These guidelines are intended to assist instructors in determining when class projects meet the definition of research with human subjects and require review by the University of San Diego’s Institutional Review Board (IRB) in compliance with federal regulations for the protection of human subjects.
If unsure how to proceed, instructors and faculty advisors should contact the appropriate College/School representative on the IRB prior to continuing with the project. For your IRB Faculty Representative's contact information, visit the USD IRB Members page.
Criteria
The review of research for ensuring compliance with regulations for the protection of human subjects is governed by federal law.
When determining if a project falls under the jurisdiction of the IRB, two questions need to be asked:
- Is it research? and if yes,
- Does the research involve human subjects?
Under the federal rule 45 CFR § 46.102, the terms "research" and "human subjects" are defined as follows:
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR § 46.102(l)).
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (45 CFR 46.102(f)).
Student work that does not require review by the IRB:
- Class projects designed solely for pedagogical purposes, that is with the objective of providing students with training about and experience with research methods
- Class projects where the data will not be presented outside of USD
For complete guidelines on student work involving human subjects that do not require IRB review, click here.
Student work that requires review and approval by the IRB:
- Class projects that involve systematic collection of data for which the design or objective is to develop or contribute to generalizable knowledge
- Class projects where the student or instructor plans to use the data outside of the class, e.g., a non-USD conference presentation or publication
If a student and/or instructor is uncertain whether or not a project will produce findings worthy of publication or dissemination outside of USD, that student and/or instructor should submit the project for IRB review before initiating the project. The IRB cannot provide post hoc approval.
The student’s faculty advisor or course instructor, as applicable, is expected to work with the student(s) to prepare the IRB application and review it prior to submission. The faculty advisor or course instructor, as applicable, must be listed on the application as the Secondary Contact for the study. In addition, the application must include a letter from the supervising faculty approving submission of the study, certifying the IRB review category, and committing and a current IRB training certificate for both the student and the supervising faculty. Please use the faculty letter template found on the USD IRB website under “Forms.”