Early Study Terminations and Suspensions

April 28, 2025

Summary: This document provides guidance and resources for researchers to consider if/when faced with an early termination or suspension of an active IRB protocol.

A premature suspension or termination of a study is when a study ends sooner than scheduled.

When research is stopped prematurely, whether due to notice of federal termination of an award or another cause, the investigators and the IRBs need to ensure that there are plans in place for appropriate monitoring and follow-up care of research participants. The Belmont Principle of Respect for Persons requires that mitigation plans be put in place when program cuts leave human research participants vulnerable. Early termination or suspension of human subjects’ protocols should prioritize the best interest and safety (i.e., the personal health and well-being) of the participants.

The International Council of Harmonization (ICH) guidelines for Good Clinical Practice (GCP) E6(R3) recommends that if a trial is prematurely terminated or suspended, the investigator/institution should inform the study participants and assure appropriate therapy and follow-up for the participants.

What are the steps to consider if you encounter a premature termination or suspension?

For active studies with subjects on study

Develop a safe discontinuation plan to move subjects off study, if appropriate
Develop a plan for monitoring and follow-up standard care of subjects, if appropriate
Develop a subject notification plan and create notification materials such as notification letters. Include the following in the notification letter, as applicable:

the reason for termination and impact on subjects’ wellbeing,
available resources for the subject,
alternative sites/studies available for transfer if needed

Submit an Amendment in Kuali Research (KR) Protocols with the discontinuation plan, notification plan, and notification letter, as applicable.
Consider whether the termination/suspension has a significant impact on the rights and welfare of participants or on the integrity of the data, OR if it meets the definition of an Unanticipated Problem.

If yes, then submit a Reportable Event in KR Protocols. Click here for instructions on how to submit a reportable event.

For studies where research intervention is complete, and subjects are off study

Submit a Close Request in KR Protocols

Upload the funder notification or any other relevant documentation for IRB review

For studies relying on external IRB

Follow IRB of Record’s plans and procedures for discontinuation and notification to subjects
Submit an Amendment as required by the IRB of Record
Submit a Reportable Event if applicable and as per external IRB policies
Submit for closure as required by the IRB of Record

Resources and References

The Secretary’s Advisory Committee on Human Research Protections (SACHRP) provides recommendations on interpretation of Best Interests Standard for the Retention of Subjects in Human Subjects Research that Has Been Suspended or Terminated here: SACHRP Recommendation on Interpretation | HHS.gov.
HRP Policy 51: Hold, Suspension, Termination of IRB Approval
ICH E6(R3) Guideline – Good Clinical Practice

UCI HRP is here to help!

For assistance with specific questions about amendment and/or reportable event submission related to suspension, please visit HRP Office Hours or send an email to IRB@uci.edu

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