When the study team and participant are not in the same physical location during the consent process, the use of Remote Consent became pivotal. Remote consent using a paper consent form (or remote paper consent) is a specific type of remote consent where a copy of the written informed consent form is provided to the participant via email, fax, mail or during a prior in-person visit. The informed consent process may be conducted over the phone or via video conference (e.g. Zoom). The participant signs and dates a hard copy of the consent form and returns it to the study team via email, fax, mail, or at their first in-person visit.
Electronic consent (e-consent) is another method of obtaining informed consent through the use of an electronic system instead of a paper consent form, e.g. in REDCap or DocuSign. Not all e-consent systems contain the ability to document legally effective signatures.
The use of e-consent system can occur in-person or remotely. An example of an in-person consent process that uses an e-consent system would be giving a potential participant an iPad that displays the consent form in REDCap, discussing the consent form in person, and then the participant agreeing to participate by tapping the appropriate button in REDCap. For a remote e-consent process, the study team may give the potential participant a link to the e-consent system and go over the consent information over the phone or via Zoom. The participant would provide their consent via the electronic platform.
How to discover the best e-consent system for your study
The most frequently used e-consent systems for studies are REDCap and DocuSign. To determine whether you can use a certain e-consent system, you need to consider the nature of your study, and which system can accommodate the consent requirements for your study. For research that requires documentation of legally effective consent, an e-consent system that is able to document legally effective signatures must be used. Research that qualifies for waiver documentation of consent, such as minimal risk research, may use e-consent systems that do not meet these requirements.
If the research poses more than minimal risk, then documentation of legally effective signatures on the consent form is required. DocuSign may be used to obtain legally effective e-consent. The JHU instance of REDCap is not automatically set up for documentation of legally effective signatures when using the e-consent framework; however, the set-up may be customized to accommodate documentation of legally effective signatures.
If the research is FDA regulated (includes drugs or devices) and does not meet the criteria for a waiver of documentation of consent (i.e., the study poses more than minimal risk to the participants), the FDA requires that the e-consent system be Part 11 compliant (21 CFR Part 11).
What does it mean for consent to be 21 CFR Part 11 compliant?
FDA requirements for electronic records and electronic signatures are set forth in 21 CFR Part 11 of the FDA regulations. When referencing a “Part 11 compliant” electronic consent system, the Office of Human Subjects Research (OHSR) is referring to use of a system that complies with FDA regulatory requirements for electronic records and electronic signatures. Compliance with these regulatory requirements is required for all FDA-regulated research that is greater than minimal risk and minimal risk research where the requirement for documentation of consent has not been waived. Please visit the FDA’s guidance on electronic consent for additional information about the requirements set forth in 21 CFR Part 11 of the FDA regulations.
Under what situations that the use of REDcap is recommended for an FDA-regulated study?
For FDA-regulated research, REDCap may be used only if the documentation of consent requirement has been waived. A waiver of documentation of consent may only be granted when the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context.
REDCap should be used for greater than minimal risk research that is not FDA-regulated [e.g. research that involves an invasive biopsy] only if certain actions are incorporated into the electronic consent set-up and process to ensure the consent will qualify as legally effective documented consent.
Diferences between DocuSign and REDcap
If your research is FDA regulated (involves drugs or devices) and does not meet the criteria for waiver of documentation of consent, you will need to use DocuSign if you wish to use a JHU-based tool for e-consent.
In terms of revising the eIRB application and maintaining consent documents, DocuSign may be easiest because it only involves adding approved language to eIRB Section 15 and adding spacing around the signature lines of the written consent. You will not need to upload a separate consent form or signature page.
Some users have found the multiple logins for DocuSign cumbersome, so if your research is not required to adhere to FDA Part 11 requirements, you may wish to consider using and adapting REDCap as needed based on the risk level of your research.
How MILO e-consent can enhance the process of requiring Remote Consent in your research
Ultimately, we can realize that a cornerstone of ethical remote clinical trials and telemedicine practice involves informed consent and the associated liabilities. Providers must ensure that patients are fully aware of the nature of the studies, including benefits, risks, and limitations before receiving virtual care or participating in a research. Furthermore, clinicians are advised to be vigilant about the potential for increased liability associated with telehealth practices and seek to mitigate these risks through quality virtual care protocols and rigorous adherence to the telemedicine regulatory framework.
MILO eConsent introduces an innovative electronic solution that complies with health authorities regulations. It ensures that patients understand the objectives of the clinical trial and provides consent directly through the MILO DCT application.