Digital health technologies are powerful–enhancing data collection, participant engagement, and personalized health interventions–yet their rapid proliferation has outpaced guidance for research participant protection. Current practice assists researchers in identifying risks but provides limited support for comprehensive risk management. To address this gap, we developed the Digital Health Checklist–Risk Management (DHC-RM) Tool, which integrates the established Digital Health Checklist with approaches from safety risk management.

We conducted a study (n=40) comparing the DHC-RM Tool with current practice using a randomized experimental difference-in-differences design. Primary outcomes were the quantity, variety, and novelty of risks identified; secondary outcomes were the same constructs applied to risk control development.

Compared with current practice, use of the DHC-RM Tool resulted in dramatically improved performance across all primary outcomes. Users identified on average 14.7 additional risks (compared to baseline) versus 0.26 in the control group and a higher number of risks in each of six pre-identified risk domains. Half of all distinct risks identified in the comparison phase were identified exclusively using the tool. The tool also improved risk control design, producing 9.63 additional risk control strategies per participant compared with 0.15 for current practice and yielding substantially greater novelty and variety.

User feedback was also positive: 75% of participants reported they would use the tool again, citing its structured workflow, just-in-time examples, improved insight into risks, and its value for IRB communication. Suggestions for refinement focused primarily on expanding training examples and providing additional support for risk control development.

The DHC-RM Tool significantly improves risk management practice in digital health research. By embedding structured, ethics-informed risk management into digital health research design, the DHC-RM Tool has the potential to improve participant protection while also streamlining ethics approval.

Author Summary Digital health research can put participants (and others) at risk in ways that don’t always occur to the researchers who are designing a study. Researchers also face challenges in prioritizing risks and coming up with ideas to reduce those risks. We developed a new approach, the Digital Health Checklist – Risk Management Tool (DHC-RM Tool), to give researchers the support they need to identify, assess, and address research participant risks in this fast-moving field.

Our experimental study found that use of the DHC-RM Tool led to a very large improvement in how well researchers managed the risks of digital health research studies. Using the toolkit, they were able to identify more risks than they identified using current practice–including risks they would not otherwise have considered. They were also able to come up with more changes to reduce the risks associated with digital health research studies, including changes they would not otherwise have considered. Those who used the toolkit found it beneficial and easy to use.

The DHC-RM Tool fills an important gap in the science and practice of participant protection in digital health research.

The authors have declared no competing interest.

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I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The UC San Diego IRB verified that this study met the criteria for exemption (protocol number 801960).

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The data underlying our study findings are available upon request to the corresponding authors.