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Submitting
Protocols with
Special Populations/Concerns
Special Population: Children
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more information
Consent / assent issues
- Parental/guardian
consent
- The
informed consent must clearly explain what is required of child as well
as what is asked of the parent. The document should also clearly state if
there is to be future contact with the family or if there will be any
observations or interactions with the child while the parent is not
present.
- Child Assent
- Since children cannot give legal consent to participate in research, we speak of parents giving consent, but their children give their assent, where
appropriate. Children
can only be approached for assent after parental consent has been
given. The assent is usually a scripted interaction, though with older
minors it can be a document. The assent must be in age-appropriate
language, explaining that their parents have
consented to have them participate, but they
do not have to participate if they don't want to. If appropriate, the
assent should state
that the research study is not school and will not affect grades or
teacher interaction. The assent should state if they will miss
any activities from the regular school day, and how that will be made
up. The script should also clearly state what the child is being asked
to do, where, for how long, and with whom, and the nature of any
compensation; explain that they can stop participating at any time
and still receive part of that compensation for their time; and the
extent that their responses will be confidential.
- Group assent
- The
IRB discourages group assenting procedures (asking children in a
classroom setting to raise their hand if they do/do not wish to
participate). This creates social pressure that may sway judgment.
If at possible, it is preferable to ask children in a
one-on-one setting or devise a system of passing out papers and having
the child decide and covertly mark the paper individually.
- Opt-Out
Consents
- The IRB
does not approve “opt out”
“consent” procedures. IRB does not recognize
“passive consent” as such; you’re
requesting a waiver of (parental) consent.
- Waiver or
Parental Consent
- The IRB
can waive parental consent under current regulations ( under 45CFR, both
46.408(b) / 46.116(d)), if the study is minimal risk, not practicable
without the waiver, and waiver won’t affect the participants'
risk or rights, and if appropriate efforts are made to inform the
parents about the work. Arguments that these conditions are met should
be included in the protocol submission. The IRB tends to be very
conservative in approving this unless the survey is benign and
anonymous. If this consent method is sought, the researchers much also
submit a letter from the school indicating their approval for the
procedure in the absence of parental consent.
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Asking children to evaluate their
peers or family
- Some
studies are interested in peer social interactions, resulting in
a need to have identified children evaluate other identified
children, for example to correlate what one says about
oneself to others’ views of them. This creates some
difficulty, however, because the the named classmates are participants
in the research, as the regulations [45 CFR 46.102(f)(2)] define human
subject as a person “about whom an investigator obtains
identifiable private information.” The consequence
is that researchers will need to get parental consent and child assent
both for children who are evaluating others and those classmates
who are being evaluated.
- If the evaluation of others is intended only to inform
you about the views of the respondents, then there may be no need
to obtain/maintain identifiers for the classmates. If that’s
the case, the procedures to keep any information about those who are being
evaluated anonymous should be made clear in the protocol and consent
forms.
- See Special Populations:
Students for more information about
classroom studies.
- When
researchers wish to ask children about their
family environment or the behaviors that they witness from their family
members, the family members are similarly participants in the
study. In such cases, there may be significant risks to the family
members if information about financial status, emotional
well-being, illegal behaviors or other sensitive topics were disclosed.
Their consent must be sought, or the researcher needs to explain why
their consent should be waived.
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Asking parents / guardians / teachers
to report on the behavior of children
- As
when children are asked to report on the behavior of
peers and parents (see above), assent may be needed from the true
subjects of the study, in this case, the children, when parents are
being asked to report about their child's behavior. This
requirement is particularly important when the child can be identified,
and the topics are sensitive ones. The IRB will consider the
particular circumstances to determine if assent is needed in all such
third-party interviews.
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Mandatory reporting of
abuse
- If the researcher or their staff obtains credible evidence that a child being evaluated for research purposes shows signs
of abuse, it is mandated by state law that the researcher must
report that
information to the Florida Abuse Hotline. Research that, because of the
topics explored (for example, parental discipline) or because of the
population to be studied (for example, children with mood disorders or
other at-risk groups), is more likely to uncover evidience of abuse,
the consent and/or assent scripts should state explicitly that any
evidence of abuse must be reported to
a state hotline.
- This is the web page detailing
the use of the abuse hotline, 1-800-96-ABUSE.
http://www.dcf.state.fl.us/abuse/
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Asking children for
information about behavior unknown
to parents / illegal behavior
- Some studies ask
children about behavior unknown to the parents; this often concerns
sensitive areas such as drug use, sexual practices, or criminal
behaviors. It is not necessary
that this information be shared with the parents, and often it is
critical that it be withheld from parents. However, researchers
must let parents and children know in the informed consent that they
will ask about
certain behaviors, and that
the parents will not be able to find out their
children’s answers.
- If this information could be
brought into a court of law or otherwise disclosed, the data should
have potential identifiers as soon as possible, either when collected,
or when
coded, so that it cannot be connected to
participants. (These include direct identifiers like social security
numbers, drivers license numbers, etc., as well as indirect information
that could uniquely identify a person, such as a combination of
demographic and descriptive information). A Certificate of
Confidentiality may provide further
protection from such disclosure. For more information, see Special
Situations: Illegal Behavior
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Children who are not
under their parents’ care (wards of
the state, foster children, etc)
- Consent
and assent must still be obtained when studying children who are not
under their parents' care.
- It
is the researchers’ responsibility to determine who is
legally responsible for
the participant (who could consent
to have
medical treatment done to the children?).
- Information about
who is legal guardian for the group of interest, and the source for
this information, should be included in the protocol.
- It
is important to note that children may have been removed from the care
of their parents for a
reason that
makes them particularly vulnerable, such as abuse/neglect. How this vulnerable population will be protected must
also be
addressed in the protocol.
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Children with compromised
mental/communicative capacities
See the section on Special Populations:
Mentally
Challenged / Communicative Challenged Participants
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Sample assent scripts
[Older children]
Hello [child’s name]. My name is
[examiner’s name] and I am a student at the University of Florida.
I am trying to learn about how students think, learn, and behave in
school. I
will be working with several students at [name of school or
after-school
program]. If you decide to participate, you will be asked to do a
series of
activities, including some reading, writing, and math activities, and answering some questions
about your feelings
and emotions. We
will
spend about an hour and a half working in a group with other students
and we
will spend another hour and a half working on tasks individually. There
are no
known risks to participation, and most students actually enjoy the
tests. You
do not have to be in this study if you don’t want to and you can quit
the study
at any time. Other than the researchers, no one will know your answers,
including your teachers or your classmates. If you don’t like a
question, you
don’t have to answer it and, if you ask, your answers will not be used
in the
study. I
also
want you to know that whatever you decide, this will not affect your
grades in
class. Your [parent / guardian] said it would be OK for you to
participate. Would
you be willing to participate in this study?
[Younger children]
Hi, my name is [examiner's name], and I'm
from the University. I'd like to tell you a few little stories and ask
you some questions about them. Your [teacher / mom] said it was OK. We'll do it in the conference room, and it takes about 15 minutes. Would you like to come do this?
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