SOP 407 - Suspension or Termination of REB Approval Due to Misconduct, Non Compliance or Other Mitigating Factors

1.0 PURPOSE

This standard operating procedure (SOP) describes the procedures associated with the suspension or termination of the Research Ethics Board’s (REB) approval of research (including the suspension or termination of approval) due to misconduct, non-compliance, or other mitigating factors.

2.0 SCOPE

This SOP pertains to REBs that review human participant research in compliance with applicable regulations and guidelines.

3.0 RESPONSIBILITIES

All REB members and REB Office Personnel are responsible for ensuring that the requirements of this SOP are met.

The REB is responsible for determining whether any information received throughout the research requires the suspension or termination of REB approval for the research being considered.

The Researcher is responsible for notifying the REB and the organization of any suspension or termination of the research by the Sponsor and for providing a detailed explanation for the action.
The REB Chair or designee is not authorized to terminate REB approval. However, the REB Chair or designee is authorized to suspend REB approval, which must be reported to the REB at its next Full Board meeting. The REB is authorized to terminate REB approval following its review at a Full Board meeting.

The REB Chair or designee shall notify the Researcher and the Organizational Official(s) of any suspension or termination of REB approval of the research and has the authority to notify the regulatory authorities (as applicable) and the Sponsor. The REB may delegate regulatory authority reporting to the organization.

4.0 DEFINITIONS

See Glossary of Terms.

5.0 PROCEDURE

As a result of ongoing review activities, the REB may require that research be modified or may suspend or terminate REB approval if the risks to the research participants are determined to be unreasonably high. For example, cases in which there are high numbers of unexpected serious adverse events, or when there is evidence that the Researcher is not conducting the research in compliance with applicable regulations and guidelines. The REB also has the authority to suspend new enrollment while additional information is requested.

A decision to suspend or to terminate REB approval of the research must include consideration of the safety, rights, and well-being of the participants already enrolled in the research. Specifically, how to continue the care of enrolled participants and how and when the notification to participants of the suspension or termination of the research will take place.

The REB has the authority to suspend or terminate the its approval of the research. The REB Chair or designee has the authority to suspend ethics approval. The Full Board must review requests to lift a suspension or re-approve the research.

A Researcher may decide to suspend or terminate some or all research activities voluntarily. However, this is not considered a suspension or termination of REB approval.

5.1    Suspension or Terminations of Research by the Sponsor

5.1.1    The Sponsor of the research may suspend or terminate the research (e.g., following results of interim analyses due to inadequate drug availability, in response to a Data and Safety Monitoring Board (DSMB) recommendation, due to pre-planned stopping criteria, etc.).

5.1.2    The Researcher must immediately notify the REB of any suspension or termination of the research and the reasons for the action.

5.1.3    Reports of suspension or termination of the research by the Sponsor will be forwarded to the REB Chair or designee for review.

5.1.4    If the REB Chair or designee decides to suspend REB approval of the research, they must notify the REB at its next Full Board meeting.

5.1.5    If REB approval is suspended, a subsequent review must be conducted, and the REB suspension must be lifted before the resumption of the research following the Sponsor’s lifting of a suspension.

5.2    Suspension or Termination of REB Approval

5.2.1    Suppose any concerns are raised during the REB’s oversight of the research related to new information or the research's conduct. In that case, the REB may suspend or terminate its approval of the research as appropriate. These concerns may include:

• The research is not being conducted in accordance with the REB- approved protocol or REB requirements,
• The research is associated with unexpected serious harm to participants (i.e., as may be determined following REB review of reportable events or DSMB reports),
• Falsification of research records or data,
• Failure to comply with prior conditions imposed by the REB (i.e., under a suspension or approval with modifications),
• Repeated or deliberate failure to properly obtain or document consent from research participants,
• Repeated or deliberate failure to limit administration of the investigational drug or device to those research participants under the Researcher’s supervision,
• Repeated or deliberate failure to comply with conditions placed on the research by the REB, by the Sponsor, or by regulatory agencies,
• Repeated or deliberate failure to obtain prior REB review and approval of amendments or modifications to the research, or
• Repeated or deliberate failure to maintain accurate research records or submit required reportable event reports to the REB;
• Failure to submit a renewal in Clinical Trials Ontario (CTO) or in TRAQ will lead to termination of the study or centres.

5.2.2    The REB Chair or designee is authorized to suspend REB approval of research. If the Chair or designee suspends approval of the research, he/she must notify the REB as per applicable requirements.

5.2.3    The REB is authorized to terminate its approval of the research following a review at a Full Board meeting.

5.2.4    Before suspending or terminating REB approval, the REB must consider:

• Risks to current participants,
• Actions to protect the safety, rights and well-being of currently enrolled participants,
• The appropriate care and monitoring of research participants,
• Whether withdrawal of enrolled participants is warranted and the specific procedures for their safe withdrawal,
• Whether participants should be informed of the termination or suspension,
• Whether adverse events or outcomes should be reported to the REB,
• Identification of a time frame in which the corrective measures are to be implemented.

5.2.5    The REB Chair or designee will notify the Researcher of any suspension or termination of REB approval and the reasons for the decision.

5.2.6    Unless otherwise stated by the REB, when the REB Chair or designee suspends or terminates ethics approval of the research, no further activities can occur other than submitting an amendment or reportable events.

5.2.7    If the research is suspended or terminated, the REB Chair or designee will issue a formal letter to the Researcher with the reason(s) for the REB action and the corrective measures proposed by the REB.

5.2.8    If REB approval of a research or if the conduct of the research has been suspended, the suspension may be lifted after corrective actions are completed to the REB’s satisfaction.

5.3    Reporting Suspensions or Terminations

The REB Chair or designee will report any suspension or termination of REB approval to the appropriate Organizational Official(s) and has the authority to notify the regulatory authorities (as applicable), and the Sponsor. The REB may delegate regulatory authority reporting to the organization.
 

6.0 REFERENCES

See References.