1. Purpose
This SOP describes the WVU IRB authority and process to suspend or terminate approval of research that is not being conducted in accordance with WVU IRB and/or institutional policy, is not in compliance with Federal Regulations, or that has been associated with unexpected serious harm to participants. Suspensions and terminations will be reported to HHS OHRP, the FDA, and appropriate institutional officials when applicable as listed in SOP 034: Reporting to External Agencies.
A PI may also place a voluntary administrative hold on previously approved research when in the judgment of the PI, an administrative hold is appropriate to protect the rights or welfare of participants.
In this policy, an IRB designee refers to the following: The IRB Chair, IRB Vice Chair, WVU OHRP Director, Institutional Official, or a person designated in writing to assume the role of one of these persons temporarily.
2. Procedures for Administrative Holds
2.1. A PI, institutional official, or sponsor may place a research project on administrative hold. Some or all research activities may be placed on hold until additional information can be obtained to determine if a change in the risk/benefit assessment of the research has occurred or if potential areas of non-compliance exist in a currently approved research protocol.
2.2. In consultation with the PI, institutional official, or sponsor, the IRB or IRB designee determines whether any additional procedures need to be followed to protect the rights and welfare of current participants.
2.3. In consultation with the PI, the IRB or IRB designee determines how and when currently enrolled participants will be notified of the administrative hold.
2.4. The appropriate party must:
- Notify the IRB in writing (email is sufficient) that the PI, institutional official, or sponsor is voluntarily placing the research on administrative hold.
- Provide a description of the research activities that will be stopped. Research activities may include but are not limited to recruitment, screening/enrollment, research intervention/interaction, follow-up, or all research activities.
- Provide a list of all currently enrolled participants’ status within the study and the proposed actions to be taken (if needed) to protect the rights and welfare of current participants during the administrative hold action.
- Provide a written description of actions that will be taken before IRB approval of proposed changes to eliminate apparent immediate harm
2.5. After written notification from the appropriate party has been received, WVU OHRP staff is notified by the IRB Chair or designee of the research project on administrative hold and the required actions.
2.6. WVU OHRP staff initiate an inquiry process and consider if the additional information gathered during the inquiry stage of an investigation determines that no change to the risk/benefit ratio has occurred, the rights or welfare of participants have not been compromised, and issues of non- compliance have been ruled out. The inquiry may necessitate a for-cause audit according to SOP 041: WVU OHRP’s Quality Improvement Program, to obtain needed information.
2.7. WVU OHRP staff write a report of the findings. The IRB Chair or designee notifies the PI and other appropriate parties in writing of these findings and the required corrective actions, if any, and allows the research to return to active status. Determinations of unanticipated problems involving risks to participants or others, or non-compliance that are a result of these findings will be reported according to SOP 031: Research Related Event Reporting and SOP 049: Non-Compliance and Research Misconduct.
3. Procedures for Suspension or Termination of IRB Approved Research by the Convened IRB or IRB Designee for Cause
3.1. If the research is not being conducted in accordance with the policies, requirements, and determinations of the IRB, or federal rules or regulations, or has been associated with unexpected serious harm to participants, the convened IRB or designee (i.e., IRB Chair) may suspend or terminate some or all research activity to protect the rights or welfare of participants.
3.2. The IRB designee considers whether any actions need to be implemented to protect the rights and welfare of current participants and orders any actions that need to be taken during the investigation process.
3.3. The IRB designee notifies WVU OHRP staff of the suspension and actions ordered.
3.4. The IRB Chair or designee notifies the PI of the suspension in writing that there are reasonable concerns, that infractions have occurred and that an investigation has been initiated. This letter is drafted according to the procedures for communication of terminations and suspensions provided below.
3.5. WVU OHRP staff initiate an investigation process and consider if the additional information gathered during the inquiry stage of an investigation determines that no change to the risk/benefit ratio has occurred, the rights or welfare of participants have not been compromised, and issues of non-compliance have been ruled out. The investigation may necessitate a for-cause audit according to SOP 041: WVU OHRP’s Quality Improvement Program to obtain needed information.
3.6. WVU OHRP staff create a written report detailing the findings of the investigation as well as appropriate corrective actions to address problems or deficiencies. The written report is sent to the convened IRB, IRB Chair, OHRP Director, and other institutional officials and other units within the university or the covered entity as appropriate.
3.7. The convened IRB considers the written report and whether any required actions need to be implemented to protect the rights and welfare of current participants. The convened IRB votes on the actions to be taken. Possible actions the convened IRB may consider include, but are not limited to:
- Continuing the interventions that are currently being administered to enrolled participants under the research protocol, at least temporarily, when the interventions could be of direct benefit to the participants or when withholding the interventions poses increased risk to the participants.
- Transferring currently enrolled participants to another institution engaged in the research so that participation of the participants may continue.
- Transitioning currently enrolled participants to medical management outside of the research context.
Note: Determinations of unanticipated problems involving risks to participants or others, or non- compliance that are a result of the findings, will be made according to SOP 031: Research Related Event Reporting and SOP 049: Non-Compliance and Research Misconduct.
3.8. The convened IRB votes to lift the suspension, continue or modify the suspension, or terminate the research.
3.9. WVU OHRP staff document in the IRB minutes the reasons for the suspension or termination, and if applicable, any required actions.
3.10. WVU OHRP staff communicate with the PI following Procedures for Communications of Terminations and Suspensions below.
4. Procedures for Communication of Terminations and Suspension of Investigators
4.1. WVU OHRP staff will draft a letter to the PI. The IRB Chair reviews and signs the letter (electronic signature is acceptable). Copies are to be provided to the Institutional Official, WVU OHRP Director, IRB members, and the immediate supervisor or department chair of the PI. The letter should include:
- The activities to be stopped;
- The required actions to be taken by the PI;
- An explanation of the reasons for the decision; and
- A request to immediately notify the IRB chair with a list of names of participants who might be harmed by stopping research and a rationale as to why they might be harmed.
4.2. The PI may appeal or respond to the convened IRB in writing.
4.3. WVU OHRP staff will follow SOP 034: Reporting to External Agencies on reporting the suspension or termination of approved research by the IRB to appropriate organizational officials, sponsors, coordinating centers, and regulatory agencies.
5. References
WVU Policies:
SOP 031: Research Related Event Reporting
SOP 034: Reporting to External Agencies
SOP 041: WVU OHRP’s Quality Improvement Program
SOP 049: Non-Compliance and Research Misconduct
Federal Regulations:
45 CFR 46.113
21 CFR 56.113
AAHRPP:
Element I.5.D.
Element II.2.H.