Assessing risk in a research study is one of the primary responsibilities of an IRB and one of its most controversial tasks. By nature, studying human beings is a complicated process because the subject matter itself is complicated. The level of risk can vary because of many factors including: the population included in the study, the situations encountered by the participants, and/ or the experience of the researcher or team. Two studies may appear similar but a few factors could make one inherently more risky than the other.
This section describes what a researcher needs to consider when developing a protocol as well as the risk analysis conducted by an IRB board member. This section does not cover ever scenario nor is it meant to be all inclusive; if you have a specific question about the risks in your study, please contact our office for further guidance.