Conducting secondary use of research data in the U.S.

Researchers and sponsors often want to use data from research studies for research not necessarily contemplated in the protocol or informed consent from the study. Scott Loughlin, co-lead of the Hogan Lovells Privacy and Cybersecurity practice, is joined by counsel Melissa Levine to discuss the complex interaction of U.S. federal and state research and privacy laws that affect the secondary use of research data. They tackle what organizations should consider when evaluating whether to proceed with a secondary research use, the compliance considerations, and approaches to obtaining consent for secondary use from the start of the study and ways to mitigate risk when the consent obtained does not cover the intended secondary uses.