You've just submitted your new study application - what comes next? Here are the steps to expect as we review your application.
Once the PI completes the New Study Application Form and any additional forms according to the instructions, the PI emails the New Study Application, additional required forms, consent documents, recruitment materials, and any other required documents to the IRB.
OPRS administrative staff receive the email submission, ensure the correct version of forms have been submitted, ensure the PI is eligible to act as PI and has signed the New Study Application Form, notify PI of any required trainings, and assign the IRB number.
If all preliminary requirements have been met, the OPRS administrative staff member will log the submission and assign it for review by a staff pre-reviewer. OPRS administrative staff will send the PI and noted research team members an email receipt of application.
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 the correct forms are included based upon the study design.
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.
The pre-reviewer will email the PI and noted research team members with any requests for revisions or additional information that are needed before the study can be fully reviewed. The PI will respond to the pre-reviewer with the responses or additional information as requested.
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:
One the pre-review has been completed, the study will be moved to the next step based on its review type.
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:
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.
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.