Research Conducted in the Digital World Track

2019 AER Conference

D15 - Mobile Health Research: Regulatory and Ethical Challenges

Speaker(s)

• 

  Luke Gelinas, PhD
  

  Chairperson, Advarra
  Senior Advisor, The Mult-Regional Clinical Trials Center of Brigham & Women's Hospital and Harvard Medical School
• 

  Barbara E. Bierer, MD
  

  Faculty Director, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
  Professor of Medicine, Harvard Medical School
• 

  Laura Odwazny, JD, MA
  

  Senior Attorney, Office of the General Counsel, US DHHS
  

The widespread use of mobile smart devices and wearables (e.g., smart phones and watches) holds the potential to drastically change how clinical research is conceptualized and conducted. While these developments can make research participation less burdensome and potentially improve participation rates, they raise challenges that IRBs and other stakeholders struggle to navigate. This session will address key ethical and regulatory issues associated with mobile health research. First, the session will describe some common forms of mobile health research, examine its key features and how it differs from more traditional research, and give attendees a sense of its breadth. Second, the session will address regulatory challenges that stem from determining the correct regulatory framework and pathway for mobile applications and wearables, stemming from the IRB's practical need to determine whether a device requires submission to appropriate regulatory authorities before research commences and/or qualifies for a non-significant risk determination. Finally, the session will address the ethical issues that bear on the IRB's device risk determination and overall review of the study. During this session, speakers and attendees will:

Learning Objectives:

• Describe some of the common types and key features of research being done with wearable devices and mobile applications
• Discuss the regulatory challenges associated with the use of wearable devices and mobile applications in research and strategies for navigating them
• Identify additional ethical challenges associated with the use of wearable devices and mobile applications in research—in particular, privacy concerns and the responsive obligations of researchers—and strategies for navigating them