Centra & Teneo IRBs Receive FDA Warning Letters


The FDA Warning Letter to the Teneo IRB is an interesting for several reasons. First, the Center for Biologics, FDA’s smallest for human clinical trial regulation, wrote the Warning Letter and they don’t do that frequently to IRBs. Second, the IRB was found to have two sets of meeting minutes in an effort to keep some activities out of the regulatory realm. Third, FDA told the IRB to stop approving studies or having current studies enroll new subjects “until adequate correction is made.” This is about as tough as it gets for an IRB. I am attaching a Thompson link about the Warning Letter. Now I am going to take a break from blogging (I think).

IRB FDA warning letter

Two IRBs receive FDA Warning Letters


Update: Another IRB, another Warning Letter. Centra IRB in Lynchburg, VA received a Warning Letter dated 20 November 09 from the Center for Devices. These folks violated a couple of Big Deals about IRB review of research. First, they forgot to review approved studies after a year. Remember the “Tuskegee Syphilis Study?” What went wrong there was no continuing review of research. Even after they discovered that penicillin worked wonders on syphilis. Then Centra forgot how many people were needed for a quorum. You need a minimum number of IRB members to approve research. Then they forgot to write down what they did. Their minutes didn’t describe what happened at the meetings. If you didn’t document it then its just a rumor. These are basic things that anyone in the IRB business should know about. Read for yourself on the FDA Warning Letter webpage.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

Comparing FDA & EMEA Requirements for Clinical Trials & Pharmacovigilance: I will be presenting an audio-conference for Thompson Interactive on this topic on March 3rd. Here is a link for further information:

http://www.thompsoninteractive.com/site/offer.jsp?promo=FDAR3KC0&priority=FKYG54693

4 Responses to Centra & Teneo IRBs Receive FDA Warning Letters

  1. roofingbird says:

    Wow, Carl that is pretty interesting!

  2. Carl's Blog on FDA Stuff says:

    Yes it is. The fact that IRBs are in this much trouble after decades of FDA regulation and intense public interest in research ethics is something of an eye opener.

  3. Jeannine Ramsey says:

    Something tells me that things aren’t going to get any easier for IRBs – especially with the Coast sting (FDA is out to show Congress and the OIG they are ramping up their enforcement activities) and the July 2009 regulatory requirements for IRBs to register with the FDA (Big Brother now knows who you are and where you are).

    • Carl's Blog on FDA Stuff says:

      I agree that things are going to be tougher for IRBs. I personally think there should be registration, but I don’t think that “consumer advocates,” the FDA, or anyone else should try to put more responsibilities on IRBs. They have it tough enough already.

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