Rethinking ethical oversight in the era of the learning health system.

View Abstract

Opportunities to advance science increasingly arise through investigations embedded within routine clinical practice in the form of learning health systems. Such activities challenge conventional approaches to research regulation that have not caught up with those opportunities, often imposing burdens generalized from riskier research. We analyze the rules and conventions in the US, demonstrating how even those rules are compatible with a much more flexible approach to participant risk, institutional oversight, participant consent, and disclosure for low-risk learning activities in all jurisdictions.

Investigators
Abbreviation
Healthc (Amst)
Publication Date
2020-08-25
Volume
8
Issue
4
Page Numbers
100462
Pubmed ID
32992106
Medium
Print-Electronic
Full Title
Rethinking ethical oversight in the era of the learning health system.
Authors
Asch DA, Joffe S, Bierer BE, Greene SM, Lieu TA, Platt JE, Whicher D, Ahmed M, Platt R