Consent Processes for Mobile App Mediated Research: Systematic Review.

BACKGROUND

Since the launch of ResearchKit on the iOS platform in March 2015 and ResearchStack on the Android platform in June 2016, many academic and commercial institutions around the world have adapted these frameworks to develop mobile app-based research studies. These studies cover a wide variety of subject areas including melanoma, cardiomyopathy, and autism. Additionally, these app-based studies target a variety of participant populations, including children and pregnant women.

OBJECTIVE

The aim of this review was to document the variety of self-administered remote informed consent processes used in app-based research studies available between May and September 2016. Remote consent is defined as any consenting process with zero in-person steps, when a participant is able to join a study without ever seeing a member of the research team. This type of review has not been previously conducted. The research community would benefit from a rigorous interrogation of the types of consent taken as part of the seismic shift to entirely mobile meditated research studies.

METHODS

This review examines both the process of information giving and specific content shared, with special attention to data privacy, aggregation, and sharing.

RESULTS

Consistency across some elements of the app-based consent processes was found; for example, informing participants about how data will be curated from the phone. Variations in other elements were identified; for example, where specific information is shared and the level of detail disclosed. Additionally, several novel elements present in eConsent not typically seen in traditional consent for research were highlighted.

CONCLUSIONS

This review advocates the importance of participant informedness in a novel and largely unregulated research setting.