Please date form: _______
UCSF COMMITTEE ON HUMAN RESEARCH
APPLICATION SUPPLEMENT
INCLUSION OF CHILDREN AND MINORS IN RESEARCH
Principal Investigator on CHR Application:
CHR # (if known):
Study Title (may not exceed 500 characters):
A. Rationale for Inclusion of Children and Minors
Please provide rationale for including children and minors as subjects in CHR application Part 2: Study Design, C.
Background. For working definitions see Children and Minors in Research, “Children” and “Minors.”
B. Age Range
Please specify the eligible age range for children and
minors in this study:
C. Subpart D, 45 CFR 46 and 21 CFR 50: Children
Research on children (who have not reached the legal age to consent for the treatments or procedures involved in the
research) must fall under at least one of the following categories. Please check all that apply. (See Section G below for
adolescents who may consent for themselves.)
[ ] “No Greater than Minimal Risk (45 CFR 46.404, 21 CFR 50.51),” with “minimal risk” defined as “the
probability and magnitude of harm or discomfort anticipated in the research are no greater than those ordinarily
encountered in daily life or during the performance of routine physical or psychological examinations or tests.”[45
CFR 46.102]
 Requires permission of at least one parent/legal guardian and assent of the child (if 7 years of age or older).
[ ] “Greater than Minimal Risk (45 CFR 46.405, 21 CFR 50.52) but presenting prospect of direct benefit to
individual subjects”
 Requires permission of at least one parent/legal guardian and assent of the child (if 7 years of age or older).
For the two categories above:
How many parents should be required to give permission?
[ ] 1 parent’s permission is sufficient. It is not likely that the study will provoke disagreement about
participation between two parents.
[ ] 2 parents’ permission should be obtained (if both are reasonably available). It seems likely that the study
will provoke disagreement about participation between some parents.
If the study seems likely to provoke disagreement between parents, explain why:
“Greater than Minimal Risk (45 CFR 46.406, 21 CFR 50.53) (though only a minor increase over minimal risk)
and no prospect of direct benefit to the individual subject, but likely to yield generalizable knowledge about
the subject’s disorder or condition”
 Requires permission of both parents/legal guardians unless one parent is deceased, unknown, incompetent, not
reasonably available, or does not have legal responsibility for the custody of the child, and assent of the child
(if 7 years of age or older).
[ ] “Research not otherwise approvable (45 CFR 46.407, 21 CFR 50.54) which presents an opportunity to
understand, prevent, or alleviate a serious problem affecting the health or welfare of children”
 Requires approval by the Secretary of the U. S. Department of Health and Human Services or the
Commissioner of the Food and Drugs Administration.
 Requires permission of both parents/legal guardians unless one parent is deceased, unknown, incompetent, not
reasonably available, or does not have legal responsibility for the custody of the child, and assent of the child
(if 7 years of age or older).
For each category checked above, briefly explain why the research in this study falls under that category:
[ ]
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Explanation of why the research falls under the checked category:
If there is more than one group of children being studied, e.g., patients and normal controls, and the groups fall into
different risk/benefit classifications, explain below, citing the applicable section of 45 CFR 46 for each group.
Explanation of multiple child subject groups with different risk/benefit classifications:
D. Informed Consent (Permission from Parents/Guardians and Assent from Children)
Please indicate all types of consent/permission and assent form(s) that will be used for this study:
[ ] Permission form addressed to the parents
[ ] Simplified assent form addressed to the child, 7-12 years old (parents get separate form)
[ ] Assent form addressed to the child, 13 years and older (for subjects and parents)
[ ] Assent form addressed to the child, 13 years and older (parents get separate form)
E. Waiver of Parental Permission (45 CFR 46.408, 21 CFR 50.55)
If you wish to request waiver of parental permission, please consult the regulations cited below and UCSF Guidance on
Research Topics and Issues, Children and Minors in Research, Exceptions to CHR Consent Guidelines for Minors.
NOTE: Waiver of parental/guardian permission is not permitted for FDA-regulated research. However, see
Section G below for adolescents who can consent for themselves.
For non-FDA-regulated studies, waiver of parental/guardian permission is possible under 45 CFR 46.408(c) if the CHR
finds one of the following:
[ ] 1. Parental permission is not a reasonable requirement.
