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eConsent in Clinical Research: Trends and Questions

April 3rd, 2017 by Robann Cunningham, VP Business Development & Marketing

As everyone familiar with eConsent is aware, FDA and OHRP released a Q&A-style guidance on electronic consent in clinical research last December. Using that guidance as a springboard, some Schulman colleagues and I met with several dozen research professionals to discuss the topic in Boston this past February. We discussed key challenges of implementing eConsent in a study and the main drivers in the industry for adoption of eConsent technologies.

I thought the broader research community may benefit from my notes, so here is a summary of our discussion:

How do potential participants take home an eConsent to review?

Since potential participants can take home a paper consent to review before agreeing to participate, we wondered how this would work with a digital ICF. We learned that many sites currently provide potential participants with a URL printed on a card—a much more secure option than sending someone home with the site’s tablet device.

The URL directs the potential participant to a website displaying the ICF exactly as it appeared on the tablet device, but in a read-only format. This way they can review the ICF in its entirety, but can’t yet agree to participate. The consent agreement conversation happens when the participant returns to the site.

Another interesting option is developing a “participant portal.” This platform could contain not only the digital ICF but also additional information about the research, making it a useful resource throughout the participant’s time in the study.

For those less savvy or without access to technology, a paper option should remain.

After a participant consents to participate, do we still send them home with a paper copy of the ICF?

IRBs expect study participants have access to the consent material after they’ve agreed to participate in the research. This could be a printed version of the digital ICF, or it could be sent via email. A few people commented that it’s nice eConsent can provide options, offering participants the ICF in a format that works for them. (Reminds me of how many stores now give you the option to print your receipt and/or receive an email copy.)

How do we determine if eConsent is appropriate when conducting the consent discussion remotely?

The challenge with remote consenting via eConsent is confirming the potential participant’s identity. Documentation of informed consent cannot be waived for FDA-regulated studies, so we still need a way to appropriately enable an individual’s consent even at a distance. One idea is to use a Part 11-compliant eConsent platform robust enough to meet the remote consent criteria, including electronic signature verification. The FDA-OHRP guidance also suggests verifying identity through state-issued IDs, personal security questions, biometrics or visual methods (like a webcam).

When will we start seeing eConsent more frequently? Will certain types of studies adopt the technology more quickly than others?

We learned that some sponsors and CROs are currently conducting or are planning eConsent pilot projects, using smaller studies to learn more about using the technology in research. They’re focusing on how effective eConsent is with sites, as well as the sites’ ability to adapt to the new technology.

Some we spoke with felt eConsent worked well in studies examining chronic indications like diabetes and hypercholesterolemia. We also discussed participant populations that might not do as well with a digital ICF; for example, a digital interface may be challenging in geriatric populations. That said, it’s also important to assess digital aptitude on an individual basis rather than relying on broad assumptions.

 


 

It was exciting to talk with people from sponsors, CROs and sites about the possibilities and challenges of eConsent. Conversations like this help us better understand that these are shared challenges, and that by working together no challenge is unbeatable. eConsent has the potential to greatly improve participant protections, and it can also help improve research conduct and management overall. I look forward to seeing more studies utilizing eConsent very soon.