Safety Oversight
The Division of Microbiology and Infectious Diseases (DMID) supports, through both the contract and grant mechanism, a large number of clinical studies and trials. All DMID studies are conducted in accordance with Department of Health and Human Services regulations 45 CFR 46, which provide for the protection of study participants. To ensure that procedures are in place to protect the safety of participants while ensuring the validity and integrity of the study, DMID has adopted policies which mandate that a safety monitoring plan be established for all clinical trials. This requirement pertains to all studies that evaluate investigational test articles, studies in which there is a potential for harm to participants, and other studies in which independent assessments are required to ensure objectivity.
The policy further elaborates that monitoring should be commensurate with risks and with the size and complexity of the trials. Generally, the National Institutes of Health requires Data and Safety Monitoring Boards (DSMBs) for Phase III clinical trials. For earlier trials (Phase I and II), a DSMB may be appropriate if the studies have multiple clinical sites, are blinded (masked), or employ particularly high-risk interventions or vulnerable populations. For other Phase I and Phase II trials, alternative formats may be utilized for monitoring.
Clinical trial safety oversight and the designated structure of either an ISM (independent safety monitor), SMC (safety monitoring committee), or a DSMB, consistent with DMID policy, should be clearly defined within the protocol.
Conflict of Interest (COI) Forms
Data and Safety Monitoring Board Guidelines COI Form: Conflict of interest certification form completed by members of the Data and Safety Monitoring Board (MS Word)
Safety Monitoring Committee Guidelines COI Form: Conflict of interest certification form completed by members of the Safety Monitoring Committee (MS Word)
Independent Safety Monitor Guidelines COI Form: Conflict of interest certification form completed by the Independent Safety Monitor (MS Word)
Policies and Safety Guidelines
Policy and Guidelines for Data and Safety Monitoring: Overview of Data and Safety Monitoring Board (DSMB) Policy and Guidelines (PDF)
Data and Safety Monitoring Board: Description of the Data and Safety Monitoring Board (DSMB) role, responsibilities, and process for setting up a DSMB (PDF)
Safety Monitoring Committee Guidelines: Safety Monitoring Committee (SMC) Guidelines and Conflict of Interest Certification (PDF)
Independent Safety Monitor Guidelines: Independent Safety Monitor (ISM) Guidelines and Conflict of Interest Certification (PDF)
back to top