REVIEWER CHECKLIST FOR RESEARCH INVOLVING CHILDREN
Study Title:
To be approved by the IRB, pediatric research must comply with all of the items in one of
the following categories. Please indicate which category you believe the research falls
under, and document if all requirements have been met by checking the appropriate Yes/No
boxes.
Note: the minutes/records must document protocol-specific information that justifies each
determination. Please be prepared to present at the IRB meeting or list below so that the
minutes/records may reflect that information.
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Research not involving greater than minimal risk. (45 CFR 46.404 &
21 CFR 50.51)
Yes
No
The research is of no greater than minimal risk to the
children.
Adequate provisions are made for soliciting the assent of
the children. (See additional checklist below.)
Select one:
 The permission of both parents are required 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.
 The 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.
Comments:
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Research involving greater than minimal risk but presenting the
prospect of direct benefit to the individual subjects. (45 CFR 46.405 &
21 CFR 50.52)
Yes
No
The intervention or procedure holds out the prospect of
direct benefit for the individual subject or the
monitoring procedure is likely to contribute to the
subject’s well-being.
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.
Adequate provisions are made for soliciting the assent of
the children. (See additional checklist below.)
Select one:
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 The permission of both parents are required unless
one parent is deceased, unknown, incompetent, or not
reasonably available, or when only one parent has
SC 501-B
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legal responsibility for the care and custody of the
child.
 The 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.
Comments:
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Research involving greater than minimal and no prospect of direct
benefit to the individual subjects (45 CFR 46.406 & 21 CFR 50.53)
Yes
No
The risk represents 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.
The intervention or procedure is likely to yield
generalizable knowledge about the subject’s disorder or
condition, which is of vital importance for the
understanding or amelioration of the subjects’ disorder
or condition.
Adequate provisions are made for soliciting the assent of
the children. (See additional checklist below.)
Adequate provisions are made for soliciting the
permission of both parents/guardians unless one is
deceased, unknown, incompetent, or not reasonably
available, or when only one parent has legal
responsibility for the care and custody of the child.
SC 501-B
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If the research involves children who are wards (i.e.
placed in the legal custody of the State or any other
agency, institution, or other entity consistent with
applicable federal, state or local laws)…
The research is:
Related to their status as wards.
OR
Conducted in schools, camps, hospitals, institutions, or
similar settings in which the majority of the children
involved as subjects are not wards.
An advocate will be appointed for each child who is a
ward, in addition to any other individual acting on
behalf of the child as guardian or in loco parentis.
(Please note: An individual may serve as an advocate for
more than one child).
1. The advocate will be an individual who has the
background and experience to act in, and agrees to
act in, the best interests of the child for the
duration of the child’s participation in the
research.
2. The advocate will not be associated in any way
(except in the role as advocate or member of the IRB)
with the research, the investigator(s), or the
guardian organization.
Comments:
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Research not otherwise approvable which presents an opportunity to
understand prevent, or alleviate a serious problem affecting the health
or welfare of children. (45 CFR 46.407 & 21 CFR 50.54)
Yes
No
Adequate provisions are made for soliciting the
permission of both parents/guardians unless one is
deceased, unknown, incompetent, or not reasonably
available, or when only one parent has legal
responsibility for the care and custody of the child.
This research should be referred to the Secretary of DHHS
and/or the Commissioner of FDA for appropriate action.
SC 501-B
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If the research involves children who are wards…
The research is:
Related to their status as wards.
OR
Conducted in schools, camps, hospitals, institutions, or
similar settings in which the majority of the children
involved as subjects are not wards.
An advocate will be appointed for each child who is a
ward, in addition to any other individual acting on
behalf of the child as guardian or in loco parentis.
1. The advocate will be an individual who had the
background and experience to act in, and agreed to
act in, the best interests of the child for the
duration of the child’s participation in the
research.
2. The advocate will not be associated in any way
(except in the role as advocate or member of the IRB)
with the research, the investigator(s), or the
guardian organization.
Comments:
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Other Considerations – These questions should be answered about all pediatric
studies under review.
Yes
No
Have appropriate studies been conducted on animals and
adults first?
If NO, is the lack of appropriate studies conducted on
animals and adults justified?
Are there special problems that call for the presence of
a monitor or advocate during the consenting process?
Are there any special problems such as confidentiality
and reporting that might arise in sensitive research
about child abuse or sexual practices of teenagers?
Should the child be re-consented when he/she reaches 18
years of age?
Is the proposed payment/compensation to the
parent/guardian and/or child appropriate?
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Has the IRB determined that the research protocol is
designed for conditions or for a subject population for
which parental or guardian permission is not a reasonable
requirement to protect the subjects (for example,
neglected or abused children)? If yes, the IRB may waive
the consent requirements, provided an appropriate
mechanism for protecting the children who will
participate as subjects in the research is substituted,
and provided further that the waiver is not inconsistent
with federal, state, or local law. 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 subjects,
and their age, maturity, status, and condition. The IRBs
deliberation and determination must be documented in the
meeting minutes.
Comments:
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ASSENT checklist – These questions should be answered about all pediatric
studies in which assent of the child is to be solicited.
Assent is a requirement of:
 All children.
 Some children. Indicate which ones do not have to assent:
_______________________
 None of the children.
If assent is not a requirement of some or all children, indicate why by
checking one of the following boxes:
 The children are not capable of providing assent based upon their
age, maturity, or psychological state.
 The capability of the children is so limited that they cannot
reasonably be consulted.
 The intervention or procedure involved in the research holds out a
prospect of direct benefit that is important to the health or wellbeing of the children, and is available only in the contact of the
research.
 The assent can be waived using the criteria for waiver of the
consent process.
Does assent need to be documented?
 YES /  NO
If YES, describe the process to document assent.
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WAIVER OF PARENTAL PERMISSION
Yes
No
Yes
No
b) The waiver of parental permission will not adversely
affect the rights and welfare of the subjects.
Yes
No
c) It is not practicable to conduct the research without
the waiver/alteration.
Yes
No
d) Is the investigator’s response regarding the
dissemination of additional pertinent information after
the subject’s participation appropriate?
Yes
No
e) The research is not FDA-regulated.
Yes
No
Yes
No
Yes
No
Has a waiver of parental permission or a waiver of the
permission procedure requirement to include all or alter
some or all of the elements of informed consent [45 CFR
46.116(d)] been requested by the investigator? For each of
the determinations, minutes or records have to document
protocol-specific information that justifies each
determination.
If Yes, please respond to each of the following statements:
a)
Will the research in its entirety involve no more than
minimal risk?
YES must be answered to all of the conditions for the
waiver of parental permission to be granted. If a waiver is
granted under the above conditions, documentation of
parental permission is also waived.
The IRB may require the researcher to provide subjects
(parents) with an information sheet (written summary) about
the research.
Do you feel that an information sheet should be provided to
the subjects?
Do you feel that a waiver of informed consent is
appropriate?
Primary Reviewer
SC 501-B
Date
v. 4/29/08