Why Now is the Right Time to Adopt eConsent
As the clinical research industry becomes more centered on technology, perhaps one of its most underused solutions is the electronic consent (eConsent) platform. A valuable tool for both sites and participants, there are many benefits to adopting eConsent. This blog outlines why adopting an eConsent platform is a beneficial and strategic step sites can take right now.
eConsent Gives Sites Flexibility
In each study, requirements, risk levels, and participant situations can vary. Typically, there are factors such as:
- The participants’ geographic location
- The general health of the targeted population
- Whether or not legally authorized representatives (LARs) or witnesses are required
eConsent has the ability to adapt to any situation and meet the participant population where they are at. This typically allows participants to consent from wherever they are; there’s no need for them to come into the clinic. This flexibility alone can significantly improve the participant experience. Potential participants can read the consent form at their own pace, re-read if needed, leverage multimedia materials if needed, and consult with family members about if the study is the best option for them.
eConsent Saves Staff Time
Clinical research staff time is incredibly valuable, and team members are constantly juggling multiple tasks at any given time. They need to keep the protocol moving along, and even the most seemingly insignificant mistakes can derail study timelines and place additional stress on staff.
One example of this is participants making mistakes on the informed consent form (ICF). Sometimes, they will write down the wrong date, or they will miss a spot in the ICF where they should’ve initialed. Situations like these can potentially be a significant regulatory burden for staff. Often, they will have to bring the participant back in to correct their mistake. In the worst cases, they may have to report the mistake to their institutional review board (IRB) or receive a warning letter or notice for an audit finding.
Since research staff time and bandwidth are limited, tending to these types of mistakes can pull their attention away from necessary tasks related to the study. Adopting an eConsent platform can significantly reduce or eliminate errors and allow team members to focus on higher-value tasks. For example, eConsent can ensure all dates are current, all signatures accounted for before submitting the ICF, and all materials have been reviewed, minimizing the staff burden and ensuring the study stays on track.
Participants Prefer eConsent
As much as eConsent benefits staff, participants are also likely to prefer it over the paper consenting process. In a recent study done by Memorial Sloan Kettering Cancer Center (MSKCC1), they found more than half of participants prefer clinical trial consent visits to occur via telemedicine versus an in-person appointment. Additionally, MSKCC found telemedicine doesn’t add additional stress during a clinical study – 17% of participants reported they were less stressed when they used telemedicine overall.
There are many other benefits for participants when they engage with an eConsent platform. When agreeing to be a part of a study, participants are giving up time to come into the clinic for appointments, almost always taking them away from their jobs. By using an eConsent platform, participants can consent on their own time and fit it into their schedule, rather than rearrange everything to come into a clinic.
Additionally, participants may feel pressure to consent on the spot; with eConsent, participants have more time to comb through the documents to truly understand what they are consenting to. Agreeing to be part of a clinical trial can be a big ask, and eConsent gives participants the time they need to help them really think through the decision and consult family members if needed.
While there are more benefits to using eConsent than the ones listed above, knowing it’s a platform designed to benefit both staff and participants is unique – and can continually benefit sites time and time again.
1: Electronic Research Consents for complex Early Phase I-II Clinical Trials Integrated with Telemedicine Visits Compared with In-Person Encounters, Michael Buckley, 2022 ASCO Annual Meeting