This document provides answers to frequently asked questions about obtaining approval from the Institutional Review Board (IRB) for research projects involving human subjects at Michigan State University. It addresses questions such as whether IRB approval is needed, whether projects can be exempt from full review, how long the approval process takes, and whether written consent from participants is always required. The goal is to help researchers in the Rhetoric & Writing program understand and navigate the IRB process.
Preparing for your Comprehensive or Doctoral Qualifying Examination
IRB FAQ for MSU R&W
1. FAQ about the IRB
Rhetoric & Writing @ MSU
Bill Hart-Davidson. Ph.D.
Associate Professor of Rhetoric & Writing
Co-Director, WIDE Research Center
Member (and past Acting Chair), Social Science IRB at MSU
2. Helpful Links
IRB at MSU
http://humanresearch.msu.edu
MSU HRP manual
http://www.humanresearch.msu.edu/hrpmanual.html
45cfr46 (protection of human subjects)
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
The Belmont Report
http://www.hhs.gov/ohrp/humansubjects/guidance/belmo
nt.htm
3. A Note…
I’ve focused, in this set of materials, on the questions I tend to
get most often from folks in the program. They come from
colleagues and students. And they are, to the best of my
recollection, truly “frequently asked questions.”
I’ve not put some of the basic kinds of questions in here, but that
doesn’t mean we can’t address these too. Just ask. And I will
do my best to add to this our list of FAQs and answers!
One final note, if you’ve run across this and are not in the
Rhetoric & Writing program at MSU…just know that some of
these things might apply to you and some might be different.
Best to check with somebody at your institution and in your
field.
4. IRB FAQ: The List
Do I really need to get IRB approval for my project?
Can my project be exempt from review? What does that mean?
If I do research as part of a class project, do I need IRB approval?
Ok, I did a project for a class, and now I think I’d like to talk about it at a
conference…what do I do now?
I know I need to seek IRB approval, what should I do to get ready to do
the online form?
How long does it take to get approved?
I’ve heard that you can’t say your project poses “no risk” to
participants…so what’s up with that?
Do I have to get written consent?
5. Do I Really Need IRB approval
for my project?
You do if:
your project involves human subjects and seeks to produce
generalizable results
For our field, this usually means that you should seek IRB approval
when your are watching, talking to, or otherwise asking living
people to do something as part of your research.
You can take generalizable to mean “publishable,” and publishable to
include presenting at a conference.
P.S. For theses & dissertations, the graduate school requires you to
seek IRB approval or to certify that your project is not human
subjects research.
6. Can my project be “exempt?”
Yes. And it may well be determined to be “not human
subjects research” at all…which means that it is not
reviewable.
But…both of these determinations still require some
correspondence (at least) with the IRB. The IRB staff can
make a determination of “not human subjects research.”
“Exempt” is a category that means the protocol has been
reviewed by the IRB and has been determined to pose
such a minimal risk to participants that it needn’t be
reviewed again.
7. If I Do a Research for a Class Project, Do I
Need IRB Approval?
Not necessarily*. In most cases where students are asked to do
research involving human subjects as part of a course, the IRB
delegates the authority to ensure that participants are dealt
with ethically to the instructor of the course.
You should still follow all the same guidelines you would if you
were doing the study with IRB approval: seeking informed
consent, taking steps to minimize risk to participants, etc.
If you are the instructor, you should guide your students through
a process similar to IRB review to ensure that they are
adequately addressing issues of risk with regard to research
participants.
*if you know you want to publish it, then the answer is yes.
8. Ok, I did a project for a class, and now I think I’d
like to talk about it at a conference…what do I do
now?
It’s possible, in this one type of instance, to get the IRB to
consider retroactive approval.
See the MSU IRB handbook section 6-9-A subsection 6.1.16.1.4
9. I know I need to get IRB approval, what should I
do in advance of filling out the form?
1. If you haven’t already, take the certification training
2. Draft a description of protocol that includes who your
participants will be and how you will recruit them, how you
will gather data, & how you will analyze that data; don’t
overdo it…just describe it in a straightforward way for an
academic, but non-disciplinary audience
3. Draft your Informed Consent Agreement (use models
provided via the IRB website)
4. Draft your recruitment language
5. Make a list of a) potential risks to participants, b) things you
are doing to minimize risks, and c) potential benefits to
participants, if any
10. How long does it take to get approved?
For most studies in our field, no more than 10 working
days. (assumes expedited review category).
The IRB is committed to getting you a response in 10
working days. The thing that makes this deadline slip,
most often, is delay by researchers in responding to
reviewer and staff requests. If you respond quickly, you
will get approved quickly too.
For studies that involve more than minimal risk to
participants, the timeline is longer because you have to
have your protocol reviewed by the full board at their
once-monthly meeting.
11. I’ve heard you can’t say your study involves “no
risk” to participants…what’s up with that?
While most of the work we do in R&W involves no more than
minimal risk, there is usually some risk involved to participants
when we collect personal information that folks would prefer
to be confidential or anonymous.
We also ask our participants to give us their time and effort,
which we should do only when there is some promise of
benefit (if not to the person directly, then to society as a whole
in the interest of building knowledge).
You do better to acknowledge these rather than to minimize or
deny them in the spirit of treating all participants as persons in
the spirit of the Belmont report that our IRB guidelines are
based on.
12. Do I have to get written consent always?
No, not always. And there may well be good reason not to.
But if you are seeking to waive the documentation of
consent, there are few conditions you need to meet.
See IRB manual section 6-4-A.