All clinical studies that involve some risk to the participants are required to have some data and safety monitoring. Investigators are responsible for establishing plans of monitoring. Specific monitoring will be correspondent with the degree of risk and scope of study. The Bioethics and Subject Advocacy Program (BSAP) can help investigators with tailoring their data and safety and monitoring based on the complexity and risk of their research study.
The BSAP team specifically can assist with determining the frequency and rigor of the monitoring that will satisfy the IRB or funding agency requirements. If a DSMB is necessary, typically for studies that poses greater than minimal risks, we can help with the organization and composition of the board, with the aim of reducing unnecessary burden.