June 1, 2020
DF/HCC Research Community,
OHRS has added a new policy, Expiration of IRB Approval and Administrative Closures, to the OHRS Policy Library. This new document outlines OHRS and the research team’s responsibilities maintaining active studies to avoid lapses in IRB approval.
As a reminder, research activities must stop upon a lapse of IRB approval. These activities include, but are not limited to, recruitment and enrollment of subjects, collection of specimens, research on previously collected specimens, review of medical records or other health information, data analysis, performance of research tests/procedures, and treatment or follow-up on previously enrolled subjects. Advertisements running in the media must also be pulled.
OHRS may provide warning notices of study expiration to Principal Investigators prior to the study expiration date, but investigators should understand that these are a courtesy and are not required. It is the responsibility of the Principal Investigator to monitor approval periods and to ensure that continuing reports are filed in ample time to allow for IRB review.
If a study has been expired beyond 90 days, the study shall be administratively closed unless this closure is waived by the Institutional Official under specific circumstances. Administrative closures shall be reported to the IRB by OHRS.
If you have any questions about this announcement, please email OHRS@dfci.harvard.edu.