/Institutions/United-States-University/json/current/IRB-Handbook-Faculty-and-Staff-Edition-local.json

/Institutions/United-States-University/json/current/IRB-Handbook-Faculty-and-Staff-Edition.json

IRB Forms

All IRB forms are available in Policy 700-41.

Once you have successfully gone through IRB review, there are three circumstances in which you may need to submit additional forms. 

Amendment Form– If you need to change any aspect of your study or project that was already approved use this form (e.g., a change to protocol, a survey instrument, an informed consent form, where the activity is taking place, or how participants are being recruited). The IRB must approve the change(s) before you proceed.

Continuing Review Form– Your IRB determination/approval letter is valid for one year. If your study will exceed this timeframe, you must submit this form to the IRB and receive approval to continue.

Event Reporting Form – Submit this form for any of the following:

•   The study received an expedited or full board review, AND

•   The reportable unanticipated problem is any incident, experience, or outcome that is: 1 ) Unexpected, 2) Related or possibly related to participation in the research, AND 3) Places participants or others at a greater risk of harm.

If all criteria are met, complete an IRB Events Reporting Form as soon as possible after learning of the event (and in all cases within 10 business days) submit it to the IRB via a Google Form.

Other events that may require reporting to the IRB include deviations from an approved study plan and violations of the terms of approval (for example, a confidentiality breach). When an IRB Events Reporting Form must be submitted, do so as soon as possible (and always within 10 business days).

If anything unanticipated happens during your study, contact the IRB immediately; they will help you decide if formal reporting to the IRB is required.