Ambra Shpendi’s research while affiliated with KU Leuven and other places

Mental health-related data generated by app users during the routine use of Consumer Mental Health Apps (CMHAs) are being increasingly leveraged for research and product improvement studies. However, it remains unclear which ethical safeguards and practices should be implemented by researchers and app developers to protect users during these studies, and concerns have been raised over their current implementation in CMHAs. To better understand which ethical safeguards and practices are implemented, why and how, 17 app developers and researchers were interviewed who had been involved in using CMHA data for studies. Interviewees discussed the impact on stakeholder interests, sufficiency thresholds and procedural alterations of informed consent, data protection, gathering app user perspectives and representing users in app design and study conduct, and ensuring adequate support. Although the reasoning behind how and why these ethical safeguards and practices should be implemented showed considerable variability and several gaps, interviewees converged on various general lines of reasoning. This allowed for the development of a coherent and nuanced account that could prove useful for future CMHA studies and which could stimulate further normative investigation of the role of ethical safeguards and practices in these studies.

Consumer mental health apps (MHAs) collect and generate mental health-related data on their users, which can be leveraged for research and product improvement studies. Such studies are associated with ethical issues that may be difficult for researchers and app developers to assess. To improve ethical study conduct, governance through rules, agreements and customs could be relied upon, but their translation into practice is subject to barriers. This qualitative interview study with 17 researchers and app developers looked into the role and impact of governance standards on consumer MHA studies. Interviewees experienced a significant number of rules, agreements and customs, although not all of the governance standards that can potentially be applicable. Standards did have an impact on the interests of researchers and app developers, app users and society, but this impact was mediated by several barriers related to their conceptualization and implementation. Conceptualization barriers impacted the development of a standard, the inclusion of relevant concepts and the coordination between standards. Implementation barriers concerned the resource cost of understanding a standard, as well as suboptimal enforcement. The framework developed in this study can support more effective efforts to improve the governance of future consumer MHA studies.