SOP #31 Suspension or Termination of IRB Approval and Report Form

Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 31
Effective Date: 10/08/2021

Policy

Under 21 CFR 56.113 and 45 CFR 46.113, an IRB shall have 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 subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB`s action and shall be reported promptly to the investigator, appropriate institutional officials, and the Food and Drug Administration.  Any suspension or termination of IRB approval of research for cause, including a statement of the reason for the IRB's action, shall be reported promptly to the investigator, appropriate institutional officials and for federally-funded research, also to the Office for Human Research Protection (OHRP) and other federal agencies as appropriate.

Purpose

To describe the conditions under which approval of previously approved research may be suspended or terminated, and the procedures to be followed for suspending or terminating research.

Definitions

Administrative Hold: A voluntary action taken by an investigator to temporarily or permanently stop some or all approved research activities. The administrative hold may be either initiated by the principal investigator or it may be in response to a request by the convened IRB or IRB designee to take such action. Administrative holds are not suspensions or terminations.

Institutional Officials: The individuals identified on the Federalwide Assurance with OHRP (the President and the Vice President of Academic Affairs at the College of St. Scholastica) as authorized leaders of the CSS IRB.

Suspension: An action taken by the IRB Chair or designated representative, or the Institutional Official to temporarily or permanently withdraw approval for some research activities, or temporarily withdraw approval of all research activities.

Termination: An action taken by the convened IRB to permanently withdraw approval of all research related activities, including the enrollment of new participants (except for follow-up activities necessary for the protection of the health and welfare of participants).

Investigator Responsibilities The investigator will:

  1. Cease research activities as specified in the IRB suspension notification until notified that the IRB has granted approval for resumption of the research activities, or in the case of termination, cease all research activities.
  2. Notify subjects of the suspension or termination as directed by the IRB.
  3. Report to the IRB any adverse event or unanticipated problems involving risk to subjects or others that occur while the research activities are suspended.
  4. Comply with all corrective action(s) as directed by the IRB.
  5. Consider actions to protect the rights and welfare of study subjects; for example, arranging for medical care outside of the study or transferring subjects to another study. IRB Responsibilities

The IRB will:

  1. Review any suspension or termination initiated by the sponsor or other outside entity.
  2. Notify the investigator that research activities have been suspended or terminated and provide the rationale for their action.
  3. Direct the investigator to undertake corrective action as appropriate. See, IRB SOP # 30, Non -compliance with Human Subjects Research Policies, for a list of possible actions.
  4. Direct the investigator to notify subjects of the suspension or termination as appropriate.
  5. Review reports of unanticipated problems involving risks to subjects or others during the time in which research is suspended for cause. (See, CSS IRB SOP # 24 Unanticipated Problems and Adverse Event Reporting.)
  6. Report any suspension for cause or termination for cause to the Institutional Official and for federally-funded research, also to regulatory agencies as appropriate.
  7. Consider actions to protect the rights and welfare of study subjects; for example, arranging for medical care outside of the study or transferring subjects to another study.

Procedure

        A.   IRB Suspension or Termination of Research

1. The convened IRB may suspend or terminate IRB approval of previously approved research as the result of the following:

  • Serious or continuing non-compliance (See, CSS IRB SOP #30 Non-compliance with Human Subjects Research Policies);
  • Reports that the research intervention or monitoring procedures present undue risk of harm to participants;
  • Reports of serious issues with study conduct discovered during the review of the research;
  • Notification of an unmanageable financial Conflict of Interest related to the research (See, CSS IRB SOP #36 Conflict of Interest (COI) and COI Disclosure for IRB Members);
  • Disqualification of the Principal Investigator by OHRP, the FDA, the study sponsor, the CSS Institutional Official or other groups involved in oversight of human subjects research activities.

        B.     Suspension of IRB Approval

  1. The convened IRB determines the reasons for suspending the research, any information needed from the PI, and/or corrective actions or events that need to take place for the IRB to consider withdrawing the suspension.  A decision to suspend, and all required actions is made by a quorum vote of the convened Board. The IRB determines which Institutional Officials and external agencies to notify.
  2. In the case of temporary suspension, the IRB Chair notifies the PI in writing of the suspension and the reason. The IRB Administrator places the item on the Agenda for the next convened meeting and distributes a copy of the current consent document, protocol (or description of the study) and supporting information relevant to the suspension. The convened IRB discusses the suspension, and votes to continue, reverse or modify the suspension.
  3. If the suspension includes the withdrawal of subjects from a research protocol, the IRB requires the PI to identify alternatives that protect subjects from harm that might be incurred from withdrawal.
  4. Notification of suspension includes:
    • Explanation of the extent of the suspension in terms of enrollment, recruitment, interventions, interactions, and data analysis;
    • Explanation of the reasons for the suspension;
    • Offer for the PI to respond to the convened IRB in writing
    • IRB action plan and established timeline for reporting progress to the IRB;
    • A request for a description of any procedures for the withdrawal of currently enrolled subjects that considers their rights and welfare;
    • A description of whether follow-up of subjects for safety reasons is permitted or required.
  5. The PI notifies enrolled subjects of any suspended research protocol and considers appropriate procedures for withdrawal of enrolled subjects that considers their rights and welfare.

