With the increase in tech-enabled research tools, researchers are challenged to design studies which take into account certain risks that may be unknown, particularly around data management and patient privacy concerns. While these studies accounted for only about 1.7% of the NIH research budget, it is a clear indication of how future research will be designed and implemented into clinical practice. Increase in digital health research and lack of associated guidanceĪ recent analysis of NIH-supported research revealed a 12-fold increase in studies using pervasive sensing technologies at years: 2005, 2010, and 2015. Given the dynamic and rapidly evolving nature of digital health technology use in research, this tool will need to be further evaluated for usefulness in technology selection. This checklist is the first step in leading the narrative of decision-making when selecting digital health technologies for research. The refined checklist contains four decision-making domains with prompts/questions and ethical principles embedded within the domains of privacy, risk/benefit, data management, and access/evidence. Findings revealed the “ethical principles” domains of respect, beneficence, and justice cut across each decision-making domains and the checklist questions/prompts were revised accordingly and can be found at. We added “ethical principles” to the APA’s hierarchical model and created a checklist that was used by a small group of behavioral scientists ( n = 7).
First, stakeholders ( n = 7) discussed and informed key decision-making domains to guide app/device selection derived from the American Psychiatric Association’s framework that included safety, evidence, usability, and interoperability. A stakeholder-engaged and iterative approach was used to develop, test, and refine a checklist designed to aid researchers in selecting technologies for their research. No guidance exists to facilitate responsible digital technology selection for research purposes. Yet, research leveraging technologies to capture personal health data involve technical and ethical consideration during the study design phase. Digital technologies offer researchers new approaches to test personalized and adaptive health interventions tailored to an individual.
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