IRB Receives FDA Warning Letter

03/28/2023

Recently, a community hospital Institutional Review Board (IRB) received a US Food and Drug Administration (FDA) warning letter for lack of appropriate members present to review research, inadequate documentation, and inadequate informed consent review.

On multiple occasions, the IRB held meetings to review FDA regulated research when there was no nonscientifc member present. The written response did not provide an adequate corrective action to prevent recurrence and only noted that a meeting would not be held without the appropriate members in attendance.

The second finding is linked to the first. The IRB did not have adequate roster documentation including details such as degrees, experience, qualifications, representative capacity, etc. There were also meeting minutes that showed voting by individuals not listed in the rosters. Due to the lacking roster, the FDA noted that it was difficult to determine the IRB had adequate representation, expertise, and experience to effectively review research.

The third finding was due to two informed consent forms being approved without the 21 CFR 50.25(c) required statement about clinicaltrials.gov. The corrective action is for best practices to be created and the statement included in a template, but these could not be evaluated since they were not provided or described adequately.

The regulatory responsibilities of IRBs are to review proposed and ongoing studies to ensure they are compliant with regulatory requirements, meet ethical standards, follow the organization’s policies, and protect the rights and safety of study participants. If the research is reviewed by inadequately qualified IRB members, it is concerning for the safety of study participants and the quality of the data collected from studies the IRB oversees.

 

- The Clinical Pathways Team

 Enjoy this blog? Please like, comment, and share with your contacts.