Formative Evaluation of Participant Experience With Mobile eConsent in the App-Mediated Parkinson mPower Study: A Mixed Methods Study

Abstract

Background: To fully capitalize on the promise of mobile technology to enable scalable, participant-centered research, we must develop companion self-administered electronic informed consent (eConsent) processes. As we do so, we have an ethical obligation to ensure that core tenants of informed consent-informedness, comprehension, and voluntariness-are upheld. Furthermore, we should be wary of recapitulating the pitfalls of "traditional" informed consent processes.

Objective: Our objective was to describe the essential qualities of participant experience, including delineation of common and novel themes relating to informed consent, with a self-administered, smartphone-based eConsent process. We sought to identify participant responses related to informedness, comprehension, and voluntariness as well as to capture any emergent themes relating to the informed consent process in an app-mediated research study.

Methods: We performed qualitative thematic analysis of participant responses to a daily general prompt collected over a 6-month period within the Parkinson mPower app. We employed a combination of a priori and emergent codes for our analysis. A priori codes focused on the core concepts of informed consent; emergent codes were derived to capture additional themes relating to self-administered consent processes. We used self-reported demographic information from the study's baseline survey to characterize study participants and respondents.

Results: During the study period, 9846 people completed the eConsent process and enrolled in the Parkinson mPower study. In total, 2758 participants submitted 7483 comments; initial categorization identified a subset of 3875 germane responses submitted by 1678 distinct participants. Respondents were more likely to self-report a Parkinson disease diagnosis (30.21% vs 11.10%), be female (28.26% vs 20.18%), be older (42.89 years vs 34.47 years), and have completed more formal education (66.23% with a 4-year college degree or more education vs 55.77%) than all the mPower participants (P<.001 for all values). Within our qualitative analysis, 3 conceptual domains emerged. First, consistent with fully facilitated in-person informed consent settings, we observed a broad spectrum of comprehension of core research concepts following eConsent. Second, we identified new consent themes born out of the remote mobile research setting, for example the impact of the study design on the engagement of controls and the misconstruction of the open response field as a method for responsive communication with researchers, that bear consideration for inclusion within self-administered eConsent. Finally, our findings highlighted participants' desire to be empowered as partners.

Conclusions: Our study serves as a formative evaluation of participant experience with a self-administered informed consent process via a mobile app. Areas for future investigation include direct comparison of the efficacy of self-administered eConsent with facilitated informed consent processes, exploring the potential benefits and pitfalls of smartphone user behavioral habits on participant engagement in research, and developing best practices to increase informedness, comprehension, and voluntariness via participant coengagement in the research endeavor.

Keywords: Parkinson disease; informed consent; mobile applications; research ethics; smartphone.