Data and Safety Monitoring
If a study is more than minimal risk and involves an intervention, a data and safety monitoring plan must be included in the proposal for IRB review.
What is minimal risk?
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological or tests (45 CFR 46.102 and 21 CFR 56.102).
Note: Studies involving prisoners have a different definition of minimal risk.
Who decides if the study is minimal risk?
The IRB (usually the IRB Chair) makes the final determination. Studies that are determined to be more than minimal risk are "full" studies and require review by the convened board.
- Studies in which a subject will be experimentally assigned to an investigational drug or device treatment intervention are considered to be more than minimal risk.
- Other studies may also be determined to be more than minimal risk.
- Contact the IRB office for questions.
What is data and safety monitoring?
Data and safety monitoring is the process for reviewing data from an ongoing study to monitor the progress of the research and the safety of participants.
The frequency of review and the intensity of the monitoring required depend on factors such as the study risk, complexity, and size.
What should be included in the plan?
The plan should include the following:
- Description of how risks are minimized and how risks are reasonable in relation to anticipated benefits and the importance of the knowledge that is expected to result
- The type of data or events that will be monitored
- Who will be monitoring the data/events
- How events will be reported
- How often the assessments will be made
- What procedures are in place to ensure protocol adherence