Skip to main content

Data Safety Monitoring

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.

Related Resources

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.

Request a Consult

Consultation is available to help clarify and address ethical issues that arise in human subjects research.

Request a Consult