TABLE 2.
Additional Requirements for Research Involving Children as Human Subjects
| Risk gradient
|
||
|---|---|---|
| Benefit gradient | Not greater than minimal risks | Greater than minimal risks |
| Prospect for direct therapeutic benefit |
(a) Not greater than minimal risk/Direct benefit Assent of child and permission of at least one parent |
(c) Greater than minimal risk/Direct benefit Assent of child and permission of at least one patent; Anticipated benefit justifies the risk; and Anticipated benefit is at least as favorable as that of alternative approaches |
| No prospect For direct therapeutic benefit | (b) Not greater than minimal risk/No direct benefit Assent of child and permission of at least one parent |
(d) Greater than minimal risk/No direct benefit Assent of child and permission of both parents, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child; Only a minor increase over minimal risk; The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; and The intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition which is of vital importance for the understanding or amelioration of the subjects’ disorder or condition. |
Note.
a
NIH, 1998; Title 45 CFR 46, 1991.
b
NIH, 1998; DHHS, 1991.