Bridging ethical gaps in digital health research: a framework for informed consent aligned with NIH guidance.

Abstract

Background: Digital health technologies, including mobile applications, wearable devices, and sensors, are rapidly transforming clinical research. However, current informed consent practices often fall short of addressing the unique ethical risks introduced by these technologies. This study aims to develop and assess a comprehensive ethical consent framework to improve transparency, equity, and participant protection in digital health research.

Methods: We developed a consent framework aligned with national research ethics guidance, including 63 attributes and 93 subattributes across four domains: Consent, Grantee (Researcher) Permissions, Grantee (Researcher) Obligations, and Technology. We conducted thematic analysis under guidance and then reviewed 25 informed consent forms from real-world digital health studies to expand the guidance and assess each form's alignment with the framework. We used descriptive statistics to measure attribute completeness and to identify missing ethical elements.

Results: None of the consent forms fully adhered to all the required or recommended ethical elements, especially those related to technology-specific risks. The highest completeness for the required attributes reached only 73.5%. We also identified four ethically salient consent elements not present in the current national guidance: commercial profit sharing, study information disclosure, during-study result sharing, and data removal requests.

Conclusions: These findings reveal persistent ethical gaps in participant protection and highlight the need for more comprehensive, equity-oriented consent practices. Our framework offers a practical tool to strengthen transparency, autonomy, and justice in digital health research.