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:

  • Studies approved before January 21, 2019 (via email): As the HRPP has transitioned to a new electronic submission management system, modifications to email-based studies are no longer being accepted. If changes need to be made to an email-based study, the PI must submit a new application in Cayuse HE. Please visit Cayuse HE Transition for more information on the Cayuse implementation and transition management.
  • Studies approved in iRIS: Only Expedited and Full Board studies were migrated into Cayuse. If your study was Expedited or Full Board and you have received notification that the migration of your study has been completed, you may submit a modification to your study in Cayuse (see instructions below). If your study was Flex or exempt, the PI must submit a new application in Cayuse HE. Please visit Cayuse HE Transition for more information on the Cayuse implementation and transition management.
  • Studies submitted in Cayuse:
    • Log in to Cayuse HE 
    • Ensure "Product" selection is set to "Human Ethics"
    • In My Studies section, select the study you wish to modify
    • Click on New Submission
    • Select Modification

    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 level of risks to subjects
    • the research design or methodology (adding procedures that are not eligible for expedited review would not be considered a minor change)
    • the number of subjects enrolled in the research (no greater than 10% of the total requested)
    • the qualifications of the research team (change in PI is not considered to be minor)
    • the facilities available to support safe conduct of the research, or
    • any other factor which would warrant review of the proposed changes by the convened IRB or was used to initially to evaluate the risk:benefit ratio or any other criteria for approval

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:

  • Studies approved before January 21, 2019 (via email) or studies reviewed in iRIS: Please contact the IRB at  irb@oregonstate.edu for guidance on submitting exceptions for email-based and iRIS studies.
  • Studies reviewed in Cayuse:
    • Log in to Cayuse 
    • Ensure Product selection is set to "Human Ethics"
    • In My Studies section, select the study
    • Click on New Submission
    • Select Modification

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:

  • Studies approved before January 21, 2019 (via email): As the HRPP has transitioned to a new electronic submission management system, renewals to email-based studies are no longer being accepted. If the PI wishes to continue an email-based study, the PI must submit a new application in Cayuse HE. Please visit Cayuse HE Transition for more information on the Cayuse implementation and transition management.
  • Studies approved in iRIS: Only Expedited and Full Board studies were migrated into Cayuse. If your study was Expedited or Full Board and you have received notification that the migration of your study has been completed, you may submit a renewal to your study in Cayuse (see instructions below). If your study was Flex or exempt, the PI must submit a new application in Cayuse HE. Please visit Cayuse HE Transition for more information on the Cayuse implementation and transition management.
  • Studies approved on or after January 21, 2019:
    • Log in to Cayuse HE 
    • Ensure Product selection is set to "Human Ethics"
    • In My Studies section, select the study
    • Click on New Submission
    • Select Continuing Review

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:

  • Studies approved before January 21, 2019 (via email) or studies reviewed in iRIS: Please contact the IRB at  irb@oregonstate.edu for guidance on submitting reportable events for email-based and iRIS studies.
  • Studies reviewed in Cayuse:
    • Log in to Cayuse HE 
    • Ensure Product selection is set to "Human Ethics"
    • In My Studies section, select the study
    • Click on New Submission
    • Select Reportable 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:

  • Studies approved before January 21, 2019 (via email) or studies reviewed in iRIS: Please contact the IRB at  irb@oregonstate.edu for information on closing email-based and iRIS studies.
  • Studies reviewed in Cayuse:
    • Log in to Cayuse HE 
    • Switch Product to Human Ethics
    • In My Studies section, select the study
    • Click on New Submission
    • Select Closure Submission

If the review of your 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: 

  • Log in to Cayuse HE 
  • Ensure Product selection is set to "Human Ethics"
  • Select New Study
  • Complete the application, indicating in the "External Collaboration" section that an external IRB will review the study and provide the requested information.
  • Ensure that all approval documents and documents approved by the external IRB are attached to the study.