Testing and Practical Implementation of a User-Friendly Personalized and Long-Term Electronic Informed Consent Prototype in Clinical Research: Mixed Methods Study

Abstract

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

Objective: This study aims 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 semistructured interviews with stakeholders on the practical integration of such an application into their daily practice.

Methods: An eIC prototype was evaluated and refined through usability testing among Belgian citizens and iterative redesign. On the basis of 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 questionnaire and taking part in a semistructured feedback interview. Furthermore, semistructured 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 the NVivo software (Lumivero).

Results: In total, 3 iterations of usability tests were conducted with 10 participants each. Each cycle involved some participants who reported having low digital skills. The System Usability Scale 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. Semistructured 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. The study findings showed that usability testing is key to assessing and increasing the user-friendliness of an eIC application. Although this eIC system has the potential to be usable by a wide audience, participants with low digital literacy may not be able to use it successfully, highlighting the need for additional support for participants or other alternatives to an eIC system. In addition, key lessons emerging from the interviews included ensuring that the application is easy to implement in practice and is interoperable with other established systems.

Keywords: digital health; human-centered design; implementation; informed consent; qualitative research; stakeholders; trial.

Figure 1

Screenshot of the electronic informed consent prototype in the first iteration—multiple layers of information. Participants can navigate between the concise and extensive layers to hide or access additional information, respectively. If the information is not clear, participants can indicate that they have questions using the buttons at the bottom of the screen.

Figure 2

Screenshot of the electronic informed consent prototype in the third iteration—offering information in layers.

Figure 3

Screenshot of the electronic informed consent prototype in the third iteration—indicating unclear information.

Figure 4

Screenshot of the electronic informed consent prototype in the third iteration—marking questions as resolved.

Figure 5

Screenshot of the electronic informed consent prototype in the third iteration—presentation of the actions of changing preferences and withdrawing consent on different interfaces.

Figure 6

Screenshot of the electronic informed consent prototype in the third iteration—presentation of the concrete changes of a new informed consent form version.

Figure 7

Screenshot of the electronic informed consent prototype in the third iteration—presentation of the information sections of a new informed consent form version.