POLICY STATEMENT

It is UAB policy that all human subjects research involving greater than minimal risk incorporates an appropriate data monitoring plan for the safety of subjects. The IRB will determine whether the research plan makes adequate provisions for monitoring the data collected to provide for the safety of subjects during initial review, continuing review, and review of modifications to research. Investigators will submit the monitoring plan in writing as part of the research protocol. Depending on the extent and severity of expected harms in a research study, the monitoring plan should include provisions to determine whether the character, incidence, and severity of harms match expected harms and should describe the stages of research at which monitoring will occur (e.g., specific points in time, after a specific number of subjects have been recruited, upon recognition of harms). Monitoring may be conducted by investigators themselves, a medical monitor, a data safety monitoring committee, or other appropriate mechanism for the research activity. (See also PRO116 Procedure for Data and Safety Monitoring for Human Subjects Research.)