Doerr Megan, Maguire Truong Amy, Bot Brian M, Wilbanks John, Suver Christine, Mangravite Lara M
Sage Bionetworks, Seattle, WA, United States.
JMIR Mhealth Uhealth. 2017 Feb 16;5(2):e14. doi: 10.2196/mhealth.6521.
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.
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.
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.
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.
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.
为了充分利用移动技术的优势，开展可扩展的、以参与者为中心的研究，我们必须开发配套的自我管理式电子知情同意（eConsent）流程。在此过程中，我们有道德义务确保知情同意的核心要素——信息充分、理解和自愿——得到维护。此外，我们应警惕重蹈“传统”知情同意流程的覆辙。
我们的目标是描述参与者体验的基本特征，包括通过基于智能手机的自我管理式eConsent流程，勾勒与知情同意相关的常见和新颖主题。我们试图识别与信息充分、理解和自愿相关的参与者反应，并捕捉应用程序介导的研究中与知情同意流程相关的任何新出现的主题。
我们对帕金森病mPower应用程序在6个月内收集的每日一般提示的参与者反应进行了定性主题分析。我们在分析中采用了先验编码和新出现编码相结合的方法。先验编码侧重于知情同意的核心概念；推导出新出现编码以捕捉与自我管理式同意流程相关的其他主题。我们使用研究基线调查中的自我报告人口统计学信息来描述研究参与者和受访者的特征。
在研究期间，9846人完成了eConsent流程并参加了帕金森病mPower研究。总共有2758名参与者提交了7483条评论；初步分类确定了1678名不同参与者提交的3875条相关回复的子集。与所有mPower参与者相比，受访者更有可能自我报告帕金森病诊断（30.21%对11.10%）、女性（28.26%对20.18%）、年龄较大（42.89岁对34.47岁）以及完成更多正规教育（66.23%拥有4年制大学学位或更高学历对55.77%）（所有值P<.001）。在我们的定性分析中，出现了3个概念领域。首先，与完全由他人协助的面对面知情同意环境一致，我们观察到eConsent后对核心研究概念的理解范围很广。其次，我们确定了源自远程移动研究环境的新同意主题，例如研究设计对对照组参与度的影响以及将开放式回复字段误解为与研究人员进行响应式沟通的方法，这些主题值得考虑纳入自我管理式eConsent。最后，我们的研究结果强调了参与者希望成为合作伙伴的愿望。
我们的研究是对通过移动应用程序进行自我管理式知情同意流程的参与者体验的形成性评估。未来的研究领域包括将自我管理式eConsent的效果与他人协助的知情同意流程进行直接比较，探索智能手机用户行为习惯对参与者参与研究的潜在益处和陷阱，以及通过参与者共同参与研究努力来制定提高信息充分、理解和自愿程度的最佳实践。
