This page has been updated to reflect the New Rule effective January 21, 2019.
Investigators, when appropriate, can request the use of electronic signature on the informed consent if such signatures are legally valid within the jurisdiction.
For subjects signing the consent in the United States, the consent will be legally binding if the investigators can satisfy the following 4 elements:
- Authentication (i.e. subject signing electronically is who he/she claims to be – through verification of ID, unique keys, password, etc.);
- Intent to sign electronically, through certification/opt-in noting that the participant is agreeing to electronic signature;
- Proof, investigator must maintain the signature and date on the actual form, and;
- Document retention (the researcher must keep a full copy of the signed document and make it available to the participant..
DocuSign is MIT’s electronic signature solution, allowing users to send and sign securely. The MIT community has access to DocuSign: https://ist.mit.edu/docusign. For technical support, please contact IS&T. Investigators are encouraged to use DocuSign whenever possible.
Investigators must ensure consent procedures comply with applicable laws within each jurisdiction. If you will be conducting research or recruiting subjects outside of United States, you must confirm that e-signature is legal in the country where the research will be conducted. For assistance, please consult with the Office of the General Counsel to ensure that your e-signature system is valid and meets the relevant local requirements, in addition to federal regulations.
The consent process must be described in the COUHES application. Subjects must be afforded an opportunity to discuss the research with a study team member (by phone calls, electronic messaging, or other interactive procedures) and allow subjects to ask questions before signing the consent form and throughout their involvement in the study. Subjects must be provided with a copy of the signed consent form.
Applications must include all forms and informational materials, including any videos and web-based presentations, which the subject will receive and view during the electronic consent process. The investigator must obtain COUHES approval for any subsequent modification to the study-related information.