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Institutional Review Board (IRB) and Collaborative Institutional Training Initiative (CITI)
Wright State University’s Institutional Review Board (IRB) requires all investigators (including faculty, residents, students, and staff) who will be engaged in research with human subjects to complete the Biomedical Research Investigators course (formerly the Basic Course in the Protection of Human Research Subjects) offered online by the Collaborative Institutional Training Initiative (CITI). This policy is set forth in the IRB Charter and Standard Operating Procedures; see Policy 5 (DOC) for details. Notation of CITI training is required on the Petition for Approval of Research Involving Human Subjects, which must be approved by the IRB before a research project begins.
Wright State is a CITI participating institution, and the course is offered free of charge to Wright State personnel.
Human Subjects IRB Submission
Information on Human Subjects IRB submission can be found on the Research Compliance webpages.
There are several pages that can be accessed. For example:
- How to start an IRB submission
- When is IRB required?
- Credentialing and Training instructions (CITI training)
- IRB meeting dates
- Templates for consent and protocol document
- Guidance Documents (how to use Cayuse)
QI Projects
Do QI projects require IRB?
Although all human subjects research requires prior institutional approval, not all data gathering by students constitutes human subjects research. To be research, an activity must be designed with the intent to develop or contribute to "generalizable knowledge."
Simulations of human experimentation and course-assigned data collection do not constitute human subjects research if:
- the activities are designed for educational purposes only
and - the data will not be generalized outside the classroom (reporting of data within the class is acceptable because the activities were performed solely for teaching purposes)
and - the data will not result in a master's thesis, doctoral dissertation, poster session, abstract, or other publication or presentation
and - the student volunteers or other participants are clearly informed that the activities are an instructional exercise, and not actual research.
Exceptions
Any activity that is a clinical investigation, involves medical intervention or procedures, or involves vulnerable populations (i.e. children, prisoners), even when they are a part of a course curriculum, always constitutes human subjects research and requires prior IRB review and approval.
Information on QI projects can be found on the Activities Requiring IRB Submission webpage.
Institutional Animal Care and Use Committee (IACUC)
Information on submission to the Institutional Animal Care and Use Committee (IACUC) can be found on the Animal Welfare webpage.