FDA 483 - BRI Institutional Review Board, Inc. - December 10, 2008

This FDA Form 483 documents observations made during an inspection of Burzynski Research Institute (IRB #370) in Houston, TX, addressed to Carlton F. Hazlewood, Ph.D., IRB Chairman. The inspection was conducted by Patrick D. Stone, Investigator, and issued on December 10, 2008.

Four observations were noted: 1. A clinical investigation requiring prior FDA submission was initiated without IRB approval. Specifically, a study protocol accrued human subjects between January and February 2007 without an effective FDA Investigational New Drug (IND) number. The BRI IRB only approved this protocol for human accrual on February 15, 2008. 2. The IRB failed to conduct continuing review of research at intervals of not less than once per year. A specific study, conducted by Carlton F. Hazelwood, Ph.D., Co-P.I., was not reviewed and approved by the IRB annually from 2005 through 2008. Additionally, no continuing review reports from the P.I. to the IRB were on file. 3. Copies of all research proposals reviewed were not maintained. Specifically, the Investigators Brochure for a particular study protocol was not found in the BRI IRB study records. 4. Documentation of written procedures for the IRB, as required by 21 CFR 56.108(a) and