Unregulated Health Research Using Mobile Devices: Ethical Considerations and Policy Recommendations

Behavioral scientists are developing new methods and frameworks that leverage mobile health technologies to optimize individual level behavior change. Pervasive sensors and mobile apps allow researchers to passively observe human behaviors “in the wild” 24/7 which supports delivery of personalized interventions in the real-world environment. This is all possible because these technologies contain an incredible array of sensors that allow applications to constantly record user location and can contextualize current environmental conditions through barometers, thermometers, and ambient light sensors and can also capture audio and video of the user and their surroundings through multiple integrated high-definition cameras and microphones. These tools are a game changer in behavioral health research and, not surprisingly, introduce new ethical, regulatory/legal and social implications described in this article.

Section: Unregulated Citizen Sciencementioning

confidence: 99%

mHealth Research Applied to Regulated and Unregulated Behavioral Health Sciences

Nebeker¹

2020

“…17 These provisions, in theory, respond to the quality concerns associated with independent researchers and citizen scientists. 18…”

Section: Virginiamentioning

confidence: 99%

Mobile Research Applications and State Research Laws

Tovino

2020

Self Cite

This article assesses the protections provided by state research laws for participants in mobile application (mobile app) mediated health research conducted by independent scientists, citizen scientists, and patient researchers. Prior scholarship in this area focuses on the lack of application of: (1) federal regulations governing research conducted or funded by one of sixteen signatory federal departments and agencies (the Common Rule); and (2) separate federal regulations promulgated by the Food and Drug Administration applicable to research conducted in anticipation of a submission to the FDA for approval of a drug or medical device. This article builds on this prior scholarship by carefully examining state research laws and suggesting ways in which these laws could be improved to better protect participants of mobile appmediated research conducted by independent scientists, citizen scientists, and patient researchers.

“…Elsewhere in this symposium, the main research team makes recommendations for a series of mea-sures, including education, consultation, transparency, self-governance, and regulation to address the welfare and interests of research participants, as well as the broader public, in mHealth research. 59 Our intent here is not to duplicate those recommendations (which we endorse), but rather to elaborate on the types of measures that should be considered when unregulated mHealth approaches aim to promote more diverse research participation. Because past research abuses have disproportionately impacted communities of color, 60 there is a heightened obligation for unregulated mHealth researchers to anticipate and, wherever possible, actively minimize such risks.…”

Section: Unraveling the "Gordian Knot": Promoting Inclusion Whilementioning

confidence: 99%

Diversity and Inclusion in Unregulated mHealth Research: Addressing the Risks

Callier¹,

Fullerton²

2020

mHealth devices and applications, with their wide accessibility and ease of use, have the potential to address persistent inequities in biomedical research participation. Yet, while mHealth technologies may facilitate more inclusive research participation, negative features of some unregulated use in research — misleading enrollment practices, the promotion of secondary mHealth applications, discriminatory profiling, and poorer quality feedback due to dependencies on biased data and algorithms — may threaten the trust and engagement of underrepresented individuals and communities. To maximize the participation of currently disenfranchised groups, those involved in unregulated mHealth research must become aware of potential risks, adopt targeted education policies, audit algorithms for hidden biases, and engage citizen scientists and other community members to identify and forestall possible harms.