How Proposals are Reviewed

A research project will be reviewed using the Expedited Review Procedure if the project (1) presents no more than minimal risk to human subjects and (2) falls into one or more of the following categories.

• Research that collects data from voice, video, digital, or image recordings, or recordings of reaction time;
• Research on individual or group characteristics or behavior, such as research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodology;
• Certain classes of studies involving biological samples
• Certain classes of clinical studies of drugs or medical devices
• Research involving materials that have been collected or will be collected solely for non-research purposes (such as medical diagnoses)

Federal guidelines define minimal risk as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Any research project that cannot be reviewed using the Expedited Review Procedure will be subject to Full Review by the Board. All members of the Board will discuss the proposal. Full Reviews are required for proposals that involve a federally protected group (children under the age of 18, prisoners, or individuals with impaired decision-making capabilities) and/or a proposal that exceeds minimal risk. The IRB will pay particular attention to the elements of the informed consent that addresses how participants will be able to make decisions to participate without coercion, and if the proposal involves more than minimal risks, those risks must be outlined in the informed consent to the participant. A majority vote of the Board is required for approval of a proposal. Minutes of Full Review discussions will be kept, and a summary of those minutes will be available, on request.