method above (A) or via a certified electronic signature program that is compliant with requirements 1-6 above.