The purpose of this document is to provide guidance on documenting consent other than by obtaining a physical inked signature on paper. This guidance describes other methods that are also sufficient documentation of informed consent.
Electronic documentation of consent may be used when researchers conduct the consent process with participants in person, as well as when potential participants are not physically present during the consent process. In either situation, the consent process itself should still be designed to ensure that participants are adequately informed about the research, can easily ask and get answers to questions, and recognize that participation is voluntary.
Federal regulations allow electronic signatures to document informed consent, so long as electronic signatures are legally valid within the jurisdiction where the research is being conducted. However, the research team must still comply with all other consent requirements (see IRB Guidance: Informed Consent) and subjects must still be provided with a written version of the consent form that they can retain for their records.
When the IRB reviews the study, it will consider how the electronic signature is being created, whether the signature can be shown to be legitimate, and how the research team plans to provide a version of the consent form to the potential subject for their review and retention.
If properly obtained, an electronic signature can be considered an ‘original’ for the purposes of recordkeeping. In other words, it would satisfy requirements in case of an audit.
Electronic Documentation of Consent vs. Waiving Documentation of Informed Consent
It is important to understand the difference between using methods other than paper and pencil to document informed consent, and waiving the requirement to document informed consent altogether.
When providing electronic consent, there are a number of ways in which an e-signature might be documented. Some examples include:
- Attaching a scanned handwritten signature or using an e-signature service such as Adobe’s EchoSign;
- Typing one’s name with an accompanying check box and statement noting an intent to affix a legal signature (e.g., “By checking this box and typing my name below, I am electronically signing this consent form”); or
- Signing with a stylus in an electronic document.
(NOTE: If accessing or using students’ education records as part of your study, please see IRB Guidance: Use of Student Records in Research for specific consent requirements.)
When a consent procedure will not include a written or e-signature, it requires a waiver of documentation of informed consent. Common examples include online consent where participants are directed to begin a survey after reading an information sheet, or eligibility screening performed over the telephone with a potential subject. In these cases, the research team must request a waiver of documentation of informed consent from the IRB. More information about requesting this waiver, as well as other requirements regarding consent can be found in IRB Guidance: Informed Consent.