Research Conducted in the Digital World Track
2019 AER Conference
E15 - The Regulatory and Ethical Implications of Melding Consumer "Big Data" With Medical "Big Data"
.jpg "Elizabeth A. Buchanan, PhD <br> photo")
Elizabeth A. Buchanan, PhD
Endowed Chair in Ethics, University of Wisconsin-Stout
James Riddle, MCSE, CIP, CPIA, CRQM
Vice President, Institutional Services & Strategic Consulting, Advarra, Inc.
Speaker(s)
The increasing availability of consumer "big data" has entered the health outcomes and research world. From the Obama administration cancer initiatives to NIH genomics sharing requirements, the utilization and re-use of data is an ever present and evolving field. What are the implications of melding all the research data, with its fortifications of protections from the Health Insurance Portability and Accountability Act and the revised Common Rule, with the relatively looser world of consumer data? How does the European Union General Data Protection Regulation fit in? If the data exists, why shouldn't consumer habits be matched with medical records to study health outcomes? This session will explore the regulatory and ethical considerations presented by use of "big data" in a research setting, along with what sponsors and investigators should know about their human subjects protections obligations in this area. During this session, speakers and attendees will:
Learning Objectives:
- Explain the regulations surrounding research use of data
- Examine where the utilization of consumer data crosses into research
- Discuss the ethical and practical implications of utilization of big data in research