- Administrative Offices
- Major University Initiatives
- Centers and Institutes
Please download and complete the current version of the applicable form(s).
All revisions or amendments to an approved study must be reviewed and approved by the IRB prior to initiating the change(s). Examples of revisions include changes to advertisements, study team members, methods and procedures, an increase in subject enrollment. Some revisions may necessitate changes to the consent forms. All revisions described on the project revision form must be incorporated into the appropriate study documents and submitted for review in track changes.
The IRB has a process for the review of minor changes. A minor change is one which, in the judgment of the IRB, makes no substantial alteration in:
Submit the Minor Change Form to request this type of change to an existing, acknowledged or approved study.
If you are adding study team members and need more space than the project revision or minor change form tables provide, please complete and submit the additional study team members table.
Under some circumstances, it is no longer necessary to submit a project revision for exempt studies. Please see the Exempt Project Revision Guidance for information on when to submit project revisions.
All non-exempt studies must be reviewed and re-approved prior to the expiration date. It is the responsibility of each investigator to be aware of when their study expires and submit a continuing review application (or final report) to the IRB at least 30 days prior to that date. In the event that a study expires prior to the submission of the renewal application, the study will be closed and a new application must submitted. No research activities, including data analysis, may be conducted in the absence of a current IRB approval.
Continuing review applications are not required for exempt studies. Exemptions are granted for five years. If the research extends beyond the expiration date, the Investigator must request a new exemption. Investigators should submit a final report to the IRB if the project is completed prior to the 5 year term.
Protocol deviations, exceptions, adverse events and unanticipated problems must be reported to the IRB. The timeline for these reports depends on the nature of the event.
Final reports should be submitted at least 30 days prior to the annual expiration date or sooner if all study activities, including data analysis, are complete.