MSU HRPP Manual Section 9-3

9-3, Termination or Suspension of IRB Approval

“An IRB shall have 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 Department or Agency head [Food and Drug Administration].” 45 CFR 46.113, 21 CFR 56.113 [FDA]

Authority
Michigan State University has given the authority and responsibility to its Institutional Review Boards (IRB) to suspend or terminate IRB approval of non-exempt research studies in order to protect human subjects, uphold ethical principles, protect the research integrity of the institution, and comply with university policy and state and federal laws and regulations. Suspension or termination may be in response to a noncompliance investigation or an unanticipated problem involving risks to subjects or others. The IRB chair or vice chair has the authority and responsibility to temporarily suspend IRB approval in urgent situations.

Definitions
Termination means that the IRB approval is terminated permanently and the research activities cannot recommence at a later date.

Suspension means that the IRB approval is suspended in whole (all research activities must stop) or in part (e.g. enrollment must stop, certain components of the research must stop), but allows for potential recommencement of the research study.

Suspensions on an Urgent Basis
The IRB chair or vice-chair may, on an urgent basis, suspend IRB approval for research studies. The IRB chair or vice-chair will consider the criteria used by the IRB, provided below, in making the determination to suspend IRB approval of research. The IRB chair or vice-chair may reach this decision after consultation from others (e.g., members of the IRB). The suspension will be reported to the IRB to inform the members of the action and will subsequently be reviewed by the convened IRB to determine if the suspension should continue or be lifted. The IRB chair or vice chair may call an emergency IRB meeting when needed.

Suspension or Termination
Except for suspensions that are made on an urgent basis, the convened IRB makes determinations to suspend or terminate IRB approval. If an IRB member recommends suspension or termination of IRB approval during expedited review or during a primary review of a full board project, the IRB staff will notify the IRB chair. The IRB chair or vice chair will determine if a suspension is needed on an urgent basis. If there is not an urgent basis, the recommendation to suspend or terminate is brought to the convened IRB for a determination. The decision to terminate IRB approval may only be made by the convened IRB.

In determining whether to suspend or terminate IRB approval, the IRB may consider, but is not limited to:

  •  The effect the suspension or termination will have on the subjects’ rights and welfare

  • Whether the suspension or termination is in the best interests of the subjects

If the research is suspended or terminated, the IRB may consider, but is not limited to:

  • The necessity of subject follow-up for safety reasons

  • Notification of current subjects

  • Procedures for withdrawal of enrolled subjects, taking into account rights and welfare (e.g., making arrangements for medical care  outside of the research study, transfer to another investigator, continuation of research under independent monitoring)

  • Reporting requirements to subjects (e.g., unanticipated problems)

  • Reporting requirements to IRB such as adverse events or outcomes

  • Other actions to protect the rights and welfare of currently enrolled subjects

  • Other actions as the IRB sees fit

Notification to Investigators and Reporting Requirements
Any suspension or termination of IRB 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 department or agency head. The IRB will ensure prompt reporting as defined in, and as required by, the policies and procedures in HRPP Manual 4-8 “Reporting Policy.”

Review by Other Officials
Research that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB, or if IRB approval has been suspended or terminated by the IRB.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 4-21-2005. Revision 1 approved by VP Research & Graduate Studies on 3-9-2008. Revision 2 approved by VP Research & Graduate Studies on 7-22-2011. Revision 3 approved by VP Research & Graduate Studies on 12-9-2015.

Related HRPP Manual Sections

Approved PDF Version

Please note that hyperlinks have been added to the web version of this document for ease of use. View approved PDF version of Section 9-3, Termination or Suspension of IRB Approval.