Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects
HHS will conduct or fund 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:
- 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 §46.408.