        C.   Termination of IRB Approval

  1. The convened IRB determines the reasons for terminating the research, any information needed from the PI, and/or corrections actions or events that need to take place for the IRB to re-consider the termination. The IRB also determines which institutional official to notify and whether an external agency must be notified.
  2. If the termination includes the withdrawal of subjects from a research protocol, the IRB considers alternatives that protect subjects from harm that might be incurred from withdrawal. These considerations include but are not limited to:
    • Transfer of subjects to another investigator;
    • Permit certain research activities to continue under the supervision of an independent monitor;
    • Require or permit follow-up of participants for safety reasons;
    • Notification of current and former participants;
    • Require reports of adverse events or outcomes to the IRB and the sponsor.
  3. The IRB Administrator notifies the PI in writing of the termination. The notification includes:
    • Explanation of the extent of the termination in terms of enrollment, recruitment, interventions, interactions, and data analysis;
    • Explanation of the reasons for the termination;
    • Explanation that any request for the IRB to reconsider termination must be made in writing within 30 days of notification;
    • IRB action plan and established timeline for reporting progress to the IRB;
    • A request for a description of any procedures for the withdrawal of currently enrolled subjects that considers their rights and welfare;
    • A description of whether follow-up of subjects for safety reasons is permitted or required.

4.    The PI notifies enrolled subjects of any terminated research protocol and considers appropriate procedures for withdrawal of enrolled subjects that considers their rights and welfare.

Reporting Requirements

When the CSS IRB suspends or terminates IRB approval for a research study involving human subjects, the IRB Chair or designee shall be responsible for reporting to the Institutional Official. The Institutional Official or designee will report suspensions and termination to the appropriate groups (e.g. FDA, OHRP) following the procedures in this SOP.  For questions on reporting, please contact the OHRP Director of the Division of Compliance Oversight, 240-453-6900 or 866- 447-4777.

Resources

45 CFR 46.108

45 CFR 46.113

21 CFR 56.108

21 CFR 56.113

MAYO CLINIC

https://www.mayo.edu/research/documents/25-suspension-term-of-irb-approval-of-researchpdf/doc-1 0026696 ST JOSEPH HEALTH

https://www.stjhs.org/documents/Clinical-Research/Suspension-and-Termination-of-Research.pdf Michigan State University https://hrpp.msu.edu/help/manual/9-3.html Fred Hutch IRB

https://extranet.fredhutch.org/en/u/irb/policies-and-procedures/_jcr_content/leftParsys/download_35/ file.res/Suspensions-Terminations.pdf

SUNY Poly https://sunypoly.edu/sites/default/files/irb/Termination_or_Suspension_of_Research_12.pdf

Children’s Hospital of Philadelphia https://irb.research.chop.edu/sites/default/files/documents/irbsop410_suspensions_3_19_18.pdf

OHRP Suspension or Termination of IRB Approval of Research or Disapproval of Research at the Time of Continuing Review

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-continuing-review-2010/index .html#section-j

The Illinois Office for the Protection of Research Subjects

 

Appendix A - OHRP Reporting Guidance

  • Did the incident occur in non-exempt human subjects research, and is it; an unanticipated problem, or serious or continuing noncompliance, or suspension or termination of IRB approval? If no, then No need to submit an incident report to OHRP.* If yes, then:
  • Did the incident occur in research that is HHS supported or conducted? If yes, then report the incident to OHRP. If no, then:
  • Is the research conducted or supported by a Federal Agency that has adopted the Common Rule?
    • If yes; Has the Federal Agency approved a separate assurance other than the FWA for the research? If no, then report the incident to OHRP
    • If no, go to next step
  • Is the research conducted at an institution with an OHRP approved assurance? If no, then no need to submit an incident report to OHRP.* If yes:
  • Does the assurance apply to all research regardless of funding? If no, then no need to submit an incident report to OHRP.* If yes, report the incident to OHRP.*

*Other reporting requirements may apply, whether or not a report to OHRP is required.

Information to be included in incident reports

To fulfill the regulatory requirements for reporting incidents, OHRP would consider it acceptable for an institution to comply with written procedures specifying that the following information be included in an incident report submitted to OHRP: C. For suspension or termination:

  • Name of the institution (e.g., university, hospital, foundation, school, etc.) conducting the research;
  • Title of the research project and/or grant proposal that was suspended or terminated;
  • Name of the principal investigator on the protocol;
  • Number of the research project assigned by the IRB that was suspended or terminated and the number of any applicable federal award(s) (grant, contract, or cooperative agreement);
  • A detailed description of the reason for the suspension or termination; and
  • The actions the institution is taking or plans to take to address the suspension or termination (e.g., investigate alleged noncompliance, educate the investigator, educate all research staff, require monitoring of the investigator or the research project, etc.)

III. Time frame for reporting incidents

The regulations at 45 CFR 46.103(a) and (b)(5) do not specify a time frame for reporting, except to say this must be done "promptly." For a more serious incident, this may mean reporting to OHRP within days. For a less serious incident, a few weeks may be sufficient. It may be appropriate to send an initial report, and indicate that a follow-up or final report will follow by the earlier of:

  • a specific date; or
  • when an investigation has been completed or a corrective action plan has been implemented.

IV. OHRP focus on corrective actions when reviewing incident reports

When reviewing a report of an unanticipated problem, OHRP assesses most closely the adequacy of the actions taken by the institution to address the problem. Likewise, when reviewing reports of non-compliance or suspension or termination of IRB approval, OHRP assesses most closely the adequacy of the corrective actions taken by the institution. In particular, OHRP assesses whether or not the corrective actions will help ensure that the incident will not happen again, with the investigator or protocol in question, with any other investigator or protocol, or with the IRB. Therefore, OHRP recommends that, when appropriate, corrective actions be applied institution wide.

V. OHRP response to incident reports

After receiving and evaluating an incident report from an institution, OHRP will respond in writing and will either state that the report was adequate or request additional information. For questions on reporting, please contact the Director of the Division of Compliance Oversight, 240-453-6900 or 866447-4777.

VI. Where to send incident reports

Please send reports (PDF or Word documents preferred) to the following email address:

IRPT.OS@hhs.gov

Content created by Office for Human Research Protections

Content last reviewed on March 19, 2016

 

Appendix B

See attachment.

 

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