Unsure whether your project falls under one of these categories and/or requires IRB review?
See the IRB Review Determination Tree or contact the IRB office - we are always happy to help.
Examples of Human Subjects Research
Some examples of research categories commonly reviewed by the Brandeis IRB are below. Keep in mind that this list is not exhaustive.
Social and Behavioral Research
Focuses on individual and group behavior, mental processes, or social constructs and usually generates data by means of surveys, interviews, observations, studies of existing records, and experimental designs involving exposure to some type of stimulus or environmental intervention. The vast majority of research reviewed by the Brandeis IRB is social and behavioral research.
Seeks to increase scientific understanding about normal or abnormal physiology, disease states, or development; and to evaluate the safety, effectiveness, or usefulness of a medical product, procedures, or intervention.
Involves the evaluation of biomedical or behavioral interventions related to disease processes or normal physiological functioning.
Quality Assurance Activities
Attempt to measure the effectiveness of programs of services. Such activities may constitute human subject research, and require IRB review, if they are designed or intended to contribute to generalizable knowledge. Quality assurance activities that are designed solely for internal program evaluation purposes with no external application or generalization may not necessarily require IRB review. In all cases, however, the IRB, not the individual investigator, will determine when IRB review of such activities is required.
Those that involve human subjects are considered human subject research and require IRB review. If IRB approval is not obtained for the pilot study, the resulting data may not be used in further studies.