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  1. Learning from 2013 Warning Letters to IRBs

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    Institutional Bulletin vol 4,  issue 2

    In the recent edition of our sister publication, The Quorum Forum, we discussed reflecting on the past year as a means to formulate possible improvements to IRB procedures.  A review of FDA warning letters to IRBs from 2013 provides an opportunity to evaluate your IRB procedures and policies and evaluate them against the regulatory requirements for IRBs. If you are interested in the specifics, FDA warning letters are posted publicly on the FDA website, here.

    The handful of warning letters issued to IRBs list several failings that may seem straightforward; however, it is worthwhile to review the issues FDA raised and evaluate your own IRB procedures and policies. This exercise can help to ensure that each of these regulatory requirements is met.

    For ease of reference covering the points noted in warning letters, Quorum Review has developed a checklist for your use:


    Another important point to consider is whether the study file provides adequate documentation that the above-referenced procedural requirements are followed. Once procedures have been identified that meet the regulatory requirements, it would be prudent to self-audit study files to ensure the documentation in the files clearly records that the IRB is following procedures and fulfilling regulatory obligations. 

    In addition, to procedural failings, the FDA warning letters addressed a lack of appropriate documentation in IRB minutes. Again, it may be worthwhile to review examples of recent minutes to ensure the following information is documented in minutes appropriately.

    For your convenience, Quorum Review has developed a checklist for Board minutes: