Modification Instructions

Approval for any modification to a protocol, instrument, or consent document under IRB jurisdiction must be approved by the IRB (except for minor items such as correction of grammatical and typographical errors). Modest changes on projects initially approved by full review (such as changes in PIs, number or participants, or minor changes in instruments or consent forms) may be approved using expedited review procedures at the discretion of the Chair. All other modification requests will be reviewed in the same way as the original proposal.

Requests for modifications should be submitted via memo to the IRB Chair. The memo should identify the IRB application number and date of approval (both are listed on all approval letters). Each requested modification should be described, and any relevant materials (e.g., new consent forms, questionnaires) should be attached. Finally, the memo should state whether the PI believes that the modifications will, in any way, increase or decrease the risks to participants.