During the conduct of human subject research, it may become necessary to suspend or terminate some or all research activities associated with an IRB approved protocol. Suspensions or terminations may be investigator/sponsor initiated or IRB initiated. In order to resume research activities, regardless of who initiated the suspension, a modification requesting re-initiation of the study must be submitted for IRB review.
Investigator/Sponsor-Initiated Termination or Suspension of a Research Protocol: A determination made by the investigator or sponsor to voluntarily suspend or terminate some or all activities of an approved protocol.
IRB-Initiated suspension of approval: A determination made by the University IRB to temporarily withdraw University IRB approval for some or all activities of a currently approved research study.
IRB-Initiated termination of approval: A determination made by the University IRB to permanently withdraw University IRB approval for some or all activities of a currently approved research study.
Investigator/Sponsor-Initiated Termination or Suspension of a Research Protocol
An investigator may choose to voluntarily suspend or terminate some or all activities of an approved protocol. This should be reported to the IRB and is not considered to be a reportable event unless the IRB independently determines that suspension or termination has occurred because there was an unanticipated problem involving risks to subjects or others or there was an incident of serious or continuing non-compliance.
If a research project is being terminated or suspended by the principal investigator and/or the sponsor based on a change in the risk-to-benefit ratio of study participation, a report should be submitted through OSIRIS within 1 working day of the receipt of the notice.
If the reason for the termination or suspension is for administrative reasons, a report should be submitted through OSIRIS within 10 working days of receipt of the notice. The termination report in OSIRIS requests information including:
- the primary reason for the termination;
- the number of subjects enrolled to date;
- the plan for notifying currently enrolled subjects, if necessary;
- the procedures that will be undertaken to ensure the orderly and safe withdrawal of currently enrolled subjects, if necessary;
- whether there were any unanticipated problems involving risks to subjects or others that were not previously reported;
- whether subjects will be notified of the study results;
- whether the study had been monitored/reviewed/audited by an outside monitor, sponsor, or agency;
- whether the report has been sent to other agencies.
The suspension report in OSIRIS requests information including:
- the primary reason for the suspension;
- the type of suspension (intervention only; all research activities)the number of subjects currently enrolled in the study;
- the procedure that will be undertaken to ensure the safe withdrawal of currently enrolled research subjects, if necessary;
- whether permission is being requested to continue research activities during the suspension period for the safety of currently enrolled subjects;
- whether subjects will be notified of the study suspension;
- whether the report has been sent to other agencies;
- a description of what must occur in order for a request for re-initiation of study activities can be submitted.
When a study is suspended in OSIRIS, all listed investigators and research personnel are notified through the system. In addition, the informed consent documents are no longer displayed on the project page. This is to ensure that new subjects are not enrolled into the study during the suspension.
Investigators who have protocols approved in paper format should follow the format noted above and e-mail the information to firstname.lastname@example.org. All reports of termination/suspension are reviewed by a member of HRPO Regulatory Affairs Division. The IRB Chair is responsible for the final disposition of study suspensions/terminations.
For research protocols suspended due to unanticipated problems, including serious adverse events, IRB approval is required to re-initiate the research study. A modification should be submitted in order to request re-initiation. The information submitted should include:
- the outcome of investigations on the causality of the unanticipated problem;
- the frequency of occurrence of the unanticipated problem at the University or UPMC sites or external sites, if applicable;
- changes to the protocol and/or informed consent document.
Human subjects currently participating in a research study may need to be notified of its termination or suspension. Upon review of the suspension or termination report, the IRB will make a determination about whether this is required as well as the best mechanism for the research team to utilize to make the notification.
IRB-Initiated Termination or Suspension of a Research Protocol
The University of Pittsburgh IRB may suspend or terminate some or all research activities on a protocol if events are identified that represent serious or continuing noncompliance or unanticipated problems involving risk to subjects or others. The University of Pittsburgh IRB may also suspend some or all of the research conducted by a principal investigator as a result of serious or continuing noncompliance with the research or if there are unanticipated problems involving risk to subjects or others. This action is most often determined by a convened board. See Chapter 12 for additional information.
However, the IRB Chair has the authority to suspend some or all research activities if exceptional human subject safety issues are identified. This authority is only exercised if an action is required prior to a convened meeting and it is not feasible to assemble an emergency meeting. When this authority if exercised, it will be reported at the next convened University of Pittsburgh IRB meeting.
For studies in OSIRIS, the IRB Chair or his designee will suspend or terminate the study within the system. Correspondence is sent to the Principal Investigator as well as to all listed co-investigators and research staff. The study moves to a “suspended” or “terminated” state and the consent documents are no longer accessible. For paper studies, reports surrounding study termination or suspension will be drafted by the IRB staff and approved by the IRB Chair or Vice Chair.
The IRB Chair or Vice Chair will ensure the report is distributed to all applicable parties. All applicable local, state, and federal regulations that pertain to reporting of suspensions and terminations will be followed. Please see Chapter 18 IRB Reporting.
- 21 CFR 56.113
- 45 CFR 46.113