When entering decisions, you can choose from the following selections. You will see different options depending on the type of review.
| Decision | Explanation | Resulting Study Status (Note: Study Status will not change for legacy studies) | Routing |
|---|---|---|---|
| Approved | The study is approved. |
Approved
|
Submission is approved and no longer editable.
The research team can add additional submissions to the study. |
| No Engagement in Research | The study does not constitute research and therefore does not require IRB approval. |
Approved
|
Submission is approved and no longer editable.
The research team can add additional submissions to the study. |
| No Human Subjects Research | The study does not include human subjects research and therefore does not require IRB approval. | Approved |
Submission is approved and no longer editable.
The research team can add additional submissions to the study. |
| Noted | The incident report has been noted by the IRB. |
Approved
|
Submission is approved and no longer editable.
The research team can add additional submissions to the study. |
| Rely on External IRB | The study and submission were reviewed and approved by an external IRB and their decision has been recorded by the IRB. |
Approved
|
Submission is approved and no longer editable.
The research team can add additional submissions to the study.
|
| Rely on NCI-CIRB | The study and submission were reviewed and approved by an NCI-CIRB and their decision has been recorded by the IRB. |
Approved
|
Submission is approved and no longer editable.
The research team can add additional submissions to the study. |
| Exempt | The study is exempt because it fits into one of the specified categories for exemption. | Exempt |
Submission is approved and no longer editable.
The research team can add additional submissions to the study. |
| Suspended | A study is suspended when the IRB decides that the research needs to stop until changes have been made to the research. A suspended decision is available on Incident Reports, Modifications, and Renewals. Suspension can only be lifted by selecting the "Suspension Removed" decision for a modification submission after it has had a full, full expedited, or expedited review. Lifting the suspension changes the study's status back to "Approved". Note: Renewal submissions for an expired suspended study can receive a decision of "Approved" in order to extend the date without lifting the suspension, or "Suspension Removed" in order to extend the date and lift the suspension. |
Suspended | Submission is returned to the PI and is no longer editable. |
| Closed | A closure submission is created and submitted when the research is done and the study can be closed. | Closed | The study is closed and no further research can be done. |
| Withdrawn | The research team decided not to proceed with the initial submission. This decision is only available for withdrawal submissions. The research team can choose to withdraw the study at any point until the initial submission has been approved. If the initial submission has been approved, the research team must create a closure submission instead. | Withdrawn | The study is closed and no further research can be done. |
| Disapproved | The full board identified major issues with the study or submission and disapproved the research. In the case of a disapproved initial study, a new study and submission will need to be created. For disapproved renewal, modification, etc. submissions, the research team will need to create a new submission if they wish to proceed. | Disapproved | The submission and/or study are disapproved and no longer editable. Disapproving an initial submission archives the study. |
| Deferred | The reviewer(s) identified major issues that the research team must correct before the submission can be approved. |
Submission is returned to the PI and reopened for editing.
|
|
| Minor Stipulations | The reviewer(s) identified minor issues that the research team must correct before the submission can be approved. | Requires Changes | Submission is returned to the PI and reopened for editing. |
| Return to PI | The study is being returned to the research team to make changes because the IRB will not approve it as-is. |
Requires Changes
|
Submission is returned to the PI and reopened for editing.
|
| Not Expedited/Not Exempt | The study will be returned to the IRB Analyst to reassign it to the correct review type. |
N/A
|
Submission is returned to the Analyst to reassign the review type and reviewers. |
| Not Reviewed | Documents that the submission was unable to be discussed at the meeting. The "Not Reviewed" decision is logged in the decision history so that a new decision can be made at a subsequent meeting. This decision type is only available for full board reviews of initial, modification, incident, and renewal submissions. |
N/A
|
Submission is returned to the Analyst to assign to a new meeting. |