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Process & Review
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Do I have to submit my research proposal to the Institutional Review Board (IRB)?
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IRB review and approval is required for projects that:
1. Meet the federal definition of research
Federal regulations define research as "a systematic investigation, including development,
testing, and evaluation, designed to develop or contribute to generalizable knowledge."
2. Involve human subjects
Federal regulations define a human subjects as "a living individual about whom an
investigator conducting research obtains (1) data through intervention or interaction
with the individual or (2) identifiable private information."
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How do I submit an application to the IRB?
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Instructions for IRB application submission can found on the butto below:
IRB Application
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What are the types of IRB review?
| There are three types of IRB review: Full board, Expedited, & Exempt. Please visit IRB Review Classifications for detailed information. |
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If my research qualifies as exempt, does this mean that I don't have to submit an
application to the IRB?
The IRB must decide whether a study can be classified as exempt. Even though an investigator
may be certain that a research project classifies as exempt, it still must be submitted
to the IRB for review. |
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I鈥檓 a student and I鈥檓 doing a class project. Does that mean I need to complete an IRB application?
Class projects or assignments involving human subjects are generally conducted for
educational purposes or training solely to fulfill a course requirement leads to the
fact that there is no intent to develop or contribute to general knowledge. This would
not meet the regulatory definition of research & therefore would not need to be submitted
to the IRB. However, if there is need for clarification, we are happy to answer any
questions. Please note that it is expected that KSU students, faculty, & staff will
uphold the same ethical treatment of those participants even if there is no need for
IRB review. |
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What is the faculty advisor's role in a student's project?
The faculty advisor is an active mentor to the student researcher and shares the responsibility for the ethical conduct of the research with the student. The advisor must support the student in the conduct of the research project after IRB approval is attained. This includes maintaining participant protections, minimizing risk, & overseeing withdrawal procedures. It is also the faculty advisor鈥檚 responsibility to ensure that ongoing IRB reporting requirements (e.g., unanticipated problems, continuing reviews, study closure, etc.) are met in a timely manner, even after the student graduates. The faculty advisor must certify the IRB application via Cayuse on the student's behalf. |
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How long does it take for my project to be reviewed by the IRB?
| This depends on the type of review your study falls under. If your study is categorized as exempt, expedited, or a limited IRB Review, then please allow 14 business days for a complete review. Full-board reviews happen based on our meeting schedule and submissions must be received at least 1 month before the next meeting. |
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Can the IRB approve a project retroactively?
No. There is no provision in the federal regulations that allow for IRB approval of
research that has already been conducted. If data was collected for purposes that
the IRB determines to be non-research (e.g., program evaluations for library or educational
programs not initially intended to be used for research), IRB approval can be sought
for the data analysis going forward. |
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How long must I retain IRB records?
Federal regulations require research records to be retained for at least three years
after the completion of the research (45 CFR 46). However, research involving identifiable
health information is subject to HIPAA regulations, which states records must be kept
for six years. Research sponsors may require records to be kept for a longer amount
of time than federal regulations require. In sum, you must keep your records for a
minimum of 3 years or longer, depending on the longest applicable standard. |
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What CITI Training do I need to take? If I'm partnering with another member from an outside institution, do they need to take the training too?
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CITI Training information can be found on the CITI Online Training page of our website. Depending on the nature of the research study, it is recommended either, 鈥淪ocial, Behavioral, & Educational Research with Human Subjects鈥� or 鈥淏iomedical Research with Human Subjects鈥� is taken.
If your collaborator has documentation of their institution鈥檚 required human ethics training, then you can email that to us. However, if they do not have specific human ethics training, then they will need to complete the KSU required CITI training. They can do this by signing up through CITI and affiliating with KSU. A KSU email is not required to do this.
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I just received a notice from the IRB that my study is not human subjects research. What does that mean?
This typically happens with student projects. We find that the results of the study are not meant to generalize to a greater population. For a study to meet the HHS definition of research, the study must be intended to contribute to a generalizable knowledge. If you are unsure if your study meets the definition of human subject鈥檚 research, please see these policies. If you are still unsure after reading these definitions, you may email us to clarify and ask questions. This determination simply means we (IRB) do not have the purview over your study as it was submitted in your application. You may continue your study without IRB purview. |
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