There is an increasing interest in using electronic media to supplement or replace paper-based informed consent processes. This guideline focuses on the use of electronic signatures to document informed consent.
If COUHES determines that documented consent is required, electronic signatures are permitted if such signatures are legally valid within the jurisdiction where the research is to be conducted.
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.
If you will be conducting research or recruiting subjects outside of Massachusetts, you must confirm that e-signature is legal in the state 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 entire consent process including documentation of consent should 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 methods must be in place to allow subjects to ask questions before signing consent as well as at any time during the subject’s involvement in the research. Subjects must be provided with a copy of the signed consent form.
The investigator should submit to COUHES copies of 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, whether electronic or in hard copy.