Testing and Practical Implementation of a User-Friendly Personalized and Long-Term Electronic Informed Consent...

Area of Science:

• Clinical Research
• Human-Computer Interaction
• Health Informatics

Background:

• Growing interest in electronic informed consent (eIC) for clinical research.
• User-friendliness and stakeholder acceptance are vital for successful eIC implementation.

Purpose of the Study:

• To gather insights for designing and implementing a user-friendly, personalized, long-term eIC application.
• To assess integration into daily practice through usability studies and stakeholder interviews.

Main Methods:

• Iterative usability testing of an eIC prototype with Belgian citizens, including those with low digital literacy.
• System Usability Scale questionnaires and semistructured interviews with participants and stakeholders (ethics committee members, healthcare professionals, pharmaceutical industry representatives).
• Thematic analysis of qualitative data using NVivo software.

Main Results:

• Usability scores for personalization and long-term interaction improved over 3 iterations, indicating above-average usability.
• Stakeholders identified needs for easy setup features, like a content library, but found some functionalities, such as new study notifications, less useful.
• Low digital literacy presented a challenge, suggesting a need for tailored support.

Conclusions:

• Usability testing is essential for enhancing eIC application user-friendliness.
• While the eIC system shows potential, additional support or alternatives are needed for individuals with low digital literacy.
• Practical implementation requires easy setup and interoperability with existing systems.