JMIR Publications

ABSTRACT

Background:

Over the years, increasing interest has been shown in electronic informed consent (eIC) in clinical research. The user-friendliness of an eIC application and its acceptance by stakeholders have a central role in achieving successful implementation.

Objective:

This study aimed to identify insights for the design and implementation of a user-friendly personalized and long-term eIC application, based on a usability study with (potential) research participants and semi-structured interviews with stakeholders on the practical integration of such an application in their daily practice.

Methods:

An eIC prototype was evaluated and refined through usability testing among Belgian citizens and iterative redesign. Based upon a digital literacy questionnaire, a heterogeneous sample of participants was established. Participants needed to complete a series of usability tasks related to personalization and long-term interaction with the research team while using the ‘think aloud’ technique. In addition, usability tests involved completing the system usability scale (SUS) questionnaire and taking part in a semi-structured feedback interview. Furthermore, semi-structured interviews were conducted with ethics committee members, health care professionals, and pharmaceutical industry representatives, active in Belgium and involved in clinical research. Thematic analysis was undertaken using NVivo software.

Results:

In total, three iterations of usability tests were conducted with 10 participants each. Each cycle involved some participants who reported having low digital skills. The SUS scores related to the tasks on personalization and long-term interaction increased after each iteration and reached 69.5 (SD=8.35) and 71.3 (SD=16.1) out of 100, respectively, which represents above-average usability. Semi-structured interviews conducted with health care professionals (n=4), ethics committee members (n=8), and pharmaceutical industry representatives (n=5) identified the need for an eIC system that can be easily set up. For example, a library could be established, enabling stakeholders to easily provide background information about a clinical study, presented in the second layer of the interface. In contrast, some functionalities, such as informing participants about new studies through an eIC system, were not considered useful by stakeholders.

Conclusions:

This study provides insights for the implementation of a user-friendly personalized and long-term eIC application. Study findings show that usability testing is key to assess and increase the user-friendliness of an eIC application. Although this eIC system has the potential to be usable by a wide audience, low-literate participants may not be able to use it successfully, arguing for additional participant support or other alternatives to an eIC system. In addition, key lessons emerging from the interviews include ensuring the application is easy to implement in practice and is interoperable with other established systems.