In part, the Office for Human Research Protections (OHRP) has guidance that states that electronic signatures may be used to document informed consent. The guidance says that “One method of allowable electronic signatures in some jurisdictions is the use of a secure system for electronic or digital signature that provides an encrypted identifiable ‘signature.’ If properly obtained, an electronic signature can be considered an ‘original’ for the purposes of recordkeeping.” (would satisfy requirements of an audit). An electronic signature can include a “digital” signature on a consent document (such as using DocuSign) or a “I agree to participate” button in an online survey. Note that DocuSign is available to both UMBC and non-UMBC recipients but must be initiated by a UMBC person.
The revised Common Rule also states that “informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject (participant)…”.
For Participants
Participants must be provided with a version of the consent form that they can retain for their records, whether it is a hardcopy or an electronic version. They (or their representatives) must be provided adequate or sufficient opportunity to read the document and consider whether or not to participate and that minimize the possibility of coercion or undue influence.
Investigator Responsibilities
The investigator continues to be responsible for ensuring that informed consent is obtained before that participant takes part in the study whether it be on-site or remotely. How this process is performed must be described in the IRB protocol application for review. The consent procedures will state how the investigator and participant review the consent content, answer questions about the material, how data obtained (either in confidence or collected anonymously), have the opportunity for follow-up discussions. As a “hand-written” signature is not obtained, an investigator will request from the IRB a waiver of written consent, provided the requirements of the waiver are met. Consider the risks associated with the research and participant population when considering the use of electronic signatures on a consent.
Investigators are reminded to forward a version of the planned consent documents with the IRB protocol for review and approval. Once the “IRB stamped” approved consent is forwarded with the IRB approval letter, create the DocuSign consent document by reviewing the link for portal access on the DocuSign myUMBC page.
IRB Responsibilities
The IRB will determine if the proposed valid or legitimate signatures represent the participant’s or legally authorized representative’s understanding about the research study and their concurrence to participate. The IRB may waive the requirement for the investigator to obtain a signed consent based on the regulations at 45 CFR 46.117(c).
The IRB, via the Office of Research Protections and Compliance, may periodically audit a protocol’s informed consent process to make sure stated procedures are followed.
return to Consent and Assent Guidelines