Anniversary Date Policy

Currently, the IRB follows the Office for Human Research Protection (OHRP) agency’s 10 November 2010 Guidance on IRB Continuing Review of Research and the Food and Drug Administration’s (FDA) February 2012 Guidance for IRB’s Clinical Investigators and Sponsors IRB Continuing Review after Clinical Investigation Approval, concerning continuing review approval and maintaining fixed anniversary dates.

Unless otherwise specified, a study will receive a full year approval period following the initial approval date.  The initial approval date will be maintained as the anniversary date. Studies that are reviewed and approved by the IRB within 30 days of their expiration date will be given the same anniversary date as the prior approval.

For example:
If a study was initially approved from June 25, 2011 to June 24, 2012, the next approval period would be from June 25, 2012 to June 24, 2013 (keeping the June 25th date from year to year). Please note, per the OHRP and FDA guidances, a study must be reviewed within 30 days of the anniversary date in order to maintain its anniversary date.