Awareness and Collaboration Across Stakeholder Groups Important for eConsent Achieving Value-Driven Adoption

Area of Science:

• Clinical Research Technology
• Digital Health Innovations
• Patient Engagement Strategies

Background:

• Traditional clinical trial informed consent remains paper-based, posing challenges to quality, compliance, participant understanding, and retention.
• The increasing complexity of clinical studies highlights the inefficiencies of paper-based informed consent processes.
• Electronic informed consent (eConsent) leverages multimedia for interactive experiences, aiming to improve data quality and address traditional process limitations.

Purpose of the Study:

• To assess stakeholder perceptions, experiences, and concerns regarding the implementation of electronic informed consent (eConsent) in clinical trials.
• To understand the perspectives of participants, clinical trial sites, ethics committees, and health authorities on eConsent adoption.
• To identify barriers and facilitators for the widespread use of eConsent technology.

Main Methods:

• A multifaceted engagement approach was employed by the TransCelerate eConsent Initiative.
• Stakeholder feedback was gathered through surveys (n=3045 participants), advisory boards (n=10), site interviews (n=9), and nonbinding meetings with health authorities.
• Analysis focused on understanding diverse stakeholder concerns and preferences related to eConsent implementation.

Main Results:

• Stakeholders expressed support for multimedia components in eConsent, but raised specific concerns.
• Participant feedback indicated data privacy concerns and varied preferences for multimedia presentation.
• Site concerns included operational burdens and technology reliability, while ethics committees noted potential impacts on operational processes. Health authority feedback varied geographically.

Conclusions:

• Despite growing interest in eConsent, continued collaboration among stakeholders and industry is crucial for its mainstream adoption.
• Developing robust technological capabilities, clear regulatory pathways, and streamlined operational processes are essential for overcoming current challenges.
• Addressing identified concerns regarding privacy, operational impact, and technology is necessary to facilitate the widespread use of eConsent in clinical research.