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Chapter XXI - Serious or Continuing Non-Compliance

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INVESTIGATING ALLEGATIONS OF NON-COMPLIANCE
Instances of non-compliance should be reported to the GA IRB. Allegations of non-compliance may be received by the IRB from a variety of sources, such as an Investigator, a research participant or their family members, institutional personnel, IRB members, the media, or anonymoussources.

Allegations of non-compliance will be documented in as much detail as possible. This documentation will serve as the basis for subsequent investigation to validate or refute the
allegation.

Allegations of non-compliance will be reported to the Institutional Official, investigator(s)’ Dean, Department Chair (or equivalent), as appropriate, and investigated by the GA IRB or an IRB Investigative Subcommittee, an experienced IRB member, an experienced IRB office staff person, or other qualified individual(s) based on the nature and substance of the allegation or expertise required during the investigation. Consultants may also be involved in an investigation asappropriate.

Alleged non-compliance that may involve risks to participants or others must be immediately investigated and actions taken to eliminate or minimize risk. Such allegations may involve:

  • Actions or omissions that adversely affect the rights, safety, or welfare ofparticipants;
  • Actions or omissions that cause harm to participants or place participants atincreased risk of harm;
  • Actions that require legal or administrative action.

The investigation of non-compliance allegations will be conducted in a manner that is timely, thorough and impartial. To the extent possible, the investigation will be documented. Investigators will have the opportunity to provide input during the investigation and to provide relevant facts to the GA IRB. Every effort will be made to protect the identity of whistle blowers during and after the investigation.

HANDLING ALLEGATIONS AND FINDINGS OF NON-COMPLIANCE
Allegations of noncompliance should be forwarded to the Principal Investigator’s Institutional Official, investigator(s)’ Dean, Department Chair (or equivalent), as appropriate. Allegations of noncompliance will remain confidential, consistent with the need to conduct an adequate investigation. The Principal Investigator’s institution or organization will take reasonable steps to protect persons who file reports in good faith from retaliatory actions based on such filing. Actions undertaken in response to an allegation or finding of noncompliance will be completed in a timely manner, based on the circumstances and seriousness of the potential noncompliance.

Under federal regulations, the IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to participants. The IRB Chair, IRB Investigative Subcommittee, or other designated IRB member may suspend or terminate approval of an investigator’s research and/or secure critical documents at any time during or following an inquiry or investigation if necessary to assure the protection of research participants.

INITIAL INQUIRY
Institutional Official’s staff will consult with the Chair of the IRB responsible for reviewing the research, on all allegations or findings of noncompliance. Any individual with a potential conflict of interest may not participate in the initial inquiry. The Principal Investigator (PI) and co-investigator(s), as applicable, may be informed of an allegation of noncompliance or contacted for a response during the initial inquiry.

Note: Minor noncompliance determinations may be made during expedited IRB review; however, serious and/or continuing noncompliance allegations identified during expedited IRB review will be forwarded to the IRB Chair for Full Board consideration.

Possible outcomes of the initial inquiry include:

  • Dismissal of the allegation (i.e., unsubstantiated);
  • Referral to other appropriate university process (e.g., misconduct review);
  • No further action required (i.e., for minor violations);
  • Corrective action(s) recommended (i.e., for minor violations);
  • Review by convened IRB required (i.e., noncompliance may be serious and/or continuing but further investigation is not needed);
  • Referral to the IRB Investigative Subcommittee;
  • Further investigation required.

Further investigation will be undertaken when the results of the initial inquiry indicate that additional fact-finding is required to assess the alleged or reported noncompliance.

When further investigation or convened IRB review is not warranted (e.g., dismissal of the allegation or minor violations), the investigator(s) will be notified in writing of the allegation/finding of noncompliance and the outcome of the initial inquiry including required corrective actions, as applicable. The Institutional Official, investigator(s)’ Dean, Department Chair (or equivalent), and/or research collaborators may also be informed, at the discretion of the IRB Chair or IRB Investigative Subcommittee. Notification will be sent to the person(s) originating the report of noncompliance, as applicable. In some cases, the convened IRB or IPC may be asked to recommend corrective actions. Suspended IRB approval may be reinstated, as appropriate, based on the outcome of the initial inquiry and the response of the investigator(s). Reinstatement of IRB approval(s) will be reported by ORRP staff to those previously informed of the suspension (i.e., Institutional Official, OHRP, any other sponsoring federal department or agency, etc.) and others (e.g., Office of Sponsored Programs), as necessary.

