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Human Subjects Research (IRB) - Application Review Outcomes
Application Review Outcomes
The review of an IRB application will result in one of several outcomes:
An approval letter is sent to all PIs and advisors that details the date of approval, the date that approval expires, and the responsibilities of the PI as they pertain to the protection of human subjects. Upon receipt of this letter, the researcher may begin research. A copy of the approval is also required as part of a thesis or dissertation submitted to the OSU Graduate College for approval.
A conditional approval letter is sent to all PIs and advisors stating that the research procedures of the protocol have been reviewed approved by the IRB, however, final approval is pending the receipt of specified documents or materials (i.e. approval for conduct of research off site, individual or institutional IRB authorization agreement, etc.). Research procedures with human subjects cannot begin until final approval is granted by the IRB via a formal approval letter.
A letter is sent to PIs and advisors detailing the revisions requested by the reviewer(s). The PI has 60 days to satisfactorily respond. Research cannot commence when the application is in the Pending Revision stage. Once the revisions have been satisfactorily addressed, an approval letter will be issued and research may begin. If no response is received within 60 days, the application will be closed.
A single IRB member may exercise all of the authorities of the IRB when reviewing a protocol qualifying for expedited review except that the reviewer may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in §46.108(b) at a convened meeting of the IRB. The investigator will be informed of this and will be advised of the outcome of the full board review.