§ 97.405. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
131 words·~1 min read·
/us/cfr/t34/s§ 97.405·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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. (Authority: 5 U.S.C. 301; 20 U.S.C. 1221e-3, 3474; and 42 U.S.C. 300v-1(b))
Connectionstraces to 2
Traces to 2 documents
1 reference not yet in our index
- 42 USC 300v-1(b)
Citation graph
cites case law
§ 97.405
Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
Cite42 USC 300v-1(b)
Cites 3Cited by 0 across 0 sources