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705. Administrative Assessment of Problem Reports

The RIO QI Officer assesses and coordinates reviews of all problem reports. Within five working days of receipt of a problem report (or within 48 hours of receipt if the report indicates participants may be at imminent risk of harm), the QI Officer or, in the absence of the QI Officer,- the RIO Director or IRB Chair, will
·        assess the information provided;
·        provide a summary to the RIO Director and IRB Chair; and
·        recommend dismissal, immediate determination of minor noncompliance, referral to another University or affiliate entity, or evaluation for noncompliance or unanticipated problem involving risks to participants or others.

NOTE: If it is determined that the matter may be more appropriately handled by another unit or department, the Director or Chair may suggest immediate referral or may give the QI Officer permission to investigate the matter before involving other parties.

Assessment for Immediate Risk of Harm

For problem reports that indicate risk of harm to participants or others may be a consideration, those involved in the initial or subsequent consultations may determine that immediate corrective actions are needed to protect the participants or others and will make the necessary recommendations to mitigate such risks.

Further Investigation Warranted

The QI Officer, RIO Director or IRB Chair may conclude that further investigation is warranted before   making a recommendation. During an investigation, the QI Officer may
·        Review research records including IRB correspondence, IRB applications and forms, recruitment and consent documents, and study data
·        Review the sponsor protocol; investigator brochures; and drug/device labels, packaging, or inserts
·        Review grant documents and records, including accounts
·        Interview study personnel, responsible officials, support staff, and research participants

Further Investigation Warranted: Notification of PI

Following the assessment and agreement of the RIO Director or IRB Chair that further investigation is warranted, the QI Officer or other experienced designee will proceed. The principal investigator (PI) 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).

Recommended Actions

The administrative assessment with or without further investigation, will result in one of the following actions.

Dismissal of the Problem as an Unjustified Claim of Noncompliance

If the QI Officer, RIO Director, and IRB Chair or designee discern that an allegation or complaint of noncompliance is without merit, the matter will be dismissed without further inquiry. The decision will be noted in the protocol file. Where appropriate, the PI will be notified in writing.

Dismissal of the Problem as Not Meeting the Criteria for an Unanticipated Problem Involving Risks to Participants or Others

Those involved in the assessment may determine that a problem did not involve noncompliance or meet the three criteria* for an unanticipated problem involving risks to participants or others (henceforth known as Unanticipated Problem). In this case, the matter will be dismissed and the PI will be informed of the dismissal and told to include the event/situation in the summary of problems when submitting for continuing review.

*Summary of Criteria for Unanticipated Problem Involving Risks to Participants or Others

  1. The problem or event was unexpected.

  2. The problem or event was related or possibly related to the research, or use of an investigational drug or device.

  3. The problem or event may involve risks to participants or others.

Determination of Minor Noncompliance

If the initial assessment or investigation indicates the situation involves minor noncompliance, the matter may be resolved by the RIO Director or IRB Chair. See noncompliance policy for details.

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 RIO Director, IRB Chair or an appointed IRB sub-committee, will refer the matter for review by a fully convened IRB. The QI Officer will notify the PI and the Responsible Official of pending IRB review. See noncompliance policy for information about IRB review and assessment.

Determination of Potential Unanticipated Problem

If the investigation suggests that the situation or event may meet the three criteria for an unanticipated problem involving risks to participants or others, the QI Officer, with confirmation from the RIO Director, IRB Chair 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 PI and the Responsible Official of pending IRB review. See unanticipated problem policy for information about assessment of the criteria and IRB review of Unanticipated Problems.

Referral of the Situation to More Appropriate Authority

If it is determined that the matter may be more appropriately handled by another University unit or department, the Director or IRB Chair may suggest immediate referral to the other entity or may give the QI Officer permission to investigate the matter before involving other parties. For example, the initial assessment or further investigation indicates that the allegation or complaint may violate other University policies, such as academic misconduct or financial mismanagement. The PI will be notified of the referral.

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