- What is remote consent?
- Remote consent refers to the use of techniques like telephone, videoconferencing, or desktop, mobile, or web-based applications (for example, Zoom) as an alternative to face to face discussions in the process of obtaining informed consent.
- HRPP policy 5.3
- To the extent that remote consent facilitates the process of consent, the IRB endorses and encourages its use. However, the Board must approve the specifics of the process.
- What is e-Signature?
- e-Signature refers to the use of various platforms (like DocuSign, or Adobe Sign) to obtain signatures on a consent form electronically.
- The use of e-signature is independent of the use of a remote consent process. A face-to-face consent process may include an electronic signature, and remote consent may include a “wet” (physical) signature.
- The UNMC IRB must approve the platform used to obtain e-signatures. The specific electronic platforms allowable are dictated by FDA regulations and by Nebraska law.
- What is the difference between remote consent and e-signature?
- Remote consent is the process of consent, when consent is not conducted face-to-face.
- E-signature is signing the consent form electronically.
- What platforms are allowed for e-signature?
- Federally funded studies: DocuSign, GMO GlobalSign and Solutions Notarius platforms are recognized by Nebraska law as equivalent to a “wet” signature. Other platforms may become available in the future, as allowed under Nebraska Law.
- FDA regulated studies (Studies involving drugs or devices): 21 CFR Part 11 (“FDA Part 11”) compliant systems.
- Federally funded + FDA regulated studies: Part 11 compliant version of DocuSign. Note that the standard version of DocuSign, which is not part 11 compliant, is not acceptable.
- RSS e-signature can only be used for research which is neither Federally funded nor FDA regulated. In addition, RSS e-signature does not at present support consent forms that require a second signature for optional studies.
- REDCap e-signature can only be used for research which is neither Federally funded nor FDA regulated
- How do I access these systems?
- DocuSign, GMO GlobalSign and Solution Notarius: must be licensed by the investigator. DocuSign (not part 11 compliant) may be available thru Nebraska Medicine - contact the CRC.
- RSS: the IRB must turn on the e-signature function
- Active Studies: no change request is required. Send a message through the message portal requesting the use of e-signature. Note: If you are adding a remote consent process, a change request will be required.
- For new studies, if you are planning to use a remote consent process, or an e-signature platform (like RSS or DocuSign), the plan must be described in the Consent section in the IRB application.