Chapter 19 - Suspensions and Terminations
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 IRB to temporarily withdraw IRB approval for some or all activities of a currently approved research study.
IRB-Initiated termination of approval: A determination made by the IRB to permanently withdraw 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 PittPRO 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 PittPRO within 10 working days of receipt of the notice.
When a study is suspended in PittPRO, 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.
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.
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
An 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. An 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 or Institutional Official 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 IRB meeting.
The IRB Chair or 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.
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