Changes to the Protocol and/or Consent

A modification is defined as any change to a protocol from what was previously approved during the period for which approval was given. Changes in research procedures or consent/assent form(s) cannot be initiated by the investigator without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject.

Approval is on the advice of the IRB Chair or a designated representative unless the nature of the proposed changes warrants full IRB review. The investigator and the IRB Contact Person will be notified through an electronic memo of the IRB's decision. If approved, the clean copy of the revised consent /assent form(s) with the valid “IRB approval” stamp and expiration date will accompany the approval letter.

Change to Protocol and/or Consent Form
Use this form for changes to protocol, consent, assent or Investigator Brochure

Change/Update Form
Use this form for letters, questionnaires, surveys, etc.

Personnel Change Form

Site Specific Change Form