Institutional Review Board
IMPORTANT NOTICE: Revisions to the Federal policy governing the use of human research subjects (The Common Rule) are set to go into effect on January 21, 2019. All protocols reviewed as of this date will be required to follow the revised policy. For studies that are not on a fixed timeline, the IRB recommends that investigators submit applications for review on or after January 21, 2019 so that the revised regulations can be used for the review process. This approach offers some key advantages for investigators, including the elimination of the continuing review requirement for studies reviewed through expedited review procedures. The IRB will accept applications for new research protocols under the expiring exemption and expedited review procedures through December 14, 2018 and for full review through November 26, 2018 for the December meeting. The review process for these applications must be completed by January 18, 2019. Investigators with applications in review are advised to consistently monitor email and promptly respond to questions and/or requests for changes. In the event that a study cannot be approved by January 18, 2019, the investigator will have to be asked to resubmit an application for review under the new guidelines. The submission window will re-open for new applications under the Revised Common Rule on January 21, 2019. For investigators who wish to work on application materials in advance for submission on or after January 21, 2019, application forms and resources will be published in early January. For more information about the changes, please click here.
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.
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 is Subject to IRB Review?
A human subject is a living individual about whom an investigator obtains
- Data through intervention: manipulation of an individual’s environment for research purposes (i.e., introduction of new instructional methods)
- Data through interaction: including both communication (written or oral) and interpersonal contact between a researcher and subject (i.e., surveys, interviews, focus groups)
- Private Information: through a third party, with or without the subject’s knowledge (i.e., medical records, assessment results)
Research is defined as “a systematic investigation, including research, development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” A systematic investigation is an activity that involves a prospective plan incorporating data collection (quantitative or qualitative) and data analysis to answer a question. Investigations designed to develop or contribute to generalizable knowledge are those that are designed to draw general conclusions, inform policy, or facilitate change in practice.
Research results do not have to be published or presented to qualify the experiment or data gathering as research. Participants deserve protection regardless of whether the research is published.
An example of a project that would not be considered human subjects research 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 to help students understand the process of conducting research, and the focus is not on producing meaningful results. In these cases, only the student and instructor have access to the results, and the project’s purpose ends when a grade is assigned. 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 share the results with an audience outside the classroom, he or she should seek IRB approval prior to initiating the data collection process. Thesis or dissertation projects conducted to meet the requirement of a degree require IRB review and approval any time human subjects are involved.
Researchers often assume that the “exempt” category means that a project is exempt from the IRB review process, but this is not the case for any study that involves human subjects. 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 Lisa Royalty, IRB Administrator.
To apply for IRB approval, please follow the procedures outlined here.