700-11-Conditional Approval

Title:	Conditional Approval
Owner:	IRB
Last Update/Revised:	05/01/2024

Policy: When an investigator collaborates with another institution or organization, that entity must grant approval/consent to the project or study being conducted before USU IRB review. If this entity requires a statement of “conditional approval” from the USU IRB prior to their review, a request is made using the IRB Review Form.

If the collaborating entity will serve as the IRB of record, then policy 700-12: Other IRB of Record is followed.

Purpose: This policy details how conditional approval is managed.

Procedures:

If an investigator requires conditional approval, this is noted on the IRB Review Form.
1. The IRB Chair or designee will review the submission using the IRB Reviewer Checklist.
  1. If the proposed activity receives a determination of either not human subjects research or exempt, a determination letter is sent to the investigator (or chair if the investigator is a doctoral student) for submission to the collaborating entity.
  2. For research eligible for expedited review, if a conditional approval can be granted, a letter is sent from the IRB to the investigator (or chair if the investigator is a doctoral student) for submission to the collaborating entity. The investigator must submit the formal approval/consent from the collaborating entity prior to approval from the USU IRB to proceed (unless the collaborating entity will serve as the IRB of record (see 700-12: Other IRB of Record).
  3. If conditional approval cannot be granted, the reasons are detailed in a letter sent from the IRB to the investigator (or chair if the investigator is a doctoral student).

Scope: This policy applies to all investigators who need conditional approval from a collaborating entity.

Documents and Forms:

IRB Review Forms: DBA Program, DNP Program, EdD Program, Faculty & Staff (available in Policy 700-41)

IRB Reviewer Checklist (available on IRB Google Drive)