June 2004

The Institutional Review Board (IRB) approval process is not a one-time step in the life of the research project. Rather IRB approval is a temporary authority that is based on the degree of risk to which study subjects are exposed. For example high risk studies might be given a three month approval period, whereas minimal risk studies might be given an annual approval period. An annual review is the greatest amount of time an IRB can grant approval for a project. Initial IRB review is based on the Principal Investigator’s best estimate about the anticipated risks, benefits, and study procedures to be conducted.

At periodic review, the IRB determines whether this estimate is reasonable and whether the project can continue. Continued monitoring of approved research is as important as the initial review and approval. Only after the research has begun can actual risks and benefits to the subjects be assessed and preliminary results of the study used to determine an evaluation of risk/benefit. Collaborative efforts between the investigator and the IRB will result in the best protection for study subjects.