If the investigator(s) is contacted for a response during the initial inquiry, a written response will be requested. If the potential noncompliance is reviewed by the convened IRB, the PI and co-investigator(s) may respond in person at the meeting during which the review will take place. A personal advisor or legal counsel may accompany the investigator(s), but the advisor or legal counsel may not participate in the discussion.

Initial inquiries will be completed promptly; however, the timing is dependent on the finding of noncompliance and on the nature of the potential noncompliance.

INVESTIGATION AND INVESTIGATIVE SUBCOMMITTEE
The IRB Chair may request that additional fact-finding be conducted by ORRP staff based upon the results of the initial inquiry and the nature the potential noncompliance.

The IRB Chair may also request that an Investigative Subcommittee of the IRB be formed to further investigate allegations or reports of noncompliance. The Chair or Vice-Chair of the IRB responsible for reviewing the research will chair the investigation, and the Chairs or ViceChairs or designees (member or alternate) of the other two Ohio State IRBs will comprise the Subcommittee. The Subcommittee will be facilitated by ORRP staff and advised by university counsel as necessary. Any individual with a potential conflict of interest may not participate in the investigation. At least one IRB member should possess expertise appropriate for review of the potential noncompliance; additional IRB members or external consultants may also be included as determined necessary by the subcommittee Chair. The Investigative Subcommittee will meet as necessary to ensure timely review of pending allegation.

 

The investigator(s) will be informed in writing of the allegation and further investigation. A written response will be requested, depending on the nature of the potential noncompliance, to facilitate review and conclusion of the investigation. The PI, research staff, or others may be interviewed and/or an audit of the investigator(s)’ research may be conducted during the investigation, as necessary.

The Investigative Subcommittee will consider materials and recommendations from the initial inquiry, the investigator(s)’ response, and other information relevant to the investigation (e.g., interviews, audit reports, literature searches, etc.). A summary report that includes the allegation, information considered by the Investigative Subcommittee, and its conclusions and recommendations will be prepared.

Possible outcomes of the investigation as determined by the Chair, Vice-Chair, or IRB Investigative Subcommittee include:

  • Dismissal of the allegation (i.e., unsubstantiated);
  • Referral to other appropriate university process (e.g., misconduct review);
  • No further action required (i.e., for minor violations);
  • Corrective action(s) required (i.e., minor violations);
  • Review by convened IRB required (i.e., noncompliance is considered to be serious and/or continuing).

When the Investigative Subcommittee believes that serious and/or continuing noncompliance has occurred, the subcommittee’s summary report will be forwarded to the investigator(s) and the IRB responsible for reviewing the research. The PI and coinvestigator(s), as applicable, will be given an opportunity to respond to the subcommittee’s findings in writing. The investigator(s) may also respond in person to the IRB at the convened meeting during which the noncompliance review will take place, to be scheduled following the receipt of the investigator(s)’ response. A personal advisor or legal counsel may accompany the investigator(s), but the advisor or legal counsel may not participate in the discussion.

When review by the convened IRB is not warranted (e.g., dismissal of the allegation or minor violations), the investigator(s) will be notified in writing of the results of the investigation and required corrective actions, as applicable. The Institutional Official, investigator(s)’ Dean, Department Chair (or equivalent), and/or research collaborators may also be informed, at the discretion of the Chair of the Investigative Subcommittee. Notification will be sent to the person(s) originating the report of noncompliance, as applicable. In some cases, the convened IRB may be asked to recommend corrective actions. Suspended IRB approval may be reinstated, as appropriate, based on the determinations of the Investigative Subcommittee and the response of the investigator(s). Reinstatement of IRB approval(s) will be reported by
ORRP staff to those previously informed of the suspension (i.e., Institutional Official, OHRP, any other sponsoring federal department or agency, etc.) and others (e.g., Office of Sponsored Programs), as necessary.

