34 CFR 97.405
§ 97.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
United States · 34 CFR — Education · Status: effective
Cite this
- Citation
- 34 CFR 97.405, § 97.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/155018
- Permanent ID
ys:prov:155018@1- SHA-256
04fc3b3813b1856cabd6c593e9687c04b2f11aac9edae135c468f88579d2e3d2
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
ED conducts or funds research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the IRB finds that—
(a) The risk is justified by the anticipated benefit to the subjects;
(b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and
(c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in § 97.408.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.