For studies previously reviewed and approved by the IRB or determined exempt, the study must be closed once human subject research activities conclude and prior to the study expiration date. It is the PI's responsibility to close the study (or the faculty advisor if the PI is a student and has left the university). If you are planning to leave the university, please be sure to close out all your IRB submissions before you leave.
Human subject research activities are complete when the research team has finished;
- Obtaining data through intervention or interaction with subjects; and/or
- Obtaining/using identifiable private information about the subjects (i.e., data has been stripped of any identifiers and any code keys linking the data to the participants are destroyed).
A Study Closure Application needs to be submitted via the RAP to request closure. RCS and/or the IRB will conduct a review of the application and verify the study is eligible for closure based on the status of reported activities. Notification of the determination will be provided to the investigator.
When submitting a closure report through the RAP, select Modification/CR ⇒ Continuing Review. For additional help, see our guidance on how to close your study in the RAP.
Records
Research records must be retained for at least three years after completion of the research and must be accessible for inspection or audit. Other regulations or requirements (e.g., study sponsor, FDA requirements) may apply to the retention of records, for a longer period of time.
Documentation of IRB approval documents, the approved Research Plan, and informed consent of subjects (without a link to data) are records related to the conduct of research that are typically held, unless the IRB has waived the requirement for informed consent or the requirement of documentation of informed consent.
If you plan to maintain identifiable private data/specimens, your study may not be able to be closed (e.g., if there is any possibility that the identifiable data/samples may continue to be used, studied or analyzed). If you need to maintain identifiable private data/specimens for safety monitoring procedures but you will not use, study or analyze them, the study can sometimes be closed. Contact RCS to discuss the specifics of your study.
If you have questions, please contact Research Compliance Services.