Human-subject research
What happens if a researcher has no institutional IRB available at all?
Plain English first, then the primary source. Education, not legal advice.
Interpretation
In short: an institution's internal policy and federal requirements are separate layers, and satisfying one does not satisfy the other.
Plain English
The absence of an in-house IRB does not eliminate the underlying obligations under 21 CFR Part 56 or 45 CFR Part 46 when they apply; researchers without an institutional IRB may need to arrange for review by an independent or commercial IRB. FDA regulations contemplate independent IRBs specifically to cover situations where a sponsor or investigator does not have access to one within their own organization.
Choosing to proceed without any IRB review, when review is otherwise required, does not convert the activity into something outside the scope of the regulations, it instead means the required review did not happen.
Why it matters
- Independent researchers and small companies sometimes assume that lacking institutional infrastructure excuses them from oversight requirements, when the more accurate framing is that they need to find an alternative path to the same 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 required at all still depends on the underlying research and product classification questions addressed elsewhere in this library.
View the source
- 21 CFR Part 56, institutional review boards, 21 CFR Part 56