§26.405. Observational research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
40 C.F.R. § 26.405
If the IRB finds that an intervention or procedure presents more than minimal risk to children, EPA will not conduct or fund observational research that includes such an intervention or procedure unless the IRB finds and documents that:
The intervention or procedure holds out the prospect of direct benefit to the individual subject or is likely to contribute to the subject's well-being;
The risk is justified by the anticipated benefit to the subjects;
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
Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in § 26.406.
Notes, amendments, and revision history
Source
Source: 71 FR 6168, Feb. 6, 2006, unless otherwise noted.
Authority
Authority: 5 U.S.C. 301; 7 U.S.C. 136a(a) and 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec. 201, Pub. L. 109-54, 119 Stat. 531; and 42 U.S.C. 300v-1(b).
Source
Source: 56 FR 28012, 28022, June 18, 1991, unless otherwise noted.