Please download and complete the current version of the applicable form(s).
Revisions or amendments to an approved study must be reviewed and approved by the IRB prior to initiating the change(s). All applicable revisions must be checked on the project revision form and must be incorporated into the relevant study documents using track changes.
For studies determined to be FLEX or exempt, the following changes do not require IRB review:
Please see the Project Revision Guidance for more information.
The federal regulations allow for expedited review of minor changes to studies previously approved by the full board. A minor change is one which, in the judgment of the IRB, makes no substantial alteration in:
The HRPP staff will make a determination regarding the appropriate review process upon receipt of the form.
A protocol exception is a single occurrence of an intentional action or process that departs from the IRB-approved protocol. Exceptions will not be granted if they increase risk, decrease benefit, or could have a negative affect a participant’s rights, safety, welfare, or the integrity of the resultant data. Examples include omitting an approved procedure that is not in the best interest of a specific participant subject or seeking permission to enroll one interested individual who does not meet the eligibility criteria.
Exceptions made without prior IRB approval are deviations and constitute non-compliance.
Expedited and Full Board 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 and FLEX approvals are granted for up to five years. Continuing review of these projects is not required. If there is a plan to extend the study beyond the expiration date, the investigator must submit a new application (See step 3 on the ‘Preparing an Initial Submission’ page). Submit a final report if the project is completed prior to the expiration date.
Reports related to protocol deviations, adverse events, and unanticipated problems must be submitted to the IRB within the required timeframe. Please see sections 12 and 13 of the Policy and Procedure Manual for more information.
Final reports should be submitted by the study expiration date or sooner if all study activities, including data analysis, are complete.