The purpose of this document is to outline the National Heart, Lung, and Blood Institute (NHLBI) policy for data and safety monitoring of clinical studies for all human subjects research funded in whole or in part by the NHLBI. The NIH requires the monitoring activities of all NIH-sponsored or -conducted clinical studies to be commensurate with their risks, nature, size, and complexity. This policy complies with the NIH mandate by making the NHLBI responsible for oversight of data and safety monitoring to ensure that an appropriate monitoring system is in place for all NHLBI-supported trials and that the Institute is informed in a timely manner of all recommendations emanating from monitoring activities. It does not usurp the role of Institutional Review Boards (IRBs) or other regulatory and monitoring bodies; the policy simply makes clear that the role of the NHLBI is to ensure that appropriate approvals have been obtained. Release of funds for human subjects research activities is contingent upon compliance with this policy.
Refer to NHLBI Clinical Research Guide Glossary for additional terms not identified.
For all interventional trials, the NIH requires documentation of an IRB-approved data and safety monitoring plan (DSM Plan). NIH further requires, as part of the DSMP, the appointment of a Data and Safety Monitoring Board (DSMB) for all clinical trials that involve:
NHLBI expands the NIH policy for an IRB-approved DSM Plan to include all human subjects research that involves greater than minimal risk to participants (as determined by the IRB).
NHLBI also requires that all multi-center trials have either a local or an NHLBI-appointed DSMB:
For epidemiological studies and registries involving multiple sites and/or conducted under a contract or cooperative agreement, the NHLBI may appoint an Observational Study Monitoring Board (OSMB), or may ask the local institution to appoint one.
For operational details refer to the FAQs.
If an IRB-approved data and safety monitoring plan is not provided for a study that requires a data and safety monitoring plan, the NHLBI may request certification by an appropriate official of the awardee institution that its IRB has concluded that the proposed research is neither a clinical trial nor a study that involves greater than minimal risk to participants.
Monitoring boards are either appointed by the NHLBI and act as an independent advisory group to the NHLBI Director, or are appointed locally for investigator-initiated studies. The NHLBI program office, in consultation with the PI and the respective institution, will determine if a locally-appointed monitoring board is appropriate for a given investigator-initiated study. Generally both types of monitoring boards should function in accordance with criteria described below, and essential elements of the board must be included in the data and safety monitoring plan.
Every board must have an executive secretary who is not otherwise involved in the study or with the study team.
Each monitoring board must have a chair and members who are independent of the study and generally have expertise in biostatistics, epidemiology, clinical trials, bioethics, and key subject areas involved in the research.
Defined terms for members of NHLBI-appointed boards.
Alll Monitoring boards must:
Monitoring board meeting minutes must summarize the topics discussed and list the all recommendations, and must be signed by the board chair. After each board meeting, throughout the active phase of a study, the lead investigators must arrange for a summary of board recommendations to be sent to each participating IRB.
Conflicts of Interest (COI) for board members must be reviewed and managed appropriately.
Board meetings generally have an Open Session, a Closed Session (for DSMBs only), and an Executive Session.
For questions and/or concerns regarding the content of this page, please contact the NHLBIDCVSOCR@nhlbi.nih.gov.
Last Updated: December 2014