How do I know if my project needs to be reviewed? back to top
The Federal Policy for the Protection of Human Subjects (Title 45 CFR part 46) outlines two requirements that must be satisfied for a research activity to be considered research with human subjects:
- Human subjects must be involved – these are living individuals about whom an Investigator conducting research obtains (1) data through intervention or interaction with the subject, or (2) identifiable private information
- The activity is a systematic investigation, including research development (pilot testing), testing, and evaluation designed to develop or contribute to generalizable knowledge.
Generalizable knowledge is information which may add to a field of study and allows for application to populations and settings different from where it was collected.
General Attributes of Non-Research Activities (these do notneed IRB review):
- The intent is to identify and control a specific problem or asses and/or improve a program or service
- Benefits are primarily or exclusively for present or future participants or their community
- Knowledge is not expected to extend beyond the scope of the activity
If an assessment or evaluation activity includes any component of research with human subjects than it needs to be reviewed.