IRB Review Process

The review process and time will vary with the category of review (exempt, expedited, full board), and whether or not submissions are complete. Applications may be submitted at any time. However, applications needing full board review must be submitted by the deadlines listed in the meeting schedule in order to be reviewed at the next meeting. The process is summarized below:

1. The investigators submit an electronic application as an email attachment to irb@nsuok.edu
2. The IRB email account generates an automated confirmation of receipt.
3. The Chair assigns each complete application a unique number and makes a preliminary decision about the category of review (exempt, expedited, or full board).
4. The Chair notifies the investigators of the review category and requests the electronic signatures of all investigators.
5. The Chair assigns the application to IRB reviewers.
6. The Chair verifies that the investigators submitted all signatures and supporting documentation.
7. The Chair notifies the investigators in writing of the IRB's decision: approve, require modifications (to secure approval), or disapprove. If the IRB decides to disapprove an application, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

The IRB Chair will make a preliminary determination regarding whether the proposal is exempt, expedited or qualifies for full review.

Exempt Review

Applications for exempt research are sent are sent by the IRB Chair to one IRB member for review to certify exemption.

Expedited Review

Expedited research applications are sent by the IRB Chair to two (2) IRB members for review. The reviewers are selected based on expertise: however, applications are not reviewed by a member from the originating department.

Exempt and Expedited proposal reviewers will review the research in accordance with the requirements of this policy, obtain additional information from the investigators if necessary, obtain other expert opinions if necessary, then report his/her findings to the IRB Chair. If favorable, the Chair shall notify the investigators that the research has been approved for the use of human subjects. If unfavorable, the research shall be reviewed by the full IRB for final disposition. IRB members conducting exempt or expedited reviews may not disapprove the use of human subjects in proposed research; only the full IRB may disapprove proposed research involving the use of human subjects. Each IRB member conducting exempt or expedited reviews shall report on his/her actions to the full IRB at the next meeting. This report shall include the names and departmental affiliations of the investigators, a short synopsis of the proposed research, and any substantive issues concerning human subjects that the research presented.

Full Board

Proposals needing full board review will be sent to IRB members prior to the meeting so that each member will have adequate time to review the proposal. Prior to the IRB meeting the reviewers may correspond with the investigator(s) to resolve any questions. Furthermore, any IRB member may contact the investigator, co-investigators, other IRB members, or outside sources as necessary to insure a thorough evaluation of risks and benefits of the proposed research.

The IRB meets at announced times to review and discuss each proposal. The proposals undergoing initial review are presented and discussed individually by the IRB, as well as those proposals undergoing continuing review. Primary reviewers of exempt and expedited proposals will report recommendations regarding the proposals they reviewed. After complete and individual discussions, each proposal is voted upon for one of four possible dispositions. The Board may vote to approve, disapprove, table, or approve with explicit conditions. The IRB accepts and endorses without reservations approved studies. Studies approved with explicit conditions, the IRB accepts and endorses provided the investigator concurs with the explicit changes and recommendations. A study may be tabled because the Board did not have sufficient time, expertise, or appropriate personnel present to vote on the study, or because the Board needed substantive clarification or modifications regarding the protocol or informed consent documents to determine whether to approve or disapprove the study. A study may be approved with explicit conditions when the convened IRB is able to stipulate specific revisions that require simple concurrence by the investigator. If the IRB approves a study with explicit conditions, then the IRB member or another member designated by the Chair may approve the revised research protocol under an expedited review procedure to determine whether the investigator has incorporated the specified explicit conditions into his or her project. The potential IRB actions are:

1. Approved Accepted and endorsed as written with no conditions.
2. Approved with Explicit Conditions Accepted and endorsed with explicit minor changes or simple concurrence of the principal investigator. All explicit conditions requested of the PI (IRB sends formal letter) must be completed and documented prior to beginning the research. For these conditions, the IRB Chair or designated reviewer can, upon reviewing the PI's response(s) to stipulations, approve the research on behalf of the IRB. If your study has received approval with Explicit Conditions, return one copy of the corrections to the IRB with any changes underlined or in bold.
3. Tabled Generally, the protocol or consent form has deficiencies that prevent accurate determination of risks and benefits or requires significant clarifications, modifications or conditions that, when met or addressed, require full IRB review and approval of the PI's responses and revisions. The deficiencies will be specified to the PI (IRB sends a formal letter), and on occasion the PI is asked to attend the full board meeting in order to clarify the points in question. If your study was tabled, re-submit revisions to the IRB. Please indicate changes by underlining, bolding, or highlighting.
4. Disapproved The protocol describes a research activity that is deemed to have risks which outweigh potential benefits or the protocol is significantly deficient in several major areas such as safety of subjects, lack of proper informed consent, lack of supervision from a school system, etc.. A principal investigator has the right to appeal the disapproval of his research protocol to the Board and asked to have the decision reconsidered. Investigators may submit a written response to the IRB for a protocol that is disapproved or tabled. The written response will be reviewed by the IRB. The IRB will invite the investigator to the IRB meeting if the IRB has additional questions for the investigator. The IRB will reconsider its decision. The second decision is final.

Following the presentation and discussion of proposals receiving either initial or continuing review, a listing of proposals reviewed and administratively approved for continuation, a listing of proposal modifications, a listing of those proposals approved through expedited review procedures, a listing of exempt proposals and other information relating to ongoing research activities are reported by the IRB chair to the Vice-President of Academic Affairs. The principal investigator is notified of the status of approval within 4 days of the IRB meeting. Letters are sent to the PI through campus mail and by electronic mail as necessary.

There are times when the risks associated with a particular protocol are such that continuing review should take place more frequently than annually. In these cases, the IRB will specify that the PI report to the IRB either at a shorter time interval or after a specified number of subjects (e.g., after each subject or after 3 subjects) are enrolled. The PI's reports must describe the observed effects of the research activities and/or how the subject(s) responded to the research interventions. The determination will be recorded in the IRB minutes and reports forwarded to the IRB, by the IRB office, when they are submitted.