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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: 1) definitions and classifications of noncompliance involving members 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.

2.0 Policy

It is the policy of the Organization that:

  • 2.1. Allegations or reports 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, or HRPP policies must be promptly reported to appropriate Organizational officials.
  • 2.2. The ORA administration and staff, IRB members and others involved in the HRPP will be proactive in identifying noncompliance, minimizing repeat occurrences, and implementing any corrective action plan required by the Organization.
  • 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)(5) and 21 CFR 56.108(b)(2) as required, in accordance with HRPP policy 8.7 (Reporting Incidents to Institutional Officials and Federal Agencies).

3.0 Definitions

  • 3.1. Noncompliance is defined as the lack of compliance by IRB members, ORA staff, or others involved in the HRPP with the applicable requirements specified in Section 2.1 above.

    Note: Noncompliance that is attributable 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, continuing, or combinations 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, or the determinations of the IRB 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); or c) otherwise compromises the rights and welfare of the research subjects.

    • 3.1.2. Non-serious noncompliance is defined as an incident that does not satisfy the definition of serious noncompliance in section 3.2 of this policy.

    • 3.1.3. Continuing noncompliance is defined as 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 an individual 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 Allegation of Noncompliance

  • 4.1. Allegations of noncompliance may be received by, or made by, an investigator, study staff, IRB members, IRB staff, the Research Subject Advocate, any other Organizational officials, or by FDA, OHRP or other federal agency.
  • 4.2. Allegations of noncompliance can be received through the UNMC 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. Additional information will be obtained from the reporter, ORA or HRPP records, or from other sources as appropriate.
  • 5.2. Based on this initial review, the UNMC Chief Compliance Officer will determine:
    • 5.2.1. Whether the allegation has a basis in fact, or
    • 5.2.2. Whether the allegation merits further investigation.
  • 5.3. The UNMC Chief Compliance Officer 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).
    • 5.3.2. 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 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 noncompliance 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.

6.0 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

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:HISTORY:

REVISEDWritten: JANUARY1/20/2016 11,(Approved: 20181/20/2016) - original author not recorded

INITIALRevised: JANUARY1/11/2018 20,- 2016revision not documented

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