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, survey questions, methods and procedures, or 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.
Minor changes can often be reviewed faster than major 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.
Please see the Exempt Project Revision Guidance for information on when to submit project revisions.
A protocol exception is defined as a circumstance in which specific procedures called for in a protocol are not in the best interests of a specific subject. Exceptions may not increase risk or decrease benefit, affect the participant's rights, safety, or welfare, or affect the integrity of the resultant data.
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 HRPP Office 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.
Exemptions are granted for five years and renewals during that time are not required. If there is a plan to extend the study beyond the expiration date, the investigator must request a new exemption. Investigators are asked to submit a final report to the IRB if the project is completed prior to the 5 year term.
Protocol deviations, adverse events, and unanticipated problems must be reviewed by the IRB. The timeline for these submissions 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.