Covered Research
The term covered research refers to activities that meet the federal definition outlined in 45 CFR 46.102(l): Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Many forms of scholarship and inquiry appear to include covered research components. To decide whether IRB review and approval is required, the following determination process is applied:
- Is the project a systematic investigation?
- Is the project designed for generalizability? (Is there scientific merit and validity?)
- Is the primary goal or intent to develop or contribute to generalizable knowledge?
If the activity does not contain all of these elements the project is not considered covered and therefore does not fall under the purview of the IRB; however, other university and departmental policies and discipline standards may apply. Consultation with your Faculty Advisor (if a student), Authorizing Official (if a faculty member), or the Office of Research Compliance and Integrity is strongly encouraged.
Additional Resources
Still not sure, whether your project constitutes covered research? Take a look at the following links for further clarification.
Human Subjects
The IRB reviews and authorizes research involving living human subjects (through interventions or interactions) or their personally identifiable private information.