Jeeva Remote Touchless Informed Consent

eConsent as a Service (eCaaS)

"It is unfair to expect patients or healthy volunteers to visit a hospital or clinic when it is really not necessary when a task can be effectively completed safely, remotely, from the comfort of where they live."

Marshall Summar, MD, Ph.D., Director of Clinical Research, Rare Disease Institute, Children’s National Hospital

What objections do you or your IRB have against the adoption of a digital solution for remote, touchless informed consent?

We have heard them all from hundreds of stakeholders of clinical research.

Our response is the Jeeva eCaaS (eConsent as a Service).

Informed consent does not mean simply getting a research participant’s signature on a consent form. It includes:

• Providing enough information to allow for an informed decision about participating in the clinical investigation
• Verifiably ensuring the potential participant understands the information
• Enough time for the potential participant to ask questions and discuss the trial with friends and family
• Obtaining the potential participant’s voluntary consent to participate
• Continuing to provide clarifications as the study progresses.

Regulators including institutional review boards (IRBs) view informed consent as a divine contract between researchers and patients that is foundational for trust-building. Their objections include a lack of ability to:

• Verify the patient’s comprehension via a quiz or questionnaire;
• Provide convenient means for the patient to ask questions;
• Document—presumably through a signed letter of agreement—that the patient has understood to what he or she is consenting.

Participants raise their own objections to the informed consenting process including:

• A sense of compulsion—that this may be the only chance they have to see the doctor before making a decision;
• A sense of being hurried to make a decision within a 15-min consultation;
• A lack of cultural humility and aspects such as language, religion, or faith, for example, precludes their doing something on a seven-day-a-week schedule.

The best way to deal with these issues, suggests Rajasimha, is to use human-centric technology to resolve these objections.

For clinical research investigators, regulators, and participants, the concerns are free information exchange and verification—all parties understanding what's been communicated—and a way to resolve side issues.

With proper bi-directional digital communication via email, SMS, telemedicine, and video calling, prospective participants can ask questions, discuss the trial with the investigator team, to complete a proper informed consent remotely. Trial sponsors can make background material available in languages relevant to the target populations, including educational videos. Enabling participants and researchers to complete the informed consent process from any browser-enabled device that they are already comfortable with—smartphone, tablet, or laptop—can deliver a superior user experience and maximize diversity, equity, and inclusion.

For far too long, the clinical research enterprise has relied on in-person visits for each activity or procedure to be completed. It is really unfair to expect patients or healthy volunteers to visit a hospital or clinic when it is really not necessary when the task can be effectively completed safely, remotely, from the comfort of where they live.

"Seamless transition to the Jeeva platform. Flexibility in programming. Outstanding live support by JEEVA staff."

Lawrence Cheskin, MD, Ph.D.

Professor and Chair, Nutrition and Food Studies, George Mason University, Fairfax, VA