Policy 802: Deviations

Policy

It is the policy of the University of Rochester IRB to require Principal 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 noncompliance

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.

Any report of a deviation to the IRB should be made in a timely fashion, but no later than within 10 business days of its occurrence or identification.

Procedures

1. The Principal Investigator reports deviations by completing and submitting a Report of New Information application. Examples of reportable deviations are posted on the OHSP website.
2. The OHSP Specialist or designee performs a thorough review and evaluation of the deviation. Requests for clarifications, corrections or revisions to the report from the PI are made if further information is needed to evaluate the deviation.
3. The deviation is evaluated to determine if it had a significant effect on the participant’s rights, safety, or welfare, or corrupted the integrity of the resultant scientific data. The IRB may be consulted at any time during this process for assistance.
4. Any corrective actions taken should be described, and the Principal Investigator’s proposed preventive action plan should include an active process addressing the causal elements so the reviewer 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 following actions may be taken:

• The deviation is completed with the determination indicated.
• The deviation is returned to the PI to be submitted as an adverse event and/or unanticipated problem involving risks to participants or others. Please see Policy 801, Unanticipated Problems Involving Risks to Subjects or Others.
• If the OHSP Specialist or designee determines that the deviation possibly meets the definition of serious or continuing non-compliance according to Policy 803, the deviation is handled according to Policy 803, HRPP and Non-Compliance.