Understanding institutional review boards: practical guidance to the IRB review process.

The purpose of this paper is to provide practical guidance to assist investigators in the preparation of materials and obtaining approval for research projects that require oversight by an institutional review board (IRB). The central requirements for IRB approval and core considerations of IRBs are described. Specific suggestions for investigators regarding how to prepare their IRB applications to anticipate and address potential IRB concerns and questions are proposed. When researchers are familiar with these criteria and how they may be interpreted by an IRB, they can avoid deferrals or lengthy requests for protocol modifications or clarifications. General tips regarding the preparation of IRB submission materials that may allow for a smoother IRB review process are also discussed. A brief list of additional resources for investigators is appended.