Informational Items

IRB Informational Items

Informational items are items sent to investigators in the form of letters, notes to file, protocol administrative changes, and other items that do not require full IRB approval but must be acknowledged by the Primary Reviewers.

To submit an informational item for IRB review, complete and submit the Clinical Trial Modification Application below.

IRB FDA 1572

This form is required for FDA approved research involving human subjects such as clinical trials and minimal risk research involving FDA approval or the use of drugs or devices.

IRB Statement for Payments to Human Subject Participants

This form is required for all Clinical Trial studies and any Minimal Risk research involving monetary incentives to participate. When submitting this form for IRB review, the appropriate Informed Consent Form should be included with the submission.

Note: This form is already included in the Clinical Trial Informed Consent document.