407: Suspension and termination
The purpose of this policy is to establish procedures for documenting the requirements for suspension or termination of IRB-approved research projects.
The institutional official (IO) shall have the authority to suspend or terminate approval of research that is not conducted in accordance with IRB requirements, federal, state, or local requirements, or has been associated with unexpected serious harm to subjects. A project may be suspended or terminated for the following reasons, including, but not limited to:
- Serious and continuing non-compliance with federal regulations and IRB policy
- Repeated failure to submit a continuation form in sufficient time to allow for an appropriate review to be conducted
- Repeated failure to obtain appropriate informed consent
- Change in the risk-to-benefit ratio of the research
- New information regarding the increased risk to the subject
Suspension: An action issued by the IO that all or some of the research activities must stop until issues have been satisfactorily resolved. Suspended projects still have IRB approval.
Termination: An action issued by the IO that all or some of the research must stop permanently except for the continuation of follow-up activities necessary to protect the subjects’ safety.
3. Specific policies
3.1 Procedures for suspension and termination
The IO may act alone to suspend or terminate previously approved human research or an investigator’s privilege to conduct human subject research if the alleged serious or continuing non-compliance with the requirements or determinations of the IRB, or any incidence that has been associated with the unexpected serious harm to subjects appears to pose imminent threat to subject safety.
The IO, ORA director and IRB chair may request a consult from an independent source with expertise in the type of research being conducted or expertise in the specific area of concern.
The IO, ORA director and IRB chair will decide on a course of action and establish a time line for the completion of that action.
The IO will notify the investigator in writing of the decision by letter within five (5) working days. The letter will include:
- Reason and rationale for the suspension or termination
- If appropriate, require the investigator to submit:
- Procedure for the withdrawal of currently enrolled subjects that considers the subjects’ rights and welfare.
- Letter or script notifying all currently enrolled subjects who are affected by the suspension or termination.
- A reminder that all study activities such as reporting adverse events, revisions to investigator brochures, and updated package inserts must still be reported to the IRB.
To reinstate a project that has been suspended, the investigator must satisfactorily resolve any pending issues required by the IRB.
To reinstate a project that has been terminated, the investigator must submit the project to the IRB as a new application and past issues must be resolved to the satisfaction of the IRB.
3.2 Reporting suspension and terminations
All suspensions and terminations will be reported to the appropriate individuals and agencies per reporting requirements.
4. Applicable regulations and guidelines
6. Procedures employed to implement this policy & assignment of responsibility
|Coordinator||Document all actions and decisions made by the IO, the ORA director and the IRB chair.|
|IO, ORA director, IRB chair||Review the facts and make determination. Establish an action plan and timeline for the investigator.|
|IO||Notify the investigator within five (5) business days of IRB determination and all relevant agencies and sponsors within the timeframes required by law.|