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 modification approval form to the OSP. As applicable, researchers should also provide a revised protocol summary, revised recruitment materials, revised consent form documents, revised surveys or other instruments, and other materials that have changed as a result of the modification. In cases of changes in personnel, researchers should provide certificates of completion of CITI training for new personnel.

Researchers requesting approval of a modification by the full Board should submit their materials to OSP a month before the Board's meeting date. Expedited review of modifications can occur at any time and will be typically reviewed within two weeks, after which the investigator will receive feedback from the reviewers.

For modifications requiring full review, OSP staff will provide the modification request and supporting materials to the IRB one week before a meeting. In the IRB meeting, the primary reviewer assigned to review a modification will explain what the proposed modification is, and the Board as a whole will consider how the modification will affect the conduct of the study, the risk/benefit ratio, and whether or not it should be approved.

If an approved research protocol is changed to eliminate apparent immediate hazards to