CHAPTER 11

11.0 Reasons for Suspension or Deactivation

Common reasons for suspending or terminating a research protocol or research activities include, but are not limited to, instances when the research:

• Led to or is associated with an unexpected, serious increase in risks of harm to subjects.
• Associated with subject injuries.
• Not being conducted in accordance with IRB requirements (researcher non-compliance).
• The IRB may suspend or terminate research based on information received during its continuing review, from the findings of the Quality Improvement visit, or from complaints made to the IRB.
• Whenever a suspension or termination is enacted, the following must be taken into consideration:
  • Actions that may be necessary to protect the rights and welfare of currently enrolled participants.
  • Whether procedures for withdrawal of enrolled participants consider their rights and welfare (e.g., arranging for medical care outside of a research study, transferring to another researcher, and continuation in the research under independent monitoring).
  • Whether there is a need to inform current participants of the termination or suspension.
  • The need to report any adverse events or outcomes to the IRB.

11.1.1 Principal Investigator

As the “front line” in subject protections, a principal investigator (PI) should always be aware of subject safety issues and should suspend research activities on a study to remove immediate hazards to subjects. If it is apparent that hazards cannot be eliminated by modification of various aspects of the study (e.g., the study design or inclusion/exclusion criteria) the study should be terminated. PIs must notify the IRB in writing immediately after suspending research activities or terminating a study. The notification should contain information on the facts leading to the decision for the action, a plan for notifying and safely withdrawing current subjects, if applicable, that considers whether the plan takes the subjects rights and welfare into account and, if applicable, a plan for notifying former subjects of the suspension/termination and any follow-up that may be required to assure their ongoing safety. The IRB will review reports of suspensions or terminations, determine what, if any further actions are required on the part of the PI, and report the suspension/termination to the IO and pertinent parties.

11.1.2 IRB Chair

The IRB Chair (and the Vice Chair if so delegated) can suspend or terminate IRB approval of a study, prior to discussion by the IRB, to remove immediate hazards to subjects or in the event there is sufficient evidence of non-compliance by the research team and that the non-compliance results in increased risk for subjects. The IRB Chair must consider protection of the rights and welfare of currently enrolled subjects (e.g., arrangements for medical or other care of subjects).

The PI will be notified of the decision immediately and be required to submit a response to the IRB Chair’s concerns. At a full board meeting of the IRB, the IRB Chair will report the suspension/termination, discuss the reasons for the decision, review the PI’s response to the suspension/termination and lead an IRB discussion of the action, response, and possible further required actions.

Possible further actions imposed by the IRB may include requiring the PI to submit a plan for notifying and safely withdrawing current subjects, a plan for notifying former subjects of the suspension/termination and any follow-up that may be required to assure their ongoing safety, if applicable, and a requirement that all adverse events or outcomes resulting from the research or the suspension/termination are reported to the IRB. A report of the suspension/termination will be submitted to the Institutional Official (IO) and others as described in Chapter 15 of this manual.

11.1.3 IRB

The IRB, at a full board meeting, may suspend research activities or terminate because of the following:

• Reports of unanticipated problems involving risks to subjects and others (including adverse events).
• Other reports that relate to participant safety in a particular protocol.
• Reports of serious or ongoing non-compliance by the PI and/or research team.

The PI will be notified of the decision immediately and be required to submit a response to the IRB’s concerns. At a subsequent full board meeting of the IRB, the IRB will review the PI’s response to the suspension/termination, discuss the response and possible further actions required to lift the suspension or rescind the decision to terminate the research.

Possible further actions imposed by the IRB might include requiring the PI to submit a plan for notifying and safely withdrawing current subjects and a plan for notifying former subjects of the suspension/termination and any follow-up that may be required to assure their ongoing safety, if applicable, and a requirement that all adverse events or outcomes resulting from the research or the suspension/termination are reported to the IRB. A report of the suspension/termination will be submitted to the IO and others as described.

11.1.4 Other

The IO may suspend a research activity or study should the need arise. Such suspension must be promptly reported to the IRB Chair and to the members convened at the next IRB meeting.

11.2 Notification of Suspension or Deactivation

In the event of a suspension or termination of approval, the IRB or person directing the suspension or termination will inform the investigator in writing. If immediate action is required, the person imposing the suspension or termination may give the directive verbally to the PI and the letter will follow. If the IRB did not suspend or terminate the research, members will be notified at the next full board meeting.

Letters to the PI will be sent within five working days of the effective date of suspension or termination. Such letters will include:

• The effective date of suspension or termination.
• If notification was initially done verbally the letter will reference the date of verbal notification.
• The reason for the suspension or termination.
• Identification of the research activity, in whole or in part, that must stop or suspension.
• Any corrective action or clarification that must occur.
• If the reason for suspension may bear on the participant’s decision to continue participation, a directive that currently enrolled participants will be informed of the suspension.
• For terminations, a directive that all currently enrolled participants will be informed of the termination.
• If applicable, provide a directive of how to deal with any currently enrolled participants.
• A direction to the PI regarding whom to submit responses.

11.3 Lifting a Suspension or Deactivation

Only the IRB can lift a suspension using a full board review. If the IO imposed the suspension, that person is responsible for notifying the IRB Chair in writing when they are satisfied that all concerns that led the suspension, have been satisfied and recommend lifting the suspension.

That person must attach a copy of the responses from the PI to the letter to the IRB.

The lifting of a suspension will be reviewed at the next convened IRB meeting.

The IRB will send written notification to the PI when the suspension is lifted. The letter will be prepared by the IRB staff, reviewed by the Chair, and sent out by the staff. The IRB staff will also send a copy of the letter lifting the suspension to all entities who received a copy of the notification of suspension.

Research that is terminated cannot be lifted or reinstated. The PI must submit a new project after all non-compliance issues are addressed and remedied.