eConsent in Clinical Research

The use of eConsent, a piece of software that facilitates the online study and signing of informed consent papers by trial participants, has taken off in recent years.

Numerous health research facilities have adopted the use of data apps, and others are considering doing so soon.

The correct technology can assist you in reaching more members, save time on administrative duties like printing and filing, and provide a better patient experience.

Why is eConsent Necessary?

During the epidemic, many locations began using eConsent. Home-based clinical research personnel faced logistical challenges while caring for patients, particularly those infected with COVID-19, and therefore shifted to using electronic resources.

According to several studies, here are factors that have led many organizations to continue using or show interest in eConsent;

Reduces Paperwork

Before the development of technology, collecting consent signatures required scanning paper forms into electronic medical records and then putting the documentation in massive file cabinets. According to clients, using eConsent saves them an average of one hour per consent.

eConsent forms allow OHSU to distribute and collect signed forms in a central location, much like a digital research binder.

Similarly, with the platform, any changes made to a form at the hub site are instantly reflected across all sites that use it. Staff at the location may now spend less time printing and duplicated forms and more time engaging with participants.

Recruitment of More Users

It’s a goal of many research facilities to recruit a more representative sample of the population. To accomplish this, sponsors and sites have begun doing decentralized tests, which use technology and may be held in many places.

Increased participation in decentralized trials is possible with the support of eConsent management. In addition to allowing users to fill out permission forms in their own time, the platform gives coordinating centers more flexibility when collaborating with community sites of a lesser scale.

Make it Easy for Participants to Provide Their Permission

If sites make innovative consent agreements simpler, they can keep more participants. A helpful tool is electronic consent software. Consent forms benefit participants because they are well informed.

Usually, a patient does not want to wait for an extra hour after their doctor’s session to read and sign the permission form. As a result of having to schedule a second visit to return the form, they are hesitant to take one home.

However, with eConsent, people do not have to make a special trip to the clinic to sign the consent form; they may do it online. Many participants prefer eConsent forms because they can review them at their own pace, in the company of their loved ones, and without rushing.

Features of an Ideal eConsent System

Many programs let users make and sign a document, but only some have the compliance and workflow options required by clinical research facilities. The following are characteristics of reliable eConsent tools;

Engage People at Their Place

Find eConsent software that can be used by those who are not computer savvy without causing problems.

Users of the platform’s applications should be able to quickly and easily access their consent papers, read them, put in sign them, load them, and share them with others.

Align With the Site’s Processes

It would be best if you found an eConsent solution that fits well with the process currently in place on your site. Incorporating new users into eConsent and regulatory is a joy if you go with the same provider for both services.

You may monitor each person’s progress through the informed consent process using appropriate software.

Compliance With HIPAA Part 11, IRB, and Other Regulations

Institutional Review Board (IRB) need eConsent solutions to comply with FDA 21 CFR Part 11, HIPAA, and other national and international requirements before they can approve a clinical research site.

Access to eConsent platforms should be controlled, identification must be verified, and users should be given precise permissions. With these settings, the site may limit access to blank and finished documents and signing capabilities for users who have them.

You should be able to see when and by whom new consent papers were posted using the audit trails provided by your program.

eConsent software

With the correct eConsent software, you may increase your site’s value to sponsors by increasing your participant pool, decreasing administrative burdens, and improving trial participants’ overall experience.

However, it would be best to locate an eConsent consistent with Part 11 and HIPAA requirements, user-friendly for participants, and built with research sites’ procedures in mind.