705. What to Report to the IRB Regarding Noncompliance

Allegations of noncompliance are best submitted in writing by completing the problem reporting form and submitting it to the RIO; however, allegations may be presented orally to RIO staff or an IRB member.

To the extent possible, the report should include the following:

  • the study title, protocol number, and name of the principal investigator;
  • a description of the situation or event, or the sequence of events that led to the potential noncompliance,
  • the reason the event may constitute noncompliance (e.g., description of the deviations with references to the specific procedures as outlined in the approved protocol);
  • an assessment of why the event occurred or may have occurred;
  • an assessment of whether participants may have been adversely affected by the event, exposed to increased risk, or reduced benefits;
  • an assessment of whether the event compromises the integrity of the study;
  • a description of any changes to the protocol that will be made as a result of the event;
  • a description of any corrective actions that can be, or have been implemented to ensure that similar events do not occur in the future; and
  • the name of the individual reporting the event (although anyone wishing to remain anonymous may refrain from giving her or his name).

NOTE: The name of the individual reporting an allegation of noncompliance will be maintained confidentially by the RIO and the IRB to the fullest extent possible.

710. Assessment of Allegations of Noncompliance and Request to Investigate

Within five working days of receipt of an allegation or report of noncompliance the RIO QI Officer (or, in the absence of the QI Officer, a qualified designee including the RIO Director or an IRB Chair) will:

·        initially assess the information provided,

·        provide a summary to the RIO Director and IRB Chair,

AND

·        request permission to proceed with an investigation;

OR

·        suggest that the matter be dismissed as not meeting the criteria for noncompliance or a reportable event, or

·        conclude that the situation may fall under the purview of another body within the University.

  • 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 to the other entity or may give the QI Officer permission to investigate the matter before involving other parties.

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