A01 - With Great Data Comes Great Responsibility—Data Lifecycle Review Strategies

While IRBs spend a lot of energy ensuring the protection of people in SBER, they may not spend equal time reviewing the management of the resultant data once a person's corporeal participation has ended in a study. Those data, however, represent real individuals and have a lifecycle all their own. Thus, one could argue, IRBs and researchers should expend equal energy developing and reviewing plans for the protection and management of the data throughout the entirety of a study—from inception to the sharing of the data after publication. Doing so requires that IRBs and researchers understand the data protection and management issues that may arise during collection and handling, sharing, re-use, and access in addition to regulatory, sponsor, journal, and professional association requirements. This session will focus on the data management and protection issues that may arise in each stage of the lifecycle of an SBE study involving human subjects and strategies for IRBs and researchers to address them.