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The Organization authorizes the JHM IRBs to suspend or terminate human subjects research studies at a convened meeting. The IRBs may determine that a study should be suspended or terminated due to: unanticipated problems involving risk to participants or others under Policy 103.6(b); serious or continuing non-compliance under Policy 103.7; findings presented in the continuing review process or change in research review process; or problems identified during a monitoring visit or directed audit.
The Organization authorizes the Institutional Official (IO), or an IRB Chair, to suspend or terminate a human subjects research study (or associated studies) when an event occurs and, in their judgment, taking such action cannot wait until a convened IRB meeting in order to protect the rights and welfare of participants. An action taken by the IO or an IRB chair to suspend or terminate research will be reported to the IRB at the next convened meeting.
“Suspension” of research is defined as a temporary or permanent halt to some or all research procedures until the IRB determines whether the research may recommence (with or without modifications to the research) or whether the research must be terminated. “Termination” of research means a permanent stop to the research and all research-related activities.
A decision by a Principal Investigator (PI) to voluntarily suspend or terminate some or all research activities being conducted under an IRB approved research protocol is not considered a suspension or termination of IRB approval. The JHM IRBs may prompt an investigator, by a verbal or written recommendation, to suspend or terminate some or all activities pending further review or investigation of the research by the IRB or an Institutional entity.
Suspension or termination of approval shall be documented in a written notice to the PI. The notice of suspension or termination of IRB approved research must include a statement of the reasons for the action. The communication to the PI will include an opportunity for the PI to respond to the decision within 10 calendar days. The communication will ask the PI to provide a plan for ensuring that the rights and welfare of all currently enrolled or previously enrolled (if appropriate) participants are protected.
The IRB will determine and inform the PI of steps to be taken as a result of suspension or termination of the research. Steps could include:
- Notification of currently enrolled participants that the study has been terminated by the IRB. In this case, communication to participants will explain the rationale for the action taken;
- Withdrawal of participants, considering the rights and welfare of those individuals before such a step is taken;
- Informing the participants of any follow-up procedures permitted or required by the IRB for participant safety; or
- Submission of reports to the IRB and the sponsor of any adverse events or outcomes that occurred during period when suspension or termination occurred.
The IRB must report in writing the suspension or termination to the IO. Reports to the IO must be sent within 30 business days of the IRB’s determination to suspend or terminate, or sooner in cases where the rights and welfare of enrolled participants requires immediate attention by the IO and the Organization.
In addition to the FDA and DHHS reporting requirements, the Department of Defense (DoD) has specific requirements for serious or continuing non-compliance. After all appeal options have been exhausted by the Principal Investigator, if the research is supported by or conducted in conjunction with the DoD, then the IO must report the serious or continuing non-compliance to the Director, Defense Research and Engineering (DoD Directive 3216.02, April 24, 2007).
If the research study was reviewed by the IRB under ICH-GCP guidance (E6), the PI must promptly notify the sponsor and provide the sponsor with the IRB suspension or termination notification (see, 4.12.3 at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073122.pdf).