The IRB Chair or Co-Chair will notify the PI or student researcher in writing of any significant deficiency including the reasons for designating the proposal "Rejected." The PI or student researcher will be allowed to make appropriate changes within the timeframe designated above and must submit any and all revisions or requests for additional information that the IRB officially requests. There is no formal appeal process once the IRB submits its final written decision.
i. The proposal application is incomplete at the time of submission,
ii. The PI or student researcher did not conform to the timeframe listed above for revisions or any other request for changes/revisions and or modification that was requested by BSU IRB,
iii. The proposal lacks merit and/or requisite information in the judgment of the Chair, Co-Chair, and initial reviewers. The lack of merit and or information does not allow for a proper evaluation of the objectives, methods, endpoint criteria, benefits, and/or risks to the participants.
iv. The proposal does not adequately address the measures needed to protect potential research subjects from risk and/or the risks in the study are not addressed,
v. The risk to the potential subjects outweigh the potential benefits,
vi. The proposal contains a significant flaw in its design that prevents it from achieving the research related, outcomes, objectives or aims in such a manner as to lack scientific merit,
vii. Any other deficiency deemed insufficient after the IRB Chair or Co-Chair/ Board members review of the proposal.