I've
heard that the Federal regulations make certain categories of research
exempt. If my research fits into one of these categories, does this
mean that I don't have to have it reviewed by the IRB?
Yes, but it is not up to the investigator alone to
determine if a protocol is exempt. Troy University has promised the
Federal government that properly trained and designated faculty have
the responsibility for determining whether or not a protocol is exempt.
"Exempt," as used here, means that it is exempt from a review by the
IRB. The IRB Chair will determine whether a study is Exempt from
review. It does not mean that the research need not be reviewed
and approved before data collection can begin. Fill and and
submit an Application form for EVERY study that deals with human
subjects.
Can
I recruit students from my own classes to participate in my research?
If you are the instructor or teaching assistant, or
anyone the students would see as having power and authority over them,
then the answer is generally "no." This is because the students could
perceive the situation as one in which they really cannot refuse, even
if they really did not want to be in your study. You must avoid even
the perception of coercion.
If your students have special skills that make them particularly
valuable as potential research participants, the IRB may approve your
request to use them provided that you structure your protocol in such a
way that the coercive potential is eliminated.
If my research protocol is only for an
undergraduate class, does it have to have IRB approval?
Not if it qualifies for an Exemption. If your
research falls into a category that can be exempt from IRB review, your
course instruction should be able to certify this exemption.
Is it true
that I need IRB review even if I am not doing an experiment,
but I am only conducting interviews, surveys, or simply observing
people?
It depends. As long as your research involves
living human beings If your research falls into a category that
qualifies for an exemption from review, your supervisor should be able
to certify this exemption. If your research falls outside this
category, you need to have it reviewed by the IRB. Under no
circumstances may Principal Investigators make the
decision to exempt their studies from review.
If I am
based at the Phenix City Campus, Montgomery Campus, Dothan Campus, or a
University College site do I still need to get approval from you?
Yes. You need to get approval from this IRB
before you can conduct research at ANY TROY site. A
representative from each site has been appointed to the IRB.
How
long will it take for me to obtain approval to do my study?
It depends on the nature of your study and the
characteristics of the people you intend to recruit.
- Allow 4-6 weeks for studies that, in the judgment
of the IRB, involve more than minimal risk to the participants, because
your protocol will need to be reviewed at a monthly IRB meeting. If the
IRB needs you to make extensive changes in your protocol and tables
further discussion of it for the next meeting, then clearly the time
could be longer. Most protocols that come to this IRB, however, are of
such a nature that they need not be reviewed at a convened meeting.
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- How will
I know when my protocol is approved?
You will receive notification by email and by letter
at the addresses that you provide when you submit your protocol to the
IRB.
Do I always have to obtain informed
consent?
There are limited exceptions. The IRB has the
authority to waive the Federal requirements for informed consent in
certain circumstances, such as when obtaining consent would not be
practical.
For example, observational studies of public behavior
would not require informed consent of the people you observe.
Do research participants always have to
sign an informed consent?
No. There are several research situations, all
involving no more than minimal risk, where the IRB can authorize you to
obtain consent orally. For example, if your participants cannot write,
the IRB will waive this requirement, provided that the study presents
no more than minimal risk. Otherwise, you would have to obtain written
consent from someone authorized to act on behalf of the participant. As
another example, if the risk to your participants would increase
markedly because they signed a consent form (as in an
interview or survey that addressed the participant's HIV status), then
the requirement could also be waived. You would still need to obtain
informed consent, but it could be obtained orally.
What do you mean by "child assent script"?
When you intend to collect data from children who are
capable of comprehending, after obtaining consent from one or both of
their parents, you must tell the children what to expect if they agree
to participate in your research. You must make as certain as possible
that the child understands that he or she has a free choice in the
matter. The words that you use to present your study to the children
are your "script." The children must give you a positive affirmation of
their interest in participating. This is their way of exhibiting
"assent."
How do I get to do research in the
public school system?
First, contact the appropriate school officials
(Director of Research in most public school systems, or individual
principals in private schools) about access to their students or
teachers. Ask them to send you a letter of support for your
research. Then you obtain IRB approval for your research.
Attach the letter of support to your application.
My research
will be done in another country. Do I have to obtain IRB review and
approval?
Yes. Moreover, you may also need to provide the
university (through the IRB) that you have authorization from the
officials in that country to conduct your protocol there.
After I download
the IRB form from the Internet and complete it, can I send it back to
you by email?
Yes. You MUST email the form and other necessary
documents. However, you will also have to fax or send the
original form with official signatures.
May I get
feedback on my application before I make hard copies to send to you?
Yes. You may email questions or a draft of your
application to your College or Site representative. You may also
call your College or Site representative with any questions you may
have. See the Committee Members
list to find your College or Site representative.
Will the
Institutional Review Board operate during the Summer semesters?
No. Institutional Review Board members may not
be on campus during the Summer semesters. If you wish to
undertake research during the summer, you must have it approved before
the end of the Spring semester. See the Meeting
Schedule for submission deadlines and meeting dates.
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