This document describes how UW-Madison IRBs and Officials suspend or terminate previously approved research.
UW-Madison IRBs have the authority to suspend or terminate previously approved research when the IRB determines that research:
is not being conducted in accordance with the IRB's requirements, federal regulations, state or local laws or institutional policies applicable to human subjects research
has been associated with actual or potential unexpected serious harm to participants.
The following definitions apply to this policy.
A suspension is a temporary cessation of some or all study activities by an IRB, IRB Chair, or IO.
A termination is a permanent cessation of study activities by an IRB.
A suspension or termination of previously approved research, for purpose of this policy, does not occur when:
A Principal Investigator (PI) initiates a suspension or termination of their study.
A study lapses due to an investigator's failure to file an application for continuing review in a timely manner, or
An IRB instructs an investigator to stop research that was begun without prior IRB approval.
An IRB cannot suspend an investigator's privileges to conduct human participants research. The IRB must bring any recommendation to suspend research privileges to the Institutional Official (IO).
The chair of a UW-Madison IRB or IO can suspend any research under their purview before a determination is made by the convened IRB, if he or she concludes that the study must be immediately suspended to protect participants.
If a study is suspended by an IRB Chair or the IO, he or she will promptly inform the reviewing IRB of his or her decision, so the IRB can review the decision.
When previously approved research is suspended or terminated, the following actions will be taken as appropriate regardless of who (e.g. IRB, IRB Chair, or IO) suspended or terminated the research.
PI should notify whoever is suspending or terminating the research of any adverse events that the PI believes will occur or that have occurred due to the suspension or termination of the study approval.
The IRB or IRB chair will evaluate the potential risks to current participants and prepare an appropriate plan to protect research participants. The plan may include:
Notifying current participants of suspension or termination
Notifying participant's primary physician of suspension or termination of research, as applicable
Providing continued treatment to current participants in potentially therapeutic research
If suspension or termination of research is the result of investigator noncompliance or misconduct, the IRB may require the continuation of treatment by a different investigator
Providing monitoring and/or follow-up care to current participants in therapeutic or non-therapeutic research
The IRB, IRB Chair, or IO suspending or terminating the study will promptly notify the investigator of the suspension or termination and take steps necessary to assure that the rights and welfare of research participants are protected.
The applicable IRB or IRB chair will report this suspension or termination promptly to the IO.
The IO will report the suspension or termination to other University officials and to federal departments and agencies, when appropriate, pursuant to the UW-Madison Reporting to Institutional and External Authorities Policy.
If the research was suspended by the IRB chair or IO, the convened IRB will determine whether to lift or continue the suspension and will notify the investigator and the IO promptly of its decision.
The IO will report any reversal of the suspension and the basis for that action to other UW-Madison officials and to federal departments and agencies, when appropriate, pursuant to the UW-Madison Reporting to Institutional and External Authorities Policy.
Even if the convened IRB decides to lift a suspension, IO may reimpose the suspension.