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Submitting Protocols with
Special Populations/Concerns
Special Population: Students
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more information
In a large university such as
UF, the classroom is the site of many research activities, both when
students are being trained in the research procedures and methods in
the behavioral and social sciences, and when investigators are
interested in research questions where students are the appropriate
population.
Class projects
- Class projects do not need to be reviewed by the IRB if
they are class projects within University of Florida classes, conducted
only for instructional purposes, and there are no plans to use the
research to“add to
generalized knowledge,”
such as presenting the results at a conference, publishing them, posting them to a publicly available website, etc.
- Any class studies where there is a possibility that the results may be
presented/published outside of the class should be reviewed and approved
by the IRB and have proper consent/assent procedures.
- Class projects may involve participants other than the
students in that class; nonetheless, if the purpose of the project is
strictly instructional, it does not qualify as "research" for
regulatory purposes, and does not need to be reviewed by the IRB.
Of course, professional and academic ethical guidelines should be
followed for such activities, and the instructor is responsible
for ethical oversight of their students' projects.
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Consenting minors
(including college students who are
younger than 18 years)
- See
section on Special Populations: Children
- College
students younger than 18 are minors,
and parental consent as well as the student's assent is necessary. When
studying a college
student population it is the responsibility of the researcher to ask
the age of
the college student and NOT TEST or COLLECT DATA FROM students that are younger than 18 years.
- If a college classroom population is being tested that
includes students younger than 18 years, and extra credit is being
offered as compensation, then an equivalent alternative non-research
opportunity must be available to those who are under 18.
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If observing
students' behavior in classroom setting or having participants fill out surveys in a classroom setting
- All consents and assents must
include what activities students may do during testing time if they do
not wish to participate in the classroom testing.
- If
participants you are observing in the classroom might be stigmatized by
being singled out for observation, appropriate precautions must be made
so that the other students will not know who is being observed and why.
Similar precautions must be taken if select students are being removed
from the classroom for some special status or if surveys are being
filled out by a whole class that only will be appropriate for a subset
of participants to fully fill out. Details must
be provided in the protocol about how this stigma will be avoided.
- Given
the sensitive nature of some surveys, participants may be afraid
that their answers will be viewed by other students or tracked back to
them. Having the survey be
anonymous and providing each participant with a unmarked closeable
envelope in which
the
surveys can be placed prior to handing them to the researcher or
advisor may decrease this risk. Providing adequate spacing between
students during data collection may be essential to ensure
confidentiality in these situations.
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Offering extra credit
as compensation for participation
- If
compensation is extra credit, those participants who do not wish to
participate in research must be given a time/effort equivalent academic
extra credit opportunity so that they
can feel
free not to participate, but still get benefits available to those who
can/want
to participate in research. This alternative activity must be described
in detail in
the protocol
submission as well as in the consent form/assent script.
- Extra credit for parcipation must be limited to no greater
than the equivalent of 2% of the student's overall grade in the course
to minimize any risk of coercion via "undue compensation."
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- Accessing academic
records
- Explicit
permission must be obtained to access confidential academic records.
The researcher must detail in the consent/parent consent to access
exactly what records will be seen and when. If the participant is a
minor, but
child is old enough to understand what these records are and how their
release
may affect them, this aspect of the research must also be assented to
by the
children.
- Records can not be accessed unless it is expressly consented
to, even if some member of the research group would otherwise have access to these records for non-research purposes.
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Students taken out of
the classroom setting for testing
- If any participants are going to be taken away from classroom activities for this research, the consent forms and
assent script must include information about what classroom activities
will be
missed by the participants when they are removed from the classroom for
testing. If
students are to miss some classroom material, it must be detailed how
it is
that they will make up this material.
- If
only a subset of students will be removed from the class to be tested
(for example, those with reading difficulties), it must be detailed in
the protocol what procedures will be used to prevent these participants
from being stigmatized by the other
students who notice that the child is being removed because they are of
a special population.
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Evaluating educational programs / educational Tools
- It’s
not uncommon for us to receive protocols that have a mix of what’s called “program
evaluation/quality assurance” aspects, such as examining
a standard
part of the curriculum or new method of educating. This may or may not
require IRB approval. It is for the IRB to decide if the project is
exempt from research. See Types of Protocol Review for more information about this determination.
- The following questions are relevant to the IRB's
review, and must be addressed in detail in any protocol studying
educational methods:
- Will students be learning something different than the regular standard educational practice?
