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IV.10
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Review of Research Involving
Children/Minors
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Objective
To safeguard the interests of
children who are participants in research and to protect them from harm,
special regulatory considerations apply for reviewing the research and special
conditions must be met prior to approval.
This Policy/Procedure describes the process by which the Committee for
the Protection of Human Subjects (CPHS) members review
protocols involving children and minors to ensure compliance with regulatory
requirements and to protect children participating in research.
Policy/Procedure
I.
The CPHS must classify research involving children into one of four
categories and document their discussions of the risk and benefits of the
research study. The four categories of research involving children that may be
approved by the CPHS based on degree of risk and benefit to individual participants, are as follows:
A. Research not involving
greater than minimal risk to the child (examples: urinalyses, obtaining small
blood samples, EEGs, allergy scratch tests, minor changes in diet or daily routine,
and/or use of standard psychological or educational tests). The CPHS may
approve the research only if the CPHS finds that adequate provisions are made
for soliciting the assent of the children and permission of their parents, or
legal guardians
B. Research
involving greater than minimal risk, but presenting the prospect of direct
benefit to an individual participant. Research in this category is approvable
provided:
1.
The risk represents a minor
increase over minimal risk;
2. The relationship of risk to benefit is at least as
favorable as any available alternative approach
C. Research involving greater
than minimal risk with no prospect of direct benefit
to individual participants, but likely to yield generalizable
knowledge about the participant's disorder or condition. Research in this
category is approvable provided:
1.
The risk represents a minor
increase over minimal risk; and
2. 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;
and
3. The intervention or procedure is likely to yield generalizable knowledge about the participant’s disorder or
condition that is of vital importance for the understanding or improvement of
the participant’s disorder or condition.
D. Research
that is not otherwise approvable, but which presents an opportunity to
understand, prevent, or alleviate a serious problem affecting the health or
welfare of children. Research that is not approvable under 45 CFR 46.404, 46.405, or 46.406
may be conducted or funded by DHHS provided that the CPHS and the Secretary of
DHHS, after consultation with a panel of experts, finds:
1. That the research presents a reasonable opportunity
to further the understanding, prevention, or alleviation of a serious problem
affecting the health or welfare of children; and
2. That the research will be conducted in accordance
with sound ethical principles
II.
Children who are wards of the State or any other agency, institution, or
entity can be included in approved research only if it is either:
A. Related to their status as
wards; or
B. Conducted in schools,
camps, hospitals, institutions, or similar settings in which the majority of children
involved as participants are not wards.
III.
If the clinical investigation is approved under 45 CFR §46.409(a) {FDA:
21 CFR §50.56(a)} the CPHS must require appointment of an advocate for each
child who is a ward. [45 CFR §46.409(b)] [21 CFR §50.56(b)]
A. The advocate will serve in
addition to any other individual acting on behalf of the child as guardian or
in loco parentis.
B. One individual may serve
as advocate for more than one child.
C. The advocate must be an
individual who has the background and experience to act in, and agrees to act
in, the best interest of the child for the duration of the child’s
participation in the research.
D. The advocate must not be
associated in any way (except in the role as advocate or member of the CPHS)
with the research, the investigator(s), or the guardian organization.
IV.
The CPHS must determine that adequate provisions have been made for
soliciting the assent of children and the permission of their parents or
guardian.
A. The CPHS must determine
for each protocol – depending on such factors as the nature of the research and
the age, status, and condition of the proposed participants – whether all or
some of the children are capable of assenting to participation taking into
account the ages, maturity, and psychological state of the children involved.
B. The CPHS should determine
that if assent is sought, the information/explanation of the proposed research
procedures are in a language that is appropriate to the child’s age,
experience, maturity, and condition. This should include a discussion of any
discomforts or inconveniences, or if the child will be required to spend time
in an unfamiliar place.
1. Verbal assent is to be obtained from children under
the age of 7 whenever possible
2. Assent documents are signed by participants 7 to 11
years of age provided the child is mature enough to understand the planned
intervention.
3. Generally, the child's veto of participation is
sufficient to make the child ineligible for inclusion in the study. However,
the parent or guardian, with CPHS and physician approval, may override the veto
if the intervention will benefit the child.
4. The PI may not approach the child to assent to the
research study until the parents or legal guardians have given written
permission.
5. When the research offers the child the possibility
of a direct benefit that is important to the health or well-being of the child
and is available only in the context of the research, the CPHS may determine
that the assent of the child is not necessary.
6. When research involves the provision of experimental
therapies for life-threatening diseases such as cancer, however, CPHS should be
sensitive to the fact that parents may wish to try anything, even when the
likelihood of success is marginal and the probability of extreme discomfort is
high. Should the child not wish to undertake such experimental therapy,
difficult decisions may have to be made. In general,
if the child is a mature adolescent and death is imminent, the child's wishes
should be respected.
7. For some research activities, the CPHS may require
that either a CPHS member, research intermediary or an advocate for the child
be present during the assent and permission procedures to verify the child's
understanding and to support the child's preferences. The CPHS may also require
that the parent(s) or a close family member be present during the research,
especially if a young child will be exposed to significant discomfort or
inconvenience, or if the child will be required to spend time in an unfamiliar
place.
8. Should the CPHS have questions or concerns it should
consult legal counsel about the applicability of any state laws affecting
consent for the proposed research.
C. Parental Permission
documents are signed by parents, or the legally appointed guardian, of children
under age 18. Consent of one parent is sufficient if research involves minimal
risk; consent of both parents is necessary if the research involves more than
minimal risk. However, if one parent is deceased, unknown, incompetent or
reasonably unavailable, or if one parent has legal responsibility or custody of
the child, one parent consent is acceptable.
1. The CPHS must determine for each protocol whether
the permission of both parents is necessary, and
2. The conditions under which one
parent may be considered “not reasonably available”.
3. Parental permission may sometimes be insufficient to
protect the child's interests particularly when the interests of one child
conflict with those of a sibling or other relation. In such cases, CPHS may seek a legal guidance
to clarify authority.
Definitions:
Assent – A child’s affirmative
agreement to participate in research. Mere failure to object should not, absent
affirmative agreement, be construed as assent.
Children – Persons who have
not attained the legal age for consent to treatment or procedures involved in
the research, under the applicable law of the jurisdiction in which the
research will be conducted.
Emancipated Minor – A legal
status conferred upon persons who have not yet attained the age of legal
competency as defined by state law, but who are entitled to treatment as if
they had by virtue of assuming adult responsibilities, such as self –support,
marriage or procreation. Those who have
had the disabilities of minority removed for limited or general purposes by the
State of Texas.
Guardian – An individual who is authorized under
applicable state or local law to give permission on behalf of a child to
general medical care.
Permission – The agreement of parent(s) or guardian to the
participation of their child or ward in
research.
Parent - a child’s biological
or adoptive parent.