Another IRB, Another FDA Warning Letter

FDA Sends Warning Letter to IRB

FDA is keeping up its scrutiny of IRBs with a Warning Letter to the Burzynski Research Institute IRB. This is a publicly traded, for profit company who decided to run their own Institutional Review Board and dispense with the formalities, and expense, of an independent IRB. The result is a length 8 item Warning Letter listing many serious problems. They include “Failure to determine risks for subjects were minimized and risks to subjects were reasonabable in relation to anticipated benefits.”

I’ve actually never seen this charge before (if my poor memory isn’t failing me) and its a pretty big deal. BRI is a large operation and this is not a very good practice, approving studies of your own research institute that is a for-profit enterprise. I discussed the Warning Letter with a colleague familiar with the operations of IRBs who said, “I’ve never seen FDA look into the details of the (IRB) board’s operations before.” And I haven’t seen the Center for Drugs write so many Warning Letters to IRBs before. Very interesting. (See previous post on the Centra and Teneo Warning Letters.)

The Burzynski IRB Chair, Carlton F. Hazlewood, Ph.D., is also a director of the for-profit research institute, raising concerns about conflicts of interest. In fact, “The IRB failed to ensure that no member participated in the initial or continuing review of a project in which the member had a conflicting interest,” is the fourth charge in the Warning Letter. The IRB would also allow non-members to vote if a board member had a conflict. Thats another big problem. There are very specific rules about the membership of an IRB.

The company is run by physician and researcher Stanislaw Burzynski, MD, PhD who has been the President and Chairman of the Board of Directors of the Burzynski Research Institute since its inception in 1984. Read the Warning Letter for yourself. Here is the URL, (WordPress isn’t letting me insert a link):

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm