Children
The legal mandate of the HSPC is to protect the rights and
welfare of human subjects. This task becomes more difficult when
considering children and minors as research subjects. The federal
regulations provide for "Additional Protections for Children
Involved as Subjects of Research" [45 CFR 46 Subpart
D].
Parental
Permission and Research of Minimal Risk:
Parental permission is required in most circumstances for the
participation of children in research. Investigators are required
to gain parental permission from at least one of the child’s
parents or guardians if the research involves only minimal risk.
(Please see Chapter 4, "Informed
Consent Requirements: Assent and Parental Permission for the
Participation of Children in Research," for detailed
guidelines regarding parental permission and child assent.)
Parental
Permission and Research of More than Minimal Risk:
- If the research poses more than minimal risk and no
direct benefit to the child, the investigator is required
to gain permission from both parents or the child’s
guardian in order for the child to participate in the
research.
- If the research poses more than minimal risk but may
directly benefit the child, only one of the child’s
parents or guardian need give permission.
- The investigator is not required to gain permission form
both parents, if one of the parents is not reasonably
available, deceased, unknown, legally incompetent, or
from a parent who does not have legal responsibility for
the care and custody of the child. This caveat does not
exempt the investigator from obtaining the permission
from at least one parent who has legal responsibility for
the child.
The HSPCs are required to make additional considerations for
the inclusion of children in research who are wards of the state
or any other agency or institution. For research that involves
more than minimal risk with no prospect of direct benefit to the
individual subjects or for research that requires approval of the
HHS Secretary, the study must either be 1) related to the
subject’s status as a ward, or 2) be conducted in schools,
camps, hospitals, institutions, or similar settings in which the
majority of children involved as subjects are not wards. [45 CFR 46.406-409]
The HSPC is required to appoint an advocate for each child
who is a ward. The advocate is required to have 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 with the research, the investigator, or the guardian
organization. The requirement for an advocate is in addition to
gaining permission from any other person acting on behalf of the
child as guardian or in loco parentis.
Subpart D of
the federal regulations requires the HSPCs to classify research
involving children into one of four categories relating to the
risks and benefits of the proposed research:
- Research involving no greater than minimal risk
- Research involving greater than minimal risk, but
presenting the prospect of direct benefit to individual
subjects. Research in this category is approvable by
the HSPC, provided: (a) the risk is justified by the
anticipated benefit to the subjects; (b) the relationship
of risk to benefit is at least as favorable as any
alternative approach; and (c) adequate provisions are
made for soliciting the assent of the children and
permission of their parents or guardians.
- Research involving greater than minimal risk and no
prospect of direct benefit to individual subjects, but
likely to yield important generalizable
knowledge about the subject’s disorder or condition.
Research in this category is approvable, by the HSPC,
provided: (a) the risk represents a minor increase over
minimal risk; (b) 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;
(c) the intervention or procedure is likely to yield
generalizable knowledge about the subjects’ disorder
or condition which is of vital importance for the
understanding or amelioration of the subjects’
disorder or condition; and (d) adequate provisions are
made for soliciting assent of the children and permission
of their parents or guardians.
- Research not otherwise approvable which presents an
opportunity to understand, prevent, or alleviate a
serious problem affecting the health or welfare of
children. This section provides a mechanism for the
approval of research not falling under categories 1-3.
The research must be approved by the Secretary of the
Department of Health and Human Services (DHHS) if it is
to be funded by the DHHS, after consultation with a panel
of experts, and the panel must find that the research
presents a reasonable opportunity to further the
understanding, prevention, or alleviation of a
significant problem affecting the health and welfare of
children.
When assessing risk to children and evaluating a research
project proposing to involve children the HSPC will consider the
following issues:
- Is the participation of children as research subjects
justified in this particular instance?
- If this research question can be addressed initially in
adults, has this work been conducted?
- Have results from any adult research indicated that the
proposed research would benefit, or at least would not be
harmful to children?
- Has every effort been made to ensure that a parent is
present when the research intervention is conducted? This
will not only comfort the child but will enable the
parent to exercise the right to end the child’s
participation in the research project at any time.
Investigators should note that in some cases (e.g.
research into sensitive personal matters, physical
examinations of adolescents, research into abuse, etc.)
it may not be appropriate to have a parent present. If a
parent will not be present during the course of the
project, has the investigator clearly stated why in the
protocol?
- Are the personnel involved in the research, and the
facility in which the research will be conducted,
knowledgeable about and sensitive to the physical an
psychological needs of the children and their families?
- Have the investigators taken into account the
child-subject’s previous experience with illness and
medical interventions? Some children may be able to cope
with stresses of research better than others as a result
of previous experiences with medicine. Younger,
"less experienced" children may be unprepared
for participation in medical research.
- How the investigator determined the number of children to
be enrolled for the study. Investigators should justify
the number of subjects they propose to study. Biomedical
Investigators should always plan to involve the fewest
number of children necessary to obtain statistically
significant data from which valid conclusions can be
drawn.
- Whether the proposed techniques are the least invasive
(physically and psychologically) in order to obtain the
information for the study.
- Have the investigators clearly defined how the assent of
the child-subjects will be obtained?
- For research involving medical interventions the
Committee will consider previous research with animals.
The investigator should indicate whether the animal
research is completed and the results to date.
All personnel working with children should be familiar with
State laws requiring reports of suspected child abuse or neglect.
The HSPC cannot approve research that exposes children as
subjects to more than minimal risk and does not satisfy the
conditions outlined above. The federal regulations, however,
provide a process for seeking approval for such research from the
DHHS Secretary. Please contact the OPRS for more information
about this process.
Contact OPRS
October 29, 2004
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