Convened Review Research involving human subjects that is classified or does not qualify for exempt or expedited review and therefore must be evaluated at a convened IRB meeting against all regulatory criteria. Convened review is required for all research that involves: greater than minimal risk, investigational drugs, investigational, devices, or prisoners. Expedited Review Research that is non-anonymous but no more than minimal risk, includes appropriate privacy/confidentiality safeguards, and falls within the “safe-to-expedite” categories; reviewed by designated IRB reviewers instead of the full board. Expedited does not mean that the review is less rigorous or happens more quickly than convened review. It refers, instead, to certain types of research considered to involve minimal risk. Exempt Review Research that is not classified, involves no minors or prisoners, and fits one of the specified exempt categories (e.g., anonymous existing data, normal educational practices, certain tests/surveys/observations, approved public program evaluations, or safe taste/food studies). Exempt studies are so named because they are exempt from some of the federal regulations (refer to §46.104). However, they are not exempt from state laws, institutional policies, or the requirements for ethical research. Non-human Subjects Research Determination Activities that do not involve living individuals or identifiable private information/interaction/intervention (e.g., secondary data analysis). The IRB will provide a determination about whether an activity is human subjects research. Only the IRB can designate research as Not Human Subjects Research. Quality Improvement/Program Evaluation Determination Activities designed to evaluate and improve performance in a clinical area, educational setting, or department. The fundamental goal of Quality Improvement and Program Evaluation activities is to improve or evaluate the practice or process within a particular institution or a specific program.