Review Process
- Office for the Protection of Research Subjects (OPRS)
- Submissions
- Review Process
An Overview of the Review Process
You've just submitted your new study application - what comes next? Here are the steps to expect as we review your application.
Step 1: New Study Application submission
The PI begins the process by creating the new submission in the IRBOnline electronic submission system. When creating a new project, the PI selects New Study Application, Facilitated Review (when relying on an external IRB), or Non-Human Subject Research application (when the PI does not believe the project meets the definition of human subject research. Once the application has been completed and all required documents are attached, the PI must submit the application via IRBOnline.
Step 3: Pre-review
The pre-review process is conducted by OPRS review staff. The pre-reviewer will review the submission to ensure that all information is complete and required documents are attached.
Additionally, the pre-reviewer is ensuring that the information provided clearly explains the research, provides consistent information throughout the submission, and the submission is compliant with regulatory and institutional requirements. This process may also include review by ancillary committees or departments dependent upon the study design and procedures.
Any requests for revisions or additional information that are needed before the study can be fully reviewed will be sent by the pre-reviewer via the IRBOnline system email. The PI will then make the required changes in the IRBOnline system via the application and re-submit the application via IRBOnline to OPRS Staff.
Step 4: Complete Pre-review
The OPRS review staff will determine the type of review for the new study application based upon the design and procedures of the research. To complete the pre-review, the OPRS review staff will verify the following items have been completed before they will move the study forward in the review process:
- All pre-review revisions are completed
- All applicable documents are attached
- The application is completed completely and correctly
- Any needed ancillary approvals (COI, Privacy, Radiation, etc.) have been received or are in process.
One the pre-review has been completed, the study will be moved to the next step based on its review type.
Step 5: Exempt or Board Review
The review type is assigned to the study based upon the design and procedures. Once the pre-review is complete the next step is based on review type:
- Exempt determinations are made by designated member of OPRS staff. The determination will be made to ensure completeness and to confirm the project qualifies for exemption.
- Expedited reviews are minimal risk studies that meet specific federal criteria for expedited review categories. They are assigned for review to a single IRB board member, rather than the convened board.
- Convened Board reviews are greater than minimal risk studies or minimal risk studies that do not meet the expedited criteria. These submissions must be reviewed by the convened board at one of its meetings.
During the expedited or convened board review process, the board reviewer(s) may require additional revisions be made to the application. An OPRS staff member will act as the liaison between the board member and PI and request the board's revisions.
Step 6: Notification of Determination
The PI and noted research team members will receive notification via email with either approval, request for additional revisions, or disapproval of the project. Revisions may be required to be reviewed by the convened board at its next meeting after the revisions have been submitted, or the convened board may determine that the OPRS and IRB chair can review the revisions.
Process for Other Types of Applications
Continuing Review and Amendment applications will follow the same general review process.
The review type is determined at the beginning of the study and does not change throughout the study unless the changes described in an amendment application alter that review type.