Research Compliance

Research Compliance

A Lapse in IRB Approval:  How to Prevent It and What to Do if It Occurs

Regulations and Responsibilities
The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) regulations, require that “an IRB shall conduct continuing review of research …at intervals appropriate to the degree of risk, but not less than once per year, …”.  The Principal Investigator is responsible for ensuring that the research is submitted to the IRB for continuing review in an appropriate time frame, in order to avoid a lapse of IRB approval.   

Implications for investigators
  •     Investigators must plan ahead to meet required continuing review dates. If an investigator fails to provide continuing review to the IRB or the IRB does not review and approve a research study by the continuing review date specified by the IRB, all research activities (including recruitment, enrollment, involvement of current participants, scheduling of study visits, looking at new subject information and data analysis) must stop.
  •     Research activities may continue if the IRB determines upon review that it is in the best interest of individual subjects to continue participating in the research interventions or interactions (refer to the UHC IRB Policy “Protocol Continuing Review”). 
  •     When continuing review of a research protocol does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically.  If subjects are studied after a lapse in approval for the research this activity becomes a research compliance issue and must be reported and explained to the IRB, UHC Compliance Officer, and to applicable regulatory or funding agencies. 
  •     Data collected after an IRB protocol has expired may not be used for research purposes.  If an investigator wishes to use data acquired after an IRB protocol has expired, he or she must petition the IRB to use the data and must provide written justification for requesting the use of the data.  This information must also be submitted to the IRB on a Report of an Unanticipated Problem or Protocol Deviation Checklist (U/D).

Notification and study termination
The principal investigator is encouraged to submit the review to the IRB at least three weeks before the continuing review date.  As a courtesy to investigators, the IRB issues reminder notices by mail or e-mail to the principal investigator and/or research staff.  The notices are sent approximately ten weeks and six weeks prior to the protocol expiration date.  Failure to submit and obtain approval for a continuing review by the due date will result in expiration of the IRB Approval (i.e., the research is no longer IRB approved), and a notice of “Administrative Deferment” will be sent to the investigator.  If the submission is not received 30 days after expiration of the study, the IRB will administratively terminate the research.  A study that is terminated cannot be reactivated.  Before any research activities can resume, a new protocol must be submitted and approved by the IRB.  Any studies carried out without an active approval, irrespective of receipt of IRB notices, are considered a non-compliance issue.