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).
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.
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: