Observational research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.

§ 26.405 Observational research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. 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: (a) 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; (b) The risk is justified by the anticipated benefit to the subjects; (c) 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 (d) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in § 26.406.