All proposal submissions must be typed and completed on the approved forms found under the "Forms" on Graduate School link on this website. All proposal submissions will be logged in with a receipt given to the investigator by the administrative assistant to the Chair of IRB when all of the required information has been submitted. For more information regarding the submission process, please refer to the "Submission Requirements" page. The primary investigator (PI) or student in the case of a student's research (dissertation/thesis/seminar paper) is responsible for all aspects of the application process.

IRB Policy:

Approval of IRB Application (Proposal): A properly submitted IRB application will receive an "Electronic Approved Letter" once the review is completed by the Chair or Co-Chair under an assigned IRB number. The standard approval period is for one year or 365 days from the date of the IRB approval notice. An authorized PI or student researcher is responsible to work within the one year period of his/her application approval to avoid the expiration of the approval. The PI or student is responsible for conducting any research or research-related activity under a valid and approved application.

Rejected Proposal: An IRB Proposal application is designated rejected when there is a need of significant revision or is incomplete. The proposed study may not begin until the BSU IRB has granted authorization in writing. The IRB Chair or the Co-Chair will notify the investigator that the proposal has not been approved or has been rejected. The PI or student researcher is responsible for addressing the concerns raised in the notice and has 21 days to complete the revisions before any additional action will be taken by the IRB. All requests for modifications must be submitted in writing to the Chair or Co-Chair of BSU IRB. If the IRB Chair does not receive an adequate response from the PI or student researcher rectifying the omissions within the allowable 21 days, the proposal will be considered inactive and the research will not move further. If a rejected proposal lapses after one year, the PI or student researcher will be required to resubmit a new application. At this point, the PI or student researcher may be required to have a full Board review of the proposal application upon request of the IRB Chair. A proposal may be rejected under the following conditions::

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.

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.