Human-subject research
Do I need IRB approval before running a study involving people?
Plain English first, then the primary source. Education, not legal advice.
Interpretation
In short: independent review exists to protect participants. Whether it is required is a fact-specific determination worth getting in writing.
Plain English
IRB review requirements come from two overlapping regulatory schemes: 45 CFR Part 46 Subpart A (the Common Rule, for federally supported or covered research) and 21 CFR Part 56 (for research involving FDA-regulated products such as investigational drugs and devices). Both generally require that an IRB review and approve research before it begins, and continue to oversee it while it is ongoing.
IRBs assess risk to participants, the adequacy of informed consent, and whether the research design is justified given the risks. This oversight exists independent of whether the researcher personally believes the study is safe.
An institution's own policies may also require IRB review more broadly than the federal floor, and many journals and funders require documented IRB approval or exemption determination before they will accept results.
Why it matters
- Skipping IRB review does not necessarily make a study 'not research', it can instead mean the research was conducted without required oversight.
Where the answer becomes fact-specific
The Foundation does not manufacture legal conclusions. These points change the analysis and may require qualified regulatory counsel.
- Whether IRB review is legally mandatory turns on funding source, institutional commitments, and whether the product involved is FDA-regulated.
View the source
- 21 CFR Part 56, institutional review boards, 21 CFR Part 56
- 45 CFR Part 46, protection of human subjects, 45 CFR § 46.101 et seq.