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Modifications to Previously Approved Research. The IRB requires that any proposed changes in approved research, during the period for which IRB approval has already been given, be reviewed and approved prior to implementing these changes to determine whether the modified research continues to fulfill the criteria for approval, except where necessary to eliminate apparent immediate hazards to the human participants. Investigators may request approval of proposed changes by the completion and submission of an Amendment form. This guidance document provides additional information for determining whether an Amendment may be reviewed and approved using expedited review procedures or if the Amendment must be reviewed at a convened IRB meeting. Please note that it is ultimately the RCA staff and IRB who makes the review level determination.

1. the proposed change(s) do not significantly alter the risk to benefit assessment;
2. the proposed change(s) do not significantly affect the safety of subjects;
3. the proposed change(s) do not involve the addition of invasive procedures (procedures not otherwise eligible for expedited review, e.g. collection blood samples in limited amounts);
4. the proposed change(s) do not involve the addition of procedures, interactions or interventions that add significant medical, social, or psychological risks;
5. the proposed change(s) do not involve addition of a vulnerable population in research not otherwise eligible for expedited review; and
6. the proposed change(s) do not significantly alter the scientific question or the scientific quality of the study.

Examples of minor amendments:

• Decrease in the amount of blood drawn
• Title change
• Principal investigator change
• Addition of co-investigators
• Clarification issues
• Additional risks due to adverse event (e.g. IRB requested addition)
• Dose reduction
• Requested changes by Radiation Safety Office
• Extending accrual period
• Addition of urine pregnancy test
• Addition of audio taping
• Advertisements or changes in recruitment when changes are easily compared to the informed consent document
• Final taped message prepared from IRB-approved text
• Addition of subjects

Major Changes in Approved Research. Major Amendments are reviewed at a convened IRB meeting. Proposed changes potentially involve increased risks or discomforts or decrease potential benefit.

Examples of major amendments: