Does PCORI require a Data and Safety Monitoring Board (DSMB) for all of its funded research projects?

PCORI requires awardees to ensure that there is a DSMP, which may include the need to appoint a DSMB for some research projects, as provided in the PCORI Policy on Data and Safety Monitoring Plans for PCORI-Funded Research. An Awardee Institution should appoint a DSMB if required by the IRB or a regulatory agency (e.g., Food and Drug Administration), or if it determines it is appropriate after considering factors such as potential risks; target study subject population, nature, and size; and the research project’s scope and complexity.

Where a DSMB is established/appointed for a research project, all DSMB members must be independent of the research study, with no vested interest in a specific treatment or therapy being studied and must not include the study investigators or other members of the research study, including patient research partners.