October 10, 2025BMC Medical EthicsOpen Access

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

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The framework aims to enhance informed consent practices in digital health research, addressing ethical gaps.
Only 73.5% of required attributes were met in reviewed informed consent forms, revealing significant compliance issues.
Thematic analysis was performed alongside reviews of 25 consent forms to assess the framework's applicability and effectiveness.
The findings emphasize the urgent need for enhanced equity-oriented consent practices in digital health research.

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Developed framework improves transparency and participant protection in digital health research, highlighting ethical gaps.

Alifia et al. (2025) studied this question.

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