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Reporting Responsibilities

  1. The UNM IRB will report to the company the following:
    • Serious or continuing noncompliance;
    • Unanticipated problems involving risks to participants 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 relying institution will promptly report to the UNM IRB the following:
    • Serious or continuing noncompliance;
    • Unanticipated problems involving risks to participants or others;
    • Suspension or termination of the institution’s approval of the research;
    • Allegations of scientific misconduct involving human research;
    • Disclosure of significant COI by the deferring institution’s researchers engaged in research;
    • Any agency or organization that initiates any action (including audits, compliance monitoring, and reporting) with regard to the research under UNM IRB oversight;
    • 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 the institution and/or OHRP as appropriate.
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