Evaluating eConsent: Some Considerations from an IRB Perspective
At Advarra we’ve been seeing more and more eConsent studies recently, which is great—eConsent technology can often better inform participants than just the traditional paper consent, which is great from an IRB perspective. We also now have federal guidance on how to implement eConsent in clinical research, making it a bit easier to implement the technology.
Given the steady increase in eConsent review, Advarra’s IRB and operational staff have been examining our processes to make sure we’re providing efficient, compliant review services for eConsent studies. We’ve learned a lot about eConsent since we first started working with the technology, and we’d like to share some of those learnings with our colleagues in the research community.
It’s a Diverse Field
eConsent comes in a variety of flavors: we’ve seen some studies with an entirely electronic consent process, studies that incorporate only certain elements of eConsent (like video or electronic content delivery via iPads or laptops), and everything in between.
With so many options available, it’s important to think about each study individually and how eConsent will impact the informed consent process. Here are a few impacts to consider:
- Will your participants be comfortable with an entirely electronic consent conversation?
- What kind of information is best presented electronically?
- How will research staff support the eConsent technology and process?
- How will new information be shared with participants?
Consider what you want the eConsent to do for your study, who will use it and who will benefit from it, to help ensure you’re assembling a tool that will be truly beneficial for your study.
IRB Review of eConsent Is Sometimes Clunky
For the IRB, reviewing an eConsent is quite different from reviewing a paper-based consent. Unlike with electronic patient reported outcome (ePRO) systems, where the IRB only approves the content, the IRB reviews the eConsent content and the eConsent platform.
This means reviewing just a Word doc of eConsent or screenshots content is not sufficient—the IRB needs to also review the content in the same context as a participant will review it, so the IRB needs to see the eConsent system including any hyperlinked or interactive portions as well.
Reviews can become tricky when the IRB needs to transmit notes on or request changes to an element of the eConsent—it’s often not as easy as turning on tracked changes or using electronic sticky notes. While some eConsent vendors have built IRB review tools into the eConsent system, which allow the IRB to review and request changes directly within the eConsent platform, many still rely on old standards like Word and PDF documents to submit content for IRB review.
This can lead to delays in the review process: for example, the IRB may provide its feedback via tracked changes in a Word document, and that feedback must then be applied to the eConsent system. Then the updated content must be re-submitted to the IRB (either using the eConsent system itself or another Word document) to confirm that the requested changes were in fact applied. These extra steps can lead to potential data entry errors and add extra time to the overall review process.
Keep in mind too that the regulations require IRBs to maintain the version of any web-based information containing the study-related information that the IRB has reviewed and approved. This includes text-based information as well as information provided via video, infographics, hyperlinks to external resources and other multimedia sources.
Because every eConsent platform is different, IRBs need to have flexible review processes to accommodate the variety of review methods available. Developing a review process around one platform can create unnecessary submission requirements and may distract the IRB from important review elements.
Version Control Can Be Challenging
Many IRBs use version control notations to track which version was approved by the IRB and which version study participants should be using. This version control notation may be referenced in approval documentation to confirm what has been approved, a helpful resource when working with an ICF that has been revised multiple times. Version control notations can also be helpful when the IRB archives materials for a closed study.
With paper-based consents, the IRB typically generates the final product (the approved ICF) so the IRB can also easily apply its standard version numbering system to the ICF. This is not possible with eConsent, as version control options vary depending on the vendor. IRBs will need to work with eConsent vendors and sponsors to figure out a good way to track versions in an eConsent format and archive each approved version.
eConsent Is Getting Better and Better
While we’ve found some ways eConsent could be improved (at least from an IRB perspective), eConsent as a whole has improved a lot over the past few years. We’re seeing innovative ways to check participant understanding (including quizzes and “spot-check” questions) and inventive methods for providing tiered information, allowing participants to dig deeper on certain topics.
We’re also seeing a wider acceptance and increasing comfort levels with receiving information digitally (as opposed to on a printed page). So while eConsent may not work for every study and every subject population, it’s certainly a worthy option in many circumstances.
It’s easy to see the benefits of eConsent and support its usage—when implemented properly, eConsent makes some real improvements to the informed consent process, which is in everyone’s best interest. But we still have much figure out with the logistics of using eConsent, and collaboration and communication between IRBs, study sponsors, researchers and eConsent vendors is critical. It may benefit be beneficial for IRBs and eConsent vendors to meet and discuss the details of potential review challenges, and at Schulman we welcome the opportunity to collaborate in this way to work toward an efficient and thorough review process. eConsent may take more time than the traditional paper-based consent process, but it’s worth it.