/Institutions/United-States-University/json/2023-2024/Policy-and-Procedure-Manual-local.json

/Institutions/United-States-University/json/2023-2024/Policy-and-Procedure-Manual.json

700-32-Protocol Deviations

Title:	Protocol Deviations
Owner:	IRB
Last Update/Revised:	05/01/2024

Policy: It is the policy of the USU IRB to require investigators to report deviations that meet one or more of the following criteria:

• intended to eliminate apparent immediate hazard to a research participant; or

• caused possible harm to participants or others, or placed them at increased risk of harm (including physical, psychological, economic, or social harm); or

• possible serious or continued non-compliance

Any changes in the research protocol during the period for which the IRB approval has already been given may not be initiated without submission of an amendment for IRB review and approval (see 700-29: Amendments/Changes to Protocol). Any report of a deviation to the IRB should be made in a timely fashion but no later than within 5 working days of its occurrence or identification.

Purpose: The purpose of this policy is to explain how protocol deviations are handled by the IRB.

Procedures:

1. The investigator (or chair of a doctoral student) reports deviations by completing and emailing an Event Reporting Form to the IRB via a Google Form.
2. The IRB Chair performs a thorough review and evaluation of the deviation. Requests for clarifications, corrections, or revisions to the report are made if further information is needed to evaluate the deviation.
3. The deviation is evaluated to determine if it significantly impacted the participants’ rights, safety, or welfare, or corrupted the integrity of the resultant data. The IRB committee may be consulted at any time during this process for assistance.
4. Any corrective actions taken should be described, and the investigator’s proposed preventive action plan should include an active process addressing the causal elements so the IRB Chair would conclude that the investigator has a serious, viable plan in place for assuring the safety of research participants and the oversight of data integrity.
5. After review and evaluation of the incident, the investigator (or chair of a doctoral student) will be notified of the action taken by the IRB:

• The deviation was warranted (e.g., eliminated immediate risk to a participant).
• The deviation is returned to the investigator to be submitted as an adverse event and/or unanticipated problem involving risks to participants or others (see 700-31: Unanticipated Problems Involving Risks to Participants or Others).

• If the IRB Chair determines that the deviation possibly meets the definition of serious or continuing non-compliance and the deviation is handled according to 700-33: Non-Compliance and Research Misconduct.

Scope: The policy applies to protocol deviations.

Documents and Forms:

Event Reporting Form