711. Possible Actions Following Assessment of Allegations of Noncompliance

Dismissal of the Allegation as Unjustified

If after reviewing the QI Officer's report of the investigation, the OHRP Director, IRB Chair or designee, find the allegation or complaint to be unjustified, the matter will be dismissed without further inquiry. The findings will be noted in the protocol file. Where appropriate, the principal investigator will be notified in writing.

Referral of the Allegation to More Appropriate Authority

If the initial assessment or further investigation indicates that the allegation or complaint is found to potentially violate other University policies, such as academic misconduct or financial mismanagement, then the complaint will be shared with or referred to the appropriate University authorities for resolution. The principal investigator will also be notified.

Further Investigation Warranted: Notification of PI

Following the assessment and agreement of the OHRP Director or IRB Chair that further investigation is warranted, the QI Officer or other experienced designee will proceed. The principal investigator will be notified in writing of the impending investigation and asked to cooperate fully by answering questions,  providing access to research records, and identifying research team members (as applicable).

Investigation of Potential Noncompliance

An investigation may include but is not limited to:

·        Review of study all records, both administrative and data related.

·        Review of grant records, including accounts

·        Interviews of study personnel, responsible officials, support staff, and human subjects

Information will be presented to the RIO Director or IRB Chair in a written report.

Determination of Minor Noncompliance

If the investigation indicates the noncompliance is minor, the issue may be resolved between any combination of the OHRP Director, QI Officer, IRB Chair or designee, principal investigator and department heads (as appropriate).

The QI Officer will

·        prepare a summary report of the investigation,

·        make recommendations for resolution of the issues identified in the report (e.g., corrective actions, education and training, or a combination), and

·        send a copy of the report to the RIO Director, IRB Chair, and the principal investigator.

Within 10 business days of receipt of the report or on a date agreed on in writing by the QI officer, the investigator must reply with an action or management plan for addressing the recommendations in the report.

Upon approval of the plan, the investigator must implement the action or management plan and notify the QI Officer (in writing) within 30 calendar days of successful implementation.

The QI Officer will send the principal investigator an acknowledgement of successful implementation of the action or management plan, and confirmation that the minor noncompliance has been satisfactorily resolved.

Determination of Potential Serious or Continuing Noncompliance

If the investigation suggests that the incident may constitute serious or continuing noncompliance, the QI Officer, with confirmation from the OHRP Director or IRB Chair and/or an appointed IRB sub-committee, will refer the matter for review by a fully convened IRB at the next scheduled meeting. The QI Officer will notify the investigator and the Institutional Official of pending IRB review.

The Chair or designee may also provide preliminary notice to the DHHS Office of Human Research Protections and the Food and Drug Administration, as appropriate.

If research participants are at immediate risk of harm or have the potential to be placed at further risk while awaiting the outcome of a convened IRB meeting, the Chair may place one or all aspects of the study on suspension pending the decision of the convened IRB.

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