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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.
To revise a study:
See the FAQ for submitting project revisions in iRIS for additional instructions.
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. 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 will not be granted if they increase risk, decrease benefit, or could have a negative affect on a participant’s rights, safety, welfare, or the integrity of the resultant data.
Exceptions made without prior IRB approval are deviations and constitute non-compliance.
To request an exception:
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 typically granted for up to five years (See exception below). 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 the ‘Preparing an Initial Submission’ page). Submit a final report if the project is completed prior to the expiration date.
EXCEPTION: If your most recent FLEX approval notice indicates that the study received a three-year approval and has instructions to submit a continuing review application, a continuing review application will need to be submitted prior to the expiration date to continue the study.
Studies approved prior to January 21, 2019: Expedited and Full Board studies must be reviewed and re-approved prior to the expiration date.
Studies approved on or after January 21, 2019: Full Board and FDA-regulated studies must be reviewed and re-approved prior to the expiration date. This requirement also applies if the IRB determined that continuing review is a requirement for an Expedited study.
To renew a study:
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.
To report an event:
See the FAQ on submitting a reportable event form for additional information.
Final reports should be submitted by the study expiration date or sooner if all study activities, including data analysis, are complete.
To close a study:
If the review of your study was deferred to an external institution, the OSU IRB is required to maintain a mirror copy of the file. If the review of your study was deferred to OHSU, see the OHSU-specific options outlined in the outcome letter received from the OSU HRPP office.
To update your study at OSU:
See the FAQ on submitting the deferral update form in iRIS for additional instructions.