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 the subject, the principal investigator is required to notify the IRB of the change(s) within 48 hours. The IRB will review at the next convened meeting to determine if the change(s) instituted were consistent with the subject's continued welfare.

Regulations permit the use of expedited procedures for review of minor changes to previously approved research during the period for which the approval is authorized. Modifications that alter the risk/benefit ratio so that risks are increased or benefits are decreased shall be reviewed at a convened meeting. Investigators are encouraged to contact the IRB Chair and the OSP staff with any questions prior to submitting a modification request if uncertain about the review type required.

Minor changes have no substantive effect upon an approved protocol or present no change to or reduce the risk to the subject. Examples of minor changes are: changes in research personnel that do not alter the competence of the research team; scientific or therapeutic changes that leave the research population at the same or lower risk than risk(s) already approved; changes in research procedures that have a minor impact on risks to human subjects; an increase in the number of study visits for the purpose of increased safety monitoring; changes to improve the clarity of research statements, enhance comprehension, to correct typographical errors, or to update templates, without altering the content or intent of the statement; clarification of discrepancies within the IRB materials submitted for initial review, such as discrepancies regarding the numbers of subjects, number and identity of research sites, and timing, nature, and duration of research procedures.