Research Involving Children
18.2.1 Definitions
Child – is a person who has not attained the legal age for consent to
treatments or procedures involved in the research under the applicable law of
the jurisdiction in which the research will be conducted.
Under Department of Education regulations - a child is a person enrolled in
research who is not above the elementary or secondary education level, and
who has not reached the age of majority as determined under state law.
Colorado regulations allow minors to consent for themselves for certain
medical treatments.
 Age of competence is 18 years old. (CRS §13-22-101)
 An emancipated minor is a minor 15 years or older who is living separate
and apart from his parent(s) or legal guardian and is managing his own
financial affairs, or any minor who has contracted a lawful marriage. (CRS
§13-22- 103)
 A minor parent may consent to health, medical, dental, emergency
health and surgical care for his child or ward. (CRS §13-22-103).
 A minor cannot consent to donation of blood or to the penetration of the
tissue for blood donation until the age of 18. (CRS §13-22-104)
 [COMIRB has interpreted, to mean donation of blood units (450 cc in one
draw) and that the small, multiple volumes of blood needed for research
are acceptable as long as they are less than 50cc (or 3 ml per kg) per
eight week period and no more than two draws a week.]
 A minor may request birth control procedures, supplies or information. (CRS
§13-22-105)
 A minor may consent for medical care and treatment for addiction to or
use of drugs. (CRS §13-22-102)
 A minor may consent to exam and treatment for sexual assault but the
physician must make a reasonable effort to notify the parent(s), legal
guardian, or
any other person having custody of such minor. (CRS § 13-22- 106)
 A minor may consent to exam and treatment for sexually transmitted
diseases. (CRS §25-4-402)
 A minor may consent to an HIV/AIDS examination and treatment. The
healthcare provider shall counsel the minor on the importance of bringing
parents into the
minor’s confidence (CRS §25-4-1405)
 A minor of 15 years of age or older may consent to hospitalization for
evaluation and treatment for mental health services (CRS §27-10-103)
 A pregnant minor may approve prenatal, delivery and post-delivery medical
care related to the intended live birth of a child. (CRS §25-2-102)
A minor who is able to give consent (as described above) under Colorado State
Law is not considered a child under federal regulations.
NOTE: It is important that investigators who conduct pediatric research
understand the limitations of these regulations. COMIRB has interpreted the
Colorado regulations to allow minors to consent for research procedures related to
the clinical treatment which the minor has sought and can consent to under the
applicable Colorado Statute without requiring parental permission. For example, if
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a child seeks treatment for an STD then the minor can consent to participate in
STD research but the study cannot include additional research procedures
unrelated to the clinical treatment sought. Also, the minor cannot participate in
genetic research as the result of seeking STD treatment.
Unless parental permission is waived, any minor parent can give permission for
their child to participate in research but the parent/guardian of the minor parent
must give permission for the minor parent to participate in research (if it does not
fall within one of the categories above for which minors can consent as an adult).
NOTE: For research conducted in jurisdictions other than Colorado, the research
must comply with the laws regarding the legal age of consent in all relevant
jurisdictions. The General Counsel of the University’s Office will provide
assistance with regard to the laws in other jurisdictions.
Guardian – In Colorado, a “Guardian” of a minor means a person with the legal
authority to make major decisions affecting a child including, but not limited to
decisions regarding medical or surgical treatment and decisions of substantial
legal significance concerning the child. There may be other individual roles, which a
court appoints, that can serve as a legally-authorized representative for a child.
Any individual other than a parent or legal guardian should be approved by legal
counsel at the institution where the research is being conducted.
NOTE: For research conducted in jurisdictions other than Colorado, the research
must comply with the laws regarding guardianship in all relevant jurisdictions.
The General Counsel of the University’s Office will provide assistance with
regard to the laws in other jurisdictions.
Parent - a child’s biological or adoptive parent.
Permission - the agreement of parent(s) or legal guardian to the participation of
their child or ward in research.
Assent - a child’s affirmative agreement to participate in research. Mere failure to
object, absent affirmative agreement, should not be construed as assent. The
child’s failure to object should not be considered assent. The assent process
should be an active process.
Wards are children in the care or custody of the state, courts, or any other
agency, institution or entity. Foster Care, under Colorado statutes, meets this
Federal definition (CRS 19-1-103).
Minimal Risk means the probability and magnitude of physical or psychological
harm that is normally encountered in the daily lives, or in the routine medical,
dental or psychological examination of healthy persons.
18.2.2 Allowable Categories
Research on children must be reviewed and categorized by the COMIRB into one
of the following groups:
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1. Research not involving physical or emotional risk greater than that
ordinarily encountered in daily life or during the performance of routine
physical or psychological examinations or tests (i.e. minimal risk).
o The panel may find that the permission of one parent is sufficient.
o Requires assent of the child.
