To have a valid signature, your e-consent process should have:

• the ability to prove that the actual signer is the intended signer;
• the inability of the signer to deny the signature; and
• an assurance that neither the record nor the signature has been altered since the moment of signing. To achieve this, the electronic signature and date should be linked to the document so that it cannot be modified or tampered with. (Having the individual type their name on a word document or other format that allows the signature to be tampered with is not valid.)

E-consent may be formatted to include the printed name of the person obtaining the consent, or the study personnel may print their name on the document when received.

When use of an electronic system does not accommodate the IRB approval stamp, the IRB may approve use of the electronic version without the stamp. 

Ensure the subject is provided with a copy of the form(s) he/she/they signed.

Electronic Platforms

Not Food and Drug Administration (FDA) 21 CFR Part 11 compliant:

• Qualtrics - HIPAA Compliant platform, includes options for providing subjects with a copy of the signed document. See Instructions for Building a Consent Form. [HTML]
• REDCap - HIPAA-compliant electronic system, used to create your e-consent, verify identity and collect signatures for research with automatic email of copies sent to both the subject and the investigator.
  
  REDCap is housed and maintained by CCTS (For additional information, view the REDCap consent feature webinar or CCTS Biobank video demo [YouTube video]).

FDA-regulated Research:

• Software systems must be compliant with all requirements under FDA 21 CFR Part 11 (e.g., restricted access, administrative controls, training, identity verification, etc.)
• FDA does not certify systems for Part 11 compliance.
• Sponsors may provide 21 CFR Part 11 compliant electronic consent.
  • You may request a statement from the sponsor or vendor of the electronic system used for obtaining the electronic signature that the system meets the relevant requirements contained in 21 CFR Part 11 and maintain documentation that your site has fulfilled applicable customer requirements such as training, password controls, etc.
• For investigator-initiated research, refer to the Resource section for 21 CFR Part 11 options including DocuSign Part 11 [HTML] and Adobe Sign Part 11 [PDF].

Generally, there is no “out of the box” software solution as the customer is responsible for setting features, demonstrating compliance, providing/documenting training, and administering operational policies and procedures. This means your unit, department, or college has the responsibility to be able to demonstrate that the software is fit for its intended use and the system meets the applicable regulations.

FDA 21 CFR Part 11 describes two types of signatures:

• Electronic signature - a computer data compilation of any symbol(s) executed, adopted, or authorized by an individual to be a legally binding equivalent of the individual’s handwritten signature.
  • Methods include computer-readable ID cards, biometrics, digital (cryptographic) signatures, and user/password combinations.
  • Electronic signatures must comply with 21 CFR 11.5 & 11.7 signature requirements:  The printed name of the signer;
    • Date and time when the signature was executed;
    • Meaning (i.e., consent); and
    • Linked to their respective electronic records to ensure that they cannot be excised, copied, or otherwise transferred (i.e., tampered with).
• Handwritten signatures executed to electronic records - hand-scripted signatures executed to electronic records by signing with a stylus, finger, or cursor drawing.
  • These may be used in a hybrid process where the only electronic component is the documentation (signature) of informed consent.
  • Handwritten signatures executed to electronic records must comply with 21 CFR 11.7:
    • Linked to their respective electronic records to ensure that it cannot be excised, copied, or otherwise transferred (i.e., tampered with). 
  • In situations where electronic signatures cannot be placed in a specified signature block, a statement of testament (e.g., “I consent to participate”) should be placed elsewhere in the document to state the meaning of the signature and link the signature to the electronic informed consent.