IRB ACTION
Select One
Should be Approved
Approvable on case-by-case basis (Risk may not be more than a minor increase over
minimal risk.)
Should Not Approve (Approval of research must be made the Secretary of Health and
Human Services with input from selected experts, and following opportunity for public
review and comment.
If research is no more than minimal risk. (One parent/guardian may sign the parental permission
document.)
If research involves greater than minimal risk but presents the prospect of direct benefit to the
individual subject. (One parent/guardian may sign the parental permission document.)
If research involves greater than minimal risk and has no prospect of direct benefit to the individual
subject, but is likely to yield generalizable knowledge about the subject’s disorder or condition.
(Both parents/guardians must sign the parental permission document.)
If research not otherwise approvable which presents an opportunity to understand, prevent, or
alleviate a serious problem affecting the health or welfare of children. (Both parents/guardians may
sign the parental permission document.)
Check the appropriate boxes below. If you answer No, describe in Requested Revisions/
Clarifications section.
If greater than minimal risk, convincing scientific and ethical justifications are provided.
YES NO N/A
If the study involves normal volunteers, this has been justified.
YES NO N/A
Have appropriate studies been conducted on animals and adults to justify studies on children?
YES NO N/A
If no to the above, the lack of appropriate studies conducted on animal and adults has been
justified.
YES NO N/A
The appropriate age groups have been included for proposed research questions.
YES NO N/A
Efforts have been made to ensure that parents’ permission to involve children is free from
coercion, exploitation, and/or unrealistic promises.
YES NO N/A
