Although eConsent struggled to gain momentum and wider acceptance pre-pandemic, it is actually powered by technology that is regularly used in daily life and is more approachable than one might think. Regardless, some researchers are still hesitant to embrace remote technology. In this article, we’ll explore three areas that researchers cite as obstacles when implementing eConsent: data safety; regulatory compliance; and identity verification. Read on to learn how these issues can be resolved safely and efficiently.
Playing it safe with data
Data integrity, safety, and privacy are of critical importance these days. And with good reason—never before has so much personal data been processed through online services. Since medical data is among the most private there is, clinical trials must adhere to the highest standards of data protection while offering their participants data privacy. Fortunately, there are several ways to accomplish this via eConsent.
In order to keep data safe and secure, opt for an eConsent solution with:
- Access control: to limit who is allowed to access data.
- Authentication: to confirm a user’s identity
- Encryption: to render data unreadable except to authorized parties
- Traceability: to establish a chain of custody to ensure accountability
When employing eConsent, investigators should use embedded HIPAA-compliant authorization forms to ensure FDA compliance. In the EU, the GDPR’s most recent guidance requires “an effective audit trail of how and when consent was given, so you can provide evidence if challenged” and “an appropriate cryptographic hash function to support data integrity.”
Any video conferencing used as part of eConsent must be secure, traceable, and fully compliant. For example, it should be encrypted and US 21 CFR Part 11 compliant.
Navigating the regulatory jungle
The regulatory jungle is complex enough to discourage researchers from changing established methods they know are fully compliant (or that they believe are fully compliant). . It doesn’t help that different countries and regions have their own regulations around the use of eConsent and acceptance of eSignatures. At the time of writing, the FDA’s most recent guidance was published in December 2016 and no EU regulation or guidance about eConsent in clinical trials exists.
Ensuring regulatory compliance is not hopeless, however. In general, Institutional Review Boards (IRBs) and ethics committee have consistent requirements for paper and electronic consent, such as:
- IRB-approved language and format
- All elements of informed consent as required by HHS or FDA
- Signatures of participant and researcher
- Study staff involvement
- A copy of consent provided to the participant
Researchers need to familiarize themselves with their applicable IRB guidelines. (Find a handy overview of eConsent guidelines in twelve different countries here.) When making a submission for an eConsent-based study, it’s important to also address:
- Who will conduct this discussion?
- How will participants be identified?
- How will participants be approached for consent?
- When will participants be asked to provide consent?
- What video conferencing platform will be used for remote consent discussion? (eg. phone, Skype, Castor eConsent, etc.)
Checking IDs at the door
Clinical investigators need to confirm the identity of all participants in a trial according to regulatory requirements. But that doesn’t mean every participant needs to present themselves at the study site—video conferencing to the rescue!
An appropriate, secure video conferencing solution provides investigators with real-time, visual interaction with participants. This allows the study team to verify the identity and, if using a hybrid wet-signature with eConsent, witness the signature of each participant. But the benefits don’t end there—video conferencing allows a clinical researcher to answer questions directly, cementing trust with a participant and increasing retention. Importantly, investigators are able to observe the participant’s behavior and determine if they are capable of offering informed consent and are consenting of their own free will.
Castor eConsent is a flexible, user-friendly, and secure solution for your next trial. If you’re interested in learning more about putting eConsent to work in your next trial, reach out to one of our friendly Castorians here.