What's The Deal With eConsent?
By Dan Schell, Chief Editor, Clinical Leader
My friend John Oncea is one of those people who likes to go down the proverbial “rabbit hole.” If I randomly mention to him that I’ve been wondering whatever happened to some old musician, band, actor, or classmate of ours from the 1980s, that’s all he needs to start his deep dive.
It was a similar innocuous comment that led me on my own — albeit shallower — journey to find out why eConsent is not more widely adopted. In this case, my curiosity was piqued when one of my Clinical Leader teammates stated that they rarely hear anyone ever asking about eConsent.
Really? I thought. Why not?
We’re always talking about being more patient-centric in this industry, and it seems to me that eConsent fits that goal. Most people are used to interacting with tablet-like devices these days in healthcare. We use them to register when we arrive at a physician’s office, and that doctor isn’t likely writing their notes on paper forms; they’re using a computer. We interact with “screens” — beyond our phones — every day. We read books on our Kindles, we use kiosks for public transportation tickets or at airports, and we choose self-checkout in grocery stores. So why would anyone be surprised if they were asked to use an eConsent app when signing up for a clinical trial as compared to being handed a packet of papers? The answer, of course, is that they likely would not be surprised, but that doesn’t mean this digital option is going to be easier/more convenient for them — or the site.
JUST A POORLY IMPLEMENTED DOCUSIGN-LIKE SOLUTION?
I reached out to my LinkedIn network and asked why people thought eConsent wasn’t more prevalent these days. Clearly, I touched a nerve with this topic, as many people were quick to contact me with their opinions. Here are a few of the responses (some have been condensed/edited) from LinkedIn:
When it first came out, it seemed like an easy win. But anything new always has a hard time fitting into our already-complicated ecosystem and needs a compelling reason to reach adoption. My guess is that there are multiple challenges:
- Solving a problem that doesn’t really exist. Paper is actually not that hard.
- Doesn’t improve the patient experience. Most people (me included!) are not excited about reading 20+ pages on a screen.
- Doesn’t fit well into sponsor workflows (I think this is the biggest one). Routing a Word doc in track changes and then locking it into a PDF is actually really easy and requires no specialized skills or training. Even an easy eConsent system needs an admin who understands it, especially if you want to use any of its “advanced” features.
- It’s more costly. It’s one thing to have to increase a line item in a trial budget, but creating a brand-new line item really ups the stakes.
eConsent is generally a great tool that’s useful to many people. I’ve heard of several studies that have used it where there’s great satisfaction with the experience and end result. However, there will always be certain cases (at the participant or study level) where it may not practical. This may be something out of their control, like a participant condition or technology issue, or it may be that a particular ClinOps or compliance perspective they have makes eConsent less palpable to them.
We've encountered ongoing glitches and connectivity issues [with eConsent] that affect our efficiency. Our primary focus is the patient, and starting a screening visit with technical problems isn't ideal. It doesn't foster confidence in the patient-clinic relationship.
eConsent is often an afterthought, and it’s not being leveraged to its full potential. For example, we are not harnessing it to maximize patient comprehension or reduce patient or site burden. And as long as that’s the status quo, eConsent is just a poorly implemented DocuSign solution that just adds more burden and doesn't solve any problems.
In my opinion, eConsent is one of the most challenging solutions to implement due to the site-level ICFs and translations of site-level ICFs. I feel some of the lack of adoption is because we’ve all gotten it wrong while learning how to do it successfully, and unfortunately that hurts sites most (since consent is such a critical piece of the trial and can impact their enrollment). I do think an opportunity still exists, but organizations must have teams that can be more strategic on how it’s rolled out and be more efficient in getting amendments up.
IN THEORY, IT'S REALLY GREAT. BUT …
Of all the people who reached out to me about this eConsent topic, Jess Thompson, MS, MBA, PMP was the most emphatic — i.e., she wrote, “PICK ME! PICK ME!” in her post (😂). She’s the founder and CEO of The Association of Clinical Research Project Managers (ACRPM), but she has experience working for AROs, CROs, and Big Pharma in ClinOps, CTM, and PM roles.
Jess Thompson elaborated on some specifics
regarding her challenges in using/implementing eConsent.
When we spoke, Thompson understood my initial impression of eConsent, saying that “In theory, it's really great.” She talked about the value of being able to send and remotely monitor the consent form (yay, patient-centricity!). There was also the ability to do easy edit checks, and it helps when auditing, such as when you need to make sure no one has missed a signature. Her list of positives, though, pretty much ended there.
The great thing about what followed in our conversation was that it was all based on her actual experiences over the years. I’ve tried to condense some of her main concerns in the bullets below:
- Having another vendor just for eConsent meant that — before we submitted to the IRB — there was an additional review step to make sure there was nothing weird in the ICD that couldn't be digitized.
- The digitization process of the ICD was awful; I don't know why it took so long. Sometimes it would take up to 14 days! And, you had to digitize every site’s ICD because they all had different doctor information.
- Getting sites to agree to eConsent could be challenging. After all, you’re asking them to have tablets onsite and be responsible for ensuring they are working and, possibly, that they have Wi-Fi connectivity. They also have to provide technical support to trial participants.
- Translations can be a problem, because a lot of times the translated versions aren't on the eConsent version; they’re on paper. And now you need a whole other digitization process, and it may even need to be certified again.
- In most studies I was involved with where we pursued eConsent, we couldn't use the actual eConsent platform because it wasn't ready in time. So you might get that IRB approval two days before you want to start enrolling, but then you have to digitize the consent form.
- After realizing the eConsent process was going to take too long, often a company would resort to doing paper ICDs because they knew that would work within their timeline. But then you’re faced with the question: Why are we paying all this money for e-consent if we're not utilizing it because it’s not ready?
This is a divisive topic in our industry, and as such, I’m sure there are plenty of people — especially eConsent vendors — who disagree with Thompson on some of her points. And to be fair, the tech is being used successfully in many cases. So, I asked her about that — where did she see eConsent being a good fit? “In my opinion, it would be something that's not fast moving, so maybe a Phase 1. Something where you’ll have the time to work through all the kinks and the procedures. I think where we fail as an industry is when we try to adopt these technologies without really vetting them on all types of studies.”
I’m sure I could have gone deeper down this eConsent rabbit hole, and I’m guessing some of you may have strong opinions on this subject that I haven’t covered. If so, shoot me an email at dan.schell@lifescienceconnect.com or connect with me on LinkedIn. I look forward to the feedback.