About IRB
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All research activities involving human subjects must be reviewed and approved by an IRB unless the Office of Responsible Research Practices prospectively determines that the research falls into a category of exemption established by federal regulation.
In accordance with OHRP guidelines and FDA regulations, the IRB reviews human subjects research proposals to ensure risks have been minimized and the potential for benefit has been maximized before human subjects participate in the research. The IRB also ensures, when required, that human subjects only volunteer to participate in research after providing legally effective informed consent. Investigators may not solicit subject participation or begin data collection until they have received approval from the appropriate IRB or written concurrence that research has been determined to be exempt from IRB review.
Institutional Review Boards
The Ohio State University has three internal IRBs to review, approve the initiation of, and to conduct periodic reviews of research involving human subjects or materials obtained from human subjects. The Western IRB (WIRB), a contract Board, reviews clinical trials that are industry sponsored and industry initiated. See Institutional Review Boards for staff contact information.
IRB Policy Committee
OSU has an IRB Policy Committee (IPC) dedicated to 1) developing policies and best practices for the Human Research Protection Program (HRPP), 2) receiving input from the university community on ways to optimize IRB and ORRP operations and 3) making recommendations on ORRP and IRB resource requirements. See IRB Policy Committee for more information.
Exempt Research
DHHS regulations describe six categories of research that qualify for exempt status. Although the regulations do not address a maximum risk level, it is implicit within the concept of exempt research that there must be very little, if any, associated risk. Therefore, research that qualifies for exemption from the requirements of 45 CFR 46 must meet the aforementioned risk threshold and fall within one or more of the six exempt categories.
See Exempt Research for more information.
