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103.6c Organization Policy on Data and Safety Monitoring of Proposed Research

August 2010

It is the policy of the Organization that all human subjects research submitted to the JHM IRB must include a data and safety monitoring plan (DSMP) 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 IRB requires a data and safety monitoring plan for all projects that present more than minimal risk to participants.

Research Involving More Than Minimal Risk

In research that involves more than minimal risk, information regarding the proposed data and safety monitoring plan 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 is the tool used to provide details of the DSMP.  The IRB may consider a range of options as appropriate monitoring plans as noted below:

  • The principal investigator will have sole responsibility for monitoring and oversight of problem/events;
  • A group of designated Johns Hopkins (JH) faculty/staff will have responsibility for monitoring, oversight of adverse events, and other protocol events;
  • An independent individual or group of non-JH 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 Stanley Kimmel Comprehensive Cancer Center, Clinical Research Review and Monitoring Committee 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.

When Following a Department of Defense Addendum:

The IRB should consider if it is appropriate to appoint a research monitor for research that involves no more than minimal risk.

For research involving more than minimal risk, the appointment of a research monitor is required.  The eIRB application must list the name of the appointed independent research monitor. 

The research 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.

AAHRPP

 

 

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