In accordance with federal and institutional regulations, any undertaking in which University faculty, staff, or students investigate and/or collect data on human subjects for research purposes must be reviewed by the Institutional Review Board (IRB). It is the responsibility of each investigator to seek review of any study involving human subjects prior to initiation of the project.

Purpose and Mission
The IRB is a University committee composed of faculty members who are appointed by the institution and a community representative. The IRB is responsible for reviewing all research activities involving human subjects regardless of the source of funding. The mission of the IRB is to promote and safeguard research activity that involves human subjects within the academic community.

What Research is Subject to IRB Review?
A common source of confusion for researchers is in determining whether a particular project requires review by the Institutional Review Board (IRB) for the protection of human subjects. The answer to this question can be found through an examination of how the federal Office of Human Research Protections (OHRP) defines human subjects research. The OHRP is the regulatory government agency responsible for overseeing research involving human subjects. The federal regulations can be accessed online at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm .

A human subject is defined as “a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction or (2) identifiable private information.” This definition means that a human subject is involved if the researcher manipulates an individual’s environment or collects data by interacting with an individual. Interaction includes communication (written or oral) and interpersonal contact between investigator and subject. Examples of interaction may range from mailing a survey to conducting an interview by telephone or in person.

Research is defined as “a systematic investigation, including research, development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” This definition means that projects must be reviewed by the IRB if they are undertaken as investigations with the intention of publicizing the results to contribute to generalizable knowledge. An example of a project that would not be subject to IRB review is a student project that occurs in the classroom if there is no intention of using the results for any purpose other than a class assignment. This type of project is undertaken as a learning experience and is not conducted with the intention of contributing to generalizable knowledge about a particular subject; therefore, it is not technically classified as research. However, some class assignments are undertaken as part of a project with a broader purpose that makes them subject to IRB review. For example, if a student intends to later use data collected as part of a class assignment for a thesis project or if a student plans to present results of a project at a conference or publish the results online, he or she should seek IRB approval prior to initiating the data collection process.

Researchers often assume that “exempt” means that a project is exempt from the IRB review process, but this is not the case. Exempt means that a project is exempt from further review by the IRB, and only the IRB has the authority to classify a project as exempt. A determination of exemption requires that the researcher complete training on the use of human subjects in research and submit an application for exemption to the IRB. The federal regulations include specific categories of exemption, and any research procedures falling outside those categories must be reviewed through expedited or full review procedures.

Questions about whether a project requires IRB review and other questions about the IRB process can be directed to Dr. Dory Marken, IRB Chair, or to Tiffany Hamblin, IRB Administrator.