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Reporting Responsibilities

  1. The UNM IRB will report to the deferring institution the following:
    • Serious or continuing non-compliance;
    • Unanticipated problems involving risks to subjects or others;
    • Suspensions or terminations of IRB approval;
    • Action initiated by any Oversight agency or other organization (including audits, compliance monitoring, and reporting).
    • Any modification to the FWA or changes to the status of the Assurance documents.
  2. The deferring institution will promptly report to the UNM IRB the following:
    • Serious or continuing non-compliance;
    • Unanticipated problems involving risks to subjects or others;
    • Suspension or termination of the institution’s approval of the research;
    • Allegations of scientific misconduct;
    • Disclosure of significant conflicts of interest by the deferring institution’s researchers engaged in research;
    • Oversight agency or other organization initiates any action (including audits, compliance monitoring, and reporting) with regard to the research under UNM IRB purview;
    • Any modification to the FWA or changes to the status of the Assurance documents;
    • Changes in the IRB Point of Contact information.
  3. The UNM IRB will promptly report (i) unanticipated problems involving risks to subjects or others, (ii) serious or continuing noncompliance, and (iii) suspensions or terminations of previously approved research related to the deferring institution’s FWA to OHRP as appropriate.
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