Stanford Medicine has published the complete results of their study, “Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation.” The study utilized user-owned Apple smartwatches to monitor irregular heart pulses in over 400,000 study participants. The study concluded that this siteless study design, “provides a foundation for large-scale pragmatic studies in which outcomes or adherence can be reliably assessed with user-owned devices.”
Mobile Apps and Human Subjects Research
Mobile Apps and Human Subjects Research is CITI Program’s latest module addition to the Human Subjects Research Catalog. It is now available as a supplemental module for the Biomedical (Biomed) Basic and Social-Behavioral-Educational (SBE) Basic courses. Mobile apps in research help gather much greater amounts of data than traditional means, however, their usage also comes with many considerations. This module:
- Provides researchers and Institutional Review Boards (IRBs) regulatory information about the use of mobile apps in research.
- Discusses ethical issues associated with mobile apps in research and gives practical advice.
- Covers IRB considerations for the review of mobile app-based research.
- Reviews key issues of applicability of FDA regulations for mobile medical apps in research.