IRB Frequently Asked Questions (FAQ) and Guidance
Frequently Asked Questions
Q: How do I know if my project is “research”?
Research is defined in the federal regulations (45 CFR 46) as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."
When an FDA-regulated drug, device or biologic is involved, the FDA definition of “clinical investigation,” which is considered to be synonymous with “research” (21 CFR 56) must also be considered: any experiment that involves a test article and one or more human subjects.
Q: What is the definition of "generalizable knowledge"?
Generalized knowledge is data and/or conclusions that can be applicable beyond a particular place, person, or setting and/or may be intended for publication or presentation.
Examples of activities that typically are not generalizable include:
• Oral histories that are designed solely to create a record of specific historical events.
• Service or course evaluations, unless they can be generalized to other individuals.
• Services or concepts where it is not the intention to share the results beyond KSU or any agency supporting the research.
• Classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices.
• Quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond KSU (e.g., teaching evaluations, customer service surveys).
Q: What is the definition of a "systematic investigation"?
The implementation of rule-based methods that are repeated with multiple participants in a consistent manner across the participants. Alternatively, the method may be implemented according to specified rules with a single participant for certain types of investigations. For example, case studies designed for publication are systematic investigations of a single person.
Q: What is the definition of "minimal risk"?
Risk is minimal when the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests [Federal Policy 45 CFR 46.102(i)] and [21CFR50.3(k)]. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of a routine physical examination.
Q: What is the difference between confidential and anonymous?
Anonymous: Data does not contain any information that would permit identification of the individual(s) about whom the data were collected.
Confidential: Data contains information that would permit identification of the individual(s) about whom the data were collected, but is maintained in a manner that protects the information from release to unauthorized individuals.
Q: What does de-identified or coded mean?
De-identified: When collected, data contained identifiers or information that would permit identification of the individual(s) about whom the data were collected, but the identifiers or other links to identity have been removed.
Coded: Data contains identifiers but the identifiers are stored separately from the data; a subject identifier or other code is used to link the two.
Q: Can I begin my project without IRB approval?
NO. Engaging in human subject research without IRB approval has serious ethical implications and violates university and federal policy. Students, faculty, and staff are required to have a KSU approved IRB before collecting any data. Even pilot studies must be approved by the IRB. IRBs cannot grant retroactive approval. If you are unsure if your project needs IRB approval, please contact the KSU Research Compliance office.