Health Research with Big Data: Time for Systemic Oversight.

To address the ethical challenges in big data health research we propose the concept of systemic oversight. This approach is based on six defining features (adaptivity, flexibility, monitoring, responsiveness, reflexivity, and inclusiveness) and aims at creating a common ground across the oversight pipeline of biomedical big data research. Current trends towards enhancing granularity of informed consent and specifying legal provisions to address informational privacy and discrimination concerns in data-driven health research are laudable. However, these solutions alone cannot have the desired impact unless oversight activities by different stakeholders acquire a common substantive orientation. [ABSTRACT FROM AUTHOR]