2. Research involving greater than minimal risk but presenting the prospect of
direct
benefit to the individual subject.
o The risk is justified by the anticipated benefit to the subjects;
o The panel may find that the permission of one parent is sufficient;
o Requires assent of the child.
3. Research involving greater than minimal risk and no reasonable prospect of
direct
benefit to the individual subject, but likely to yield generalizable knowledge
about the subject’s disorder or condition.
o The risk represents a minor increase over minimal risk;
o 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;
o Permission of either both parents, or legal guardian, is requiredunless one parent is deceased, unknown, incompetent, or not
reasonably available; or only one parent has legal responsibility for
the care and custody of the child;
o Requires assent of the child.
4. Research not otherwise approvable which presents an opportunity to
understand, prevent, or alleviate serious problems affecting the health or
welfare of children.
o Federally-funded research in this category must be approved by the
Secretary of Health and Human Services, and requires consent of
either both parents, or legal guardian.
o For non-federally-funded research, COMIRB will consult with a
panel of experts in pertinent disciplines (for example: science,
medicine, ethics, and law). Based on the recommendation of the
panel, the COMIRB may approve the research based on either:
That the research in fact satisfies the conditions of the
previous categories, as applicable;
or
The following:
The research presents a reasonable opportunity to further
the understanding, prevention, or alleviation of a serious
problem affecting the health or welfare of children;
The research will be conducted in accord with sound ethical
principles; and Informed consent will be obtained in accord
with the provisions for informed consent and other applicable
sections of this manual.
18.2.3 Parental Permission
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18.2.3.1 Parental Permission
In accordance with 45 CFR 46.408(b) and 21 CFR 50.55 (e), the COMIRB
must determine that adequate provisions have been made for soliciting the
permission of each child’s parents or guardians. Permission from both
parents is required for all research to be conducted with children 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; or the research falls under 1 or 2 above and the COMIRB has
determined that the permission of one parent is sufficient.
Parents or guardians must be provided with the basic elements of
consent as stated in 45 CFR 46.116(a) (1-8) and 21 CFR 50.25(a) (1-8)
and any additional elements the IRB deems necessary.
The COMIRB may find that the permission of one parent is sufficient for
research to be conducted under 45 CFR 46.404 (21 CFR 50.51) or 45 CFR
46.405 (21 CFR
50.52). The COMIRB’s determination of whether consent must be obtained
from one or both parents will be documented in the Children addendum
checklist when a protocol receives expedited review, and in meeting minutes
when reviewed by the convened committee.
Consent from both parents is required for research to be conducted under 45
CFR
46.406 (21 CFR 50.53) and 45 CFR 46.407 (21 CFR 50.54) unless
 One parent is deceased, unknown, incompetent, or not r
reasonably available or;
 When only one parent has legal responsibility for the care and
custody of the child.
Under DHHS regulations, the COMIRB may waive the requirement for
obtaining consent from a parent or legal guardian if:
 The research meets the provisions for waiver in 45 CFR 46.116(d)
(1-4), OR
 if the COMIRB determines that the research protocol is designed for
conditions or a subject population for which parental or guardian
permission is not a reasonable requirement to protect the subjects (for
example, neglected or abused children);and an appropriate
mechanism for protecting the children who will participate as subjects
in the research is substituted, and 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.
Under FDA regulations, parental permission cannot be waived.
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18.2.3.2 Assent from Children and the Assent Form
See above in section 14.8
18.2.3.3 Children who are Wards
Children who are wards of the State or any other agency, institution, or entity
can be included in research involving greater than minimal risk and no
prospect of direct benefit to individual subjects, but likely to yield generalizable
knowledge about the subject’s disorder or condition (45 CFR 46.406; 21
CFR 50.53), only if such research is:
related to their status as wards; or
conducted in schools, camps, hospitals, institutions, or similar settings in
which the majority of children involved as subjects are not wards.
If the research meets the condition(s) above, an advocate must be appointed
for each child who is a ward (one individual may serve as advocate for more
than one child), in addition to any other individual acting on behalf of the child
as legal guardian or in loco parentis.
The advocate must 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 and who is not associated in any way
(except in the role as advocate or member of the COMIRB panel) with the
research, the investigator(s),
or the guardian organization.
18.2.3.4 VA Regulations: Children as Vulnerable Population in Research
VA is authorized to care for veterans and to conduct research that supports the
mission of VHA and that enhances the quality of health care delivery to
veterans. Therefore, research involving children must not be conducted by VA
investigators while on official duty or at VA or approved off-site facilities unless
a waiver has been granted by the Chief Research and Development Officer.
If the waiver is granted, the research must be in accordance with applicable
Federal regulations pertaining to children as research subjects (see 45 CFR
Part 46, Subpart D 46.401 – 46.409, Additional Protections for Children Involved
as Subjects in Research). NOTE: For requirements for requesting a waiver
contact VA ECHCS Research Office.
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