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Human Subjects Division (HSD)

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Data Safety and Monitoring

When research involves more than minimal risk of harm due to something other than breach of confidentiality, then there must be a Data and Safety Monitoring Plan. A DSMP is a plan for oversight and monitoring of the study to ensure the safety of subjects and the validity and integrity of the data.

Templates for a DSMP are widely available on the websites of the individual institutes of the National Institutes of Health or from the facility where the research will be performed. DSMPs often include stopping rules for when the occurrence of identified events, patterns, or interim results would cause the research to be halted (temporarily or permanently).

A Data and Safety Monitoring Board (DSMB) oversees the implementation of the DSMP.  This committee of scientists, physicians, statisticians and others collects and analyzes data during the course of a study to monitor for adverse effects and other trends (such as an indication that one treatment is significantly better than another, particularly when one arm of the study involves a placebo control) that would warrant modification or termination of the study or notification of subjects about new information that might affect their willingness to continue in the study.

Submit a Data and Safety Monitoring Report to the IRB using the Modification Form, section "N".