Do I need IRB approval?

All research activities that involve living human subjects or biospecimens (including genetic data and, in some cases, biospecimens from deceased subjects) require IRB review and approval before research can begin.  Not doing so is considered unethical and, in some cases, illegal.  The most difficult question in determining if a project requires IRB review is whether it constitutes "research" as defined by the Office of Human Research Protection (OHRP)(definitions are provided in 45 CFR 46.102).  The OHRP discourages researchers from making this determination on their own.

The OHRP provides basic guidance here: OHRP Decision Charts

The following are common examples of human subject research studies that must be reviewed and approved by the IRB:

Projects or assignments involving collection of data from living human subjects or employing human biospecimens may or may not meet the definition of human subjects research and require IRB review.  If you are unsure if your project requires review, please submit a request to determine exclusion to the IRB.

Lawrence University requires that Honors Projects involving human subjects or biospecimens be review by the IRB.

Pilot studies involving human subjects are considered human subject research and require IRB review.

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.  Behavioral and social science research generally requires IRB review.

Epidemiological and Public Health 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.  Epidemiological and Public Health research often requires IRB review.

Activities involving interaction with living human subjects, including interviews, oral histories, and public observation, may or may not require IRB review.  Activities focused solely on deceased persons or employing only archival, historical, literary, or existing visual sources do not require IRB review.  Individuals interacting with living human subjects as part of a humanities project should submit a request to determine exclusion from IRB review if they believe their project does not constitute human subjects research and require review (see 45 CFR 46.102 for definitions of activities excluded from review).

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 should contact the IRB for a determination. If such studies are designed for internal university (including individual courses and programs) quality assurance or program evaluation, with no external application or generalization, IRB review is not required.

If you are unsure whether your activities are subject to IRB review please submit a request to determine exclusion. 

If it is determined that your project requires IRB review, you will be asked to submit a New Protocol Application.