American Thrombosis and Hemostasis Network and DFconsent

Grappling with the inadequacies of the existing paper-based consent process — magnified when patients are children — prompted ATHN to look for a better solution. This success story shares the development journey of DFconsent, an eConsent solution that informs and engages.

DFconsent: An eConsent Solution that Informs and Engages

DFconsent is an integrated electronic informed consent (eConsent) application, developed with the core mission of providing a valid, 21 CFR 11-compliant, electronic informed consent process that:

Facilitates clinical trials,
Is participant-friendly and easy to navigate, and
Integrates with DFdiscover and other EDC platforms.

The Timing Was Perfect

The DFconsent solution hit the market at just the right time. Development of the application began in 2017, in partnership with the American Thrombosis and Hemostasis Network (ATHN), which wanted to reconstruct its informed consent process with the twin goals of better informing patients and replacing one of the last paper-based forms they were using.

Then, beginning in early 2020, the COVID-19 pandemic exponentially accelerated the paradigm shift to increasingly digital management of clinical trials. Sponsors and sites were and are looking for better ways to facilitate informed consent without requiring face-to-face contact between study participants and study staff.

The Need for Better Informed Consent

The American Medical Association states that: “Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care.

Successful communication in the patient-physician relationship fosters trust and supports shared decision making.”1 However, in practice, what this often looked like was a document filled with legalese, often thrust upon patients to read and sign right before their procedure. Informed consent seemed focused more on protecting the provider than on educating and empowering the patient. It was widely felt that clinical trials used informed consent forms that contained information but did not inform.

First Developed for Pediatric Clinical Trials

The American Thrombosis and Hemostasis Network (ATHN), founded in 2006, is a non-profit organization serving people affected by bleeding and clotting disorders through its clinical studies, its national database of research, and its partnerships with the national network of hemophilia treatment centers. Grappling with the inadequacies of the existing paper-based consent process — magnified when patients are children — prompted them to look for a better solution.

Programmatically, the step from electronic data capture (EDC) development to electronic informed consent development was easy.

DFconsent developers worked to identify essential overall clinical concepts in pediatric studies to ensure those were embedded in the DNA of the application. In pediatric trials, lab normals are more complex, six-month age differences often require different data ranges, and how information is provided to children and their parents requires more steps and more attention to language than adult-only studies do.

The developers also used culturally appropriate language to solicit ages, genders, ethnicities, identities, financial, and social information.

To comply with 21 CFR Part 11, the developers built in a validated electronic signature process with the required authentication and audit trails.

Next, they worked to create a consistent experience within a specific informed consent interaction, using common elements such as radio buttons, check boxes, and text boxes in the electronic forms that closely matched the paper originals while translating easily to different screen sizes and operating systems.

The study narrative is spread through several ‘pages’ of the informed consent process, replicating in-person interactions in easily digestible amounts.

Multiple Options for Clinicians and Patients

The education and signing process can be paused and recontinued at any time and pace that suits the participant. Each radio button, check box, text entry, and deletion is captured in an audit trail, giving the site administrator evidence of the participant’s ability to complete or challenges with the forms.

Within the DFConsent app, study participants can move forward and backward through the various screens, use the chat function at any time to connect with the site personnel, view educational videos, click on links to navigate to a glossary where concepts are described in more detail with plain language, or make a call by simply clicking a phone icon. This allows participants to ask questions, express doubts, receive answers, and learn more, making the process more educational and less intimidating.

Simple Yes/No or A/B choice questions at each stage of the process confirm the participant’s understanding; incorrect answers take the participant to additional education and guidance until that particular step was clearly understood.

Administrators also have the ability to reset a form or introduce new forms to a participant. This makes it possible to customize forms based on a participant’s age, or to add screens to capture the signature of a guardian or other patient representative.

Acceptance Success

The draft DFconsent forms were submitted to ATHN’s Institutional Review Board, and were approved.

The development process was a positive experience for everyone. ATHN successfully adopted the DFconsent application, experiencing no “first-to-market” failures. Everyone involved in the process chose to use DFconsent in their next studies.

The Benefits of DFconsent

The success of DFconsent in ATHN’s pediatric studies demonstrated the application’s efficacy and effectiveness. Additionally, DFconsent’s operational efficiencies provided both immediate improvements and long-term financial advantages to the informed consent process. ATHN adopted it for use in its following studies and features it on their website.

DFconsent can be a success story for any clinical trial. As an optional tool in the DFdiscover suite, it integrates with DFdiscover. Its forms can be quickly and easily tailored to capture the requirements of any study, and it supports other languages, with ease of choice among them.

As clinical studies become increasingly electronic, there are opportunities for CROs, clinical trial sponsors, and site personnel to adopt electronic informed consent. DFconsent is participant- friendly, educational, streamlined, easily customizable, and a regulation-compliant solution that can be effortlessly added to any study managed by DFdiscover. DFconsent will increase your ability to recruit and engage an informed cohort, moving studies forward to a better future.

1 https://www.ncbi.nlm.nih.gov/books/NBK430827/

To see how DFconsent can improve your clinical trials, schedule a demo today.