Common examples of activities requiring IRB approval
The following are common examples of human subject research studies that must be reviewed and approved by the IRB:
Pilot studies involving human subjects are considered human subject research and require IRB review.
Behavioral and Social Sciences Research:
Behavioral and social sciences 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.
Epidemiological research focuses on health outcomes, interventions, disease states and conclusions about cost-effectiveness, efficacy, efficiency, interventions, or delivery of services to affected populations. This research may be conducted through surveillance, monitoring, and reporting programs.
Quality Assurance/Quality Improvement Activities:
Activities that attempt to measure the effectiveness of programs or services may constitute human subjects research and require IRB review if they are designed or intended to contribute to generalizable knowledge. Individuals must be certain that their activities are not human research. The IRB has the sole authority to determine whether an activity is human research. Individuals who are uncertain whether an activity is human research must contact the IRB for a determination. The investigator is responsible for submitting the description of the activity to the IRB. If such studies are designed for internal university quality assurance or program evaluation, with no external application or generalization, IRB review is not required.
Projects or assignments involving collection of data from human subjects may or may not meet the definition of research. Course instructors are responsible for making the decision whether the activities meet the definition of “research” (i.e. determining if the activities are systematic and will contribute to generalizable knowledge). For assistance, faculty are encouraged to contact the IRB.
Please contact the IRB firstname.lastname@example.org if you are unsure whether your activities are subject to IRB review.
If it is determined that your project requires IRB review, you must submit a New Protocol Application.