Enhancing Research Conduct Using eConsent
Perhaps one of the most important aspects of a clinical trial is the informed consent process. Stemming from the ethical principle of Respects for Persons in 1976, the Belmont Report established informed consent parameters, a process designed to provide information to allow potential participants to make the best decision for themselves. This must occur prior to participating in the research.
Since then, there have been U.S. federal regulations established for informed consent, primarily through OHRP, and codified in 45 CFR 46.116 and 46.117. FDA-regulated products are codified in 21 CFR 50.25 and 50.27.
Currently, there are no federal regulations specifically covering electronic consent. This blog defines eConsent, offers considerations for conducting eConsent, and navigates communicating with your institutional review board (IRB) as you figure out how to include this process at your organization.
What is eConsent?
Simply put, eConsent is the documentation of informed consent that is done electronically. It can facilitate informed consent over long distances via methods such as video conference, telephone, or eConsent platform.
Using various media can enhance the potential participant’s understanding of the clinical trial while being more interactive. eConsent can include hyperlinks, images or videos, and other interactive elements. The idea is to give potential participants a better understanding of things such as definitions, procedures they will have, or perhaps what it will look like to them the day they come into the clinic, all in an understandable and easy-to-read format.
eConsent is not an all or nothing process, and it does not mean you will conduct all of your informed consents virtually, remotely, or without study team interaction. Depending on your study type and needs, eConsent can be used:
- A fully in-person consenting workflow
- A fully virtual or remote consenting workflow
- A hybrid in-person and virtual consenting workflow
Moving to an eConsent method should positively impact your staff and study timelines, too. Ultimately, you should want to see staff time going toward meaningful and valuable things. From a data perspective, on average, 5-8% of data entered is wrong – think one in every 20 fields has an error. If your organization can reduce errors through having correct dates in the right places and documents where they need to be, it will benefit researchers analyzing data, the monitors, and the rest of the staff.
There are many elements to consider when designing a research study to include eConsent, including programmatic, study, and regulatory factors.
You should understand if your research site can access proper technology to adequately execute an eConsent process. Technology should enhance the process, not become burdensome. Is it easy to use for your coordinators? Ask yourself this question before implementing a process on coordinators that could potentially add more work on top of what they’re already doing.
It helps to create template plans and standard operating procedures (SOPs) outlining how to conduct a consenting process over video conference, phone, or without any direct contact. As staff talk to potential participants, they will need to have account access to record information and track consenting. These SOPs should help everyone understand how to make the process more sustainable. It also helps to work with your IRB to create consistencies across studies to avoid study deviations.
Using eConsent still needs to make sense to both staff and participants. As previously mentioned, using eConsent doesn’t mean all informed consents are conducted without an in-person component. Keeping this in mind, study staff will need to decide who needs to be in the room while having these conversations.
Additionally, there must also be a component defining how staff will assess participant understanding. There are many factors to consider as you ensure your participants will still understand the consent process, including:
- Do they have technology available and know how to use it?
- Is the informed consent form (ICF) in their primary language?
- Are you gaining their trust before inviting them to participate?
- Do they know how to get any study questions addressed?
Staff teams must also make sure regulatory compliance is upheld during the electronic consenting process. If you’re conducting Food and Drug Administration (FDA)-regulated research, electronic signatures will fall under 21 CFR Part 11 compliance. In order to meet this standard, you must make sure both your platform and processes are validated before moving forward.
For non-FDA-regulated research, participant confidentiality is still of utmost importance. Data, including participant signature, name, and identification in the research, must also be protected. Enforcing processes will make sure everything is protected.
Communicating With Your IRB
As your organization begins to move towards an electronic consenting process, you must communicate with your IRB. Keep in mind, the IRB only grants permission, not forgiveness. Your IRB must issue approval on your processes prior to using eConsent.
Your IRB will have many of the same considerations for an eConsent process as a traditional consent process. They’ll look for components such as if the consent form is in a participant’s primary language and uses understandable terms. Participating in a clinical trial often takes up a considerable amount of time for a participant. The IRB will want to know if they are given opportunities to ask questions during the consenting process, receive clarifications, and have time to decide if this opportunity is right for them.
Lastly, technology is a huge component of eConsent. With this in mind, IRBs will want to know how equitable selection of participants occur. Will technology usage inhibit people with impaired access from being able to participate? Having these questions at the ready as you approach your IRB will help keep the process smooth and show the IRB you’re keeping the participants in mind.