Once a study receives IRB approval, any changes or modifications to an Exempt study, or the approved Expedited or Full Board study (e.g., revising a questionnaire, adding a new data collection instrument, modifying the recruitment strategy, changing the number of research subjects, revising eligibility criteria, changing the study principal investigator, etc.), will require IRB submission and approval PRIOR to that change/modification.
All amendments must be completed through Kuali using the function within the protocol. Only use C1 if instructed to do so in Kuali.
Legacy protocols created before/outside Kuali will still need to be submitted through Kuali and may require attaching the word version of the (amended) Protocol Form when submitting. When legacy protocols were entered into Kuali, research assistants may not have been listed. If you need to have a student who is working on the project added to the protocol so that they can create an amendment submission please contact Jessica.
C1 Waiver to Obtain/Document/Alter Informed Consent Complete this form if you are requesting to NOT obtain informed consent (e.g., secondary data analysis); requesting to NOT obtain documentation (i.e., subject does not sign the consent form); or seeking to modify the consent document/process (e.g., verbal consent, eliminating required language in the consent).