Abstract: Academic institutions are building large extracts of their electronic health record (EHR) for discoveries, data sharing, registries, multiple machine learning (ML), and other research projects. Many institutional review boards (IRB) are unclear how to provide governance for such pluripotent databases. IRBs are conflicted between the need to protect patients and conform to regulations, through release of the “minimal” amount of information possible, while at the same time promoting research. Using a real case, an example of an IRB Big Data request submitted to the Johns Hopkins Data Trust Research Subcouncil will be presented. Four panelists from the informatics community will provide 5−10 min comments of their perspectives. A fifth panelist, the assistant dean responsible for human subject protection at Johns Hopkins, will respond. We will then have a brief response by the panelists and an open discussion by the audience.

Learning Objective 1: Articulate the dilemmas in creating pluripotent databases for discovery and other research

Learning Objective 2 (Optional): Describe the federal regulatory regime that governs the creation and oversight of pluripotent databases for research

Learning Objective 3 (Optional): Explain the degree to which informatics solutions may alleviate the dilemma

Learning Objective 4 (Optional): Specify action items the informatics community can take to further the use of pluripotent databases for research


Harold Lehmann (Presenter)
Johns Hopkins

William Hersh (Presenter)
Oregon Health & Science University

Jihad Obeid (Presenter)
Medical University of South Carolina

Megan Singleton (Presenter)
Johns Hopkins School of Medicine

Anthony Solomonides (Presenter)
NorthShore University HealthSystem

Umberto Tachinardi (Presenter)
University of Wisconsin-Madison

Presentation Materials: