715. IRB Review of Potential Serious or Continuing Noncompliance

As noted above, allegations of noncompliance that may constitute serious or continuing noncompliance are reviewed by the convened IRB.

Materials for Primary Reviewer

·        The report of findings prepared by the QI or designee

·        The approved protocol with attachments, if necessary

·        Noncompliance checklist

Materials for IRB Members

·        The report of findings prepared by the QI or designee

·        The approved protocol with attachments, if necessary

·        Noncompliance checklist

IRB Determinations

Following review and discussion of these materials, the IRB will make one of the four following determinations:

  1. The incident does not meet the criteria for serious or continuing noncompliance but it constitutes minor noncompliance and should be addressed accordingly.
  2. Further investigation by the QI Officer is needed before the IRB can make a determination. The QI Officer will present a revised report at the next scheduled IRB meeting.
  3. Further investigation and consideration by an ad hoc panel is warranted. The panel will report its findings at the next scheduled IRB meeting for review and recommendations.
  4. The incident constitutes serious or continuing noncompliance. The IRB takes whatever actions are deemed necessary to protect the rights, welfare or both of the participants involved.

NOTE: The convened IRB may determine the matter doesn't constitute noncompliance and should be dismissed. However, given the rigor of the process for assessing and investigating allegations of noncompliance, it is unlikely that this would occur.

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