 Permission is not a reasonable requirement to protect the subjects (e.g., neglected or abused children); and
 An appropriate mechanism for protecting the children in the research is substituted; and
 The waiver is not inconsistent with Federal, State, or local law.
Explanation of why study meets above bulleted criteria for waiver of parental permission:
OR
[ ]
2. The waiver meets the provisions set forth in 45 CFR 46.116, Subpart A.
 Research involves no more than minimal risk;
 Waiver will not adversely affect rights and welfare of the subjects;
 Research could not practicably be carried out without waiver; and
 Whenever appropriate, subjects will be given additional information after participation.
NOTE: If you are applying for permission waiver under 45 CFR 46.116, you must complete CHR form
Request for Waiver of Consent/Authorization for Minimal Risk Research or for Screening for Recruitment.]
F. Waiver of Assent (45 CFR 46.408, 21 CFR 50.55)
If you wish to request waiver of a child’s assent, please consult the regulations cited below and UCSF Guidance on
Research Topics and Issues, Children and Minors in Research, Exceptions to CHR Consent Guidelines for Minors.
Waiver of child’s assent (45 CFR 46.408(a) and 21 CFR 50.55) is possible if the CHR finds one of the following:
[ ] 1. Children cannot be consulted or the research has prospect of direct benefit only available in the study:
 The capability of some or all of the children is so limited that they cannot reasonably be consulted; OR
 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.
Explanation of why study meets at least one of the above criteria for waiver of child’s assent:
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[ ]
OR
2. The waiver meets the provisions set forth in 45 CFR 46.116 or 21 CFR 50.55(d).
 Research involves no more than minimal risk;
 Waiver will not adversely affect rights and welfare of the subjects;
 Research could not practicably be carried out without waiver; and
 Whenever appropriate, subjects will be given additional information after participation.
NOTE: If you are applying for assent waiver under 45 CFR 46.116 or 21 CFR 50.55(d), you must complete
CHR form Request for Waiver of Consent/Authorization for Minimal Risk Research or for Screening for
Recruitment.]
G. Enrollment of People Under 18 Who Can Consent for Themselves
California law establishes several groups of people under 18 years of age (referred to as “children” or “minors” in state
law) who are legally able to consent to treatment or procedures involved in research. Under federal regulations (45 CFR
46.402(a) and 21 CFR 50.3(o)), these people do not meet the definition of “children” and therefore are able to consent for
themselves as if they were adults. Outside of California, the age of consent depends on the local jurisdiction. See Children
and Minors in Research, Legal Exceptions Permitting Certain Minors to Consent for a more complete explanation.
[ ] The study will enroll people under the usual age of consent (18 in California) who are permitted by law to consent for
themselves.
Describe the types of people under the usual age of consent who will be allowed to consent for themselves:
H. Children Who are Wards of the State (45 CFR 46.409; 21 CFR 50.56)
Federal regulations do not have special requirements for enrollment of wards in research approved under 45 CFR 46.404
or 45 CFR 47.405 (FDA: 21 CFR 50.51 or 21 CFR 50.52); see explanations of categories above. However, children who
are wards of the state or any other agency, institution, or entity can be included in research approved under 45 CFR
46.406 or 45 CFR 46.407 (FDA 21 CFR 50.53 or 21 CFR 50.54) only if such research is:
1. Related to their status as wards; OR
2. Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as
subjects are not wards.
The inclusion of children who are wards requires the following conditions be met:
 Appointment of an advocate 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.
 One individual may serve as advocate for more than one child.
 The advocate shall 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.
 The advocate must 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.
[ ] The study falls under 45 CFR 46.406 or 45 CFR 46.407 (FDA 21 CFR 50.53 or 21 CFR 50.54) and will enroll wards
of the state.
Explain why it is appropriate to enroll wards in this study:
Describe your plans for appointing advocates and what their duties will be:
[ ]
The study falls under 45 CFR 46.404 or 45 CFR 46.405 (FDA 21 CFR 50.51 or 21 CFR 50.52) and the researchers
are required by a sponsor or group to have documented IRB approval for enrollment of wards of the state.
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Explain why it is appropriate to enroll wards in this study:
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