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:

  1. Revising surveys or interview questions to make minor edits that do not alter the nature of the questions being asked (e.g., fixing typos/grammatical errors, restating the same questions for clarity, reordering the questions, splitting one question into multiple questions)
  2. Revising interview or focus group questions to include follow-up clarifying questions (i.e., questions that cannot be known to the researcher in advance because they are based on the individual responses of the participants).
  3. Adding or removing study personnel who meet all of the following criteria: (a) Are affiliated with OSU, (b) are not going to serve as the principal investigator, (c) are not a student conducting the study for a thesis or dissertation. Note: The PI is responsible for ensuring that all study staff have completed the appropriate online ethics training before they are added to the study team.
  4. Revising recruitment materials, so long as the four required elements are still present and they conform to the OSU policy

Please see the Project Revision Guidance (PDF) for more information.

To revise a study:

  • Studies approved before January 21, 2019: Please download and complete the Project Revision and Minor Change Form (DOCX). Then submit the form, along with any revised or new documents, to IRB@oregonstate.edu.
  • Studies approved on or after January 21, 2019:
    • Log in to iRIS
    • Go to Study Assistant
    • Select View My Studies
    • Locate and click on the study
    • Under Action, select Forms and choose the Project Revision Form from the list

    See the FAQ (PDF) 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 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 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:

  • Studies approved before January 21, 2019: Please download and complete the Request for Exception Form (DOC). Then submit the form, along with any applicable documents, to irb@oregonstate.edu.
  • Studies approved on or after January 21, 2019:
    • Log in to iRIS
    • Go to Study Assistant
    • Select View My Studies
    • Locate and click on the study
    • Under Action, select Forms and choose the Request for Exception Form from the list

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:

  • Studies approved before January 21, 2019: Please download and complete the Continuing Review Application (DOCX). Then submit the form, along with any applicable documents, to IRB@oregonstate.edu.
  • Studies approved on or after January 21, 2019:
    • Log in to iRIS
    • Go to Study Assistant
    • Select View My Studies
    • Locate and click on the study
    • Under Action, select Forms and choose the Continuing Review Application from the list

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: Please download and complete the Reportable Event Form (DOCX). Then submit the form, along with any applicable documents, to irb@oregonstate.edu.
  • Studies approved on or after January 21, 2019
  • Log in to iRIS
  • Go to Study Assistant
  • Select View My Studies
  • Locate and click on the study
  • Under Action, select Forms and choose the Reportable Event Form from the list

See the FAQ (PDF) 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:

  • Studies approved before January 21, 2019: Please download and complete the Final Report Form (DOCX). Then submit the form, along with any applicable documents, to irb@oregonstate.edu.
  • Studies approved on or after January 21, 2019
    • Log in to iRIS
    • Go to Study Assistant
    • Select View My Studies
    • Locate and click on the study
    • Under Action, select Forms and choose the Final Report Form from the list

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:

  • Studies approved before January 21, 2019: Email all approval documents and study documents approved by the external IRB within 30 days of approval for all submission types (i.e., initial, revisions, annual reviews, adverse events, etc.) to the OSU HRPP office (irb@oregonstate.edu).
  • Studies approved on or after January 21, 2019:
    • Log in to iRIS
    • Go to Study Assistant
    • Select View My Studies
    • Locate and click on the study
    • Under Action, select Forms and choose the Deferral Update Form from the list
    • Ensure that all approval documents and documents approved by the external IRB are attached to the form.

    See the FAQ (PDF) on submitting the deferral update form in iRIS for additional instructions.