Review of Data and Safety Monitoring in Research

This policy describes when UW-Madison IRBs require data and safety monitoring as part of a research study and how they evaluate the adequacy of the monitoring plan.

  1. As part of their review and approval of non-exempt research involving human participants, UW-Madison IRBs determine whether data and safety monitoring is necessary for the study to adequately minimize risks and ensure participant safety.

  2. The UW-Madison IRBs generally require data and safety monitoring plans (DSMPs) for studies involving more than minimal risk, but can require them for minimal risk studies as warranted (e.g., a study team member has a potential financial conflict of interest, the UW-Madison serves as a coordinating center for a study, or an investigator-initiated multi-site research study).

    1. Funding and other federal agencies also may require a DSMP for a study they support or oversee. For example, the National Institutes for Health require the establishment of the data safety monitoring boards (DSMBs) for multi-site clinical trials involving interventions that entail potential risk to the participants.

  3. The UW-Madison IRBs review DSMPs to ensure they are appropriate to the risks the study may present, complexity of the research, and participant population that will participate in the study.

  4. The type of monitoring the IRB requires depends on the type of research being performed and can include monitoring by the study team, an individual or group independent of the study team, or a formal and independent Data Monitoring Committee (DMC) or Data and Safety Monitoring Board (DSMB).

    1. Formal, independent DMCs or DSMBs are often required for Phase III studies, studies involving interventions that are blinded, and investigator-initiated, multi-site clinical trials.

  5. When reviewing research subject to the Department of Defense regulations, the IRB ensures that an independent medical/research monitor is named to oversee studies that are more than minimal risk and has the authority to stop a study in progress, remove individuals from a study, or take other steps to protect the safety and well being of participants until the IRB can assess.

  6. If a DSMP was required at the time of initial approval, the IRBs will assess the effectiveness of the DSMP and any information about data monitoring as part of the continuing review of a study. The IRB can require revisions to the DSMP if the committee determines that additional or a different type of monitoring is necessary.

  7. If a study team or study sponsor wishes to alter the DSMP approved by the IRB, the IRB must approve this revision in order for it to be implemented.

Adopted By: All Campus IRB
Adoption Date: December 8, 2005
Revised: March 1, 2012 by HRPP Advisory Committee
Revised By: Cross-Campus HRPP Committee
Effective Date of Revision: August 28, 2015

Copyright © 2015 University of Wisconsin System Board of Regents

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Keywords:data safety monitoring plan IRB review   Doc ID:29497
Owner:Ryan M.Group:VCRGE and Graduate School
Created:2013-04-16 12:25 CDTUpdated:2015-09-30 13:46 CDT
Sites:VCRGE and Graduate School
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