According to recent records published by the U.S. Food and Drug Administration (FDA), the medical industry is experiencing an alarming rise in the number of failures to follow protocol. A report produced by FDA’s Bioresearch Monitoring Program (BIMO) states that of the 400 reported failures within Fiscal Year 2018, 30%, 118 instances were due to failure of following investigation protocol.1 This marks a 5% increase from 2015. The other reasons for failure include insufficient case records, inadequate drug disposition records, and lack of consent, signatures, or dates.
Chief medical officer of WIRB-Copernicus Group (WCG) Lindsay McNair recently spoke on the matter to CenterWatch, stating that she believes the key reasons for these failures include the following: belief/use of nonexistent protocol waivers, failure of principal investigators to obtain control of inspections, and failure to update investigation protocol to align with new requirements. According to McNair, “there is no mechanism through which prospective planned deviations from the protocol can be granted; these will still be considered failure to follow the investigational plan even if done intentionally”1, meaning there are no excuses for failure to reject a product that can be granted if the principal investigators were made aware of an issue beforehand.
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1 https://www.centerwatch.com/cwweekly/2019/01/28/investigators-most-likely-to-be-cited-for-failing-to-follow-protocols-fda-records-show/