allow for continuing review through the expedited process of a protocol that was originally approved by the full Board. Projects originally approved through expedited review will, in most cases, be eligible for continuing review through the expedited process.
Researchers requiring continuing review of their research should contact the OSP for the continuing review application form. Applications will require signatures or endorsements by all researchers involved in the project. For students submitting an application, a signature by a faculty sponsor or advisor is required.
Before submitting the application to the OSP, researchers should ensure that the application is complete and accurate, and they thoroughly address all items and questions on the application. In the application, the researcher will provide an updated summary of the protocol and provide justification for any proposed amendments to the protocol; a status report on the progress of the research, including the number of participants involved in the research and a description of participants; a summary of any adverse events that have occurred and/or any unanticipated problems involving risks to participants; and a summary of recent literature, findings, or other relevant information, if any, that may have an impact on the research and risks for human subjects.
As with the original application for IRB approval, all applicable supporting documents must be included with the application, such as recruitment materials, informed consent documents, and any test or survey instruments to be used. Application forms will have further instructions as to the additional documents required for review. In addition, researchers must ensure that the OSP staff has on file certificates demonstrating that the researcher and their assistants completed CITI training within the last three years.
After receiving the complete application package, OSP staff will conduct a preliminary screening of the application, and once the screening has been completed and any issues with the screening have been addressed, OSP staff will provide the application package to the IRB at least one week before the full Board meeting.
All procedures outlined for the initial review of research by the full Board will be followed in the continuing review of research by the full Board, including the use of a primary/secondary reviewer system and a checklist for reviewers.
Applications for full continuing review should be submitted to the OSP approximately two months before the approval end date to allow ample time for processing, review, and approval. Applications for expedited continuing reviews should be submitted at least 30 calendar days prior to the approval end date.
Applications that are not processed and approved before the approval expiration date will result in the expiration of the protocol's approval and will require that researchers delay