- Are
there plans to publish or present the evaluation of this new
educational procedure at a conference or publish it such that it can
be accessed by other educators, researchers, or the public at large?
- Additionally, if the new educational program requires some action of the teachers or access
to schools, it is necessary to have an informed consent for the teachers and the principals listing what
expected of them and also what expected of the children.
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Classroom observation
- Common issues and considerations for protocols that observe students in classroom settings include the following:
- Is it public? As
with publically accessible websites and "chatrooms," there is some
controversy about what constitutes "public behavior," and what a person
might have a "reasonable expectation of privacy" about.
- Data will be
collected on which students? Are some singled out, because of teacher selection or other criteria?
- Is consent
necessary for all students about whom data is recorded, even if
identifiers are not recorded?
- Teacher
consent may also be necessary.
- Each of these issues must be addressed by researchers submitting a protocol of this nature.
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Wanting to test
students in a class where a researcher is
teacher/supervisor/teacher’s aide, etc
- Though it may be convenient, there are many reasons NOT to
test one's own class.
- In fact, unless there is a compelling reason other than
convenience to test one's own class, it is highly encouraged to test another teacher's class to
prevent some of the problems of potential coercion.
- The idea of “coercion” is that
students may feel obliged to
participate, even if there is no direct
“compulsion” to do so. This is a specific instance of a general problem
that
occurs when researchers are in some supervisory capacity regarding
their
targeted participants.
- Often two
professors will swap classes so to not be testing their own students,
who may feel pressured to participate.
- If for some reason it is
essential to test own students,
it sometimes can be done. However, the reason why it must be one's own class must be argued in the protocol.
- When this is allowed, special procedures must be in place to prevent coercion.
- Generally, this is managed by preventing instructor/supervisor knowledge of who
has and has not consented to participate in the study.
- For the same
reason that
we ask investigators collecting data from their own classes that they
be blind to who
has been / will be participating until the final exams are graded.
- Specifically, the researchers must explain
how they will be blind to who has agreed
to participate until after grades are finalized – or
alternatively, how grades
are determined “mechanistically” (e.g., objective
tests) and the instructor is
not making any judgments regarding grades. There is more of
a problem if there is a “subjective” component to
grading that could be
influenced, even slightly, by the instructor’s knowledge of
who has and has not
agreed to participate.
- The
procedure for doing this must be detailed in both the protocol and the
consent forms.
- In these
cases,
there are often ways to arrange things to avoid the
potential for coerciveness, for example, by
having everyone do some activity or exercise as part of the regular
class; then after final grades are
determined,
ask students if their data can be used for research purposes.
- In other
cases,
when this is not practicable, the instructor can have the
research component
conductedd by an assistant, and the instructor remains blind as to who
has and
has not participated.
- It’s also helpful if it can be
confirmed that there is no
“subjective” component to the grade that could be
so influenced.
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Use of materials that
have already been collected for
non-research purposes
- These documents, such as class assignments/papers/etc, can be examined for research. However,
these materials need to be those that were gathered for purposes other
than for the research study.
- The researcher must explain that prior
purpose in the protocol submission and who
is
offering the data and how it will be transferred to the
researcher.
- If at all possible, the data need to be processed before
they are given to the researcher such that all identifiers have
been removed. Any
identifier is
something that could be tracked identity back, for example birth date
within a
classroom full of people could be an identifier.
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Use of UF
ID’s or Gatorlink information for Identifiers
with University of Florida
students
- Gatorlink signon and passwords
BOTH should not be requested
since that allows access to many of the students' UF computer records/
functions. Researchers may never ask for participants' gatorlink
password.
- UFID can be used as identifiers for research, and may be
useful as thus if extra credit is being assigned as compensation for
participation.
- However, collection of UFID is an identifier and should not be stored on data that is being kept confidential.
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Opt out (passive) consent in schools/classroom settings
- We
don’t approve “opt out”
“consent” forms. IRB
doesn’t recognize “passive consent” as
such; you’re requesting waiver of
consent/parental consent.
- The regulations allow for waiver of parental consent/consent for minimal risk research
under
appropriate conditions, i.e., that the research has potential benefit
but could
not be practically carried out without the waiver.
- We tend to be very
conservative in approving this, but have approved this in the some
cases where
the potential benefit is very high or the survey is benign and
anonymous. If
this is to take place in a school, there needs to be a letter submitted
along
with the protocol indicating the school principal’s approval
for the procedure
in the absence of parental consent.
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