The COVID-19 pandemic has necessitated changes to traditional informed consent processes that require in-person interaction and the sharing of physical documents. Remote eConsent solutions allow patients to electronically review, sign, and return consent forms without physical contact with healthcare providers, reducing risks of virus transmission. Benefits of remote eConsent include increased patient engagement, process efficiencies, safety through minimizing in-person interactions and surfaces requiring sanitization, accuracy in documentation, and compliance with regulations through organized electronic records. The pandemic has accelerated adoption of technologies like remote eConsent that were previously seen as optional but are now essential for healthcare organizations to safely operate.

1. Remote eConsent in the COVID-19 Era
Although digital informed consent solutions have been in the marketplace for many years, their
adoption has been slow. For the most part, doctors and medical professionals have remained steadfast
in their approach to the informed consent process. The traditional process is simple and straightforward
enough that it hasn’t required any real change – until now. It’s hard to believe that in 2020, many
healthcare professionals still rely on paper informed consent forms.
In light of the recent COVID-19 pandemic, healthcare organizations around the globe are racing to
update their day-to-day protocols in order to meet new standards, protect their workers, and in some
cases like clinical trials, begin to operate their business again.
New Challenges With The Old Process
In the ERA of COVID-19, the parking lot has become the new waiting room for patients/subjects and
their caregivers. Whereas both parties were welcomed into offices just a few months ago, now the
patient/subject is the only one allowed to enter the hospital or office and their caregiver is required to
stay outside.
The process of carrying clipboards with informed consent to cars, although riddled with inefficiencies
might be acceptable when the weather is nice, but when it’s raining, cold and/or snowing, this process
will no longer be appropriate.
The other inherent challenge with the parking lot paperwork is exposing staff members to many
unnecessary risks such as being hit by a car, slipping on wet pavement, and close interaction with more
people, increasing the risk of contracting COVID-19.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, recently stated: “Even
informed consent has to be re-thought in an era where you don’t want to be passing papers around
amongst various parties.”
Benefits Of Moving To Remote eConsent:

2. Apart from maintaining separation between staff and patients/subjects during a pandemic, eConsent
has numerous advantages over the traditional methods of obtaining informed consent:
Remote eConsent:
Most of the eConsent solutions in the market require a 2-step process, meaning the patient/subject
must sign in front of the healthcare provider, the healthcare provider then signs, and some states even
require a witness to sign as well.
A one step process, on the other hand, allows for a complete remote digital experience. The eConsent
form link is emailed to the patient/subject, they can review it prior to the surgery in the privacy of their
home with caregivers, and signatures are captured from a smartphone, tablet, or desktop computer.
When the provider sees they have completed the eConsent process, they sign in the same manner and
the entire process is complete and stored in a HIPAA compliant database for future reference if needed.
Patient/subject Engagement – Remote eConsent gives patients/subjects more time to read and
comprehend the risks and options available to them before a medical procedure or prior to deciding to
participate in a clinical trial. Studies show an engaged patient/subject produces better outcomes and
helps solidify the doctor/patient/subject relationship.
Efficiency – As with most paper-based processes, moving to a digital process is much more efficient. If
you think about it, using paper informed consent forms requires many small steps that are extremely
inefficient. They are to open the form, fill it out by hand, print, hand it to the patient/subject, retrieve
the form from patient/subject, and scan and attach it to the patient/subject file. On the flip side, digital
informed consents can be generated in seconds, emailed to the patient/subject, reviewed, signed by the
patient/subject or caregiver, and can be completed and accessed by staff for final signature from the
doctor.
Safety – Remote eConsent post COVID-19 helps to minimize face-to-face interaction and eliminates the
possibility of spreading the virus on clipboards, pens, and paper. The fewer items you touch, the fewer
items that need to be sanitized. The chain of touches with paper involves 5 separate “touches” to spread
viral exposure. Front desk person printing the document, assistant/nurse presenting to patient, patient,
back to assistant/nurse, back to front desk to scan into system. Remote eConsent has zero touches
between staff and patients.
Accuracy – With most front-office manual processes, accuracy is diminished when compared to going
digital. Many healthcare organizations and Clinical Research Organizations (CRO) are rightfully
concerned about having the patients/subjects sign the wrong versions of the informed consent forms or
papers getting lost in the shuffle. A Johns Hopkins study found consent forms were missing for 66% of
surgical patients/subjects, which resulted in one out of ten cases being delayed. With eConsent,
participants can complete the forms on their own time, flag sections they want further information from
their doctor about and ask questions directly on the form itself. All of these features are date and time
stamped creating an audit trail if a dispute arises down the road.
Compliance – In connection with the CDC’s guidance and advisories (many of which have been echoed
by state governors), health care practices and facilities should consider implementing a new COVID-
19/Coronavirus Patient/Subject Notice and Acknowledgement Form to:

3. 1. Screen patients/subjects for symptoms of COVID-19, recent international travel history and
knowledge of potential exposure events;
2. Notify patients/subjects of the practice’s/facility’s policies with respect to COVID-19; and
3. Obtain an acknowledgement from the patient/subject that the practice/facility may reschedule
a patient/subject’s appointment for elective care if the patient/subject is exhibiting symptoms
of COVID-19, recently traveled abroad or was subject to a known exposure event.
An eConsent solution should be flexible enough to incorporate the COVID-19 form with the informed
consent form, making the review/signature process fluid. Healthcare regulations must be followed
rigorously to avoid compliance risks and moving to an eConsent solution can help you keep your
documents organized and respond faster and with more confidence in audits and inquiries.
Summary:
This pandemic has accelerated the adoption of technology like never before. What was a “nice-to-have”
became a “must-have” for organizations across all industries to survive working remotely.
Like many other technologies developed over the years, eConsent was once viewed by most healthcare
organizations as a “nice-to-have but we could still get by doing it the old way” mentality. Times have
changed as a result of COVID-19 and all of a sudden, eConsent and other digital healthcare technologies
have moved to one of the top priorities to put in place.