May 2005 It is the policy of the Organization that all human subjects research submitted to the IRBs must include a data and safety monitoring plan that is appropriate to the risk level of the proposed research. The IRBs will determine whether an activity represents minimal risk or more than minimal risk to participants and then determine whether a data safety monitoring plan is required. In research that involves no more than minimal risk, a monitoring plan is usually not required. The IRBs, require a data and safety monitoring plan for all projects that present more than minimal risk to participants. In research that involves more than minimal risk, information regarding the proposed data and safety monitoring plan must be submitted for IRB review. When research represents more than minimal risk, the plan should include information such as procedures for analysis and interpretation of data, actions the responsible party will take concerning specific events or end points, time points for review, and reporting mechanism. The application form is the mechanism used to provide details of a plan. The IRB may consider a range of options as appropriate monitoring plans as noted below: - The principal investigator will have sole responsibility for monitoring, or
- A group of designated JH faculty/staff will have responsibility for monitoring, or
- An independent individual or group of non-JH individuals will have responsibility for monitoring, or
- A designated medical monitor, or group of monitors, for commercially funded or for not-for-profit sponsored studies will have responsibility for monitoring, or
- The SKCCC Clinical Research Office will perform data and safety monitoring for the project, or
- A formal Data and Safety Monitoring Board (DSMB) will have responsibility for monitoring.
In the event that a formal DSMB is to be constituted by a federal funding agency, or by a clinical consortia conducting the protocol, or is required by the IRB, the IRBs may determine that a formal DSMB represents sufficient data and safety monitoring oversight. Names of specific members of a DSMB need not be provided to the IRB as long as the DSMB description contains sufficient information about individuals who will be selected to serve on the DSMB. The IRB’s decision regarding the adequacy of the plan will be recorded in the review checklists used at the meeting. |
