Researchers seeking expedited review will submit an application package to the OSP. The application package will include a completed continuing review application form and all applicable supporting documents, such as recruitment materials, informed consent documents, and any test or survey instruments to be used. In the application, as with the application for continuing review by the full Board, the researcher will address any changes in the protocol or any developments affecting the research and risks for human subjects that have occurred since the initial approval of the research.
Once OSP has received the application package, OSP staff will conduct a preliminary screening of the application package, and once the screening has been completed, OSP staff will consult with the IRB Chair to determine who will be responsible for the expedited review. The expedited review may be carried out by the Chair, another IRB member, or the HRPP specialist serving as an alternate IRB member. All other procedures outlined for the initial review via the expedited process in section 9 apply for the expedited continuing review, including procedures regarding conflict of interest.
The expedited reviewer will make one of the following recommendations: APPROVED, REVISIONS and/or ADDITIONAL INFORMATION REQUIRED, or FULL REVIEW REQUIRED. OSP staff will then notify the researcher of the reviewer's decision by email. Once approved, OSP staff will provide an approval letter. OSP staff will include in the approval letter the beginning and end date of approval. The date the primary expedited reviewer approves the study is the date the approval period starts. The approval period will last no more than one year.
Researchers for whom a protocol has been approved by the IRB should report any changes in the protocol and plans to make changes to the protocol to the IRB. Except in cases where modifications in a protocol are necessary to eliminate apparent immediate hazards to the subject, the IRB must review and approve all modifications to currently approved research protocols prior to implementation. Examples of modifications that researchers should report and seek approval for include, but are not limited to, changes in study personnel, recruitment materials and procedures, research procedures, subject populations, location where the research will be conducted, changes in consent or assent forms, and dates when the study will be completed.
All modifications of a protocol approved by the full Board will be reviewed by the full Board, except where the modification is minor and qualifies for expedited review. The IRB Chair, in consultation with OSP staff, will make the final determination as to whether a modification is considered minor and qualifies for expedited review taking into account the totality of the circumstances. The IRB will follow the same procedures as described in section 8 when reviewing modifications at convened meetings.
Researchers seeking approval for a modification should provide a completed request for