The Institutional Review Board (IRB) at Chapman University is an authority that reviews, approves, denies and provides ongoing oversight of research involving human subjects in accordance with FDA regulations.
The IRB is composed of Full Board Members and Alternate Members representing the faculty, administration and community of Chapman University. With backgrounds in the physical, medical and social sciences, IRB Board Members are guided by regulations and standards of practice as formulated and enforced by various government departments including the Department of Health and Human Services.
Common Rule Changes
In January, PRIM&R hosted PRIM&R’s Primer on the Revised Common Rule, a webinar to introduce the human subjects research community to the changes present in the revised Federal Policy for the Protection of Human Subjects. Presented by P. Pearl O’Rourke, MD, and Heather Pierce, JD, MPH, this webinar provided an overview of the noteworthy changes from the current rule, as well as a discussion of various possible fates of the revised Common Rule under the new presidential administration.
While there is nothing that you need to do currently, we strongly recommend that you familiarize yourself with the regulatory changes in order to understand how they may or may not impact your current or future human subjects research projects. Click here for a quick reference guide and for more information please visit the Educational Resources section.
Gaining IRB Approval
Instructors and students preparing to conduct research requiring human or animal participation should visit the IRB Submission and Approval Process section to learn more about the requirements to earn IRB approval.
Research is a component of many courses at Chapman including in-class exercises, out-of-class assignments, term papers and capstone projects. While these often include some measure of research methodology, they may not constitute research that warrants oversight by the IRB. All faculty, staff and students at Chapman University conducting research involving human subjects as defined in 45 CFR 46.102 must submit their research protocol to the Institutional Review Board for review and approval prior to commencing the project. In order to assist investigators in deciding whether a planned activity constitutes research involving human subjects, the following federal definitions of research and human subject are provided:
- Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
- Human Subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:
- Data through intervention or interaction with the individual, or
- Identifiable private information