“Research” in this context is defined by the Common Rule regulations as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
“Human subject” is defined as “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.”
Guidance about what classifies as non-human research can be found on the HHS website. In addition, the application form below includes a checklist to help guide researchers in determining if their study meets these criteria.
Investigators may request that an activity be classified as non-research or non-human research, and therefore requiring no IRB oversight, but the final determination will be made by the ORSP/IRB Office.
Please complete the forms below and any other requested items and submit to email@example.com per the submission instructions.
- Non-Research or Non-Human Research Requests Form
Also attach, if applicable
- Consent Form
- Participant Solicitations
The IRB documents have been revised as of January 2018 and can be found in the ORSP Canvas Classroom. You may enroll in the classroom by clicking here.