Investigations will be completed promptly; however, the timing is dependent on the nature of the potential noncompliance and the complexity of the investigation.

CONVENED IRB REVIEW
At a convened meeting, the IRB responsible for reviewing the research will review allegations or findings of noncompliance following initial inquiry or further investigation. The IRB will consider the information from the initial inquiry, further investigations, summary report from the Investigative Subcommittee (if any), the investigator(s)’ response (if any), and any other relevant materials (e.g., research protocol, consent form, etc.) to assess the seriousness of the potential noncompliance and to consider possible corrective action(s). The primary reviewer will lead discussion; materials as described above will be distributed to all scheduled attendees in advance of the meeting. The IRB will make final determinations in closed session by majority vote of a quorum of the members/alternates at the convened meeting.

The investigator(s) will be notified in writing of the final decision of the IRB. Notification will also be sent to the person(s) originating the report of noncompliance, as applicable. If not previously reported, any suspension or termination of IRB approval or noncompliance that is determined to be serious or continuing will be reported by Institute Officials’ staff (see below).

CORRECTIVE ACTIONS
Corrective action(s) will be based on the nature of the noncompliance, degree to which research participants were placed at risk, occurrence of previous noncompliance, etc. The range of possible corrective actions that the Chair, Vice-Chair, IRB Investigative Subcommittee, or IRB may consider includes, but is not limited to the following:

  • Modification(s) of the research protocol or procedures;
  • Modification(s) of the consent process or consent form;
  • Providing additional information to current research participants (required when such information may relate to their willingness to continue in the research);
  • Providing additional information to past research participants;
  • Reconfirming consent of current research participants;
  • Requiring additional follow-up/monitoring for current and/or past research participants;
  • Monitoring of the research (including audits) or consent process;
  • Education or mentoring for the principal investigator and/or research staff;
  • Additional reporting, including modifications of the continuing review schedule;
  • Requiring additional resources to support the investigator’s research activities;
  • Placing limitations (e.g., restriction to co-investigator status) on the investigator’s research activities or use of research data;
  • Suspension of IRB approval for one or more of the investigator(s)’ studies;
  • Termination of IRB approval for one or more of the investigator(s)’ studies.

The Chair or Vice-Chair of the IRB responsible for reviewing the research, Investigative Subcommittee, or convened IRB may review the investigator(s)’ response to corrective actions. If the PI and co investigator(s), as applicable, do not comply with the required corrective action(s) within the time specified in the corrective action plan, additional action may be required, including suspension or termination of IRB approval(s) for ongoing human participants research activities. The investigator(s) will be notified of resolution of corrective actions or the need for additional action(s).

INVESTIGATOR APPEALS
As required by regulations, any decision of the IRB with respect to research involving human participants is final. However, the convened IRB may review an investigator’s request for reconsideration or appeal to a determination regarding noncompliance and/or corrective actions as warranted by the presentation of new information or unusual circumstances. All investigator petitions must be made within 30 days of his/her notification of the IRB’s findings. The IRB will review an investigator’s request or appeal within 30 days, and the investigator will be notified in writing of the IRB’s decision within 14 days of the review.

REPORTING
Noncompliance determined to be serious and/or continuing or any suspension or termination of IRB approval will be promptly reported to the investigator(s), IRB, Institutional Official, investigator(s)’ Dean and Department Chair (or equivalent), and research collaborators and to OHRP, FDA (as applicable for FDA-regulated research), Sponsored Programs) as necessary, in accordance with the Principal Investigator’s organizational Federalwide Assurance.

RECORD RETENTION
Records relating to review and investigation of noncompliance will be retained by the Institutional official for a minimum of three years after completion of the research or any corrective actions (whichever is longer), in keeping federal regulation, applicable state and local law policy.

APPLICABLE REGULATIONS/GUIDANCE
21 CFR 50.25(b)(5), 21 CFR 56.108(b)(2), 21 CFR 56.112, 21 CFR 56.113, 21 CFR 56.115(b), 45 CFR 46.103(b)(5)(i), 45 CFR 46.111(b)(5), 45 CFR 46.112, 45 CFR 46.113, 45 CFR 46.115(b), “Guidance on Reporting Incidents to OHRP” (06/20/11).

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