Ethical Considerations in the Conduct of Unregulated mHealth Research: Expert Perspectives

Abstract

To assist in resolving ethical questions surrounding unregulated mHealth research, we conducted in-depth qualitative interviews with experts from four key stakeholder groups: patient/research advocates, researchers, regulatory professionals, and mobile app/device developers. They discussed challenges and potential solutions in the context of two hypothetical scenarios involving unregulated mHealth research, including notifications/permissions for research use of mHealth data, data access procedures, new primary data collection, offering individual research results, and data sharing and dissemination.

Patients’ and Members of the Public’s Wishes Regarding Transparency in the Context of Secondary Use of Health Data: Scoping Review

“…Notwithstanding this important preference for the return of individual results, many underlined the associated challenges, including the interpretation of results by the individual participants [127,146,152], and to a lesser extent, the risk of breach of confidentiality [150]. In addition, other factors seemed to influence preferences regarding the return of individual results, such as whether the medical condition was rare [76]; whether a health professional would be available to explain the results [69]; whether it had been agreed upon at the time of initial consent [81,91,163] (eg, at time of broad consent in the context of a biobank); whether there would be sharing of data with third parties [97], in particular those belonging to nonregulated, nonresearch settings [81]; and whether there might be logistical hurdles or excessive use of resources [146,152,170]. Indeed, many biobank participants may be primarily driven by altruistic motives and do not wish to allocate excessive resources to the return of results [83].…”

“…• Who: identity of data overseers [11,31,41,49,53,76,83,85,98,[100][101][102]115] and data users [11,31,33,34,36, about biobanking generally centered around the control and ownership of biological [11,31,52,[73][74][75][76][77][79][80][81]86,91,113,114,[40][41][42]49,[52][53][54]57,59,60, samples and data, especially with respect to potential misuse by insurers, the government and other third parties" (Joly et al [64] on the views of members of the public). 117,118] • "I'm just trying to say there is this framework, you know we say that there is a governance system in place which will protect the patient and we can look at them…”

“…The second set of generic content is related to data governance (Table 2, row 2). Comprehensive and transparent governance emerged as a key point in the literature from biobanking [64,69,78,102] and appeared to apply to more novel uses of data; for example, secondary use of anonymized mobile phone data [33,65,66,80], unregulated mobile apps [81], novel data linkages [75,132], sharing genomic data [57,85,91], distributed data networks [40,109,138], or artificial intelligence [79,108,139]. The most common content elements pertain to the structure of governance, nature of secondary use [42,76], and the identity of data users, in particular if sharing with the industry [38,40,61,75,93,97,104].…”

“…Legal framework [35,81,124,126,127] aspects [31,33, demonstrate the legitimacy of researchers' access to data" (Mamo et al [40] on the…”

Expert Perspectives on Oversight for Unregulated mHealth Research: Empirical Data and Commentary

“…• Patient and research participant advocates ("Advocate") • Researchers who are integrating mHealth technologies into their studies, including independent researchers and citizen scientists ("Researcher") • Regulatory and policy professionals ("Regulatory") • App and device developers ("Developer") Data collection and analysis are described in detail elsewhere in this issue. 5 In brief: Based on our knowledge of the issues and in consultation with the larger research team, we developed, pilot tested, and finalized a semi-structured interview guide centered around hypothetical scenarios involving two commercial mHealth apps collecting health, behavioral, and other data which may be shared for various purposes including research. Here we report findings in response to the following question:…”