Developing and Implementing a Successful eConsent Process
A highly valuable tool for research staff, electronic consent (eConsent) can simplify the consenting process for both staff and participants. Used effectively, eConsent can increase consenting quality while reducing audit findings at sites. As the industry continues to shift from studies conducted exclusively in person to more convenient hybrid formats, eConsent can be very useful.
When organizations begin to implement an eConsent platform, there are various things to consider to ensure a seamless implementation process.
Understand Organizational Requirements
Before implementing a specific eConsent tool, it may be helpful to understand how this can directly affect not only your organization, but other review committees as well. Specifically, you will need to consult your independent review board (IRB) as you use this platform for informed consent purposes.
Depending on the individual IRB, processes may differ. For example, some IRBs may not require approval of a specific eConsent system, but rather, rely on an attestation stating the eConsent is aligned with the approved consent. In other cases, some IRBs may review the system one time, and any subsequent protocols on the same system are fine. However, other IRBs may want more detailed documentation and screenshots.
In order to effectively understand your organization’s processes, the best thing you can do is speak directly with your IRB. They are there to help you and are willing to answer any questions you may have to ensure a seamless review.
Consider Participant Population
Equally important as organizational requirements, sites must consider their participant population and if the process they are using is effectively serving them. The right process will depend on the type of study conducted; a low risk study has a different process compared to a high risk study. There are also additional factors of the participant population staff need to consider, such as:
- Learning styles
- Access to email
- Access to a clinic
Finding an eConsent platform to support multiple options in regard to language, location, or learning styles is key to ensuring a seamless user experience for participants. Thoughtfully implementing an eConsent platform tailored to your participant population can improve your organization’s patient centricity and help participant-study retention.
Thoroughly Set up the eConsent Platform
Before staff teams begin to use the eConsent system, it must be successfully implemented so they can effectively use it. Investing in the platform’s configuration setup up front will save staff headaches in the future. It gives staff a chance to become confident with the platform prior to a study, and when they work with participants to navigate the platform, it makes it easier for participants to understand what they are using. The more staff understand how to navigate the system, the easier it will be for them to teach participants, which also saves participants time as they use it.
As staff are going through the setup process, it’s helpful to know the way they can configure the eConsent system to streamline the consenting process. eConsent allows staff to configure various requirements, such as signatures, initials, or checkboxes. Additionally, it allows staff to build “rules” or “required fields” around document signatures. This enables coordinators to complete their tasks and necessary signatures (and completing them themselves).
Conduct a Mock Visit
With everything set up in the consent platform, to test everything out, sites may want to consider conducting a mock visit. This is a great way to test the workflows for both participants and staff. Mock visits can be helpful for both remote and in person consenting processes.
While a mock visit is helpful for many reasons, it’s particularly beneficial as research staff are getting ready to use it with trial participants. For many patients, this will be the first time they use a platform to consent, rather than setting up an appointment to go into a clinic to walk through it with a coordinator. They will only be confident using the system if staff are knowledgeable and thorough in explaining how it works. Conducting a mock visit will enable staff to see eConsent from the patient’s viewpoint, understand what they see as they use the platform, and this will help staff better explain the tool as patients navigate it.
Mock visits are also beneficial for staff. Doing a test-run of the platform helps ensure everyone is on the same page and coordinated within the system. Encouraging staff to test out the system helps them see where sticking points could occur within the system. For example, going through a visit may help staff see if all required initials or signatures are marked, or if one particular section of consent needs to be explained in further detail.
An eConsent platform has the ability to transform how participants understand the study they are a part of, and can make the process easier on sites’ behalf as well. Taking steps like these helps ensure your organization is set up for success well before the first patient successfully uses the platform.