April 15 2025
Written by Jamie Saunders, M.S., Research Program Manager, MaineHealth Cancer Care Network NCORP
There are multiple methods that may be employed to conduct and document the informed consent discussion. They range from in-person discussions with hard copy signatures to fully remote options. Options for remote consent vary and include mailing documents to potential participants and carrying out the discussion over the phone, to using a videoconference platform and obtaining signatures using an electronic signature system such as DocuSign or RedCap.
- In-Person Consent: Participant and study team member are at the same location for the consent discussion. Signatures are obtained on a hardcopy document.
- In-Person Consent with electronic signature: Participant and study team member are in the same location for the consent discussion but signatures are obtained using an electronic platform such as DocuSign or RedCap.
- Remote Consent with hardcopy signatures:Participant and study team member are not in the same location for the consent discussion. Discussion is conducted over the phone or via videoconference. Participant signs and dates a hard copy of the consent form and returns it to the study team via mail or at their first in-person. Please note that the consent is not completed until it is returned to study team and study team member who conducted the discussion has signed and dated the document using the date it was received by mail or in-person. No study specific assessments are to be performed prior to the completion of the consent process.
- Remote Consent with electronic signature:Participant and study team member are not in the same location for the consent discussion. Discussion is conducted over the phone or via videoconference. Signatures are obtained using an electronic platform such as DocuSign or RedCap.
It is important to note that eConsent can occur in person or remotely. This type of documentation refers to the manner in which the signatures were obtained not to how the discussion was conducted. Additionally, in instances when electronic signatures are allowed, a system that is able to document legally binding signatures must be used.Further, if the research is FDA regulated (drug or device), there is a requirement for a Part 11 compliant system to be used.
There are several factors that must be taken into account prior to determining the appropriate method; they include but are not limited to the type and risk of the research and the reduction of burden to potential participants.The methods that may be employed for each study will be outlined in the protocol and need to be IRB approved.
Through the Study Specific Worksheet or the Signatory Institution Worksheet, the Central IRB is to approve local remote consent and eConsent processes.The institution’s local IRB may provide additional details, including state law and institutional policy, regarding the conduct and limitations of remote consent and eConsent.
Before implementing a remote consent process or electronic signature process, be sure to address all regulatory requirements and institution policies.
When using remote consent, there may be additional guidance that needs to be followed as well.
For instances when remote consent is used, and the study is overseen by the CIRB, the CIRB provides guidance on documentation.
CIRB SOPS instructs that once all signatures are obtained on the consent document, the person obtaining consent must add a statement to the ICF document, under the signature line that includes the following:
Method of discussion (telephone, video conference)
Date of discussion
Date the signed consent was received
Reason the discussion and signatures were completed remotely
Stay tuned for Part III which will highlight consent waivers and Part IV will highlight how to document the informed consent process.