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103.6c Organization Policy on Data and Safety Monitoring of Proposed Research
It is the policy of the Organization that all human subjects research submitted to the JHM IRBs must include a data and safety monitoring plan (DSMP) that is appropriate to the risk level of the proposed research. The IRBs will require a data and safety monitoring plan for all projects that present more than minimal risk to participants. If a study presents no more than minimal risk to participants, the IRBs may determine that no formal plan is required and that sole oversight by the Principal Investigator (PI) is appropriate.
Research Involving More Than Minimal Risk
In research that involves more than minimal risk, information regarding the proposed DSMP must be submitted for IRB review. 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 a reporting mechanism. The eIRB application and/or the research protocol must provide the details of the DSMP. The IRB may consider a range of options as appropriate monitoring plans as noted below:
- The PI will have sole responsibility for monitoring and oversight of problem/events;
- A group of designated Hopkins/Affiliates faculty/staff will have responsibility for monitoring, oversight of adverse events, and other protocol events;
- An independent individual or group of non-Hopkins/Affiliates individuals (e.g., coordinating center) will have responsibility for monitoring, oversight of adverse events, and other protocol events;
- A designated medical monitor, or group of monitors for commercially funded or for not-for-profit sponsored studies, will have responsibility for monitoring, oversight of adverse events, and other protocol events;
- The Sidney Kimmel Comprehensive Cancer Center, Clinical Research Review and Monitoring Committee (SKCCC CRO) will perform data and safety monitoring, oversight of adverse events, and other protocol events; or
- A formal Data and Safety Monitoring Board (DSMB) will have responsibility for monitoring, oversight of adverse events, and other protocol events.
In the event that a formal DSMB is to be constituted by a federal funding agency, or by a clinical consortium conducting the protocol, or is required by the IRB, the IRB 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 on the review checklists used at the meeting.
Department of Defense (DoD)-Funded Studies
The IRB must make a determination as to whether the research constitutes minimal risk or more than minimal risk to participants.
For research involving more than minimal risk funded by DoD, the appointment of an independent research monitor is required. The protocol and/or eIRB application must list the name of the appointed independent research monitor and the IRB must confirm that the monitor has the authority to:
- Stop a research project in progress;
- Remove individuals from a project; and
- Take any steps to protect the safety and well being of participants until the IRB can assess the issues or concerns of the research monitor.
For minimal risk studies funded by DoD, the IRB may require the appointment of an independent research monitor with this authority, though it is not required.