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700-28-Continuing Review

Title: Continuing Review
Owner: IRB
Last Update/Revised: 05/01/2024

Policy:  When considering whether to renew a project or study, the IRB revisits the same criteria used to grant initial determination or approval. During continuing review, the IRB determines whether the study can be renewed at the same category type (e.g., not human subject research, exempt, etc.), or if new information may change the original determination. As an outcome of continuing review, the IRB may require the project or research to be modified or stopped altogether. Additionally, the IRB may need to impose new precautions or revise those it had previously imposed on the protocol.

The continuing review form must describe the progress of the project/study; enrollment and withdrawals; adverse events, complaints, and other problems that have occurred; and safety monitoring results. Investigators have the option to add an amendment in combination with the continuing review. The amendment will be reviewed and approved in combination with the continuing review.

Purpose: The USU IRB will conduct a continuing review for projects/research that extend beyond the one-year expiration date to ensure human subject protections remain appropriate and to determine if it is appropriate for the study to continue as is, or with modifications. This policy outlines the standards the IRB must follow in considering continuing review.

Procedures:

  1. Investigators are required to submit a continuing review form to the IRB via a Google Form at least 10 business days prior to the expiration of the study. Please see 700-27: Length of Approval for the policy regarding the expiration of a study.
  2. The IRB Chair or designee will use the IRB Reviewer Checklist to determine if the study approval can be renewed as is, or if a board meeting is required. In the case that a board meeting is required, policy 700-23: Full Board Review is followed.

Scope: This policy applies to all projects and research being conducted at USU.

Documents and Forms:

Continuing Review Form