The completion or early termination of a study is a change in research activity and must be reported to the IRB. Although subjects will no longer be “at risk” under the study, a final report to the IRB allows us to close our file for the study. Studies may be closed when the involvement of human subjects ceases. This means that interventions, interactions, observations, and the gathering, use, study, and analysis of identifiable private information, including specimens, are all complete.
For multi-center research, the study may be closed once all research activities (as above) are complete at the University of Tennessee, Knoxville, and at any sites for which the IRB is serving as the “IRB of record.” If the investigator is serving as the lead investigator or the site is the coordinating center, the study must remain open as long as the lead investigator or coordinating center is still receiving, studying, using, or analyzing identifiable private information from other sites (even if local interventions, interactions, observations, and data gathering is complete).
Investigators may submit study closures to the IRB on a Study Closure Form. With closure submissions, the investigator must provide a summary of the research activity and any findings available at that time.
Investigators may maintain the data that they collected, including identifiable private data, if this is consistent with the IRB-approved research plan. However, investigators may not conduct any additional analysis of identified data without applying for IRB approval or exemption. Investigators must continue to protect the confidentiality of the data as described to the IRB and honor any other commitments that were agreed to as part of the approved research including, for example, future use of data or specimens, provision of research results to subjects, and provision of any outstanding payments or compensation.
The IRB will review study closure reports, typically by expedited review, and either approve the closure of the study or request additional information or confirmation of facts from the investigator.