• Does my research need data and safety monitoring?
• Does my research need a Data and Safety Monitoring Plan?
• Does my research need a Data and Safety Monitoring Board?

Does my research need data and safety monitoring?

45 CFR 46.111(a)(6) states the following requirement for IRB approval of human subjects research:

“When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.”

Does my research need a Data and Safety Monitoring Plan?

The NIH Policy for Data and Safety Monitoring states that all NIH funded clinical trials require a Data and Safety Monitoring Plan and that monitoring should be commensurate with risk.

Most NIH Institutes/Centers have individual Data and Safety Monitoring policies. Click here for the links to I/C-specific policies.

Does my research need a Data and Safety Monitoring Board?

• Data and Safety Monitoring Boards (DSMBs) are specifically required for multi-site clinical trials with interventions that entail risk(s) to participants
• DSMBs are generally required for Phase III clinical trials
• A DSMB may be required for Phase I, Phase II or Phase III clinical trials if:
  • The clinical trial is blinded
  • The clinical trial involves high risk intervention(s), or
  • The clinical trial includes vulnerable population(s)