OREGON STATE UNIVERSITY
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Modifications to approved studies must be reviewed and approved by the IRB prior to initiating the change(s). All applicable changes must be identified in the modification submission and incorporated into the relevant sections of the study application and any applicable attachments.
For studies determined to be exempt or FLEX, many minor changes do not need to be submitted for IRB review. Please see the Project Revision Guidance (PDF) for more information.
To modify a study:
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 modification.
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. Continuing review of these projects is not required. If there is a plan to extend the study beyond five years, the investigator should submit a renewal request. Submit a final report if the project is completed prior to the end of the five year period.
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:
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 IRB review of a non-exempt* study is to be ceded to an external institution's IRB, a reliance agreement between the institutions must be executed and the OSU IRB must maintain current protocol records for the study.
To request that OSU rely on an external institution's IRB review:
*If a study is determined to be exempt by either OSU or the external institution's IRB, OSU will not enter into a reliance agreement. In this case, each institution will need to perform their own IRB review or issue an exempt determination.