Version 5/18/15
Checklist for Research Involving CHILDREN
(45 CFR 46 Subpart D)
Equivalent protections may be considered by the IRB for research that is not federally-supported.
The minutes or records must document protocol-specific findings justifying each of the following determinations.
IRB number:
PI:
A. THE RESEARCH MUST FIT INTO ONE OF THE FOLLOWING THREE CATEGORIES:
1. 45 CFR 46.404
(All must be “Yes”)
No greater than minimal risk to children is presented.
Yes
No
[Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those
ordinarily encountered in daily life of normal children or during the performance of routine physical or psychological examinations or
tests in normal children.]
Provide protocol specific findings justifying this determination:
Yes
No
Adequate provisions are made for soliciting the assent of the children and permission of the parents or guardians.
(Complete SECTIONS B, C, and D on the next page)
2. 45 CFR 46.405
(All must be “Yes”)
More than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct
Yes
benefit for the individual participant, or by a monitoring procedure that is likely to contribute to the participant’s wellNo
being.
Provide protocol specific findings justifying this determination:
Yes
No
The risk is justified by the anticipated benefit to the participants.
Provide protocol specific findings justifying this determination:
Yes
No
The relation of the anticipated benefit to the risk is at least as favorable to the participants as that presented by
available alternative approaches.
Provide protocol specific findings justifying this determination:
Yes
No
Adequate provisions are made for soliciting the assent of the children and permission of the parents or guardians.
(Complete SECTIONS B, C, and D on the next page)
3. 45 CFR 46.406
NOTE that children who are wards of the state or any other agency, institution, or entity can
only be included in this category of research if the additional protections from 45 CFR 46.409 are applied.
(All must be “Yes”)
More than minimal risk is presented by an intervention or procedure that does not hold out the prospect of direct
Yes
benefit for the individual participant, or by a monitoring procedure which is not likely to contribute to the well-being
No
of the participant.
The risk represents a minor increase over minimal risk. (“Minor increase over minimal risk” means no greater than risk
Yes
in the daily lives of children with the condition or disorder under study, but still socially acceptable.1)
No
Provide protocol specific findings justifying this determination:
Yes
No
The intervention or procedure presents experiences to participants that are reasonably commensurate with those
inherent in their actual or expected medical, dental, psychological, social, or educational situations.
Provide protocol specific findings justifying this determination:
Yes
No
The intervention or procedure is likely to yield generalizable knowledge about the participants’ disorder or condition
which is of vital importance for the understanding or amelioration of the participants’ disorder or condition.
Provide protocol specific findings justifying this determination:
Yes
No
Adequate provisions are made for soliciting the assent of the children and permission of the parents or guardians.
(Complete SECTIONS B, C, and D)
Version 5/18/15
Checklist for Research Involving CHILDREN
(45 CFR 46 Subpart D)
B. PERMISSION OF PARENTS/GUARDIANS
(One must be selected)
Permission of one parent is sufficient even if the other parent is alive, known, competent, reasonably available, and shares
legal responsibility for the care and custody of the child.
(Sufficient for 45 CFR 46.404 or 46.405. May not be selected for 45 CFR 46.406)
Permission is obtained from 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.
(Required for 45 CFR 46.406)
Parental permission may be waived because the research protocol is designed for conditions or for a population for which
parental or guardian permission is not a reasonable requirement to protect the participants (for example, neglected or
abused children).
(If this option is selected, BOTH of the following must be “Yes”)
Yes
No An appropriate mechanism for protecting the children is substituted. The choice of an appropriate
mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk
and anticipated benefit to the research participants, and their age, maturity, status, and condition.
Yes
No The waiver is not inconsistent with federal, state, or local law
Parental permission may be waived under circumstances in which consent may be waived according to 45 CFR 46.116.
(If this option is selected, ALL of the following must be “Yes”)
Yes
No The research involves no more than minimal risk to the participants;
Yes
No The waiver or alteration will not adversely affect the rights and welfare of the participants;
Yes
No The research could not practicably be carried out without the waiver or alteration;
Yes
No Whenever appropriate, the participants will be provided with additional pertinent information after
participation.
C. ASSENT PROCESS
(One option in the left most column must be selected)
Assent is required of:
All children.
None of the children or only Some of the children. If “Some”, please define (eg. Some of the participants are babies):
(If this option is selected, one of the following must be “Yes”)
Yes
No The capability of the children from whom assent would be waived is so limited that they cannot reasonably
be consulted.
(The IRB shall take into account the ages, maturity, and psychological state of the children involved.)
Yes
No The intervention or procedure involved in the research holds out a prospect of direct benefit that is
important to the health or well-being of the children and is available only in the context of the research.
Yes
No Assent may be waived under circumstances in which consent may be waived according to 45 CFR 46.116.
(If this option is selected, ALL of the following must be “Yes”)
Yes
No The research involves no more than minimal risk to the participants;
Yes
No The waiver or alteration will not adversely affect the rights and welfare of the
participants;
Yes
No The research could not practicably be carried out without the waiver or alteration;
Yes
No Whenever appropriate, the participants will be provided with additional pertinent
information after participation.
D. ASSENT DOCUMENTATION
(May be “Yes” or “No.”)
Yes
No Assent documentation is required.
If “Yes,” what is the process for documentation?