Consent Processes for Mobile App Mediated Research: Systematic Review

Abstract

BackgroundSince 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.ObjectiveThe 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.MethodsThis review examines both the process of information giving and specific content shared, with special attention to data privacy, aggregation, and sharing.ResultsConsistency 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.ConclusionsThis review advocates the importance of participant informedness in a novel and largely unregulated research setting.

Development and Presentation of an Ethical Framework for Health and Medical Apps

“…A total of 32 references has been included in this review. (Figure 1) Of these, 18 references were journal articles, [9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] seven reviews, [27][28][29][30][31][32][33] three systematic reviews, [34][35][36] two survey results from Australia 37 and the USA, 38 one study report from Germany 6 and one qualitative study from Australia. 39 For further discourse, the principles of biomedical ethics defined by Beauchamp and Childress function as ethical endpoints.…”

“…25 In addition, several publications have highlighted the use of health applications in research and related ethical challenges. 16,31,32,38 Five publications deal with ethical concerns regarding the regulation and approval of health and medical apps. 6,11,18,33,34 Only one publication addresses developers of health and medical apps and emphasises ethical principles that should be considered in the development phase.…”

“…6,9,10,12,13,15,16,20,21,22,25,26,30,31,37,38 In this context, privacy means having the individual right to be in control of the collection, use and transfer of personal data whereby the ways of delivering information should be communicated transparently. 10,12,13,16,20,31,32 The confidential handling of sensitive information can be ensured, for example by encryption via password or access authorisation by authorised persons. 10,14,23 Privacy includes data privacy, personal privacy and security.…”

“…Thirteen publications deal with this concept. 6,9,12,13,22,24,26,29,31,32,35,36,38 Access to health services is facilitated by the ubiquity of health and medical apps. The main purpose is to reduce global health inequalities by including groups that are hard to reach, and to enable disease control.…”

Human-Computer Interaction, Ethics, and Biomedical Informatics

“…Other efforts have explored interface designs intended to slow users down in the hopes of increasing comprehension [70], and the use of learning theory to design consent content [71]. A review of research on consent processes for research mediated by mobile apps found a range of practices, including some not found in traditional consent, such as assessments of consent understanding and the use of finger-drawn singatures [72]. The broad range of delivery methods, study designs, and assessments used in these studies suggests a need for further work to better understand which approaches might work best in which contexts.…”