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8.5 Noncompliance by the IRB or Other Components of the HRPP

1.0 Purpose

The purpose of this policy and procedure is to describe the:the 1)process definitionsfor reviewing and classificationsreporting incidents of noncompliance involvingby membersthe IRB and/or other components of the IRB, ORA staff, and others involved in the HRPP; 2) procedures for reporting noncompliance, 3) possible actions in response to noncompliance; and 4) procedures for reporting noncompliance to OHRP, FDA, and Organizational officials.HRPP.

2.0 Policy

It is the policy of the Organization that:

  • 2.1. Allegations or reportsReports of noncompliance by members of the IRB, ORA staff, or others involved in the HRPP with Federal Regulations related to the protection of human subjects of research,research or HRPP policies mustby be promptly reported to appropriate Organizational officials.
  • 2.2. The ORA administration and staff,the IRB membersor andother otherscomponents involved inof the HRPP willshall be proactivereviewed, in identifying noncompliance, minimizing repeat occurrences,investigated and implementingreported anyas correctiveoutlined action plan required by the Organization.below
  • 2.3. All allegations or incidents of noncompliance will be promptly reviewed by the UNMC Chief Compliance Officer and appropriate action taken in order to ensure ongoing adequate protection of the rights and welfare of research participants.
  • 2.4. Findings of serious or continuing noncompliance will be promptly reported to OHRP, FDA and sponsors or funding agency heads in accordance with the requirements of 45 CFR 46.103(b)108(a)(5)4) and 21 CFR 56.108(b)(2), and the Organization’s Federalwide assurance, as required,specified in accordance with HRPP policy 8.7 (Reporting Incidents to Institutional Officials and Federal Agencies).

3.0 Definitions

  • 3.1. Noncompliance by the IRB or other components of the HRPP is defined as thefailure lackto offollow compliancefederal byregulations IRB(including members,but ORAnot staff,limited to 45 CFR 46, and applicable subparts, or others21 involvedCFR in50, the56), HRPP withpolicies, theand/or applicableOrganizational requirements specified in Section 2.1 above.

    Note:policies. Noncompliance thatmay isbe attributableserious to study personnel is covered in HRPP policy 8.4 (Review of Noncompliance Involving the PI and Study Personnel).

    Findings of noncompliance are classified as non-serious, serious,and/or continuing, or combinationsneither serious nor continuing.

    • 3.1.1. Serious noncompliance by the IRB or other components of these.
      It should be noted that noncompliance may also constitute an unanticipated problem involving risk to the subject or others (UP) as defined in HRPP policy 8.3 (IRB Review of Unanticipated Problems Involving Risk to the Subject or Others).

      • 3.1.1. Serious noncompliance is defined as an incident that represents a violation of applicable federal regulations, HRPP policies, and/or theOrganizational determinations of the IRBpolicies which include one or more of the following consequences: (a) significantly increases the risk to subject(s); b) appreciably decreases the potential direct benefit to the subject(s);subjects, or c) otherwise compromises the rights and welfare of research subjects, or (b) places the researchOrganization subjects.

        at risk of significant regulatory, financial or reputational harm.

      • 3.1.2. Non-seriousContinuing noncompliance by the IRB or other components of the HRPP is defined as an(1) incidentrepeated incidents of the same or substantially similar noncompliance, after the IRB or other component has been notified that does not satisfy the definitionaction ofrepresents seriousnon-compliance, noncomplianceor indespite sectionappropriate 3.2retraining ofand/or thisspecific policy.

        corrective
        • action,
      • or

        3.1.3. Continuing noncompliance is defined as(2) repeated incidents of the same or substantially similar noncompliance that indicates an inability or unwillingness to comply with federal regulations, or HRPP policies.

        Note: In general, to represent continuing noncompliance, the events must have recurred after appropriate retaining and/or specific corrective action plan, or must be of such a nature that anthe individualIRB or other component of the HRPP should have reasonably been expected to know that such an action was noncompliance.

    • 3.2. Allegation of noncompliance is defined as an accusation or unproved assertion of noncompliance.

    • 3.3. Incident of noncompliance is defined as a proven noncompliance.

    4.0 Reporting an AllegationResponsibilities of Noncompliancethe ORA, Chief Compliance Officer (CCO) and Institutional Official (IO)

    • 4.1. AllegationsUpon receipt of a report of noncompliance mayattributable beto receivedany by,component or made by, an investigator, study staff, IRB members, IRB staff,of the ResearchHRPP: Subject
      • Advocate,

        4.1.1. anyThe otherORA Organizationalwill officials, or by FDA, OHRP or other federal agency.

