When may I begin data collection for my study?
- You may begin data collection after your study has received
approval (expedited or full board review) or determination (i.e.
exempt, not research, needs review) by the IRB, but not before. You
will receive e-mail notification and a letter will be posted on
IRBManager as evidence of your approval.
My graduate student has to have Responsible Conduct of
Research (RCR) Training. I should probably have that too. Where do I
go for this training?
- Currently GVSU uses CITI for
its online human and animal subjects responsible conduct of research
training. For registration and access instructions, please click
here. In addition to RCR training, the IRB requires completion of
the Human Subjects Research course. If you are receiving grant
funding (NSF, NIH), there may be required face to face training needed.
Do I need IRB approval if I am only doing a Pilot or
- Yes! A pilot study, sometimes called a feasibility study is still
a systematic investigation that may produce generalizable results.
The subjects involved would need to provide informed consent, and
therefore you must wait until you have project approval before beginning.
What if I am just working on developing my methods, nothing
systematic? Do I need IRB review first?
- No, since you are trying to work out methodologies and techniques,
is not a systematic investigation, this would be allowed prior to
obtaining IRB approval. You do not need IRB review if no data are
collected, and no subjects are involved.
- If you are in any way unsure whether or not your project needs
prior approval, please submit the Non-Human Subject Research
Determination Form found on the IRB website. The Office of
Research Compliance and Integrity will review your form and provide
you a determination. Your unit may also have a process in place for
Someone told me my research is probably Exempt. Does that mean
I don’t have to submit anything for review?
- NO! Exempt is a category of IRB review. Projects that fall within
the Exempt category are very low risk projects, and subjects are not
identified. There must be a consent process and other steps that
must follow ethical research practice. See Policy
911 for more information
- Researchers do not make the Exempt determination. This must be
done by the IRB.
- If the project changes, then changes must be reported to the IRB.
My student is going to present at Student Scholars Day. Must
they have IRB approval of their project first?
- Maybe. It depends on whether the project is considered covered
human subjects research (that is: a systematic investigation,
producing generalizable results). Some class projects may be
systematic, but using only students in the class as subjects
(therefore not generalizable). However, other projects may be linked
to a greater project, like service learning research or an ongoing
investigation. These projects would need approval. Please check with
the Office of Research Compliance and Integrity for assistance to
help with a determination. You can
also see the helpful information on the IRB webpage.
I’m teaching research methods in my class, and we are doing
mini-projects where we collect some data (in class). Do I need IRB review?
- Probably not. The key question to answer is “Does this meet the
federal definition of Research?" Is it
- A systematic investigation (maybe)
- Are the results generalizable (probably not)
- If you have any doubts, simply contact the Office of Research
Compliance and Integrity for assistance.
I’ve decided to publish. Should I get approval for my project
after I have already collected the data?
Yes. If a student or instructor wishes to conduct
research on data previously collected as part of a class activity in
order to validate, expand or otherwise enhance generalizable
knowledge, a research protocol must be approved by the IRB before
the data may be used. There are a number of factors that come into
play, so please contact the Office of Research Compliance and
Integrity for assistance with existing or previously collected data.
- In most cases this type of research will be exempt under category
#4 (existing data, records or specimens), or if not exempt, then
expedited category #5 (data previously collected for non-research
purposes). Failure to acquire IRB approval before utilizing data
that needed IRB approval would be considered conduct of unapproved
research and is a form of research non-compliance.
I’m working with colleagues from another University. Are they
covered under my IRB approval?
- No. If you have other faculty, staff or students engaged in
research with you, then you have two options:
- Your project may be reviewed and approved by the Research
review committees (IRBs) for both institutions. This is assuming
the other institutions (like a hospital or university) have an
IRB and are covered by an FWA (Federal-Wide Assurance).
- You may apply for a deferral at one of the institutions for
single IRB review. This means that one institution’s IRB defers
review and accepts the review of the other. See the IRB Reliance webpage for further
information regarding reliance agreements and step-by-step
instructions for how to request a reliance review from the GVSU
IRB. If you wish to discuss your particular situation, please
contact the Office of
Research Compliance and Integrity.
I have colleagues not affiliated with any FWA (i.e community
organization) working with me. Are they covered under my IRB
I’m only doing a case report. Does that need IRB review?
- A case report for IRB purposes is a retrospective analysis of one,
two, or three clinical cases. If more than three cases are involved
in the analytical activity, the activity will constitute “research.”
So, if your case involves three or fewer cases, it does NOT need IRB
approval because it does not meet the federal definition of
IRB Guidance on Case Reports.
I’m doing Ethnographic research involving the community. Does
my project need IRB review?
- Ethnography is the study of human behavior in the natural setting
in which a population lives.
- If the project involves living human subjects,
utilizes a systematic investigative process and produces
generalizable results, then YES it must be reviewed by the IRB.
- If you have any doubts, always check with the Office of Research
Compliance and Integrity.