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Your Ongoing Responsibilities After Your Protocol Has Been Approved

  • Reporting Adverse Events
  • Revisions/Amendments
  • Continuing Review
  • Closing Projects
Protocol Revisions
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If you wish to make a change to an approved research protocol, please be aware that all substantive revisions (i.e., modifications, addenda, amendments) to a project must be reviewed and approved by the IRB prior to initiation.

Principal investigators should submit a Revision Request form to the IRB and provide any modified supporting documents (e.g., informed consent documents, data collection instruments, etc.) affected by the change. Project revisions can often be reviewed and approved by one IRB member; however, a project that was initially reviewed by a full board must be reviewed again by a full board for any revisions.

IMPORTANT! Approval must be granted before any changes can be initiated.

See the IRB Forms & Policies for the Revision Request Form.

Continuing Review
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Except for studies determined to be exempt from IRB oversight, all research involving human participants must undergo continuing review by the IRB. The frequency of continuing review is based on the level of risk initially assessed by the IRB, but will occur no less than annually.

A principal investigator should submit a Continuation Request Form to the IRB at least one month before the project expires to ensure enough time for it to be reviewed. A project is considered open and requires IRB approval to continue beyond the expiration date if:

  • participants are still being recruited,
  • participants are still taking part in the research,
  • the research is permanently closed to the enrollment of participants but follow-up with participants may occur, or
  • data is still being analyzed and poses ongoing risk to participants (e.g., due to privacy and confidentiality issues).

Continuing review for a project may be requested each year for two years. However, if a project will continue after the third year of its initial approval anniversary, a new IRB application for the project must be filed with the IRB. A continuing review project can be reviewed by one IRB member; a project that was initially reviewed by a full board must be reviewed again by a full board for continuing review.

Principal investigators should plan ahead to meet required continuing review dates. If an investigator fails to request a continuation of their project to the IRB or the IRB has not reviewed and approved a research project by the expiration date specified by the IRB, the research must stop, unless the IRB finds that it is in the best interests of individual participants to continue participating in the research interventions or interactions. Enrollment of new participants cannot occur after the expiration of IRB approval. When continuing review of a research protocol does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. At the discretion of the IRB, a principal investigator who allows a study to expire without requesting a continuation from the IRB may be asked to submit a new IRB application for review to re-activate the project.

The Continuation Request form may be accessed by visiting the IRB Forms page.