      • 4.2. Allegations of noncompliance can be received throughconduct the UNMCinitial IRB website, utilizing the “Report a Problem or Complaint” tab, or though other electronic reporting systems sponsored by the Organization.

      5.0 Procedures for Reviewing Noncompliance

      • 5.1. Allegations or incidents of noncompliance are reviewed by the UNMC Chief Compliance Officer.investigation. Additional information will be obtained from the reporter, ORA or HRPP records, and/or from other sources as appropriate.

      • 5.

        4.1.2. BasedIf on thisthe initial review,investigation does not confirm that noncompliance occurred, the UNMC Chief Compliance OfficerORA will determine:prepare

        • 5.2.1.a Whetherreport to the allegationCCO has a basis in fact, or
        • 5.2.2. Whetherdescribing the allegationallegation, meritsand explaining why it does not represent noncompliance. The CCO may accept the report and notify the IO and IRB, or may request clarification or additional information, or may conduct further investigation.

        • 4.1.3. If the initial investigation confirms that noncompliance occurred, the Executive Chair of the IRB, the Assistant Vice Chancellor for Regulatory Affairs or designee will prepare a report to the CCO describing the noncompliance. The report will classify the noncompliance as minor, serious and/or continuing and include a proposed corrective action plan (CAP) as appropriate.

        • 4.1.4. The CCO may:

          • Accept the report and CAP as proposed

          • Request modifications to the CAP

          • Request clarification or additional information

          • Conduct further investigation

        • 4.1.5 Upon conclusion of the investigation of noncompliance, a report of the noncompliance and the CAP will be presented to the IRB, IO and other organizational officials as appropriate.

      • 5.3.4.2. The UNMCIRB ChiefExecutive ComplianceChair/designee Officerand/or CCO, as appropriate, will promptly initiate all necessary action(s) to ensure that human subjects are fully protected, and the interests of the Organization are appropriately considered. These actions could include, but are not limited to, any or all of the following:
        • 5.3.1. Requesting that the Executive Chair convene an emergency meeting of the IRB (HRPP policy 2.2: Full IRB Review).
        • 5.4.3.2. Recommend the IO and/or the IRB Executive Chair immediately suspend IRB approval of some or all research activities in accordance with HRPP policy 8.6: Study Hold, Suspension, and Termination.
        • 5.3.3. Refer the allegation or incident of noncompliance for investigation by a specially appointed ad hoc Subcommittee.
      • 5.4. A record of the report and actions taken under this policy by the Chief Compliance Officer will be maintained on file.
      • 5.5. All involved individuals will be afforded due process, and Whistleblower protection will be provided in accordance with UNMC Policy 8003.
      • 5.6. Upon conclusion of an investigation of noncomplianceby the UNMC Chief Compliance Officer will report of the results of the investigation to the IO, other Organizational officials, and to the IRB as appropriate.
      • 5.7. The UNMC Chief Compliance Officer may recommend to the IO actions which are appropriate for the circumstances of noncompliance. These actions could include, but are not limited to, any or all of the following:
        • 5.7.1. Make modifications to HRPP policies and/or procedures.
        • 5.7.2. Inform the Organization’s general counsel of the noncompliance.
        • 5.7.3. Refer the noncompliance to Nebraska Medicine or CHMC Risk Management for further action.
        • 5.7.4. Take other actions against the involved parties.
        ORA.

      6.5.0 Reporting Noncompliance to Organizational Officials, OHRP, FDA and Department or Agency Heads

      All required reports will be submitted in accordance with HRPP policy 8.7 (Reporting Incidents to Institutional Officials and Federal Agencies).

      DOCUMENT HISTORY:

       Written: 1/20/2016 (Approved: 1/20/2016) - original author not recorded

       Revised: 1/11/2018 - revision not documented

       Revised: 3/7/2023 – revised definitions; clarified that the ORA will conduct initial evaluation and pass recommendations to CCO; simplified throughout; stylistic changes.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

       Revised: 5/9/2023 – Deleted reference to “minor” non-compliance and substituted “neither serious nor continuing”; revised definition of serious non-compliance to include putting Organization at risk of significant regulatory, financial or reputational harm; revised definitions of serious non-compliance and continuing non-compliance to delete parts of the definition more appropriate for PI or research staff non-compliance; clarified possible actions of CCO.{Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

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