Data Safety Monitoring

Overview:

Data safety monitoring is a key part of research, and a plan for evaluating data safety are required for many research studies. These range from plans where the principle investigator or research team reviews the data, to ones where an independent board does so, looking for benefits and dangers of the experimental intervention that may not be apparent or expected. Data safety is an ethical requirement, but much complexity arises in reviewing and assuring this aspect of research.

Ethical Analysis:

Content Needed

General Readings:

FDA guidance for data safety and monitoring committees 

NIH guidelines for data safety and monitoring committees

DeMets, D. L., & Ellenberg, S. S. (2016). Data monitoring committees—expect the unexpected. New England Journal of Medicine, 375(14), 1365-1371.