Posted: March 24th, 2023

Data Safety and Monitoring Committee Versus IRB

The Data Safety and Monitoring Committee/Board (DSMC/DSMB) plays a significant role in clinical trials. It is an independent body composed of professionals who provide the necessary monitoring of the level of risk involved in clinical trials. The organization establishes safe and effective behavior and suggests solutions when considerable risks or benefits have been determined. The role is necessary when a clinical trial is likely to be conducted successfully, regardless of risks or benefits. However, the board ensures that risk to subjects is minimized to a practical level (Carlisle, Kimmelman, Ramsay, & MacKinnon, 2015). The members of the board operate independently to offer professional guidance and recommendations necessary to minimize risk in beneficial clinical trials. They are responsible for periodical review and evaluation of the accumulated data related to the safety of participants, the performance, progress of a study, and efficacy of research. The organization gives recommendations to NIDCR relating to trial’s continuation, adjustment, or termination.

The DSMB plays a similar role with the Institutional Review Board (IRB) of protecting human subjects in clinical trials. Both organizations ensure that the study is not performed in a way that harms or risks the safety of participants (Schneider, 2015). However, the two bodies play the role differently. The IRB examines the potential risk before the performance of the study to determine whether to allow the trial to commence (Eckstein, 2015). The IRB plays the role by reviewing reports from a monitoring body, such as the DSMB, to make the necessary decisions regarding the safety of human subjects in a trial. Unlike the DSMB, the IRB does not perform data monitoring to determine the level of risk to subjects in a trial.