policy
National Institutes of Health
National Institutes of Health
Human Subjects Research
This is the NIH's consolidated hub for human subjects requirements, covering the definition of human subjects research, how to work out whether your project counts, the regulations that apply, required training, and what you must supply in an application. The definitions used here are the ones your IRB and your funder will both apply. Use it to settle the threshold question early, before you write a protocol for a study that turns out to be exempt.
- Task
- Ethics & compliance
- Time
- 30 min
- Level
- intermediate
- Cost
- Free — Nothing to pay. A free account at most.
- Tools
- None in particular
- Published
- 2026-07