TL22: IRB and DSMC: Who is responsible for what?
*Charles Anello, Applied Statistical Concepts, LLC 

Keywords: DSMC, IRB, patient safety, consent, confidentiality

Before human subjects enter into a clinical study, an Institutional Review Board (IRB) reviews the protocol for this study. The role of the IRB includes but is not limited to being sure that the study design is sound, that appropriate scientific methods are being applied, that the benefit and risk to the study subjects have been carefully considered. If the IRB concludes the study is justified on scientific grounds, they will also consider issues like; does the study contain vulnerable populations, is informed consent adequate and is confidentiality assured. In some studies where the risk is less than minimal, an additional review body, referred to as a Data Safety Monitoring Committee (DSMC), may be established. The main role of the DSMC is to protect the well being of the subjects participating in the study. The DSMC is a review body that function independently of the sponsor. Even when there is a DSMC there may also be one ore more IRBs (e.g., when multiple institutions are jointly participating in the same study protocol). When there are both an IRB and a DSMC issues concerning who is responsible for what may arise. This roundtable is aimed at letting those individuals who have served on or interacted with an IRB or a DSMC have an opportunity to share their experiences with their colleagues. It would be useful if the roundtalbe participants considered the following questions: What are the important responsibilities of an IRB? What are the important responsiblities of a DSMC? Do their responsibilties overlap? If a clinical study has both an IRB and a DSMC who is responsible for what?