Protocol Review Process & Information

Protocol Review Process 

Exempt Reviews: Exempt reviews are conducted by Sponsored Programs. Exempt reviewers decisions include 1) approve the protocol as submitted; 2) approve the protocol with minor modifications; or 3) require significant modifications before approval is given.

Expedited Review: An expedited review will consist of protocol review by two committee members of the IRB.  The IRB members selected to review the expedited protocol can request that the protocol be raised to full review status or reduced to an exempt review. The IRB members reviewing the research may exercise all of the authority of the IRB, except that the reviewers may not disapprove the protocol. The IRB members may decline a proposal with the option for the researcher to present the research at an IRB meeting for full IRB consideration.  A disapproved research protocol may be resubmitted as a full proposal for full IRB review.  Expedited IRB reviewers decisions also include 1) approve the protocol as submitted; 2) approve the protocol with minor modifications; or 3) require significant modifications before approval is given.

Full Review: If the research does not satisfy the guidelines for exempt or expedited review, it will require full IRB review. The IRB may request the researcher to discuss problems at a meeting, request an outside review of the application, approve the protocol as submitted, conditionally approve the protocol with minor changes, require significant modifications before approval is given, or reject the protocol.

Types of IRB Protocol Decisions

Approved: No Changes have been requested by the IRB and a Notice of Approval will be processed. Commencement of research related activities may only start upon e-mail receipt of a Colorado Mesa University (CMU) IRB Approval Letter.

Approved pending MINOR modifications: The IRB requires minor, administrative, or change(s) requiring simple concurrence from the PI prior to final IRB approval and study activation. The committee's requested changes will be explicitly communicated to the investigator, in writing, with appropriate rationale. An investigator's response to these committee specified changes will be reviewed by the IRB chair or his/her designee. If the chair or designated IRB member conducting the review of the investigator's response is satisfied that all committee specified changes were incorporated, Sponsored Programs may then route all final approval documents to the investigator and the study may be initiated. 

MAJOR modifications required: Requested modifications or clarifications are substantive, or require explanation by the PI, including request for additional information that would affect the IRB's determinations with regards to the criteria for approval (for example, risk/benefit determination, confidentiality/privacy, appropriate informed consent process, etc.). These types of responses from the investigator must be brought back to the IRB committee for final approval determination.

Disapproved: The study is disapproved. Disapproval may occur because the IRB determines that the study is not scientifically sound, the risks are not reasonable given potential benefit, or any of the factors that would make it impossible for a required approval criterion to be met. The committee is required to notify the investigator, in writing, the decision to disapprove the research application as well as the justification for reaching the decision.