Human-subject research
If I test something on myself or a friend, is that 'human subjects research'?
Plain English first, then the primary source. Education, not legal advice.
Interpretation
In short: whether the Common Rule applies depends on the activity, the funding, and the institution, not on how a researcher describes themselves.
Plain English
The Common Rule, codified at 45 CFR Part 46, defines human subjects research broadly. It generally covers systematic investigation designed to develop or contribute to generalizable knowledge, involving a living individual about whom an investigator obtains data or biospecimens through intervention or interaction.
The Common Rule applies to research that is conducted or funded by covered federal agencies, or that occurs at an institution that has agreed to apply it more broadly. It does not automatically apply to every private experiment a person conducts, but many institutions extend equivalent obligations by policy, and separate FDA human subject protection rules can apply independently when a test article regulated by FDA is involved.
Whether a given activity is 'research' with 'human subjects' in the regulatory sense is a fact-specific legal determination, often made by an Institutional Review Board, not by the person doing the testing.
Why it matters
- People sometimes assume the Common Rule only applies to formal university studies, but the underlying ethical protections it embodies, and separate FDA rules, can still be relevant even outside that specific regulation.
- Calling something 'informal' or 'personal' does not by itself resolve whether human-subject protections should apply.
Where the answer becomes fact-specific
The Foundation does not manufacture legal conclusions. These points change the analysis and may require qualified regulatory counsel.
- Institutional affiliation, funding source, intent to publish or generalize findings, and whether a regulated test article is used all affect which rules apply and to whom.
View the source
- 45 CFR Part 46, protection of human subjects, 45 CFR Part 46